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On May 1, 2024, the NAM filed an amicus brief urging the Michigan Supreme Court not to overturn its precedent that renders the Michigan Consumer Protection Act inapplicable to transactions or conduct specifically authorized by law. In this case, Michigan lower courts found that binding Michigan Supreme Court precedent foreclosed the Michigan Attorney General’s claim that the MCPA applies to a drug manufacturer’s drug pricing because the manufacturer has authorization from both state and federal agencies to manufacture and sell those medications. The Michigan Supreme Court granted the AG’s petition requesting that it abandon its precedent, which would significantly expand the scope of claims and exposure for any manufacturer doing business in Michigan.

We argue that the Michigan Legislature expressly exempted from the MCPA’s reach transactions governed by regulatory regimes and that maintaining the court’s precedent provides stability and clarity to manufacturers with authorized transactions.

On November 15, 2023, the NAM filed an amicus brief asking the D.C. Circuit to review an EPA rule concerning the treatment of confidential business information reported to or obtained by EPA under the Toxic Substances Control Act. TSCA requires EPA to maintain an inventory of chemicals manufactured, imported, and processed in the United States for non-exempt commercial purposes. Accordingly, companies must report a new chemical substance or a new use of an existing substance to EPA. Companies that manufacture the substance can claim confidentiality for the submitted information when reporting to EPA.

In this case, EPA's final rule allows third-party waivers of TSCA’s confidentiality protections when a third party, such as a chemical customer or processor, reports a new use of a substance that a manufacturer claimed was confidential. This could allow downstream customers or processors of a chemical who submit information to EPA to waive manufacturers’ confidentiality claims and rights. We argue in our amicus brief that TSCA does not authorize third party waiver of a manufacturer’s confidentiality protections in the fashion contemplated by EPA in its final rule. Protecting confidential business information is important to the competitive strength of the chemical industry to bring innovative solutions and new products to market. Making confidential business information freely available to other companies will disincentivize companies from investing in product development.

On September 30th, the NAM filed an amicus brief urging the Middle District of Tennessee to vacate the SEC’s recission of the rule. As in our case, plaintiffs U.S. Chamber of Commerce, Business Roundtable, and Tennessee Chamber of Commerce and Industry, brought this challenge to the 2022 rescission arguing that it is both substantively arbitrary and capricious several times over and was adopted without good-faith observance of the Administrative Procedure Act’s mandated rulemaking procedures. Both cases seek to have the 2022 recission vacated ahead of the 2023 proxy season. Our amicus brief expands on the plaintiffs’ position that the concerns about proxy firms that animated the 2020 proxy firm rule have not abated, that the SEC failed to provide meaningful opportunity for comment prior to rescission of the 2020 rule, and that the SEC’s policy reversal is arbitrary and capricious.

Unfortunately, on April 24, 2023, the court denied the plaintiffs' motion for summary judgment and granted the SEC's cross-motion.

In July 2022, the SEC issued a final rule to rescind the 2020 critical reforms subjecting proxy advisory firms—unregulated third parties with outsized influence on shareholder votes and manufacturers’ corporate governance policies—to reasonable SEC oversight just like every other participant in the securities markets. The NAM sued the SEC in the Western District of Texas arguing that the 2022 recission is arbitrary and capricious as well as procedurally defective. We have asked the court to vacate the 2022 recission in its entirety and declare that the recession is unlawful and void.

Unfortunately, on December 4, 2022, the court denied the NAM’s motion for summary judgment and granted the SEC's cross-motion.

On August 28, 2023, tthe NAM filed an amicus brief opposing the FTC’s attempt to block Amgen’s merger with Horizon, the sole manufacturer of two unique FDA-approved medicines for thyroid eye disease and chronic refractory gout. Even though Amgen and Horizon are not competitors, the FTC seeks to prevent the merger based on the speculative theory that hypothetical new competitors to Horizon’s products might achieve regulatory approval at some undetermined time in the future and that Amgen may then engage in price discounting practices to limit competition.

We argue in our brief that the FTC’s speculative theory of competitive harm is unsupported by antitrust law. Adopting the FTC’s theory would harm competition and consumers by chilling merger activity--due to uncertainty over what activity the FTC could construe as anticompetitive--which could result in further innovation and efficiencies.

Fortunately, on September 1, 2023, the parties reached an agreement on a consent order to resolve the case and allow Amgen to continue with its acqusition of Horizon.

On October 20, 2023, the NAM filed an amicus brief urging the full 9th Circuit to enforce the robust pleading standards required by the Private Securities Litigation Reform Act (PSLRA) to assert a securities fraud claim. Public companies, including many NAM members, are often the targets of frivolous securities litigation. The PSLRA created a heightened pleading standard for bringing securities fraud suits. Nevertheless, a 9th Circuit panel allowed the plaintiffs in this case to rely on an expert’s post hoc analysis to support their securities fraud claim without alleging with particularity the contents of any internal report or data source that would have put the defendant’s executives on notice that their public statements about who was purchasing the company’s gaming processing units were false or misleading when made.

We argue in our amicus brief that the full 9th Circuit should rehear this case. The panel’s decision will create a playbook for securities plaintiffs to evade the PSLRA’s stringent pleading requirements by pointing to post-hoc, made-for-litigation expert opinions resting on unreliable assumptions and devoid of any basis in internal company data.

Unfortunately, on November 15, 2023, the 9th Circuit declined to rehear the case.

Yesterday, the NAM filed an amicus brief urging interlocutory review of a district court’s flawed class certification ruling that artificially inflated the size and scope of the putative class by allowing the named plaintiffs to (1) bring antitrust claims under the laws of states where they neither reside nor were injured, and (2) to seek “umbrella damages”—damages for paying for a competitor’s product because a generic drug was unavailable. In this case, In re HIV Antitrust Litigation, the named plaintiffs alleged that defendants engaged in anticompetitive conduct that prevented generic drug companies from selling cheaper HIV drugs. Ignoring the Supreme Court’s and other California district courts’ precedent, the district court here concluded that whether a named plaintiff can bring class claims under the laws of a state where they neither reside nor were injured should be considered under the typicality or adequacy requirements of Rule 23, not as a threshold Article III standing issue. According to the court, the named plaintiffs satisfied those requirements by asserting individual claims sufficiently like the antitrust or consumer protection claims under the laws in states where they neither reside nor were injured. And the damages class could include individuals who purchased competitor HIV drugs, not defendants’ HIV drug, because the alleged anticompetitive conduct could have been the proximate cause for those individuals paying more for competitor HIV drugs.

The NAM filed an amicus brief in support of the pharmaceutical defendants’ petition for interlocutory review emphasizing that plaintiffs seeking to represent a class must have Article III standing to bring each claim asserted. Here, the district court erred by following the minority approach, holding that whether a plaintiff can assert claims under laws of states other than those where the plaintiff resides or was injured is an issue of adequacy or typicality. Further, the district court artificially enlarged the class size by including in the class those who bought products from the defendants’ competitors, not defendants. As we explain in our brief, the 9th Circuit should grant the petition to protect “the courts and defendants from prolonged, expensive litigation, as well as abusive, in terrorem settlements driven by defendants’ risk aversion, not justice.” All manufacturers have an interest in ensuring that class certifications are properly tailored to concrete claims and that aggregating litigation does not distort outcomes that would have resulted had the litigants filed their claims individually.

Last Friday, the NAM filed an amicus brief in the 1st Circuit asking the court to affirm dismissal of a putative class action where the proposed class members sustained no concrete harm. In this case, Xavier, et al. v. Evenflo Co., Inc., et al., the class alleged a purely economic injury—that they would not have purchased defendant’s booster seat or would have paid less for it had they known about the seat’s purported safety risks for children weighing under a certain amount. But each member of the proposed class received the full benefit of the bargain: they paid for a booster seat, they received a booster seat, and they used the booster seat without suffering any harm. Accordingly, the District of Massachusetts dismissed the claims for failing to allege a cognizable injury. The instant appeal followed.

As NAM’s brief explains, no-injury class actions can wreak havoc on the judicial system. They often lead to prolonged litigation, vacuous settlements that provide no real benefits to the class, and outcomes inconsistent with product liability and other substantive areas of law. Despite the U.S. Supreme Court’s recent holding in TransUnion v. Ramirez—"under Article III, an injury in law is not an injury in fact,”— class counsel around the country continue to bring cases under inventive damage theories, suggesting that the discovery of a potential defect or an alleged misrepresentation, even if it never caused physical harm, created a theoretical risk of harm and an undefined economic loss for the entire class based on that unrealized risk. Here, the district court properly applied the law and dismissed the claims because the plaintiffs made no showing in their pleadings that they suffered any real-world harm. The 1st Circuit should affirm that ruling to rein in abusive class actions and ensure that judicial resources are spent on claims involving actual injuries.

Unfortunately, on November 23, 2022, the 1st Circuit held that the plaintiffs have standing to seek monetary relief and remanded the case for further proceedings.

The NAM filed an amicus brief in the Texas Supreme Court concerning the interpretation and enforceability of indemnity provisions in contracts between sophisticated commercial entities. In this case, the owner and operator of an oil refinery contracted with a large industrial contractor to perform specialty work. In the contract, the contractor agreed to indemnify the owner for losses or other liabilities due to bodily injury claims in connection with the contractor’s work. The owner was later sued after some of the contractor’s employees were injured. Although the owner reached a settlement with the injured workers, the contractor refused to participate in that settlement or honor its indemnity obligations. The owner filed suit, and the contractor moved for summary judgment, arguing that the owner had forfeited its contractual rights by settling with the workers. That motion was denied, and the instant interlocutory appeal followed.

Manufacturers consistently enter into contracts, like the general services agreement at issue in this case, with indemnification provisions governed under Texas law. The ability of sophisticated private parties to negotiate the allocation of risks and potential liability through contract is crucial to manufacturers’ business interests. The NAM’s brief argues that fundamental principles of contract law require Texas courts to honor the contractor’s express agreement to indemnify. The contractor’s position here would disrupt countless contracts between commercial parties and severely disincentive personal injury settlements, unnecessarily wasting judicial resources. Happily, on December 10, 2021, the court agreed to hear the case.

The MCLA filed an amicus brief in support of Fluor Corporation's petition to the Fourth Circuit Court of Appeals seeking review of a trial court order requiring Fluor to produce privileged communications related to an internal investigation because they had been disclosed to the government pursuant to a regulatory requirement. Under the Federal Acquisition Regulation Mandatory Disclosure Rule (MDR), federal contractors must timely disclose instances in which the contractor has credible evidence that an employee has violated certain criminal laws or the civil False Claims Act. While investigating an employee's actions, Fluor found “credible evidence” of misconduct, and reported the conclusions of its investigation to the Defense Department pursuant to the MDR. That employee then sued Fluor, asserting defamation and other claims, and sought Fluor’s internal investigative files in discovery. Fluor objected on the basis that the files were protected by the attorney-client privilege and attorney work product doctrine. The district court held that Fluor’s governmental disclosure had waived privilege because it made a set of statements as part of its MDR disclosures that were “legal conclusions, . . . which only a lawyer is qualified to make,” and because Fluor had inadvertently characterized these disclosures as “voluntary” in filings before the court. Fluor sought emergency relief in the form of a writ of mandamus, and on March 6, 2020, the MCLA filed a coalition amicus brief arguing that the trial court's order poses significant adverse consequences for manufacturers in numerous regulated industries, and may ultimately chill participation in voluntary and mandatory disclosure and compliance programs. On March 13, 2020, while denying our motion to participate as amicus, the Court granted mandamus review indicating that the district court’s decision was “clearly and indisputably incorrect.”

On February 1, 2022, the NAM filed an amicus brief in support of Enbridge Energy’s lawsuit seeking to prevent Michigan from revoking its easement and shutting down its Line 5 pipeline. Enbridge has operated the Line 5 pipeline—which originates in Wisconsin, passes through Canada, and transports light crude and natural gas liquids into Michigan since 1953. In 2020, Michigan unilaterally revoked and terminated the nearly 70-year old easement because Enbridge had purportedly violated the public trust doctrine due to the risk of an anchor strike and potential rupture. Various lawsuits followed, including the current case, Enbridge Energy Ltd. V. Whitmer, in which Enbridge is seeking summary judgment in the Western District of Michigan on its claims that Michigan’s actions (1) are preempted by the Pipeline Safety Act and (2) violate the Foreign Affairs Doctrine.

The NAM’s amicus brief emphasizes the federal government’s exclusive role in regulating pipeline safety under the Pipeline Safety Act (49 U.S.C. § 60104). We further argued that permitting Michigan to shut down an international pipeline governed by treaty would undermine the U.S. government’s exclusive authority over transboundary pipelines, unduly burden international commerce, and weaken the federal government’s ability to speak with one voice on foreign affairs. Manufacturers have a shared interest in preventing novel attempts by states to force closure of vital pipelines based on speculative risks and despite significant economic impacts.

On September 20, 2024, the NAM filed an amicus brief urging the full D.C. Circuit to rehear this energy case that raises an issue of exceptional importance—whether a state’s energy policies can override federal energy decisions Congress assigned to the Federal Energy Regulatory Commission alone. Here, FERC approved a pipeline project carrying natural gas through New Jersey, New York, Delaware, Maryland and Pennsylvania. Following a challenge by environmental groups, the D.C. Circuit concluded that in approving the pipeline, FERC failed to adequately consider evidence suggesting a lack of market need for the pipeline’s additional capacity in New Jersey and New Jersey state laws mandating reductions in natural gas consumption.

We argue that the Natural Gas Act authorizes FERC to ensure that the public has access to an affordable and reliable energy supply. Full D.C. Circuit review is necessary to prevent states—which have their own natural gas reduction goals—from controlling federal energy policy, a matter of federal concern.

On August 14, 2023, the NAM requested permission to file an amicus brief in an enforcement action the EPA commenced in the Eastern District of Louisiana under the Clean Air Act to compel Denka Performance Elastomer to limit its chloroprene emissions or cease production of the chemical. Chloroprene is a chemical used to manufacture synthetic rubber. The EPA brought this action, based on its Integrated Risk Information System (IRIS) value for chloroprene and view that the IRIS value demonstrates that the emissions from Denka’s plant exceeding that value present an imminent risk of harm to the public.

We argue in our brief that IRIS values are neither statutes nor regulations and therefore the values are an improper basis for an enforcement action. IRIS simply assists the EPA in developing its emissions standards and other related rules under the Clean Air Act to assess the possible health effects of chemical exposure; IRIS does not definitely measure adverse effects of exposure. If the use of IRIS values for an enforcement action is condoned, companies could be subject to liability for their chemical emissions levels even if compliant with statutes, regulations and permit requirements.

Unfortunately, on August 16, 2023, the district court denied our motion for leave to file an amicus brief.

The NAM joined with partner organizations to bring a prophylactic challenge to a final rule regulating PIP (3:1)—a persistent, bio-accumulative chemical that is ubiquitous in manufacturing operations and supply chains—under the Toxic Substances Control Act. The rule called for the prohibition of PIP (3:1) on an aggressive timeline that would have severely impacted supply chains for a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature. After the NAM coalition files it petition in the D.C. Circuit raising these compliance issues, the EPA agreed to seek additional public input on the rule for a period of 60 days, with a special focus on alternative exposure reduction measures for certain products. The agency also issued a issued a rare “No Action Assurance” to notify regulated industry that it would not enforce the rule for 180 days pending next steps in the rulemaking process to provide longer-term relief. The case is currently in abeyance pending the new rulemaking.

In 2017, the MCLA sued the EPA to challenge the agency’s rule governing risk management plans for chemical facilities and oil refineries. The rule imposed costly and burdensome requirements on facilities that handle hazardous substances without improving worker or community safety. The court stayed the litigation after the EPA delayed enforcement of the rule and proposed a substantive replacement. The EPA then issued a final rule in 2019. The litigation remains stayed pending further orders from the court.

On June 11, 2024, the NAM filed a petition in the D.C. Circuit challenging EPA’s final rule setting individual standards for six per- and polyfluoroalkyl substances (PFOA, PFOS, PFHxS, HFPO-DA, PFNA and PFBS) in municipal water systems. PFAS are a diverse group of chemicals essential to modern life, including in the transformers used to power electric grids; in the semiconductors and solar components needed for clean energy transition; and in the aircraft, munitions, fire suppression systems and communication devices required for national security. EPA’s new rule sets a “Maximum Contaminant Level” for each of the six substances at or near zero—equivalent to a few drops in an Olympic swimming pool. The standards are so low that full compliance may never be achieved—meaning PFAS manufacturers and users will be unable to obtain discharge permits. And as municipalities face the high costs of coming into compliance (an estimated $3.8B annually), water systems, state attorneys general and other stakeholders have, and will continue to, bring litigation against manufacturers to defray those costs. Enterprising plaintiffs’ lawyers have also started using the infeasible standards to assert toxic tort and personal injury suits against manufacturers.

In our opening brief, filed on October 7, 2024, we explain that in plowing ahead with its unattainable rule, EPA violated the express requirements of the Safe Drinking Water Act and engaged in arbitrary and capricious decision making in violation of the Administrative Procedure Act. The rule’s many deficiencies include:

• A deeply flawed cost-benefit analysis that combines costs and benefits for multiple substances into a group determination, ignores substantial costs raised by commenters and improperly relies on “nonquantifiable benefits” where it lacked empirical data;

• A woefully incomplete feasibility analysis that fails to grapple with whether the technology and facilities necessary for compliance even exist;

• The novel and unlawful use of a “hazard index” (for PFHxS, HFPO-DA, PFNA, and PFBS), never before used in the SDWA’s 50-year history;

• Failure to consider reasonable alternatives or respond meaningfully to public comments that undercut its judgment; and

• Significant procedural deficiencies in regulating the hazard index substances like collapsing two distinct rulemaking steps into a single step and forgoing Science Advisory Board review along the way.

For these reasons, we are asking the D.C. Circuit to vacate the rule.

On May 20, 2024, the NAM filed an amicus brief urging the D.C. District Court to vacate EPA’s final rule setting Washington’s water quality standards. In this case, EPA imposed water quality standards on Washington state. It based those standards, in part, on the fish consumption rate of Indian tribes within the state, instead of consumption rates of the general population, to reflect consideration of tribal treaty-reserved rights to fish. Business groups sued EPA arguing that the standards—set so low that they cannot be measured with existing technologies—are arbitrary and capricious in violation of the Administrative Procedure Act.

Our brief underscores the threat to permitting and growth of domestic manufacturing if the district court upholds EPA’s infeasible water quality standards. Further, EPA’s novel reliance on treaties with Indian Tribes for the imposed standards exceeds the agency’s authority under the Clean Water Act. If allowed to stand, this approach could enable EPA to override state-established CWA standards whenever it deems them inconsistent with its own, EPA-specific interpretation of tribal treaty rights, regardless of the scientific basis of its decision.

A group of individual plaintiffs brought a class action lawsuit against defendant Saint-Gobain Performance Plastics Corp., alleging that Saint-Gobain released perfluorooctanoic acid (PFOA) into groundwater that seeped into the plaintiffs' nearby land. The plaintiffs argued that they are entitled to financial damages to pay for ongoing medical health monitoring because of their alleged exposure to PFOA, and to compensate them for lower property values allegedly caused by the contamination. Saint-Gobain moved to dismiss the complaint because New York law does not recognize claims for medical monitoring absent any evidence of physical harm and does not recognize diminution of property value due to alleged groundwater contamination. The district court denied the motion to dismiss but certified immediate appellate review by the United States Court of Appeals for the Second Circuit. The NAM filed an amicus brief on behalf of Saint-Gobain to ensure that the law limiting medical monitoring and diminution-of-value claims remains appropriately balanced and favorable to manufacturers. Without appropriate limitations on these types of claims, manufacturers would be subject to massive and unwarranted increases in liability exposure.

On February 12, 2024, the NAM filed an amicus brief asking the U.S. Supreme Court to address whether the Clean Water Act allows the EPA to include generic (and vague) prohibitions in National Pollutant Discharge Elimination System permits that subject permitholders to enforcement for exceedances of water quality standards. A NPDES permit is required to discharge a pollutant through a “point source” into “a water of the United States.” In this case, the 9th Circuit affirmed EPA’s use of a generic prohibition in San Francisco’s NPDES permit for a water treatment facility—stating that water discharge “shall not cause or contribute to the violation of any applicable water quality standard.” This ruling directly conflicts with 2nd Circuit precedent deeming generic prohibitions impermissible and could impact manufacturers’ ability to assert the permit shield defense—a defense that provides protection from liability if a manufacturer is operating under a valid permit and its facility discharges waste in accordance with the permit. Permit operators need specific guidance as to allowable discharges in accordance with the permit.

Our brief urges the Supreme Court to review this case to resolve the circuit split and highlights the key role of the permit shield defense in guarding against citizen suits and unforeseen enforcement actions. Happily, on May 20, 2024, the Court granted the petition for certorari.

On July 26, 2024, the NAM filed an amicus brief emphasizing the practical importance of clear and predictable CWA compliance and enforcement and demonstrating that generic prohibitions are inconsistent with the text and design of the CWA.

On March 6, 2024, the NAM joined a coalition of other major business trade associations to file suit in the D.C. Circuit to challenge the Environmental Protection Agency’s misguided final rule lowering the National Ambient Air Quality Standards for fine particulate matter (PM2.5) to 9 micrograms per cubic meter. The Clear Air Act requires manufacturers to obtain preconstruction permits for new and modified emissions sources obtainable only after showing that emissions from the proposed new source will not cause or contribute to a PM 2.5 NAAQS violation. The Clean Air Act also requires the EPA to review the NAAQS every five years to determine whether the PM2.5 standard should be retained or revised. In December 2020, following a complete review of the PM NAAQS, the EPA decided to retain the PM2.5 standard of 12 micrograms per cubic meter. But in June 2021, the agency announced it would reconsider that decision. The EPA ultimately issued the revised standard in an out-of-cycle reconsideration becoming the first administration to redo a promulgated NAAQS. The standard stands to impede economic development in much of the country due to many manufacturers’ inability to establish that a proposed new construction or modified emission source will not cause or contribute to a PM 2.5 NAAQS violation. The NAM therefore sued to protect manufacturers’ ability to obtain permits, expand facilities and pursue long-term investment plans, and defend our country’s competitive advantage.

On June 6, 2024, our coalition filed its opening brief arguing that the EPA lacks the authority under the Clean Air Act--the law that authorizes it to establish the NAAQS--to "reconsider" a decision made in 2020 to not lower the PM2.5 standard; that the agency failed to take into account the cost and feasibility of a tightened standard; and that it failed to give a "reasoned explanation for key aspects of its decision."

The NAM filed an amicus brief in support of rehearing en banc by the 9th Circuit in one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. This case is part of a coordinated, national litigation campaign filed in carefully chosen states and federal circuits by agenda-driven lawyers and activists. The issue presented is whether putative state-law tort claims alleging harm from global climate change are removable because they arise under federal law. In April 2022, the 9th Circuit rejected federal-question jurisdiction and all other bases for subject matter jurisdiction and remand the case to state court. In support of rehearing, the NAM filed an amicus brief arguing that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws.

Unfortunately, on June 27, 2022, the 9th Circuit denied the petition for rehearing.

In 2015, the NAM filed an amicus brief in the U.S. Court of Appeals for the Fifth Circuit supporting a federal judge’s decision not to impose excessive penalties on ExxonMobil for various permit violations. On remand to the district court, the groups reduced their requested penalties from $642 million to about $40 million, and the district judge awarded them about $20 million, prompting Exxon’s appeal back to the Fifth Circuit. In 2018 and 2021, the NAM filed additional amicus briefs arguing that the Constitution and Clean Air Act limit citizen suits under the Clean Air Act and asking the Fifth Circuit to enforce the constitutional line that limits federal courts to deciding discrete cases and controversies and prevents them from acting as regulators or policymakers.

Unfortunately, on August 30, 2022, the Fifth Circuit affirmed the district court's latest decision imposing a $14.25M penalty on defendant-appellants (for 3,651 purported violations). On, October 20, 2022, the NAM filed an amicus brief in support of Exxon’s petition for the 5th Circuit to rehear en banc its appeal challenging the district court’s penalty award.

Happily, on February 17, 2023, the 5th Circuit granted the petition for rehearing en banc and vacated the panel decision. On March 27, 2023, the NAM filed an amicus brief asking the full 5th Circuit to reverse the panel’s decision to enforce the limits of federal courts’ jurisdiction. This case is important to manufacturers because courts should exercise discretion in determining civil penalties to prevent creating perverse incentives for plaintiffs.

The NAM sued the EPA in 2015 to challenge the EPA’s declaration that 36 states’ state implementation plans (SIPs) under the Clean Air Act are invalid because they allow air emissions in excess of permit limits during startup, shutdown or equipment malfunctions. That flexibility is important to manufacturers that might temporarily exceed permit limits for reasons beyond their control. The litigation has been held in abeyance since April 2017 while the EPA considers whether to revise or rescind the rule.

On June 25, 2018, the NAM moved to intervene in a case involving permitting requirements for manufacturers under the Clean Air Act. Environmental groups sued to challenge a guidance document from the U.S. Environmental Protection Agency (EPA) that streamlines Clean Air Act permits under the New Source Review program for facilities that expand or modify their operations. If the plaintiffs' claims are successful, facility modifications could be significantly delayed and rendered more expensive. The NAM's motion asks the court to allow the NAM to become a co-defendant in the case with EPA to bring the voice of manufacturers in defense of the EPA's sensible policy.

On July 13, 2018, the court held the case in abeyance pending the completion of an EPA rulemaking to implement the terms of the guidance document. The litigation is expected to reactivate when the final rule issues.

On May 7, 2024, the NAM filed an amicus brief urging the 10th Circuit to clarify the proper application of the economic substance doctrine, a tax doctrine found in the Internal Revenue Code. That doctrine allows the Commissioner of the IRS to disallow a tax benefit for engaging in a transaction not likely to produce economic benefits aside from reducing tax liability. In this case, the District of Colorado granted summary judgment to the government and determined that the economic substance doctrine applied to disallow Liberty Global Inc.’s $110 million tax refund claim based on its sale of stock in a controlled foreign corporation. In doing so, the district court misinterpreted the economic substance doctrine to apply to all transactions which is an overbroad view of the economic substance doctrine’s scope. Liberty appealed the decision to the 10th Circuit.

We will argue that the doctrine does not apply to transactions for which the tax code authorizes tax-beneficial treatment and courts are required to first determine whether the doctrine should apply before proceeding to apply it to disallow a tax benefit. Failing to first determine whether the economic substance doctrine is relevant to a transaction has the consequence of expanding the reach of the doctrine in ways that could nullify Congress’s policy judgment regarding which transactions should receive tax benefits that allow manufacturers to compete in a global economy.

The NAM filed an amicus brief in a case involving the state of Washington’s authority to prohibit certain exports from Washington’s coastal ports. Washington state denied several environmental permits necessary to construct a new coal export terminal near Longview, Washington. The denials were improperly based on concerns about the use of coal for electricity generation in foreign countries. The state’s actions have dangerous implications for the power of individual states to interfere with interstate and international trade. A federal district court rejected the plaintiffs’ claims. On appeal to the 9th Circuit, the NAM’s amicus brief explained how state and local interference with foreign trade undermines a uniform foreign policy and is harmful to the national economy. Moreover, we argued that Washington’s actions violate the foreign commerce clause and that allowing the state’s actions to stand would give a green light to state and local interference with foreign trade policy.

On February 6, 2018, the EPA issued a final rule that adds an applicability date of February 6, 2020, to the EPA’s 2015 rule governing jurisdictional “Waters of the United States” under the Clean Water Act (2015 WOTUS rule). A coalition of environmental groups sued EPA to challenge the rule, arguing that EPA lacks the statutory authority to impose an applicability date. The applicability date rule is important to manufacturers because it precludes application of the 2015 WOTUS rule while EPA develops and issues a sensible replacement WOTUS rule. The 2015 WOTUS rule asserts federal jurisdiction over millions of acres of landscape features throughout the United States, triggering permitting requirements that will slow development and increase permitting costs on manufacturers. The rule’s vague and ambiguous terms also create confusion and increase the risk of inadvertent violations. The NAM intervened in the litigation to help EPA defend the applicability date rule to allow EPA the necessary time to develop and issue a new WOTUS rule.

On 2/16/17, the NAM and other associations moved to intervene in a case brought by North Dakota challenging the EPA's latest action on its Clean Power Plan (CPP). The agency rejected a petition to reconsider the rule, and that decision is now being challenged in court. The case is likely to be affected by the court's soon-to-be-issued ruling in our main challenge to the CPP rule, since the procedural and substantive defects in the petition for reconsideration overlap significantly with the issues raised in the case already before the court. A motion to hold the case in abeyance pending EPA reconsideration was granted, and the case remains in abeyance.

The NAM sought review in the U.S. Court of Appeals for the D.C. Circuit of the Environmental Protection Agency’s (EPA) 2015 Clean Power Plan rule governing New Source Performance Standards (NSPS) for greenhouse gases from electric utilities. The rule is an attempt to address emissions from new, modified and reconstructed electric generating units. This case is important for manufacturers because EPA should not rely on policy preferences rather than the rule of law.

The NAM sued the EPA with a broad industry coalition to challenge the NSPS rule. We seek to invalidate the rule to pave the way for a sensible alternative. Our briefs argue that the rule is unlawful because EPA’s conclusions are arbitrary and capricious, not supported by substantial evidence, and fail to make the requisite endangerment findings. In 2017, the D.C. Circuit held the rule in abeyance while the current administration considers whether to revise or rescind the rule.

Upon promulgation of the EPA's 2015 rule defining jurisdictional "Waters of the United States" (WOTUS) under the Clean Water Act, a coalition of states led by North Dakota sued the EPA in federal district court in North Dakota to challenge the rule. The states then moved for preliminary injunction against the rule, which the court granted within the territorial boundaries of the plaintiff states (North Dakota, Alaska, Arizona, Arkansas, Colorado, Idaho, Missouri, Montana, Nebraska, New Mexico, Nevada, South Dakota, and Wyoming). Soon thereafter, however, the U.S. Court of Appeals for the Sixth Circuit claimed authority to consider all challenges to the WOTUS rule—to the exclusion of the North Dakota district court and several other district courts in which lawsuits had been filed, including an NAM coalition lawsuit in the U.S. District Court for the Southern District of Texas. In January 2018, however, the U.S. Supreme Court ruled that the Sixth Circuit lacked jurisdiction to consider the various WOTUS challenges. This reactivated the North Dakota case, allowing the court to proceed to the states’ merits challenges to the 2015 rule. On June 8, 2018, the NAM filed an amicus brief on behalf of the states that explains how the rule was promulgated without required procedure and how the rule violates the Clean Water Act and the U.S. Constitution.

Oklahoma and a coalition of business groups sued to challenge the EPA's 2015 rule governing jurisdictional "Waters of the United States" under the Clean Water Act. The rule adversely impacts manufacturers by asserting federal jurisdiction and permitting requirements over millions of acres of dry land throughout the country and by imposing unclear rules on land development. Oklahoma sought a preliminary injunction to stop the rule. A district court denied that injunction, and Oklahoma appealed. In support of their appeal, the NAM filed a coalition amicus brief that explains the impact of the rule on manufacturers and other sectors of the economy and supports an injunction in Oklahoma.

The NAM filed an amicus brief in the U.S. Court of Appeals for the First Circuit to overturn the city of South Portland, Maine’s ban on crude oil exports from the city’s harbor. The city council claimed it enacted the ban for health and safety reasons, but various public statements revealed a political opposition to the planned transportation of Canadian crude oil by pipeline to the harbor for export. The pipeline owner sued the city, arguing the ban violates the U.S. constitution’s commerce clause. A federal district court sided with the city. If such local energy export bans are allowed to stand, energy production and transportation would be restricted, shutting some products out of some markets, and increasing energy prices for many manufacturers. On appeal to the First Circuit, the NAM’s amicus brief explains the importance of the free trade of energy for manufacturers and argues that the city’s interference with free trade violates the U.S. constitution. On January 10, 2020, the court "sidestepped" the federal constitutional questions and certified three questions to Maine’s high court concerning potential preemption of the ordinance by state law.

On January 22, the NAM filed an amicus brief in an appeal to the 9th Circuit challenging a lower court finding that an Idaho land exchange between a manufacturer and the federal government violated federal law. In this case, Shoshone-Bannock Tribes of the Fort Hall Reservation v. DOI, Simplot acquired federal land from the Bureau of Land Management in accordance with the Federal Land Policy and Management Act (FLPMA) to build new gypstacks containing waste products from fertilizer in exchange for Simplot land. Nevertheless, the trial court agreed with a local tribe that the exchange was precluded by a 1900 law that restricted the potential uses of exchanged federal land.

We argue in our brief that the exchange is authorized by both the 1900 Act and FLPMA. FLPMA is a comprehensive land management statute that must be read to allow for all federal land dispositions to satisfy business expectations and foster resource development on public lands in the United States, which are crucial to supply chain and energy security for American manufacturing.

On May 2, 2024, the NAM filed an amicus brief urging the 6th Circuit to recognize wildfires as an exceptional event properly excluded by EPA when determining compliance with National Ambient Air Quality Standards. In this case, Sierra Club challenges EPA’s redesignation of the Detroit area from nonattainment to compliant with the 2015 ozone NAAQs. In making this determination, EPA excluded from its calculations monitoring data on two days that the Detroit area was adversely affected by wildfires. We argue that EPA properly excluded the data influenced by wildfires, which are exceptional events that need not be included in state reporting data under the Clean Air Act. Excluding exceptional events from determinations of whether areas have attained the NAAQS standard provides needed relief for business from the costly and burdensome requirements to limit their emissions based on circumstances beyond a state or businesses’ control.

In June, 2014, the Sierra Club challenged 9 EPA Clean Air Act rules in court, alleging that provisions in each rule are no longer valid as a result of a decision in April by the U.S. Court of Appeals for the D.C. Circuit. The provisions at issue allows companies an affirmative defense to civil penalties for exceeding emissions limits that are caused by malfunctions. A company must prove that the malfunction was sudden, infrequent, not reasonably preventable and not caused by poor maintenance or careless operation, and that it took steps to correct the malfunction and minimize resulting emissions.

In April, the court decided in Natural Resources Defense Council v. EPA to vacate portions of a Portland cement industry rule pertaining to the affirmative defense, finding that the EPA lacked the authority to create a defense applicable in federal court. This Sierra Club suit attempts to remove the defense from 9 other rules in which it arises, involving various industries and kinds of equipment. Challenges to regulations must be brought within 60 days of their promulgation unless the petition "is based solely on grounds arising after such sixtieth day . . . ." The suit claims that the NRDC case decision constitutes grounds arising after the rules were promulgated.

In July, the NAM and 13 other business associations filed a motion to intervene in the suit. Manufacturers will be negatively impacted if the suit is successful, since it could make them liable for permit violations arising from unavoidable equipment malfunctions. That liability can arise both from EPA citations and from citizen suits around the country.

The rules at issue govern chemical manufacturing, pulp and paper mills, steel pickling, marine tank vessel loading operations, industrial steam-generating units, nitric acid plants and others.

On July 25, the court ordered the case held in abeyance while the EPA decided on a pending administrative petition from the Sierra Club to revise the rules. The EPA granted the petition, and on December 17, 2014, the court held this case in abeyance until the EPA completes the rules revision process. As of July 30, 2019, the EPA has not yet completed its administrative process.

The MCLA intervened in an environmental group’s legal challenge to the EPA’s rescission of the prior administration’s 2015 “Waters of the United States” rule. The EPA rescinded the 2015 rule because the rule’s lack of clarity resulted in regulatory uncertainty and confusion. Additionally, because some federal courts invalidated the 2015 rule in some parts of the country and not others, manufacturers faced a regulatory patchwork that made compliance across different states very difficult. The EPA’s rescission of the 2015 rule restored regulatory consistency and clarity. A coalition of environmental groups sued to challenge the rescission, arguing that the EPA exceeded its authority in doing so. The NAM and other leading industry trade associations intervened in the case to help defend the rule and to represent the interests of our members in the litigation.

On February 6, 2018, the EPA issued a final rule that adds an applicability date of February 6, 2020, to the EPA’s 2015 rule governing jurisdictional “Waters of the United States” under the Clean Water Act (2015 WOTUS rule). A group of states led by New York sued EPA to challenge the rule, arguing that EPA lacks the statutory authority to impose an applicability date. The applicability date rule is important to manufacturers because it precludes application of the 2015 WOTUS rule while EPA develops and issues a sensible replacement WOTUS rule. The 2015 WOTUS rule asserts federal jurisdiction over millions of acres of landscape features throughout the United States, triggering permitting requirements that will slow development and increase permitting costs on manufacturers. The rule’s vague and ambiguous terms also create confusion and increase the risk of inadvertent violations. The NAM intervened in the litigation to help EPA defend the applicability date rule to allow EPA the necessary time to develop and issue a new WOTUS rule.

On October 17, 2024, the NAM filed an amicus brief urging the D.C. Circuit to vacate EPA’s flawed rule for conducting risk evaluations of chemical substances under the Toxic Substances Control Act. The rule—which was challenged by a union and several industry groups—requires EPA to take a “whole chemical” approach to risk evaluation under which EPA makes a single risk determination for all conditions of use of a chemical. This approach potentially subjects all uses of a chemical to regulation, even if all but one of the chemical’s uses poses no risk. The rule also requires EPA to assume that workers do not use personal protective equipment when dealing with chemical substances in manufacturing.

We argue in our brief that EPA’s “whole chemical” approach is contrary to both the text of TSCA and the case-by-case approach to risk determinations endorsed by EPA for decades. The new rule will lead to complex risk revaluations that cannot be completed within statutory deadlines. We further argue that EPA’s PPE presumption is inconsistent with industry practice and ignores existing legal requirements.

On February 18, 2022, the NAM filed an amicus brief urging the U.S. Supreme Court to review and reverse a 9th Circuit decision which sanctions a patchwork system of local regulation of healthcare and retirement benefits in square conflict with ERISA’s expansive preemption provision. This case, ERISA Industry Committee (ERIC) v. City of Seattle, involves a challenge to a Seattle ordinance requiring certain employers to make monthly healthcare expenditures to employees at Seattle-specific thresholds. The 9th Circuit rejected the challenge even though Congress intended for federal law—the Employee Retirement Income Security Act of 1974 (ERISA)—to provide a single uniform national scheme for the administration of healthcare and retirement plans without interference from states or municipalities. Indeed, the 1st and 4th Circuits have held that similar laws are preempted under well-established ERISA preemption principles.

The NAM filed an amicus brief in support of Supreme Court review explaining that ERISA preemption plays a critical role in making benefits possible for employees, and state and local rules that conflict with ERISA’s national uniformity must be struck down. As a practical matter, state and local mandates like this one harm workers, forcing employers to divert resources away from providing quality health coverage, and instead spend money to comply with a complex and mismatched patchwork of state and local rules. Already, localities across the country have begun to adopt similar ordinances with varied minimum benefit rates, timelines, definitions, and recordkeeping requirements—a completely unworkable, fragmented regulatory regime. Supreme Court intervention is sorely needed.

Unfortunately, on November 21, 2022, the Supreme Court denied cert.

The NAM filed an amicus brief urging the U.S. Supreme Court to review and reverse a deeply flawed Eighth Circuit opinion applying an erroneous standard to the admissibility of expert testimony and usurping the gatekeeping role of the trial court. This multidistrict litigation involves allegations that 3M’s Bair Hugger patient warming device causes surgical site infections. After conducting a thoughtful and thorough review of plaintiffs’ general causation experts’ opinions—a faithful application of Fed. Rule of Evidence 702—the district court found that the opinions included large analytical gaps and were not generally accepted, and, accordingly, granted summary judgment in favor of 3M.

The Eighth Circuit reversed, applying a pre-Daubert standard. Under that standard, it is an abuse of discretion to exclude expert testimony unless the experts’ opinions are “so fundamentally unsupported” that they’re of no help to a jury. This obsolete standard essentially abrogates any discretion a district court has to exclude expert testimony.

The NAM filed an amicus brief urging the Court to grant 3M’s cert petition to resolve the widespread confusion in the courts on applying Rule 702 and safeguard the scientific underpinnings of the American health care system. The Eighth Circuit’s liberal admissibility standard threatens to adversely affect those who rely on the benefits of a medical device or drug—approximately 50,000 people per day. Such critical products, which are subject to substantial scientific analysis and review by the federal government, should not be deemed defective by juries applying an erroneous, overly permissive admissibility standard.

Unfortunately, on May 16, 2022, the Supreme Court denied cert.

On February 28, 2023, the NAM filed an amicus letter requesting that the California Supreme Court review and reverse a California Court of Appeal decision affirming the trial court’s admission of unreliable expert testimony that equated talc with asbestos. In this case, the plaintiff-appellee maintained that the defendants’ cosmetic talc products were contaminated with asbestos and that her exposure thereto caused her mesothelioma. A California trial judge allowed, over defendants-petitioners’ objection, the admission of expert testimony proffered by the plaintiff-appellee that equated talc’s and asbestos’ effects on DNA--a novel theory excluded in other talc trials. After a jury returned a verdict in the plaintiff-appellee’s favor, a California Court of Appeal affirmed the trial judge’s evidentiary ruling on the ground that the appellants-petitioners did not invoke a particular case name to support their challenge. In fact, the appellants-petitioners validly challenged the admissibility of the disputed testimony as an unsupported and unreliable scientific theory not accepted within the scientific community.

In our letter brief, we argue that review is necessary to clarify how to challenge a novel scientific technique--the Court of Appeal’s holding sows confusion in how to preserve expert challenges and creates an artificial, distinct standard for evaluation of certain expert testimony that is not supported by the relevant case law or California’s evidentiary rules. Unfortunately, on April 12, 2023, the California Supreme Court denied the petition for review.

On October 2, 2024, the NAM filed an amicus brief urging the 7th Circuit to affirm a trial court decision excluding the plaintiffs’ expert’s testimony. In this multidistrict litigation, over 5,000 plaintiffs sued manufacturers alleging that they developed Parkinson’s disease due to their exposure to the herbicide paraquat. The Southern District of Illinois granted summary judgment for the defendants after carefully evaluating and rejecting the opinions of plaintiffs’ sole general causation expert. Plaintiffs have appealed that decision to the 7th Circuit.

We argue that the district court properly performed its gatekeeping function in excluding the plaintiffs’ expert testimony. We ask the Court to take this opportunity to reaffirm the court’s gatekeeping role and the standards under the amended Rule 702 for admissibility of expert testimony—namely, the proponent must establish by a preponderance of the evidence that the expert’s opinion meets the applicable indicia for reliability, which the plaintiffs did not due in this case. All manufacturers have an interest in keeping junk science out of the courtroom.

On June 17, 2024, the NAM filed an amicus brief asking the Delaware Superior Court to certify its problematic decision admitting unreliable expert testimony in a mass tort action for interlocutory appeal to the Delaware Supreme Court. In this case, plaintiffs have brought more than 70,000 lawsuits against pharmaceutical companies alleging that the heartburn and acid reflux drug ranitidine—widely sold under the name Zantac—caused them cancer. The Delaware Superior Court denied the defendants’ request to exclude the plaintiffs’ unreliable expert testimony from trial which, if granted, would have resulted in the dismissal of the plaintiffs’ case. The court’s ruling is contrary to a federal court’s ruling in the Zantac multidistrict litigation which dismissed all cases alleging similar cancer claims in 2022.

In our brief, we argue that the Delaware Superior Court improperly interpreted the Delaware rule governing the admission of expert testimony as more lenient than federal law and that Delaware Supreme Court review is required to stop the forum shopping that the court’s opinion will encourage.

Unfortunately, on July 1, 2024, the Delaware Superior Court refused to certify its decision for interlocutory appeal.

On December 9, 2022, the NAM filed an amicus brief urging the Supreme Court of Wisconsin to review and reverse a trial court’s failure to exercise its gatekeeping duty to exclude unreliable expert testimony. In this case, Vanderventer, et al. v. Hyundai Motor America, et al., the plaintiffs allege that the defective design of a driver seat caused one of the plaintiffs to experience enhanced injuries from a car accident. Over the defendant’s objection, the trial court admitted the testimony of plaintiffs’ expert witnesses and the jury returned a verdict of $38 million in the plaintiffs’ favor.

Our coalition brief argues that the Supreme Court of Wisconsin should grant the petition to clarify Wisconsin trial courts’ gatekeeping obligation to ensure that expert testimony is the product of reliable principles and methods prior to admission into evidence. The trial court failed in this regard by allowing (1) plaintiffs’ expert witnesses—a biomechanical engineer and a medical doctor—“to extend their [causation] testimony beyond their specific fields of expertise”; and (2) the plaintiff’s biomechanical engineer to give design defect testimony without his ever testing the actual car seat at issue under conditions similar to those that occurred during the accident. All manufacturers have an interest in ensuring that trial courts closely scrutinize the factual foundation of expert testimony, as that testimony tends to have an outsized influence on juries.

Unfortunately, on February 21, 2023, the Supreme Court of Wisconsin denied the petition for review.

On June 9, 2022, the NAM filed an amicus brief in the 9th Circuit arguing that, where a business acts in accordance with an objectively reasonable interpretation of an ambiguous government regulation, the business’s conduct does not fall within the ambit of the False Claims Act (FCA.) Originally enacted in 1863 in response to defense contractor fraud during the Civil War, the FCA is a federal statute used to combat fraud against the government. In this case, U.S. ex rel. Island Industries, Inc. v. Sigma Corp., a company brought a FCA suit against its competitor based on the purported failure to pay required antidumping duties. In a separate proceeding before the Court of International Trade, however, the court ruled that the antidumping duty order at issue was ambiguous and based upon the publicly available information, it was not clear whether the defendant’s product was subject to the duty. Further, the Department of Commerce thereafter agreed that the order was ambiguous, and as a result, held that no duties were owed. Nonetheless, a C.D. Cal. jury found the defendant liable for failing to pay the duties, returning an $8M verdict, before trebling.

The NAM filed a brief arguing that exposing companies to this type of draconian penalty for behaving in conformance with reasonable interpretations of legal requirements would create untold liability traps and unmoor the FCA from its narrow fraud-prevention purpose. Where, as here, a company takes an “objectively reasonable” position regarding a regulation or contract term that it was not warned away from by authoritative guidance, the FCA’s scienter—or knowledge—requirement simply is not satisfied. Further, a reasonable interpretation of an ambiguous regulation defeats any claim that there is an obligation to pay the government, or that the failure to adhere to a different reasonable interpretation is material to any payment to the government. Allowing the judgment to stand would transform the FCA into a blunt enforcement instrument and would impose unwarranted risks and uncertainties on manufacturers and other businesses that must navigate complex regulatory terrains.

On December 22, 2023, the NAM filed an amicus brief asking the 7th Circuit not to impose False Claims Act liability where a defendant subjectively believes that it is following a legal obligation based on an objectively reasonable interpretation of an ambiguous statutory, regulatory or contract provision. In this case, a drug manufacturer participated in the federal government’s Medicaid drug rebate program which requires manufacturers to pay a rebate back to the state and federal government for each drug sold to the program based on the Average Manufacturer's Price for the drug. The plaintiff-relator alleged that Lilly miscalculated the rebate it was required to provide under the program by miscalculating the AMP even though Lilly based its calculation on a reasonable interpretation of an ambiguous term and informed the government of its interpretation without the government taking any action. The relator obtained a verdict of over $61 million, which the district court subsequently trebled.

We joined other business groups in arguing that the plaintiff failed to satisfy the falsity and knowledge requirements necessary to impose False Claims Act liability. We explained that those requirements are not satisfied where, as here, a party’s legal obligations are unclear, and the party acts in accordance with its genuinely held reasonable interpretation. Expanding False Claims Act liability to situations like this would expose government contractors to protracted litigation and potential liability any time a relator comes up with an alternative interpretation to a manufacturer’s interpretation of an ambiguous legal obligation.

On October 7, 2024, the NAM filed an amicus brief urging the Illinois Supreme Court to maintain the doctrine of intrastate forum non conveniens. That doctrine allows an Illinois trial court to transfer a case to another court in the state that would be more convenient for the parties or to better serve the ends of justice. In this case, a store in Madison County sued the Illinois Attorney General challenging the constitutionality of a new state consumer protection law. The AG sought to transfer the case pursuant to a state law that requires constitutional challenges to state laws be filed in Cook County (Chicago) or Sangamon County (Springfield). However, relying in part on the forum non conveniens doctrine, a Madison County Circuit Court Judge struck down the state law as unconstitutional citing concerns over plaintiffs’ due process rights. The AG appealed to the Illinois Supreme Court.

On appeal, the AG and Illinois Trial Lawyers Association, as amicus curiae, invite the court to use the case as a vehicle for abandoning the longstanding doctrine of intrastate forum non conveniens even though doing so is not necessary to deciding the constitutionality of the law at issue. We argue that the doctrine is still needed to curtail plaintiffs from forum shopping to courts where they expect a more favorable outcome.

The NAM filed an amicus brief to oppose overbroad government investigations intended to chill corporate scientific inquiry, debate, and discussion. ExxonMobil sued the attorneys general of New York and Massachusetts to challenge overbroad subpoenas and civil investigative demands seeking more than 40 years of communications between the company and other parties involving the topic of climate change. On appeal to the U.S. Court of Appeals for the Second Circuit, the NAM’s brief explains that corporations contribute to important policy discussions involving economic, scientific and other issues of public concern and that expansive use of government investigatory powers can chill corporations’ contributions to the free exchange of ideas.

The NAM filed an amicus brief in support of the pharmaceutical industry's challenge to the Trump administration's Most-Favored Nation (MFN) Rule. The rule, which bypassed the notice and comment process that agencies must ordinarily follow before making rules effective, creates a new payment model for Medicare Part B drugs, tying payments for certain drugs (a set of 50 that encompass a high percentage of Medicare Part B drug spending) to the lowest price paid by other wealthy countries. In this case, the NAM filed an amicus brief in the Northern District of California in support of plaintiffs'--the Biotechnology Innovation Organization (BIO) and two California-based biotechnology organizations--motion for preliminary injunction. A near-identical case was filed in the District of Maryland by the Pharmaceutical Research and Manufacturers of America (PhRMA) and groups representing cancer treatment providers. The NAM's brief argues that the MFN rule is yet another fatally flawed attempt by the government to use the COVID-19 pandemic as the basis for an end-run around the Administrative Procedure Act's (APA) notice and comment procedures. The NAM's members have a vital institutional interest in ensuring that the federal government is held to the procedural safeguards provided in the APA.

Happily, oOn December 28, 2020, the district court granted the plaintiffs' motion for a preliminary. Injunction .

On June 24, 2024, the NAM filed an amicus brief urging the 8th Circuit to vacate the SEC’s final climate disclosure rule. Back in March, the SEC voted to approve the final rule instituting new climate disclosure requirements on public companies. As requested by the NAM, the final rule omitted the onerous and unworkable Scope 3 supply chain emissions reporting mandate the SEC included in its original proposal. Although the final rule is significantly more workable for manufacturers than the proposal, questions remain about the SEC’s authority to adopt it in the first place. In this case, several groups sued challenging the final rule as exceeding the SEC’s authority and those cases were consolidated in the 8th Circuit.

We argue in our amicus brief that even though the SEC has authority to require a public company to disclose information that would be material to a reasonable investor and climate information can be material, provisions of the rule suggest the SEC is prescribing climate policy. The EPA, not the SEC, has authority to make climate policy.

On April 29, 2024, the NAM filed an amicus brief urging the 8th Circuit to vacate the FCC’s digital discrimination rule. Under the Infrastructure Investment and Jobs Act of 2021, FCC was required to promulgate rules prohibiting intentional discrimination in the deployment of broadband based on a protected classification—such as income level, race, or religion. The FCC’s digital discrimination rule, however, goes further. It prohibits broadband providers from implementing practices or policies that “differentially impact consumers” access to broadband internet access. Accordingly, business trade groups sued the FCC in multiple circuits, challenging the rule as exceeding the FCC’s authority and those actions were consolidated in the 8th Circuit.

We argue in our amicus brief that the IIJA only prohibits intentional discrimination in the deployment of broadband. The disparate impact standard unliterally imposed by the rule will deter investment in critical broadband infrastructure necessary for manufacturers to innovate and compete in the global economy.

The NAM filed an amicus brief urging the U.S. Supreme Court to review and reverse the lower courts’ dismissal of a challenge to a California ballot initiative that regulates the conduct of farmers, manufacturers, and producers nationwide. Proposition 12 bans the sale of imported pork and veal in California unless farmers and producers outside of California meet strict animal confinement standards set by California voters. The NAM argued in the brief that Proposition 12 violates the Commerce Clause by regulating conduct beyond California’s borders, impinging on other states’ sovereign authority to legislate within their own jurisdictions, and, substantially burdening out-of-state pork producers absent a sufficient and legitimate local interest.

On May 28, 2022, the Supreme Court granted the cert. petition. On June 17, the NAM filed an amicus brief asserting the same arguments included in its amicus brief filed in support of the U.S. Supreme Court granting review. This litigation is important to all manufacturers because if upheld, Proposition 12 may embolden other states to regulate out-of-state conduct, resulting in a complex web of inconsistent and competing extraterritorial regulations in the agriculture and food industries, and beyond.

Unfortunately, on May 11, 2023, the Supreme Court affirmed the 9th Circuit's decision affirming the lower court's dismissal of the case.

The NAM filed an amicus brief in the Ninth Circuit in support of PhRMA’s constitutional challenge to California’s Senate Bill 17, a drug pricing law that allows California to control wholly out-of-state prices and directly regulate conduct outside its borders. SB 17 effectively freezes a prescription drug’s wholesale acquisition cost (WAC)—the uniform, nationwide list price, akin to the sticker price for a car— nationwide for 60 days before it can be raised. As the NAM’s brief explains, by freezing a nationally uniform pricing benchmark, SB 17 impermissibly regulates the price of wholly out-of-state drug transactions. Further, upholding SB 17 threatens the success of the national common market by encouraging every state to find and manipulate pricing benchmarks in hopes of influencing downstream prices.

Unfortunately, on July 25, 2022, the Ninth Circuit affirmed the district court's decision, concluding that it did not err in finding that issues of fact exist regarding whether "SB 17's practical effect is to directly regulate transactions in interstate commerce."

On May 14, 2024, the NAM filed an amicus brief urging the Northern District of Texas to stay the FTC’s sweeping ban on noncompete agreements—a rule that threatens to hamstring innovation in the manufacturing sector and damage the competitiveness of American industry. In January 2023, the FTC proposed an across-the-board rule that would flatly prohibit employers, as an unfair method of competition prohibited under Section 5 of the Federal Trade Commission Act, from entering into a noncompete clause with a worker, and would also retroactively invalidate any existing noncompete agreements. The NAM opposed the rule as proposed, and submitted comments detailing the harms to manufacturers that would result. In April 2024, the FTC finalized a comprehensive noncompete ban with only two limited exceptions (for the sale of a business and for existing non-compete agreements with senior executives).

Ryan, a Texas accounting firm, sued the FTC in the Northern District of Texas, challenging the FTC’s authority to issue the rule and seeking a stay of the rule pending the district court’s decision on the merits. We argue in support of that stay that noncompete agreements are essential for protecting manufacturers’ trade secrets and other proprietary information. Effective protection for confidential commercial information is critical to maintaining incentives for manufacturers to make capital-intensive investments in R&D that ultimately power innovation and American economic competitiveness.

Our brief debunks the FTC’s assertion that trade secret misappropriation litigation and nondisclosure agreements are adequate alternatives for protecting companies’ proprietary information. Misappropriation suits are costly, slow and extraordinarily difficult to prosecute, requiring knowledge of a rival’s misappropriation by improper means. NDAs are similarly difficult to prove as there is no ready way to determine if the agreement has been breached, and litigation is slow and expensive. Further, the final rule’s “functional” definition of noncompete clauses will deem many—if not most—NDAs to be non-compete clauses, thus barring them wholesale. And both misappropriation litigation and NDAs function only retrospectively, attempting to compensate for detected and completed wrongdoing rather than preventing it in the first place. Although these concerns were raised by the NAM and many other commenters, the FTC failed to meaningfully respond to them. We argue, accordingly, that the agency acted arbitrarily and capriciously and that the final rule must therefore be set aside.

On July 3, 2024, the district court issued an order barring implementation and enforcement of the rule against the named plaintiffs.

The NAM filed an amicus brief seeking to enjoin the federal government from publicly disclosing sensitive risk assessment and hazard modeling documents associated with Sunoco's pipeline operations. Sunoco initiated this lawsuit in the U.S. District Court for D.C. after the Pipeline and Hazardous Materials Safety Administration—which had historically protected this type of information from public disclosure under the Freedom of Information Act (FOIA) given its sensitive nature—reversed course and sought to disclose the information publicly within a matter of days. Our amicus brief argues that risk assessment and hazard modeling documents provided to the federal government to help protect against a major physical or cyber-attack are critical to maintaining pipeline operations and should be protected from disclosure under FOIA for both security and commercial reasons. Manufacturers in the oil & gas industry and beyond customarily protect the type of information at issue in this case from public disclosure due to significant threats to disruption of operations and public safety from bad actors seeking to exploit potential vulnerabilities. The government's decision to disregard the applicable FOIA exemptions presents grave concerns regarding the treatment of similar information that manufacturers routinely provide to regulators.

Citing the COVID-19 pandemic as a pretext for emergency rulemaking, the Departments of Labor and Homeland Security issued two rules in mid-October 2020 creating a series of new restrictions on the H-1B visa program that would have slammed the door on talented workers in hard to fill specialty and technical roles. The rules were especially unsound because they were directly issued as final rules, with no notice or opportunity to provide comment on their harmful impacts despite cost estimates that put these rules among the most expensive federal rules ever issued. The NAM joined with a coalition of business groups, health care organizations and prominent universities to challenge the rules, filing a lawsuit against the Trump administration arguing that they were unlawful and hugely detrimental to American competitiveness. On December 1, 2020 a federal judge agreed and handed manufacturers a crucial victory that immediately vacated both rules and protected the H-1B program.

In July 2020, the NAM filed a lawsuit in the Northern District of California against the Trump administration’s unlawful restrictions to a wide range of nonimmigrant work visas. The restrictions, which were part of a June 22 Presidential Proclamation that essentially shut off the flow of high-skilled workers for hard-to-fill jobs in the manufacturing sector, were the subject of intense member interest and concern. The restrictions were so disruptive that they quickly began to inflict irreparable harm on our members, and we argued that they lacked legal basis because economic policy–the justification for the Proclamation—is a uniquely Congressional domain, and the Proclamation exceeds the President’s constitutional authority by rewriting existing law. On October 1, 2020, Judge White granted our request for a preliminary injunction. The Justice Department has appealed that decision to the Ninth Circuit for review.

The NAM filed an amicus brief in the U.S. District Court for the District of Columbia supporting employers in their efforts to retain highly skilled workers. Spouses of H-1B skilled workers who have been approved for permanent residence can apply for and receive H-4 visas allowing them to work in the United States. If this rule were invalidated, manufacturers would lose access to leading talent, harming their ability to remain competitive in the global economy. A federal district court ruled that the plaintiffs lacked standing to bring the case, but the D.C. Circuit reversed and remanded the case for further proceedings. Now, following cross-motions for summary judgment, the NAM filed an amicus brief urging the court to preserve H-4 employment authorization. The NAM’s brief details the devastating impact that eliminating H-4s would have on affected employees and their families, employers, and the health of the overall economy.

Happily, on March 28, 2023, the district court upheld the rule allowing H-4 visa-holders to apply for employment authorization.

On February 1, 2024, the NAM joined a coalition amicus brief urging the 5th Circuit to uphold DHS’s new Deferred Action for Childhood Arrivals rule. DACA is a program that allows undocumented immigrants who were brought to this country as children to apply for protection from deportation and permission to work in the United States. In this case, the 5th Circuit affirmed a district court ruling that DHS lacked authority to adopt DACA. The 5th Circuit remanded the case to the district court for consideration of whether DHS may accept new and renewal DACA applications based on DHS's promulgation of a new DACA rule. On remand, the district court invalidated the new rule, and barred DHS from approving new DACA requests.

Alongside 55 other businesses and trade associations, we argue in our brief that invalidating DACA will harm the economy because (1) businesses rely on DACA recipients as employees, customers, and job creators; and (2) DACA recipients fill jobs that would otherwise remain vacant. Moreover, DACA is a lawful exercise of executive authority.

On October 2, 2023, the NAM filed an amicus brief urging the New Jersey Supreme Court to affirm the Appellate Division’s determination that Merck’s insurers improperly denied coverage for losses arising out of a cyberattack. In this case, Merck sought coverage for losses from the 2017 NotPetya cyber event under its "all risk" property policies. The policies contained an express grant of coverage for electronic data corruption or destruction, including broad business interruption coverage. Nevertheless, the insurers denied coverage, contending that standard-form “war” exclusions—developed by the insurance industry years before cyber-risks emerged—barred coverage. The trial court and Appellate Division agreed with Merck that, by its plain language, the war exclusion was limited to situations involving the use of armed forces, and therefore did not apply. The instant appeal followed.

The NAM’s amicus brief underscores the significant threat posed by cyber risks to businesses of all sizes and across all industrial sectors. By developing and employing consistent rules of interpretation, New Jersey courts have created an environment in which policyholders can conduct business and prepare for cyber risks in a predictable and reasonable manner. The NAM further explains that the result advocated for by the insurance industry would undermine core principles of insurance policy interpretation that are critically important to manufacturers seeking coverage under policies purchased at considerable expense.

The case was resolved by the parties prior to oral argument.

The NAM led a group of associations in filing two World Trade Organization (WTO) statements because Thailand failed to abide by its WTO commitments on customs valuation and now threatens a company with fines of more than $2 billion and imprisonment of several individuals. Proper valuation is important because many manufacturers operate through interconnected commercial relationships and supply and production chains with producers and suppliers throughout the United States and foreign countries. The statements emphasize the importance of the WTO’s customs valuation rules to international trade, which allow companies to produce goods as efficiently as possible and to access international consumers in the global marketplace.

On September 22, 2023, the NAM filed an amicus brief urging the 5th Circuit to decline to extend Texas personal jurisdiction to an out-of-state manufacturer who never sold the product at issue in a lawsuit to consumers, advertised it to consumers, or directed anyone else to sell or advertise it to consumers. In this case, the plaintiff claims that a Samsung-manufactured 18650 lithium-ion battery in the plaintiff’s e-cigarette exploded in his pocket, causing severe burns. Although the plaintiff claimed that he purchased the battery on Amazon.com from a third-party seller, he sued Samsung in Texas state court asserting contract and tort claims. The defendants removed the case from state to federal court and the federal district court granted the defendants’ motion to dismiss for lack of personal jurisdiction, concluding that Samsung’s contacts with Texas were insufficient for it to exercise personal jurisdiction. Although Samsung provided batteries to companies in Texas engaged in manufacturing or repairing products, Samsung did not authorize the sale of its battery by a third-party to the plaintiff or sale of its batteries to be used in an e-cigarette.

We argue in our brief that there is an insufficient basis to exercise personal jurisdiction where a claim arises independent of a defendant’s deliberate efforts to serve a market. And exercising personal jurisdiction in this case would create unpredictability for the business community.

On September 21, 2023, the NAM filed an amicus brief in support of energy manufacturers’ petition seeking U.S. Supreme Court review of a lower court’s remand order in a case asserting state liability claims related to climate change. This is a case seeking to hold oil and gas companies liable for the impacts of climate change in Minnesota. The 8th Circuit upheld the federal district court’s decision to remand the case to state court for lack of subject matter jurisdiction. In our brief, we argue that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. This case has important implications for all manufacturers because of the growing trend among plaintiffs’ lawyers of using public nuisance and consumer deception claims to seek monetary damages from manufacturers for broad, societal issues that are ill-suited for consideration by a patchwork of state court determinations and should be addressed in the policy process.

Unfortunately, on January 8, 2024, the U.S. Supreme Court denied the energy manufacturers' petition.

On February 9, 2024, the NAM joined 15 other leading business groups in filing an amicus brief urging the court to reject the National Labor Relations Board’s decision that does away with the longstanding policy of protecting workers’ rights to secret ballots in union organizing efforts. This case involved a bargaining unit of approximately 366 cement truck drivers who voted against representation by the International Brotherhood of Teamsters. Following this “no” vote, the Union accused the employer of unfair labor practices—specifically, that the employer engaged in coercive conduct to dissuade employees from voting in favor of Union representation—and asked that the results of the election be set aside, and that the employer be ordered to bargain with the Union. Although an Administrative Law Judge recommended that a new election be held, the NLRB’s Democratic majority instead used the case to announce a troubling new framework for determining when employers are required to bargain with unions without a representation election. The NLRB determined that if a union claims to have majority support and demands recognition, an employer must either (1) grant recognition without the benefit of a secret ballot election, or (2) file its own NLRB petition seeking an election. If the employer fails to take either step, the union can file an unfair labor practice charge, and the NLRB will order mandatory union recognition unless the employer proves the union did not have majority support in an appropriate bargaining unit. And, perhaps most worrying, even if the employer files a petition for election, the NLRB may cancel the election and issue a bargaining order if the employer commits virtually any unfair labor practice during the period preceding the election—this would include seemingly innocuous conduct like having a “workplace civility rule” in an employee handbook.

Our coalition argues that the Cemex decision is contrary to congressional intent by defaulting union representation to card check rather than via secret ballots and puts the burden on employers to call for an NLRB-supervised election, rather than the union as currently required. The brief also argues that the decision violates Supreme Court precedent by making any unfair labor practice sufficient to support the issuance of a bargaining order against the employer, forcing the employer to recognize a union that may not have majority support from the workforce.

On Wednesday, December 28, the NAM filed an amicus brief in support of energy manufacturers’ petition seeking U.S. Supreme Court review of the lower courts’ remand order in a case asserting “public nuisance” claims related to climate change. This case, Chevron Corporation, et al. v. San Mateo County, California, et al., is one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. The 9th Circuit upheld the district court’s decision to remand the case to state court for lack of subject matter jurisdiction.

In our brief, the NAM argues that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. This case has important implications for all manufacturers because of the growing trend among plaintiffs’ lawyers of using public nuisance and consumer deception claims to seek monetary damages from manufacturers for broad, societal issues that are ill-suited for consideration by a patchwork of state court determinations and should be addressed in the policy process.

Unfortunately, on April 24, 2023, the Court denied the energy manufacturers' petition.

On September 12, 2023, the NAM joined a coalition brief in the 5th Circuit concerning removal under federal officer jurisdiction. This case is one of over 40 cases filed by a group of Louisiana parishes seeking relief for alleged damage to Louisiana’s coastal environment. The plaintiffs allege that the defendants--energy producing companies--violated the Louisiana State and Local Coastal Resources Management Act by violating or failing to obtain a use permit for oil production activities on the Louisiana coast. Defendants are authorized to remove cases against them from state to federal court for actions taken while “acting under” an officer of the United States. The defendants removed this case, in part, based upon acts taken to assist the Allies in World War II, pursuant to Shell Oil Company’s contracts with the government to refine oil. The district court found that Shell Oil Company’s contracts were insufficient to establish "acts under" a federal officer because the defendants failed to show that Shell Oil Company was "acting under" a federal officer in carrying out a specific directive to engage in the activity that provides the basis for the plaintiff’s suit.

In our amicus brief, we argue that Shell Oil Company "acted under" a federal officer because oil production was how the companies fulfilled their contractual obligation to produce refined oil to the government. Ensuring that courts properly apply federal-officer removal jurisdiction is important to all manufacturers who provide goods or services to the United States government pursuant to a contract and face potential liability claims in state courts. Unfortunately, on May 29, 2024, the 5th Circuit affirmed the trial court's decision.

On July 10, 2024, the NAM filed an amicus brief requesting that the full 5th Circuit rehear the case. We argued that full 5th Circuit review is necessary to correct the panel’s interpretation of the federal officer removal statute which is inconsistent with circuit precedent and narrower than the interpretation employed by other circuits. Further, if left uncorrected, the panel’s decision will create forum uncertainty and will discourage private companies from aiding the federal government.

The case concerns a group of Louisiana parishes, supported by the Louisiana Department of Natural Resources and the Louisiana Attorney General as intervenors, seeking relief for alleged damage to Louisiana’s coastal environment based on acts committed during World War II that were controlled, directed, and regulated by the federal government. After learning of the WWII connection to plaintiffs’ claims via the plaintiffs’ 2018 expert report, the defendant oil companies sought to remove 42 related cases to federal court. In the defendants' first appeal, the Fifth Circuit held that removal was untimely because the defendants should have ascertained the federal question earlier based on vague references buried in an exhibit to the plaintiffs’ complaint. On September 15, 2020, the NAM filed an amicus brief in support of the defendants’ petition for rehearing en banc, arguing that the court's decision created uncertainty in all forms of removal, forcing defendants to file protective removal notices for fear that even equivocal and uncertain statements by plaintiffs may start the 30-day removal clock. The NAM maintained that the decision undermined the purpose of the removal statute to the detriment of both litigants and courts. On August 5, 2021, the court agreed with the defendants that their removal based on federal-officer jurisdiction was timely, but remanded the case for consideration of whether federal question jurisdiction exists.

On remand, the district courts found federal questions jurisdiction wanting, which the Fifth Circuit affirmed. The panel held that the defendants failed to present evidence that they acted pursuant to a federal officer's directive in the absence a contract that made them accountable to the federal government. On November 16, 2022, the NAM filed an amicus brief in support of the defendants' petition for a panel rehearing or, in the alternative, rehearing in banc, arguing that the panel decision conflicts with Congress's expressive directive, Supreme Court precedent, and other Circuits' case law, which do not require evidence of an express contract to establish "guidance or control" by the federal government for removal purposes.

Unfortunately, on November 29, 2022, the Fifth Circuit the petition.

On January 5, 2023, the NAM filed an amicus brief in support of energy manufacturers’ petition seeking U.S. Supreme Court review of the lower courts’ remand order in a case asserting “public nuisance” claims related to climate change. This case is one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. The 1st Circuit upheld the district court’s decision to remand the case to state court for lack of subject matter jurisdiction.

In our brief, the NAM argues that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. This case has important implications for all manufacturers because of the growing trend among plaintiffs’ lawyers of using public nuisance and consumer deception claims to seek monetary damages from manufacturers for broad, societal issues that are ill-suited for consideration by a patchwork of state court determinations and should be addressed in the policy process.

Unfortunately, on April 24, 2023, the Court denied the energy manufacturers' petition.

On January 5, 2023, the NAM filed an amicus brief in support of energy manufacturers’ petition seeking U.S. Supreme Court review of the lower courts’ remand order in a case asserting “public nuisance” claims related to climate change. This case is one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. The 9th Circuit upheld the district court’s decision to remand the case to state court for lack of subject matter jurisdiction.

In our brief, the NAM argues that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. The NAM also argues that the petitioners plainly satisfy the requirements for federal officer removal by asserting they are “person[s]” in a “civil action” “for or relating to” acts performed while “acting under” federal officers and “raise[d] a colorable federal defense”—which are the only requirements Congress and the Court have established for when the statute provides a right of removal. This case has important implications for all manufacturers because of the growing trend among plaintiffs’ lawyers of using public nuisance and consumer deception claims to seek monetary damages from manufacturers for broad, societal issues that are ill-suited for consideration by a patchwork of state court determinations and should be addressed in the policy process.

Unfortunately, on April 24, 2023, the Court denied the energy manufacturers' petition.

On November 22, 2023, the NAM filed an amicus brief urging the Pennsylvania Superior Court to review and reverse a trial court decision finding Pennsylvania’s consent by registration statute—which conditions the privilege of doing business in the State on an out-of-state corporation’s submission to general personal jurisdiction—constitutional. In this case, the plaintiffs assert that they developed Parkinson’s disease from exposure to Syngenta’s herbicide and sued Syngenta in Pennsylvania state court even though a majority of the plaintiffs’ claims and Syngenta itself have no significant connection to the state. Syngenta objected to the trial court’s exercise of jurisdiction on the ground that Pennsylvania’s consent by registration statute violates the U.S. Constitution. The trial court, however, denied Syngenta’s request to dismiss the case for lack of personal jurisdiction.

We argue that the Pennsylvania Superior Court should hear the case to address a question left unresolved by the U.S. Supreme Court in Mallory v. Norfolk Southern Railway Co., 143 S. Ct. 2028 (2023): whether Pennsylvania’s consent by registration statute violates the dormant Commerce Clause. We maintain that the statute violates the dormant Commerce Clause by interfering with the efficiency of company operations and forcing companies to defend suits in locations where alleged injuries did not occur and neither party is a resident. In addition, Pennsylvania’s exercise of jurisdiction over residents of another state in cases asserting claims unconnected to the State raises federalism concerns as that conduct should be rightfully policed by some other State. Pushing back against expansion of a state court’s jurisdiction to hear such cases is important to prevent plaintiffs from forum shopping to plaintiff-friendly jurisdictions.

Unforturnately, on August 8, 2024, the court denied the request to hear the case.

On August 26, the NAM filed an amicus brief urging the National Labor Relations Board to reject General Counsel Jennifer Abruzzo’s radical proposal to overturn longstanding and established precedent by awarding prospective, compensatory make-whole relief for the period when an employer refuses to bargain while challenging a union’s certification in court. The traditional remedy for cases where an employer unlawfully refuses to bargain with the chosen bargaining representative of its employees is a bargaining order whereby the NLRB commands the employer to stop its unlawful refusal and bargain with the representative. Over 50 years ago, in Ex-Cell-O Corp., the Board explicitly rejected make-whole relief—in that case raises for employees—as too speculative. The Board concluded that compelling employers “to accede to terms never mutually established by the parties” would violate the plain language of the National Labor Relations Act and Supreme Court precedent.

In this case, Arrmaz Prods. And Internat’l Chem. Workers Union, GC Abruzzo asked the Board to “make the bargaining unit employees whole for the lost opportunity to engage in collective bargaining” during the period when the employer refuses to bargain in order to test the union’s certification in the courts.” As the NAM’s brief explains, this inherently speculative and arbitrary remedy would chill the protected rights of every employer to petition a court to review certification of a union as the exclusive representative of the employer’s employees. Further, section 8(d) of the National Labor Relations Act flatly states that the obligation to bargain collectively “does not compel either party to agree to a proposal or require the making of a concession.” Here, the proposed make-whole remedy cannot be calculated without presuming an agreement that the Board is not entitled to presume or to compel. Employers and employees alike rely on the Board to maintain labor relations stability. Such reliance interests are severely undermined when longstanding and established precedents are overturned without adequate justification, as is threatened in this case.

On December 8, 2022, the Board held that respondent ArrMaz Products, Inc. violated the National Labor Relations Act by refusing "to recognize and bargain with the Union as the exclusive collective-bargaining representative of the employees in the appropriate unit." The Board did not address make-whole relief. The Board has severed this issue and plans to issue a supplemental decision regarding a make-whole remedy at a later date.

The IRA includes provisions to lower prescription drug prices for people with Medicare by requiring manufacturers of certain drugs covered under Medicare Part D (starting in 2026) and Part B (starting in 2028) to negotiate prices with the government. That drug negotiation program would establish an upper limit for the maximum “fair” price for a given drug according to the government. That is, the program establishes price controls for certain prescription medications that will preclude manufacturers of those medications from receiving fair market value. And in June 2023, the Centers for Medicare and Medicaid Services—a component of the Department of Health and Human Services—issued guidance on the agency’s plans for implementing the program.

In this case, Bristol Meyers Squibb and Jassen Pharmaceuticals, Inc.—whose drugs are two of the 10 initial drugs subject to the drug negotiation program—challenged the constitutionality of the program in the District of New Jersey. The drug manufacturers allege that the program violates: (1) the First Amendment by compelling them to agree to a drug price the government states is “fair”; (2) the Fifth Amendment’s Takings Clause by not providing just compensation for their drugs; and (3) the unconstitutional conditions doctrine—a doctrine that limits the government’s ability to condition the receipt of a benefit on the waiver of a constitutional right. Unfortunately, the district court granted judgment for the government, concluding that the program neither affects a taking nor violates the unconstitutional conditions doctrine because participation in the program is voluntary and that the program regulates conduct, not speech. The drug manufacturers appealed the district court’s decision to the 3rd Circuit.

On July 19, 2024, the NAM filed an amicus brief in support of the appeal arguing that the program violates the Fifth Amendment’s Takings Clause and unconstitutional conditions doctrine by forcing manufacturers to transfer title in their drugs to third parties for less than fair market value. The “option” to exit the Medicaid and Medicare program is only hypothetical considering the government’s dominant share of the market for prescription drugs and devastating effects an exit would have on drug manufacturers. Further, forcing manufacturers of selected drugs to sell their products for less than fair market value will cause research and development of new drugs to stagnate, depriving patients of new therapeutic options.

On May 21, 2024, the NAM sued OSHA in the Western District of Texas, challenging the agency’s final walkaround rule that would allow labor organizers, community activists, plaintiffs’ attorneys or even disgruntled former employees to accompany OSHA compliance officers during workplace safety inspections. The OSH Act, the 1970 law that created OSHA, authorizes an employee representative to accompany OSHA during a walkaround inspection. Since OSHA’s inception over half a century ago, that representative had to be an employee of the employer absent a few narrow exceptions. The new walkaround rule makes a radical change to that paradigm by permitting non-employee third parties to serve as the employee representative.

On summary judgment, we argued that the rule exceeds OSHA’s authority as Congress did not authorize third-party access to non-union workplaces or non-union third parties to represent unionized employees during OSHA inspections. The rule also violates the Fifth Amendment’s takings clause—which protects employers’ right to exclude third parties from their private property—by requiring third party access to employers’ property. And the rule is otherwise arbitrary and capricious in violation of the Administrative Procedure Act because OSHA failed to (1) reasonably explain its policy change from only allowing employees of an employer to accompany OSHA inspectors during an inspection; (2) consider all important concerns about the rule raised during the comment process like how employers can protect trade secrets and confidential business information; (3) consider alternatives to third-party access (e.g., allowing OSHA inspectors to retain experts and consultants); and (4) consider all the costs the rule imposes on employers.

On April 15, 2024, the NAM filed an amicus brief asking the 1st Circuit to reverse a district court decision that requires employers to hire a “surrogate” employee as a reasonable accommodation under the Americans with Disabilities Act. In this case, an employee suffered from severe anxiety that made it difficult for her to perform her essential, public-facing job functions. She requested from her employer the accommodation of a “surrogate” to perform those essential functions, which her employer denied as unreasonable. The plaintiff subsequently sued her employer in the District of Massachusetts alleging that her employer violated the ADA by failing to grant her request for accommodation. The district court, over the employer’s objection, instructed the jury that an example of a reasonable accommodation included “qualified readers” which the plaintiff’s counsel equated to a “surrogate” during closing arguments at trial. Thereafter, a jury returned a verdict of $24 million in damages for the employee, which the district court refused to overturn—the employer appealed the decision to the 1st Circuit.

We argue in our amicus brief that the ADA does not require employers to hire someone else to perform the essential functions of an employee’s job. Unlike a surrogate, a “reader’ helps an employee perform the essential functions of the job himself; readers do not do the job for that employee. Expanding the notion of reasonable accommodation to include job surrogates is a misguided approach that imposes an unreasonable burden on employers.

On April 1, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to resolve a circuit split regarding the proper legal framework to apply for determining whether time spent putting on and taking off personal protective equipment (“donning and doffing” time) is compensable under the Fair Labor Standards Act. In this case, the plaintiff oil rig workers sued their employer under the FLSA for failure to compensate them for time spent donning and doffing generic PPE—fire retardant overalls, steal-toe boots, hard hats and safety glasses—at the beginning or end of their workday. The district court held that the time is not compensable, but the 3rd Circuit reversed on appeal. The 3rd Circuit rejected the test applied by the lower court—also adopted by the 2nd Circuit—and embraced a different, more plaintiff-friendly test to govern compensability determinations.

We argue that review is necessary to resolve the circuit split and provide certainty to manufacturers regarding their compensability determinations. If the U.S. Supreme Court does not agree to hear the case, manufacturers will be harmed by the 3rd Circuit’s test which not only calls standard compensation practices into question, but potentially expands the workday to include activities commonly completed at home and could spur a flood of litigation.

Unfortunately, on June 3, 2024, the Court denied the petition for certiorari.

On March 21, 2022, the NAM filed an amicus brief urging the National Labor Relations Board to adhere to U.S. Supreme Court and Board precedent by preserving the validity of employment arbitration agreements. In Epic Systems v. Lewis, the Supreme Court held that the Federal Arbitration Act prevents the NLRB from challenging enforcement of arbitration agreements between employers and employees. Building on that holding, the NLRB ruled in 2020 that an arbitration agreement explicitly and prominently assures employees that their right to file charges with the Board does not interfere with employee rights under the National Labor Relations Act.

Despite this clear precedent, the current NLRB is seeking to abrogate its prior holdings and reconsider whether arbitration agreements interfere with employees’ right to file Board charges or otherwise access the Board’s processes. The NAM filed an amicus brief urging the Court to adhere to its current standard. Our brief highlights the Court’s holding in Epic Systems—that Congress does not alter the fundamental details of one statutory scheme (the FAA) through vague pronouncements in another (the NLRA). Any action by the Board to overrule its prior precedent and impose liability on an employer for enforcing its arbitration agreement would violate the FAA and lead to another confrontation with the Supreme Court. Many NAM members rely on lawful, voluntary arbitration agreements with their employees to reduce litigation costs and reach timely resolution of employment disputes through neutral fact finding and decision making, consistent with the FAA.

On October 30, 2023, the NAM filed an amicus brief urging the U.S. Supreme Court to review the 4th Circuit’s refusal to reverse a National Labor Relations Board decision that eviscerates the long-standing prohibition on secondary boycotts (where a union coerces a neutral employer to cease doing business with an employer with whom a union has a labor dispute). In this case, the South Carolina State Ports Authority operates the Port of Charleston by employing state workers to run lift-equipment and having International Longshoremen’s Association members perform the other longshoreman work there. After SCSPA opened another terminal at the port in 2022 and attempted to use the same division of labor, ILA sued the United States Maritime Alliance (USMX), a multi-employer association of carriers that deliver and pick up containers at the ports, and two of its carrier-members, alleging that they were violating the parties’ collective bargaining agreement by using state employees to perform port work. USMX, the State of South Carolina and SCSPA countered by filing unfair labor charges, maintaining that the lawsuit sought to obtain an illegal secondary objective in violation of the NLRA’s secondary boycott provision. The NLRB disagreed and the 4th Circuit refused to reverse the NLRB’s decision on appeal.

We argue in our amicus brief that the union’s actions in this case constitute a quintessential secondary boycott: the union is coercing neutral parties (the carriers) to stop doing business at a port unless a different party—the South Carolina State Ports Authority—accedes to the union’s demands. All manufacturers have an interest in limiting this type of coercive and intimidating conduct by unions. Unfortunately, on February 20, 2024, the U.S. Supreme Court declined to hear the case.

On November 6, 2023, the NAM filed an amicus brief urging the U.S. Supreme Court to review a lower court decision granting preliminary relief in favor of a union—including forcing the employer to reinstate terminated employees—while the Board’s adjudication process remains ongoing. Under the National Labor Relations Act, federal district courts are empowered to grant preliminary relief at the NLRB’s request while an NLRB adjudication remains pending. In this case, the 6th Circuit affirmed a district court’s grant of preliminary relief—which is considered an extraordinary remedy reserved for extreme cases—under an unduly permissive standard. Specifically, the 6th Circuit, along with the 3rd, 5th, 10th and 11th Circuits, has held that the NLRB is entitled to preliminary relief upon a showing of reasonable cause to believe that the unfair labor practice alleged has occurred and that preliminary relief is just and proper. By contrast, other circuit courts have applied the traditional, and more stringent, four factor test to determine whether the NLRB is entitled to preliminary relief. Under that test, the NLRB must establish that (1) that it is likely to succeed on the merits of its claim, (2) that it is likely to suffer irreparable harm in the absence of preliminary relief, (3) that the balance of equities tips in its favor, and (4) that an injunction is in the public interest.

We argued in our amicus brief that the Court should grant Starbuck’s petition to resolve the circuit split and that the 6th Circuit’s lenient standard places unreasonable burdens on employers subject to unfair labor practice proceedings. Happily, on January 12, 2024, the Court granted the petition.

We filed another amicus brief on February 28, 2024, urging the Court to reverse the 6th Circuit's unsupported watered-down injunction standard that the Board has leveraged to interfere with American business. On June 13, 2024, the Court reversed the 6th Circuit's decision and made clear that the traditional, and more stringent, four-factor test used for determining a party’s entitlement to a preliminary injunction applies to the NLRB.

The NAM filed an amicus brief supporting safety incentive programs and post-incident drug testing. Since 2016, the NAM has fought the U.S. Occupational Safety and Health Administration's (OSHA) overreaching "injury and illness" rule, which sought to restrict employers' ability to administer drug tests to employees after safety incidents. The rule also limited incentive programs that encourage safe workplaces. The incoming presidential administration in 2017 announced it would reconsider the rule, then OSHA issued guidance to clarify that post-incident drug testing and safety incentive programs are not prohibited. This case is important because a favorable ruling will help preserve pro-safety measures and keep a future administration from easily reinstating the guidance that was so harmful to manufacturers. The NAM’s brief asks a federal judge to invalidate the regulatory provisions underpinning OSHA's 2016 restrictions on post-incident drug testing and safety incentive programs.

The NAM filed an amicus brief urging the U.S. Supreme Court to grant cert to reinforce the preemptive authority of the federal government to regulate pharmaceutical drug labeling. Federal law bars drug manufacturers from unilaterally changing drug labels to include warnings for off-label uses; in fact, manufacturers can face potential criminal liability for “misbranding” a drug if the label includes information about unapproved uses. Yet in this case, Janssen Pharm., et al. v. A.Y., et al., a Philadelphia jury awarded plaintiffs $70 million in damages because the manufacturer did not include a warning about an off-label use of the drug Risperdal. There are over 10,000 nearly identical cases still pending against the company in Pennsylvania state court. Manufacturers across federally regulated industries are subject to carefully calibrated federal labeling regimes that provide the certainty and predictability needed to operate. As the NAM’s brief argues, the use of state tort law to undermine federal labeling requirements will, if allowed to continue, create a confusing and ultimately destructive “dual track” system where federal agencies and state tort law will conflict and ultimately undermine the federal goal of targeting labeling to a specific audience.

Unfortunately, on May 17, 2021, the Supreme Court denied cert.

The NAM filed an amicus brief to argue that the 6th Circuit should hold that businesses that hire independent trucking companies to transport goods are not liable for the negligent acts of those independent truckers. An individual was injured in a traffic collision involving a trucking company hired by a freight broker. The injured person argued that the broker was negligent in selecting the trucking company because it knew or should have know about the company’s prior regulatory infractions. The freight broker responded that the hiring directly concerns the services a freight broker provides under the Federal Aviation Administration Authorization Act of 1994, and therefore preempts state law, including state common law for negligence. The district court agreed. On appeal to the 6th Circuit, the NAM’s amicus brief explained the careful balance that congress struck in regulating drivers under the Act, and why the plaintiffs’ theory of liability is unworkable in practice.

On September 26, 2024, the NAM filed an amicus brief urging the full 6th Circuit to consider whether the Clean Air Act preempts plaintiffs’ state law consumer protection claims. In this case, plaintiffs allege that Defendants are liable under state law for failing to disclose to consumers that auxiliary emission control devices (AECDs) constitute a prohibited defeat device—a device that reduces the effectiveness of an emissions control system. A split 6th Circuit panel held that plaintiffs’ claims are not preempted by the CAA.

We argue that plaintiffs are attempting to relitigate EPA’s determination that GM’s AECDs are not prohibited defeat devices. The 6th Circuit should rehear the case as claims that seek to second-guess EPA’s decision making, purport to rebalance Congress’s objectives and risk broader destabilization of the vehicle approval regime are plainly preempted by federal law.

The NAM filed an amicus brief in the Second Circuit seeking to uphold a summary judgment ruling in favor of the manufacturing defendants in a helicopter design defect case based on the doctrine of implied field preemption. The case arose from a fatal crash of a U.S. Army helicopter. The decedents’ estates brought design defect and manufacturing defect claims against the manufacturers of the helicopter, even though the Army required that the Federal Aviation Administration (FAA) approve all aspects of the helicopter’s design. The trial court rejected the plaintiffs’ claims after finding clear congressional intent to occupy the entire field of aviation safety, including aviation product liability cases. The NAM joined the General Aviation Manufacturers’ Association (GAMA) in filing an amicus brief arguing for affirmance of the trial court’s ruling. As the NAM’s brief explains, the FAA exercises pervasive authority to establish aviation design standards and approve compliance with those standards. The FAA also retains ultimate, exclusive authority over changes to approved designs and monitors aviation products throughout their lives in service to address any safety issues. This federal regulatory scheme requires preemption to prevent an unworkable array of conflicting requirements that would jeopardize the safety and viability of the aviation industry—in the United States and globally.

On April 1, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to review a Hawaii Supreme Court decision allowing plaintiffs to pursue claims under state law that seek to hold energy companies liable for climate change. In this case, the trial court denied the defendants’ motion to dismiss the plaintiffs’ state law claims, arguing that the claims are preempted by federal common law or the Clean Air Act. The Hawaii Supreme Court affirmed that decision, reasoning that neither federal common law nor the CAA preempt the plaintiffs’ state law claims. Our brief urges the Court to grant the petition because the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature—such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws.

The NAM filed an amicus brief supporting BNSF and underscoring the importance of the freight rail network for manufacturers that rely on it to efficiently move materials. The plaintiff seeks an unprecedented injunction restricting the type and quantity of goods that can be shipped over an interstate railway that crosses its land, particularly hazardous materials. Such an injunction would disregard the exclusive federal regulatory scheme governing interstate rail transportation, would undermine shippers’ common-carriage rights and would obstruct interstate commerce in economically critical products. The NAM’s brief explained why the court should not allow the obstruction of commerce of lawful products by giving landowners an unprecedented ability to veto the quantity or types of cargo being shipped through interstate commerce.

On September 5, 2023, the NAM filed an amicus brief arguing to the Ohio Supreme Court that commercial general liability (CGL) insurance policies cover public nuisance claims. In this case, a California trial court held Sherwin-Williams liable for public nuisance claims, alleging that it contributed to a public health crisis by promoting lead paint for interior and exterior use despite knowing the use of lead was hazardous to human beings. The parties subsequently settled the case and Sherwin-Williams sought insurance coverage for monies paid to abate the conditions created by interior residential lead paint in 10 California jurisdictions. An Ohio court of appeal held that Sherwin-Williams' insurance policies provide coverage for the monies Sherwin-Williams had to pay, and the Ohio Supreme Court granted the insurers’ request to hear the case.

In our brief, we argue that the monies Sherwin-Williams was ordered to pay to abate the public nuisance are “damages” and that the Insurers’ CGL policies cover public nuisance claims. Further, knowledge of the risk of harm a product poses at the time of manufacturing and selling the product is not a sufficient basis to deny coverage under the clause in CGL insurance policies that excludes damages that are “expected or intended.” That exclusionary clause only applies to allow an insurance company to deny coverage when a company that is insured intends for a resulting harm or injury to occur. This case is important to prevent insurance companies from being able to deny coverage under their insurance policies any time a manufacturer has knowledge that a product might cause harm.

On July 23, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to hear 19 Republican State Attorneys General’s complaint seeking to block five states—California, Connecticut, Minnesota, New Jersey and Rhode Island—from pursuing climate change litigation against energy manufacturers. The Constitution authorizes the Court to hear disputes between states. In this case, the 19 State AGs contend that the States that have brought climate change litigation are attempting to regulate interstate GHG emissions through tort actions against energy producers—actions that violate the “horizontal separation of powers, usurp federal authority over a federal issue, and violate the prohibition on extraterritorial regulation embodied in the Commerce Clause.”

We argue in our brief that review is necessary because the subject matter and remedies sought in the climate change lawsuits are inherently national, as well as legislative and regulatory in nature—such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. Further, state courts have thus far been split on whether a state can sue energy manufacturers for emissions that occur outside their borders. The Court’s review is needed now to provide guidance.

On August 5, 2024, the NAM filed an amicus brief in support of the petitioners’ request that the Colorado Supreme Court overturn the lower court’s refusal to dismiss climate change litigation brought by Boulder County and the City of Boulder. We argue that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature—such complex policy matters should not be decided by state courts under state liability laws.

The NAM filed an amicus brief in the U.S. Court of Appeals for the Second Circuit to oppose misguided efforts to impose “public nuisance” liability on energy manufacturers. The city of New York sued several energy companies to seek damages for local impacts of climate change, arguing that the defendants’ sale of fossil fuels is a public nuisance that entitles the city to financial compensation. This theory of liability poses a grave risk for manufacturers because it would impose liability on manufacturers despite a plaintiff’s inability to prove the manufacturer actually caused the plaintiff’s injuries. A federal district court dismissed the lawsuit. On appeal to the Second Circuit, the NAM’s amicus brief explains how Supreme Court precedent forecloses such lawsuits by recognizing the federal legislature as the appropriate branch of government to set national energy policy, including addressing climate change. Our brief also highlights the extensive technological innovations that manufacturers have already deployed to reduce carbon emissions, and which they will continue to pursue to address climate change and other environmental challenges.

On November 2, 2023, the NAM filed an amicus brief asking the Maine Supreme Court to affirm a trial court decision rejecting public nuisance claims brought by various hospital operators based on the manufacturing defendants' marketing or distribution of opioid medications. In this case, the hospital operators allege that marketing and distribution of opioids contributed to the opioid epidemic and increased operating costs to treat impacted patients.

We argue in our amicus brief that the trial court's decision is consistent with longstanding public nuisance liability principles and to reverse the decision would threaten open ended, industry-wide liability for a variety of products that may also have foreseeable risks or inherent externalities, including pharmaceuticals, oil and gas, and household chemicals. This case is important for all manufacturers because if the lower court's ruling is reversed, manufacturers could be subject to industry-wide liability in Maine for selling and marketing products with known risks of harm with few, if any, defenses.

On March 12, 2023, the NAM filed a coalition amicus letter urging the California Supreme Court to review a Court of Appeal decision endorsing a novel theory of liability where plaintiffs do not have to prove that a product is defective or unreasonably dangerous, but rather can assert that a company is liable for researching and developing another product that it “knew” was “safer” and failing to bring that product to market. In this case, the plaintiffs concede that the product at issue—a medication used to prevent and treat HIV/AIDS—is useful and not defective. Nevertheless, the Court of Appeal agreed with the plaintiffs that the manufacturer of the product can be held liable for the delay in bringing to market a different product the plaintiffs contend is safer.

We will argue that the decision conflicts with longstanding law and will result in a flood of litigation if left in place. The negligence theory that the Court of Appeal accepted could be repurposed against any manufacturer, not just a drug maker. And it will not be hard for enterprising plaintiffs’ lawyers to plead a claim under this new theory of negligence. California Supreme Corut review is necessary to clarify the scope of manufacturer liability and to bring California law back in line with the general and sound rule that a manufacturer can be held liable only for the products it made and sold, not products it could have made and sold.

Happily, on May 2, 2024, the California Supreme Court agreed to hear the case.

On December 19, 2022, the NAM filed an amicus brief urging the 7th Circuit to stay or enjoin ongoing mass tort litigation against a manufacturer’s solvent parent to allow the manufacturer to resolve its overwhelming tort liabilities through bankruptcy. Debtor Aearo Technologies LLC sought chapter 11 relief and, on the same day, requested, under relevant provisions of the Bankruptcy Code, a stay or injunction of all pending and future actions seeking to hold Aearo and 3M (its parent) liable for alleged injuries related to military earplugs manufactured by the companies. Litigation over the earplugs’ alleged defective design and marketing has become the largest multidistrict litigation in history, with over 290,000 claims. The bankruptcy court denied Aearo’s request, finding that the Bankruptcy Code only authorized it to enter orders to protect the “debtor, not non-bankruptcy co-debtors like 3M. The bankruptcy court further determined that a stay of pending litigation and an injunction against future actions were unwarranted because, ultimately, under the terms of their funding agreement, 3M will fully fund any liability incurred by Aearo” related to the earplugs. The instant appeal followed.

Our brief argues that bankruptcy, unlike MDL, is well equipped to resolve mass-tort lawsuits of this magnitude in an efficient manner. Further, unlike in the MDL context, bankruptcy promotes global resolution of a company’s liabilities, by sweeping in even future claims based on injuries that have not yet manifested. We urge the 7th Circuit to clarify that a bankruptcy court can and should do what is necessary and appropriate to enable a bankruptcy proceeding’s success—including staying parallel mass-tort litigation against a related entity whose liabilities redound to the debtor.

The NAM filed an amicus brief in the Texas Supreme Court to seek reversal of a Texas appellate court decision that improperly imposed liability on a manufacturer for its alleged failure to adequately warn of risks from one of its commercial air conditioners. An experienced HVAC repairman was injured when an HVAC compressor released pressurized fluids. The repairman sued the manufacturer, claiming the warning of such releases was insufficiently descriptive. A Texas jury found in the plaintiff’s favor, and an appeals court affirmed. In support of review by the Texas Supreme Court, the NAM filed an amicus brief that argued against the court of appeals’ unsupported expansion of the duty of a manufacturer to warn licensed professionals of known risks. The NAM’s brief also asks the court to clarify the jury instructions in failure-to-warn cases such as this.

The court granted review in June 2020. On April 16, 2021, the court affirmed the jury verdict, however the court took a giant leap forward by agreeing with NAM and Emerson's position that a jury in a design-defect case can be instructed on the five risk-utility balancing factors commonly used in other jurisdictions. The court failed to address the court of appeals’ unsupported expansion of the duty of a manufacturer to warn licensed professionals of known risks, deeming the issue waived based on Emerson's failure to object to a particular jury instruction. The NAM filed an amicus brief in support of Emerson's petition for rehearing on that issue, arguing that the court should have requested supplemental briefing before disposing of a case on an issue not raised or briefed by the parties.

Unfortunately, on September 3, 2021, the Texas Supreme Court denied the petition for rehearing.

The NAM filed an amicus brief urging the U.S. Supreme Court to review California’s imposition of over $300 million in civil penalties under California’s Unfair Competition Law (UCL) and False Advertising Law (FAL) without providing fair notice of the conduct that gave rise to those penalties and the scope of the potential punishment. In this case, the trial court imposed $344 million in civil penalties under the UCL and FAL—an amount 50 times greater than the largest penalties previously awarded under those statutes and larger than all other reported UCL and FAL awards combined—based on communications about FDA-approved pelvic mesh products. A California court of appeal reduced the civil penalty award to approximately $302 million but rejected the defendants-appellants’ argument that the trial court’s imposition of over $300 million in penalties violated their Fourteenth Amendment due process rights. The Supreme Court of California denied review.

We argue in our amicus brief that California’s—as well as many other states’—unfair, deceptive, and abusive practices statutes have failed to provide fair notice of the conduct that gives rise to civil penalties and the scope of the potential punishment. We urge the Supreme Court to grant the defendants-appellants’ petition for certiorari to (1) articulate the constitutional bounds for civil penalties; (2) establish principles states can use to ensure their civil penalties are objective and rational; and (3) draw from the principles the Court applies in the punitive damages and civil forfeiture contexts to place similar bounds on the aggregation of “per violation” civil penalties.

Unfortunately, on February 22, 2023, the Supreme Court denied the petition for certiorari.

The NAM filed an amicus brief in support of an application to the U.S. Supreme Court to stay a remand order transferring litigation involving “public nuisance” claims related to climate change to state court. Twenty-six energy company defendants in the case filed the stay request to allow appeals to progress on the question of which court has proper jurisdiction over the claims. The case is part of a coordinated, national litigation campaign involving over two dozen public nuisance cases filed in carefully chosen states and federal circuits by agenda-driven lawyers and activists. This issue is important to energy producers and all manufacturers because public nuisance claims involving climate change implicate federal questions and the preemption of federal laws that are appropriately heard by federal courts rather than state courts. The NAM’s amicus brief explained to the court the broader context of the plaintiffs’ legal strategy and that these suits implicate federal issues and therefore should be in federal court. Unfortunately, Chief Justice Roberts denied the stay petition. Thereafter, following the Fourth Circuit's decision to remand the case to state court, the NAM filed an amicus brief in support of BP's petition for cert. pressing the high court to resolve the circuit split regarding the scope of appellate review of remand orders involving the federal officer removal statute. Happily, on October 2, 2020, the Court granted review.

On November 23, the NAM filed an amicus brief on the merits in support of removal jurisdiction in this case, asking the Court to ensure that lower courts evaluate all grounds for removal prior to issuing remand orders.

On May 17, 2021, in a 7-1 decision with Justice Gorsuch writing for the majority, the Court reversed the Fourth Circuit’s denial of full federal appellate review of the important jurisdictional issues raised by this case and remanded the case for the Fourth Circuit to consider those issues in the first instance. Unfortunately, on April 7, 2022, the Fourth Circuit affirmed the district court's remand order, holding that none of the asserted basis for removal permit the Court to exercise jurisdiction.

On November 17, 2022, the NAM filed an amicus brief in support of the petitioners' petition to the U.S. Supreme Court for cert. The NAM's brief again argues that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws.

Unfortunately, on April 24, 2023, the Court denied the petition.

The NAM filed an amicus letter urging the California Supreme Court to review a lower court decision that eviscerates the rational boundaries for liability under California’s Unfair Competition Law (UCL) and False Advertising Law (FAL). In this case, the trial court imposed $344 million in civil penalties under the UCL and FAL—an amount 50 times greater than the largest UCL or FAL award previously reported and larger than all other reported UCL and FAL awards combined—based on the defendant’s communications about its FDA-approved pelvic mesh products. To reach this extraordinary result, the court refused to judge the communications from the perspective of their target audiences: trained physicians who treat pelvic floor conditions and the patients whom those physicians consent prior to prescribing mesh products. Instead, the court ruled that medical device risk disclosures must include all potential risks, no matter whether they are already known to physicians or likely to mislead prospective patients.

The NAM’s amicus letter emphasizes that proper application of the “likely to deceive” standard under the UCL and FAL is vital to protect against speculative allegations of deceit that are not grounded in the real-world context in which the communications were made. The UCL and FAL have already spawned a number of product lawsuits premised on idiosyncratic readings of existing representations or demands that every conceivable malfunction be disclosed prominently before purchase. Ensuring that any omission of risk information is assessed through a rigorous “likely to deceive” standard keeps the most highly speculative UCL and FAL lawsuits from clogging the judicial system

Unfortunately, on July 13, 2022, the California Supreme Court denied the petition for review.

On May 22, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to review a 1st Circuit decision allowing Mexico to proceed on claims attempting to hold firearms manufacturers liable for cartel violence in Mexico. In this case, the 1st Circuit reversed a District of Massachusetts decision dismissing Mexico’s tort claims against firearm manufacturers under the Protection of Lawful Commerce in Arms Act’s general prohibition of tort suits against firearms manufacturers. The 1st Circuit reversed, however, after finding Mexico’s claims exempt from the PLCAA because Mexico alleged that the defendants proximately caused it harm (expenditure of money to combat cartel violence).

We argue that the PLCAA’s proximate cause requirement incorporates traditional notions of proximate cause that have served to protect manufacturers engaged in lawful commerce of products with inherent risks from unprincipled liability. U.S. Supreme Court review of the 1st Circuit’s decision is necessary to (1) resolve the circuit split created by the 1st Circuit’s erroneous conclusion that foreseeability alone could satisfy proximate cause; (2) reaffirm that foreseeability is insufficient to establish proximate cause; and (3) ensure that no government—foreign or domestic—can use the civil justice system to regulate lawful products by imposing untenable liability costs on their continued production and sale.

On July 8, the NAM filed an amicus brief asking the U.S. Supreme Court to grant cert in one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. The case, Suncor Energy Inc., et al v. Board of Cnty. Commissioners of Boulder Cnty., et al., is part of a coordinated, national litigation campaign filed in carefully chosen states and federal circuits by agenda-driven lawyers and activists. The issue presented is whether putative state-law tort claims alleging harm from global climate change are removable to federal court because they arise under federal law. On the few occasions where federal courts have reached the substance of these claims, the courts have concluded that the claims arise under federal common law and are displaced by the Clean Air Act.

Earlier this year, the 10th Circuit agreed with the plaintiffs’ novel argument that their claims became viable under state law and could not be removed because Congress exercised its authority and displaced the federal common law by enacting the Clean Air Act—a theory that the Second Circuit referred to in a related case as “too strange to seriously contemplate.” Further, the 10th Circuit concluded that under the well-pleaded complaint rule, federal courts are not permitted to look behind the veneer of the claims’ state law labels even when the labels are clearly masking federal law claims. In support of Supreme Court review, the NAM filed an amicus brief arguing that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws.

Unfortunately, on April 24, 2023, the Court denied the petition for cert.

On April 16, the NAM filed an amicus brief urging the 6th Circuit to affirm a lower court dismissal of a no-injury class action. The plaintiffs in this case instituted a putative class action against Whirlpool in the Western District of Michigan alleging that the company engaged in fraud and violated various state consumer protection laws by selling ranges without disclosing a latent product defect—control knobs susceptible to unintentional actuation that create a risk of hazardous conditions. Although the district court agreed with the plaintiffs that their “benefit of the bargain” theory of harm—that they would have paid less for the ranges or purchased another brand had they known of the alleged defect—established the requisite injury necessary to support standing to sue, the court granted Whirlpool’s motion to dismiss for failure to state a claim. The court concluded that the plaintiffs failed to allege that Whirlpool had presale knowledge of the safety risk presented by the defect, a necessary element of the plaintiffs’ claims. The plaintiffs appealed that decision to the 6th Circuit.

We explain in our amicus brief that to state a claim and establish a concrete injury to support Article III standing, plaintiffs must allege that they were harmed by the alleged defect. Claims of injury premised on an overpayment for a product require plaintiffs to provide an objective measure against which their claims may be measured. The plaintiffs here, however, do not specify the value of the range they contend they bargained for versus the value of the range they actually received, i.e., how much the ranges diminished in value to them given the knobs’ “defect.” We further argue that enforcing the pleading standards will prevent plaintiffs from masking their allegations of product defect as consumer fraud class actions.

On May 1, 2023, the NAM filed an amicus brief urging the Alabama Supreme Court to review and reverse a lower court order extending Alabama’s law of public nuisance to the marketing and distribution of legal and highly-regulated products—FDA-approved medications. In this case, Ex Parte Janssen Pharmaceuticals, Inc., Alabama hospitals sued the manufacturers and distributors of opioid medications in Alabama state court alleging that the defendants’ activities created a public nuisance—the opioid epidemic—that caused them to incur increased operational costs. Notably, however, public nuisance law in Alabama—as in other states—is a land and water use cause of action, directed at resolving local disturbances that interfere with the right of the public to use a public road, communal space, or local waterway.

We argue in our brief that the trial court’s decision departs from long-standing public nuisance liability principles and threatens open-ended, industry-wide liability for a variety of products that may also have foreseeable risks or inherent externalities, including pharmaceuticals, oil and gas, and household chemicals. This case is important for all manufacturers because if the trial court’s ruling can stand, manufacturers could be subject to industry-wide liability in Alabama for selling and marketing products with known risks of harm with few if any defenses.

Unforturnately, on June 2, 2023, the Alabama Supreme Court denied the request for review.

On June 26, 2024, the NAM filed an amicus brief in this take home asbestos exposure case. In this case, a worker worked around asbestos-containing molding compounds used to make finished plastic products. The worker’s family member sued Schneider and Union Carbide alleging that her mesothelioma diagnosis derived from exposure to asbestos from her father’s contaminated work clothes. The trial court granted summary judgment for Schneider and Union Carbide, concluding that they had no duty to protect against secondary exposure to asbestos. Kentucky’s intermediate appellate court, however, reversed on appeal and recognized a duty “to household members who regularly and repeatedly came into close contact with an employee's asbestos-contaminated work clothes over an extended period.” We argue that no such duty exists under Kentucky law.

This case was brought in the 5th Circuit by activist group NCPPR accusing the SEC of applying its Rule 14a-8 in an inconsistent and politically motivated manner. Under SEC Rule 14a-8, public companies are required to include certain shareholder proposals on their proxy ballot. Historically, companies could exclude proposals that encroached on the company’s "ordinary business operations." However, in November 2021, the SEC released new guidance (SLB 14L) making proposals that raise issues with "broad societal impact" presumptively non-excludable. And activist groups from across the ideological spectrum are increasingly using shareholder proposals to inject contentious ideological policy fights into corporate governance. In May 2023, we intervened in this case to push back on this troubling trend.

On July 21, 2023, we filed our opening brief arguing that Rule 14a-8 violates the First Amendment by compelling a company to include shareholder-selected proposals unrelated to the company’s core business or the creation of shareholder value on the company’s own proxy statement at the company's own expense. Aside from these constitutional concerns, the SEC lacked authority to issue Rule 14a-8. Congress only authorized the SEC to enact rules prohibiting deceptive or misleading statements by corporations when they solicit shareholder-proxy votes. Rule 14a-8, however, does not address such statements.

On October 3, 2023, we filed our reply brief urging the 5th Circuit to reject the SEC's jurisdictional and procedural arguments and hear this important challenge to the SEC's authority to dictate which proxy ballot items investors should consider. We explain in our reply brief that, contrary to the SEC's assertions, there are no jurisdictional or procedural barriers preventing the 5th Circuit from holding that the SEC lacks authority to compel companies to include and subsidize shareholder speech within the company's own proxy statement. And in addition to the SEC's failure to clear the First Amendment barrier to its compelled subsidized speech regime, the SEC fails to identify a clear statement from Congress giving it the authority to hijack a corporation's own speech in contravention of state corporation law that does not enable shareholders to insert their speech or voting proposals onto a corporation's own proxy statement.

This case was brought in the 5th Circuit by activist group NCPPR challenging an SEC no-action letter--stating that it would not recommend enforcement action against Kroger if Kroger excluded NCPPR's proposal from its proxy ballot--and accusing the SEC of applying its Rule 14a-8 in an inconsistent and politically motivated manner. Under SEC Rule 14a-8, public companies are required to include certain shareholder proposals on their proxy ballot. Activist groups from across the ideological spectrum are increasingly using shareholder proposals to inject contentious ideological policy fights into corporate governance. We intervened in this case to raise two arguments not addressed by the parties: (1) Rule 14a-8 violates the First Amendment by compelling a company to include shareholder-selected proposals unrelated to the company’s core business or the creation of shareholder value on the company’s own proxy statement at the company’s own expense; and (2) the SEC lacks authority to compel company speech on its own proxy statement.

On April 5, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to enforce the robust pleading standards required by the Private Securities Litigation Reform Act to assert a securities fraud claim. Public companies, including many NAM members, are often the targets of frivolous securities litigation. The PSLRA created a heightened pleading standard for bringing securities fraud suits. Nevertheless, a 9th Circuit panel allowed the plaintiffs in this case to rely on an expert’s post hoc analysis to support their securities fraud claim without alleging with particularity the contents of any internal report or data source that would have put the defendant’s executives on notice that their public statements about who was purchasing the company’s gaming processing units were false or misleading when made.

We argue in our amicus brief that Supreme Court review is needed to resolve a circuit split on the pleading standards under the PSLRA. The panel’s decision will also create a playbook for securities plaintiffs to evade the PSLRA’s stringent pleading requirements by pointing to post-hoc, made-for-litigation expert opinions resting on unreliable assumptions and devoid of any basis in internal company data. Happily, on June 17, 2024, the Court granted the petition for certiorari.

On August 20, 2024, the NAM filed an amicus brief urging the Supreme Court to reverse the 9th Circuit's decision. We argue that affirming the 9th Circuit’s decision would undermine the PSLRA’s pleading standard by allowing plaintiffs to point to post-hoc, made-for-litigation expert opinions instead of particularized factual allegations. Affirming would also hamper the economic competitiveness of domestic industry by creating excessive litigation risk.

On February 16, 2023, the NAM filed an amicus letter seeking intervention by the California Supreme Court in a case involving a party’s ability to challenge agency action under the California Environmental Quality Act (CEQA). This case arises from the California Department of Toxic Substances Control (the Department) listing spray foam systems as a priority product under California’s "Green Chemistry" law. This listing subjects the spray foam industry in California to potential restrictions or ban on the sale of its product. The petitioners--American Chemistry Council (ACC) and General Coatings Manufacturing Corp--sued the Department challenging the listing as a violation of the CEQA. The trial court found for the petitioners on their CEQA claim. On appeal, however, the Department maintained that the petitioners’ claim should have been dismissed as untimely under CEQA’s 180-day statute of limitations. In turn, the petitioners argued that their claim was timely because the statute of limitations period began to run after ACC fully exhausted the Department’s administrative appeals process under relevant regulations implementing the Green Chemistry law. The Court of Appeal agreed with the Department, concluding that litigants do not need to exhaust administrative remedies before initiating CEQA claims unless the underlying administrative review process specifically references CEQA--here, the relevant regulations make no reference to CEQA. We argued in our amicus letter that review is necessary because the Court of Appeal’s decision provides little guidance as to what level of detail is required to incorporate CEQA claims into administrative exhaustion procedures enumerated in other statutory schemes. Allowing the Court of Appeal’s decision to stand will undermine three key tenants of the California judicial system: (1) the efficiency and conservation of resources that administrative exhaustion affords; (2) legal clarity that precludes agencies from shielding their decision-making from judicial review; and (3) a preference for resolving disputes on the merits instead of on technicalities. All manufacturers involved in CEQA litigation would benefit from clear rules regarding what steps are required before CEQA litigation can be initiated. Unfortunately, on March 29, the California Supreme Court denied theh petition for review.

On February 22, 2023, the NAM filed an amicus brief urging the Federal Circuit to reverse the lower court’s dismissal of over $19M in breach of contract claims against the federal government as barred by the statute of limitations for submitting a claim to a contracting officer, a prerequisite to pursuing litigation. In this case, a contracting officer denied Textron’s claim for payment of pension costs recoverable under government contracts as time-barred under the applicable six-year statute of limitations for submitting a claim. Textron promptly filed a complaint against the government in the U.S. Court of Federal Claims, which granted summary judgment in favor of the government based on the statute of limitations, holding that Textron’s claim had accrued more than six years before July 2020 (when Textron submitted the claim).

We argue in our brief that the trial court failed to apply the proper claim accrual standard. Textron’s request for the government to pay its share of pension costs following a segment closing should not be considered a "claim"--it is a routine submission that is not in dispute when submitted and the government must be afforded sufficient time to conduct its administrative review of the submission before the request can be considered a claim. Even assuming a request for payment of pension costs after a segment closing could be considered a claim, the trial court misapplied the remaining elements of claim accrual. Textron did not experience an injury and was unable to present its claim until the government denied payment. Claim accrual can only commence when all events have transpired to fix the government’s liability. All manufacturers who are government contractors subject to administrative adjustments between contracting partners have an interest in an efficient, collaborative, and non-litigious framework for the claim accrual standard.

On February 14, 2024, the NAM filed an amicus brief urging the 8th Circuit to reverse the IRS’s increase of a manufacturer’s taxable income by more than $23 million. In this case, 3M v. Commissioner, 3M licensed certain intellectual property to a Brazilian subsidiary who was barred by Brazilian law from paying 3M the arms-length price for use of the IP. The Tax Court erroneously endorsed the IRS’s view that it could increase the company’s taxable income to reflect a hypothetical arms-length transaction even though foreign law precluded the company from receiving the arms-length price in the transaction.

We argue in our brief that the IRS’s actions contradict controlling precedent and that allowing the IRS to increase 3M’s revenue would upend the public’s settled expectations upon which businesses rely to make investment decisions. We will also argue that the 8th Circuit should not allow the IRS to flout its Administrative Procedure Act obligations by relying on a rule for its actions that did not go through the notice and comment process.

On March 31, 2022, the NAM filed an amicus brief urging the Seventh Circuit to reverse the Tax Court’s misapplication of tax code regulations which rendered a taxpayer’s valid research expenditures ineligible for the R&D tax credit. This case is of critical importance to manufacturers as the manufacturing sector leads all others in performing private sector R&D. Here, after finding that the taxpayer (a manufacturer of oil tankers and dry docks) undertook the type of research that the credit was intended to incentive, the Tax Court nonetheless denied the claimed credit after concluding that the taxpayer failed to prove that “substantially all” (80%) of its development activities “constitute[d] elements of a process of experimentation.” To reach this erroneous conclusion, that Tax Court distinguished costs incurred for employees engaging in qualified research from costs incurred for those directly supporting or supervising qualified research—a distinction not supported by the tax code or the relevant Treasury regulations.

The NAM’s brief explains that the Tax Court’s approach is inconsistent with the text, structure, history, and purpose of the Tax Code and with the relevant implementing regulations. Fabrication of prototypes or pilot models used in testing can be essential to the development of new products, particularly in the manufacturing sector. And, as was true in this case, the labor costs for such fabrication can be substantial. The Tax Court’s reasoning inexplicably penalizes manufacturers who, in performing legitimate and potentially important R&D, incur substantial costs to test new designs or concepts. If affirmed, that reasoning will undermine Congress’ efforts to encourage increased investments in domestic R&D, including increased spending on employees who directly support R&D efforts—results completely at odds with the purpose of the law.

On March 7, 2023, although the Seventh Circuit affirmed the Tax Court's decision, it clarified that both support time and supervision time as well as the costs of building and testing a prototype can be elements of a process of experimentation for purposes of the R&D tax credit.

On April 17, 2023, the NAM filed an amicus brief urging the U.S. Supreme Court to review and reverse a North Carolina Supreme Court decision disregarding precedent that precludes a state from taxing the sale of goods that occurs outside its borders. Quad Graphics is a Wisconsin-based commercial printer that prints books, magazines, catalogs, and direct-mail items for customers throughout the United States, including in North Carolina. The North Carolina Department of Revenue imposed a sales tax on Quad for sales to North Carolina residents even though those sales were consummated in Wisconsin by passing title to the merchandise (and risk of loss) when the merchandise arrived at a common carrier’s shipping dock outside of North Carolina for shipping. The North Carolina Supreme Court upheld the tax, concluding that subsequent U.S. Supreme Court precedent implicitly overruled McLeod v. J.E. Dilworth Co., 322 U.S. 327 (1944), which precludes taxing out-of-state sales.

We argued in our amicus brief that review is necessary for manufacturers to have clear rules about where and when taxes will be imposed. Further, the U.S. Supreme Court should grant the petition because the Commerce Clause precludes a state regulating conduct outside its borders. All manufacturers have an interest in limiting a state’s ability to regulate conduct occurring outside its borders as well as reducing the untenable risk of double taxation.

Unfortunately, on June 20, 2023, the Court denied the petition for certiorari.

The NAM filed an amicus brief in the U.S. District Court for the Western District of Washington supporting protection of confidential communications between taxpayers and their non-attorney tax advisors. Federal law under the “tax Privilege” generally makes such communications confidential, but an exception exists for communications relating to “the promotion of the direct or indirect participation” in a “tax shelter.” While a tax shelter is broadly defined, “promotion” is not, and the government wants to remove routine tax advice and common tax planning from the protections of the tax privilege, which would make it more difficult for manufacturers access to important tax advice. The NAM filed an amicus brief arguing that Congress did not intend such a broad interpretation, tax policy favors the free flow of information between taxpayers and their advisors, and routine advice should not make a tax advisor a promoter of a tax shelter. The court refused to consider NAM's or any other amici briefs and the case was closed in 2017.

This white paper explores the First Amendment implications of mandatory product disclosures and transparency initiatives, when such disclosures compel manufacturers to disparage their own products, or to in-effect take sides in controversial public policy debates they might otherwise avoid. Such mandates raise important free speech concerns under the First Amendment, and as a result courts should apply strict scrutiny when reviewing them.

The First Amendment prohibits public officials from wielding the coercive power of the government to silence private organizations—including corporations—with differing or opposing viewpoints on controversial issues of public concern. Corporations, either alone or through their participation in trade associations, and in conjunction with other third parties, make substantial and important contributions to issues of public debate contributing their industry knowledge, experience and research to enhance understanding of important issues of public concern.

This white paper argues that in order to safeguard these rights, Government officials and courts must cautiously evaluate motives for subpoenas and investigative demands that target activities relating to legitimate participation in the public policy process and must guard against the use of these powers to silence or censure particular points of view.

This white paper explains how regulatory actions can impinge on core First Amendment rights and identifies fundamental principles that should inform agency action and judicial review of such action to ensure that agencies properly recognize the First Amendment as a limitation on government power.

On November 15, 2023, the NAM filed an amicus brief asking the D.C. Circuit to review an EPA rule concerning the treatment of confidential business information reported to or obtained by EPA under the Toxic Substances Control Act. TSCA requires EPA to maintain an inventory of chemicals manufactured, imported, and processed in the United States for non-exempt commercial purposes. Accordingly, companies must report a new chemical substance or a new use of an existing substance to EPA. Companies that manufacture the substance can claim confidentiality for the submitted information when reporting to EPA.

In this case, EPA's final rule allows third-party waivers of TSCA’s confidentiality protections when a third party, such as a chemical customer or processor, reports a new use of a substance that a manufacturer claimed was confidential. This could allow downstream customers or processors of a chemical who submit information to EPA to waive manufacturers’ confidentiality claims and rights. We argue in our amicus brief that TSCA does not authorize third party waiver of a manufacturer’s confidentiality protections in the fashion contemplated by EPA in its final rule. Protecting confidential business information is important to the competitive strength of the chemical industry to bring innovative solutions and new products to market. Making confidential business information freely available to other companies will disincentivize companies from investing in product development.

On September 30th, the NAM filed an amicus brief urging the Middle District of Tennessee to vacate the SEC’s recission of the rule. As in our case, plaintiffs U.S. Chamber of Commerce, Business Roundtable, and Tennessee Chamber of Commerce and Industry, brought this challenge to the 2022 rescission arguing that it is both substantively arbitrary and capricious several times over and was adopted without good-faith observance of the Administrative Procedure Act’s mandated rulemaking procedures. Both cases seek to have the 2022 recission vacated ahead of the 2023 proxy season. Our amicus brief expands on the plaintiffs’ position that the concerns about proxy firms that animated the 2020 proxy firm rule have not abated, that the SEC failed to provide meaningful opportunity for comment prior to rescission of the 2020 rule, and that the SEC’s policy reversal is arbitrary and capricious.

Unfortunately, on April 24, 2023, the court denied the plaintiffs' motion for summary judgment and granted the SEC's cross-motion.

In July 2022, the SEC issued a final rule to rescind the 2020 critical reforms subjecting proxy advisory firms—unregulated third parties with outsized influence on shareholder votes and manufacturers’ corporate governance policies—to reasonable SEC oversight just like every other participant in the securities markets. The NAM sued the SEC in the Western District of Texas arguing that the 2022 recission is arbitrary and capricious as well as procedurally defective. We have asked the court to vacate the 2022 recission in its entirety and declare that the recession is unlawful and void.

Unfortunately, on December 4, 2022, the court denied the NAM’s motion for summary judgment and granted the SEC's cross-motion.

On August 28, 2023, tthe NAM filed an amicus brief opposing the FTC’s attempt to block Amgen’s merger with Horizon, the sole manufacturer of two unique FDA-approved medicines for thyroid eye disease and chronic refractory gout. Even though Amgen and Horizon are not competitors, the FTC seeks to prevent the merger based on the speculative theory that hypothetical new competitors to Horizon’s products might achieve regulatory approval at some undetermined time in the future and that Amgen may then engage in price discounting practices to limit competition.

We argue in our brief that the FTC’s speculative theory of competitive harm is unsupported by antitrust law. Adopting the FTC’s theory would harm competition and consumers by chilling merger activity--due to uncertainty over what activity the FTC could construe as anticompetitive--which could result in further innovation and efficiencies.

Fortunately, on September 1, 2023, the parties reached an agreement on a consent order to resolve the case and allow Amgen to continue with its acqusition of Horizon.

On October 20, 2023, the NAM filed an amicus brief urging the full 9th Circuit to enforce the robust pleading standards required by the Private Securities Litigation Reform Act (PSLRA) to assert a securities fraud claim. Public companies, including many NAM members, are often the targets of frivolous securities litigation. The PSLRA created a heightened pleading standard for bringing securities fraud suits. Nevertheless, a 9th Circuit panel allowed the plaintiffs in this case to rely on an expert’s post hoc analysis to support their securities fraud claim without alleging with particularity the contents of any internal report or data source that would have put the defendant’s executives on notice that their public statements about who was purchasing the company’s gaming processing units were false or misleading when made.

We argue in our amicus brief that the full 9th Circuit should rehear this case. The panel’s decision will create a playbook for securities plaintiffs to evade the PSLRA’s stringent pleading requirements by pointing to post-hoc, made-for-litigation expert opinions resting on unreliable assumptions and devoid of any basis in internal company data.

Unfortunately, on November 15, 2023, the 9th Circuit declined to rehear the case.

Yesterday, the NAM filed an amicus brief urging interlocutory review of a district court’s flawed class certification ruling that artificially inflated the size and scope of the putative class by allowing the named plaintiffs to (1) bring antitrust claims under the laws of states where they neither reside nor were injured, and (2) to seek “umbrella damages”—damages for paying for a competitor’s product because a generic drug was unavailable. In this case, In re HIV Antitrust Litigation, the named plaintiffs alleged that defendants engaged in anticompetitive conduct that prevented generic drug companies from selling cheaper HIV drugs. Ignoring the Supreme Court’s and other California district courts’ precedent, the district court here concluded that whether a named plaintiff can bring class claims under the laws of a state where they neither reside nor were injured should be considered under the typicality or adequacy requirements of Rule 23, not as a threshold Article III standing issue. According to the court, the named plaintiffs satisfied those requirements by asserting individual claims sufficiently like the antitrust or consumer protection claims under the laws in states where they neither reside nor were injured. And the damages class could include individuals who purchased competitor HIV drugs, not defendants’ HIV drug, because the alleged anticompetitive conduct could have been the proximate cause for those individuals paying more for competitor HIV drugs.

The NAM filed an amicus brief in support of the pharmaceutical defendants’ petition for interlocutory review emphasizing that plaintiffs seeking to represent a class must have Article III standing to bring each claim asserted. Here, the district court erred by following the minority approach, holding that whether a plaintiff can assert claims under laws of states other than those where the plaintiff resides or was injured is an issue of adequacy or typicality. Further, the district court artificially enlarged the class size by including in the class those who bought products from the defendants’ competitors, not defendants. As we explain in our brief, the 9th Circuit should grant the petition to protect “the courts and defendants from prolonged, expensive litigation, as well as abusive, in terrorem settlements driven by defendants’ risk aversion, not justice.” All manufacturers have an interest in ensuring that class certifications are properly tailored to concrete claims and that aggregating litigation does not distort outcomes that would have resulted had the litigants filed their claims individually.

Last Friday, the NAM filed an amicus brief in the 1st Circuit asking the court to affirm dismissal of a putative class action where the proposed class members sustained no concrete harm. In this case, Xavier, et al. v. Evenflo Co., Inc., et al., the class alleged a purely economic injury—that they would not have purchased defendant’s booster seat or would have paid less for it had they known about the seat’s purported safety risks for children weighing under a certain amount. But each member of the proposed class received the full benefit of the bargain: they paid for a booster seat, they received a booster seat, and they used the booster seat without suffering any harm. Accordingly, the District of Massachusetts dismissed the claims for failing to allege a cognizable injury. The instant appeal followed.

As NAM’s brief explains, no-injury class actions can wreak havoc on the judicial system. They often lead to prolonged litigation, vacuous settlements that provide no real benefits to the class, and outcomes inconsistent with product liability and other substantive areas of law. Despite the U.S. Supreme Court’s recent holding in TransUnion v. Ramirez—"under Article III, an injury in law is not an injury in fact,”— class counsel around the country continue to bring cases under inventive damage theories, suggesting that the discovery of a potential defect or an alleged misrepresentation, even if it never caused physical harm, created a theoretical risk of harm and an undefined economic loss for the entire class based on that unrealized risk. Here, the district court properly applied the law and dismissed the claims because the plaintiffs made no showing in their pleadings that they suffered any real-world harm. The 1st Circuit should affirm that ruling to rein in abusive class actions and ensure that judicial resources are spent on claims involving actual injuries.

Unfortunately, on November 23, 2022, the 1st Circuit held that the plaintiffs have standing to seek monetary relief and remanded the case for further proceedings.

The NAM filed an amicus brief in the Texas Supreme Court concerning the interpretation and enforceability of indemnity provisions in contracts between sophisticated commercial entities. In this case, the owner and operator of an oil refinery contracted with a large industrial contractor to perform specialty work. In the contract, the contractor agreed to indemnify the owner for losses or other liabilities due to bodily injury claims in connection with the contractor’s work. The owner was later sued after some of the contractor’s employees were injured. Although the owner reached a settlement with the injured workers, the contractor refused to participate in that settlement or honor its indemnity obligations. The owner filed suit, and the contractor moved for summary judgment, arguing that the owner had forfeited its contractual rights by settling with the workers. That motion was denied, and the instant interlocutory appeal followed.

Manufacturers consistently enter into contracts, like the general services agreement at issue in this case, with indemnification provisions governed under Texas law. The ability of sophisticated private parties to negotiate the allocation of risks and potential liability through contract is crucial to manufacturers’ business interests. The NAM’s brief argues that fundamental principles of contract law require Texas courts to honor the contractor’s express agreement to indemnify. The contractor’s position here would disrupt countless contracts between commercial parties and severely disincentive personal injury settlements, unnecessarily wasting judicial resources. Happily, on December 10, 2021, the court agreed to hear the case.

The MCLA filed an amicus brief in support of Fluor Corporation's petition to the Fourth Circuit Court of Appeals seeking review of a trial court order requiring Fluor to produce privileged communications related to an internal investigation because they had been disclosed to the government pursuant to a regulatory requirement. Under the Federal Acquisition Regulation Mandatory Disclosure Rule (MDR), federal contractors must timely disclose instances in which the contractor has credible evidence that an employee has violated certain criminal laws or the civil False Claims Act. While investigating an employee's actions, Fluor found “credible evidence” of misconduct, and reported the conclusions of its investigation to the Defense Department pursuant to the MDR. That employee then sued Fluor, asserting defamation and other claims, and sought Fluor’s internal investigative files in discovery. Fluor objected on the basis that the files were protected by the attorney-client privilege and attorney work product doctrine. The district court held that Fluor’s governmental disclosure had waived privilege because it made a set of statements as part of its MDR disclosures that were “legal conclusions, . . . which only a lawyer is qualified to make,” and because Fluor had inadvertently characterized these disclosures as “voluntary” in filings before the court. Fluor sought emergency relief in the form of a writ of mandamus, and on March 6, 2020, the MCLA filed a coalition amicus brief arguing that the trial court's order poses significant adverse consequences for manufacturers in numerous regulated industries, and may ultimately chill participation in voluntary and mandatory disclosure and compliance programs. On March 13, 2020, while denying our motion to participate as amicus, the Court granted mandamus review indicating that the district court’s decision was “clearly and indisputably incorrect.”

On February 1, 2022, the NAM filed an amicus brief in support of Enbridge Energy’s lawsuit seeking to prevent Michigan from revoking its easement and shutting down its Line 5 pipeline. Enbridge has operated the Line 5 pipeline—which originates in Wisconsin, passes through Canada, and transports light crude and natural gas liquids into Michigan since 1953. In 2020, Michigan unilaterally revoked and terminated the nearly 70-year old easement because Enbridge had purportedly violated the public trust doctrine due to the risk of an anchor strike and potential rupture. Various lawsuits followed, including the current case, Enbridge Energy Ltd. V. Whitmer, in which Enbridge is seeking summary judgment in the Western District of Michigan on its claims that Michigan’s actions (1) are preempted by the Pipeline Safety Act and (2) violate the Foreign Affairs Doctrine.

The NAM’s amicus brief emphasizes the federal government’s exclusive role in regulating pipeline safety under the Pipeline Safety Act (49 U.S.C. § 60104). We further argued that permitting Michigan to shut down an international pipeline governed by treaty would undermine the U.S. government’s exclusive authority over transboundary pipelines, unduly burden international commerce, and weaken the federal government’s ability to speak with one voice on foreign affairs. Manufacturers have a shared interest in preventing novel attempts by states to force closure of vital pipelines based on speculative risks and despite significant economic impacts.

On September 20, 2024, the NAM filed an amicus brief urging the full D.C. Circuit to rehear this energy case that raises an issue of exceptional importance—whether a state’s energy policies can override federal energy decisions Congress assigned to the Federal Energy Regulatory Commission alone. Here, FERC approved a pipeline project carrying natural gas through New Jersey, New York, Delaware, Maryland and Pennsylvania. Following a challenge by environmental groups, the D.C. Circuit concluded that in approving the pipeline, FERC failed to adequately consider evidence suggesting a lack of market need for the pipeline’s additional capacity in New Jersey and New Jersey state laws mandating reductions in natural gas consumption.

We argue that the Natural Gas Act authorizes FERC to ensure that the public has access to an affordable and reliable energy supply. Full D.C. Circuit review is necessary to prevent states—which have their own natural gas reduction goals—from controlling federal energy policy, a matter of federal concern.

On August 14, 2023, the NAM requested permission to file an amicus brief in an enforcement action the EPA commenced in the Eastern District of Louisiana under the Clean Air Act to compel Denka Performance Elastomer to limit its chloroprene emissions or cease production of the chemical. Chloroprene is a chemical used to manufacture synthetic rubber. The EPA brought this action, based on its Integrated Risk Information System (IRIS) value for chloroprene and view that the IRIS value demonstrates that the emissions from Denka’s plant exceeding that value present an imminent risk of harm to the public.

We argue in our brief that IRIS values are neither statutes nor regulations and therefore the values are an improper basis for an enforcement action. IRIS simply assists the EPA in developing its emissions standards and other related rules under the Clean Air Act to assess the possible health effects of chemical exposure; IRIS does not definitely measure adverse effects of exposure. If the use of IRIS values for an enforcement action is condoned, companies could be subject to liability for their chemical emissions levels even if compliant with statutes, regulations and permit requirements.

Unfortunately, on August 16, 2023, the district court denied our motion for leave to file an amicus brief.

The NAM joined with partner organizations to bring a prophylactic challenge to a final rule regulating PIP (3:1)—a persistent, bio-accumulative chemical that is ubiquitous in manufacturing operations and supply chains—under the Toxic Substances Control Act. The rule called for the prohibition of PIP (3:1) on an aggressive timeline that would have severely impacted supply chains for a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature. After the NAM coalition files it petition in the D.C. Circuit raising these compliance issues, the EPA agreed to seek additional public input on the rule for a period of 60 days, with a special focus on alternative exposure reduction measures for certain products. The agency also issued a issued a rare “No Action Assurance” to notify regulated industry that it would not enforce the rule for 180 days pending next steps in the rulemaking process to provide longer-term relief. The case is currently in abeyance pending the new rulemaking.

In 2017, the MCLA sued the EPA to challenge the agency’s rule governing risk management plans for chemical facilities and oil refineries. The rule imposed costly and burdensome requirements on facilities that handle hazardous substances without improving worker or community safety. The court stayed the litigation after the EPA delayed enforcement of the rule and proposed a substantive replacement. The EPA then issued a final rule in 2019. The litigation remains stayed pending further orders from the court.

On June 11, 2024, the NAM filed a petition in the D.C. Circuit challenging EPA’s final rule setting individual standards for six per- and polyfluoroalkyl substances (PFOA, PFOS, PFHxS, HFPO-DA, PFNA and PFBS) in municipal water systems. PFAS are a diverse group of chemicals essential to modern life, including in the transformers used to power electric grids; in the semiconductors and solar components needed for clean energy transition; and in the aircraft, munitions, fire suppression systems and communication devices required for national security. EPA’s new rule sets a “Maximum Contaminant Level” for each of the six substances at or near zero—equivalent to a few drops in an Olympic swimming pool. The standards are so low that full compliance may never be achieved—meaning PFAS manufacturers and users will be unable to obtain discharge permits. And as municipalities face the high costs of coming into compliance (an estimated $3.8B annually), water systems, state attorneys general and other stakeholders have, and will continue to, bring litigation against manufacturers to defray those costs. Enterprising plaintiffs’ lawyers have also started using the infeasible standards to assert toxic tort and personal injury suits against manufacturers.

In our opening brief, filed on October 7, 2024, we explain that in plowing ahead with its unattainable rule, EPA violated the express requirements of the Safe Drinking Water Act and engaged in arbitrary and capricious decision making in violation of the Administrative Procedure Act. The rule’s many deficiencies include:

• A deeply flawed cost-benefit analysis that combines costs and benefits for multiple substances into a group determination, ignores substantial costs raised by commenters and improperly relies on “nonquantifiable benefits” where it lacked empirical data;

• A woefully incomplete feasibility analysis that fails to grapple with whether the technology and facilities necessary for compliance even exist;

• The novel and unlawful use of a “hazard index” (for PFHxS, HFPO-DA, PFNA, and PFBS), never before used in the SDWA’s 50-year history;

• Failure to consider reasonable alternatives or respond meaningfully to public comments that undercut its judgment; and

• Significant procedural deficiencies in regulating the hazard index substances like collapsing two distinct rulemaking steps into a single step and forgoing Science Advisory Board review along the way.

For these reasons, we are asking the D.C. Circuit to vacate the rule.

On May 20, 2024, the NAM filed an amicus brief urging the D.C. District Court to vacate EPA’s final rule setting Washington’s water quality standards. In this case, EPA imposed water quality standards on Washington state. It based those standards, in part, on the fish consumption rate of Indian tribes within the state, instead of consumption rates of the general population, to reflect consideration of tribal treaty-reserved rights to fish. Business groups sued EPA arguing that the standards—set so low that they cannot be measured with existing technologies—are arbitrary and capricious in violation of the Administrative Procedure Act.

Our brief underscores the threat to permitting and growth of domestic manufacturing if the district court upholds EPA’s infeasible water quality standards. Further, EPA’s novel reliance on treaties with Indian Tribes for the imposed standards exceeds the agency’s authority under the Clean Water Act. If allowed to stand, this approach could enable EPA to override state-established CWA standards whenever it deems them inconsistent with its own, EPA-specific interpretation of tribal treaty rights, regardless of the scientific basis of its decision.

A group of individual plaintiffs brought a class action lawsuit against defendant Saint-Gobain Performance Plastics Corp., alleging that Saint-Gobain released perfluorooctanoic acid (PFOA) into groundwater that seeped into the plaintiffs' nearby land. The plaintiffs argued that they are entitled to financial damages to pay for ongoing medical health monitoring because of their alleged exposure to PFOA, and to compensate them for lower property values allegedly caused by the contamination. Saint-Gobain moved to dismiss the complaint because New York law does not recognize claims for medical monitoring absent any evidence of physical harm and does not recognize diminution of property value due to alleged groundwater contamination. The district court denied the motion to dismiss but certified immediate appellate review by the United States Court of Appeals for the Second Circuit. The NAM filed an amicus brief on behalf of Saint-Gobain to ensure that the law limiting medical monitoring and diminution-of-value claims remains appropriately balanced and favorable to manufacturers. Without appropriate limitations on these types of claims, manufacturers would be subject to massive and unwarranted increases in liability exposure.

On February 12, 2024, the NAM filed an amicus brief asking the U.S. Supreme Court to address whether the Clean Water Act allows the EPA to include generic (and vague) prohibitions in National Pollutant Discharge Elimination System permits that subject permitholders to enforcement for exceedances of water quality standards. A NPDES permit is required to discharge a pollutant through a “point source” into “a water of the United States.” In this case, the 9th Circuit affirmed EPA’s use of a generic prohibition in San Francisco’s NPDES permit for a water treatment facility—stating that water discharge “shall not cause or contribute to the violation of any applicable water quality standard.” This ruling directly conflicts with 2nd Circuit precedent deeming generic prohibitions impermissible and could impact manufacturers’ ability to assert the permit shield defense—a defense that provides protection from liability if a manufacturer is operating under a valid permit and its facility discharges waste in accordance with the permit. Permit operators need specific guidance as to allowable discharges in accordance with the permit.

Our brief urges the Supreme Court to review this case to resolve the circuit split and highlights the key role of the permit shield defense in guarding against citizen suits and unforeseen enforcement actions. Happily, on May 20, 2024, the Court granted the petition for certorari.

On July 26, 2024, the NAM filed an amicus brief emphasizing the practical importance of clear and predictable CWA compliance and enforcement and demonstrating that generic prohibitions are inconsistent with the text and design of the CWA.

On March 6, 2024, the NAM joined a coalition of other major business trade associations to file suit in the D.C. Circuit to challenge the Environmental Protection Agency’s misguided final rule lowering the National Ambient Air Quality Standards for fine particulate matter (PM2.5) to 9 micrograms per cubic meter. The Clear Air Act requires manufacturers to obtain preconstruction permits for new and modified emissions sources obtainable only after showing that emissions from the proposed new source will not cause or contribute to a PM 2.5 NAAQS violation. The Clean Air Act also requires the EPA to review the NAAQS every five years to determine whether the PM2.5 standard should be retained or revised. In December 2020, following a complete review of the PM NAAQS, the EPA decided to retain the PM2.5 standard of 12 micrograms per cubic meter. But in June 2021, the agency announced it would reconsider that decision. The EPA ultimately issued the revised standard in an out-of-cycle reconsideration becoming the first administration to redo a promulgated NAAQS. The standard stands to impede economic development in much of the country due to many manufacturers’ inability to establish that a proposed new construction or modified emission source will not cause or contribute to a PM 2.5 NAAQS violation. The NAM therefore sued to protect manufacturers’ ability to obtain permits, expand facilities and pursue long-term investment plans, and defend our country’s competitive advantage.

On June 6, 2024, our coalition filed its opening brief arguing that the EPA lacks the authority under the Clean Air Act--the law that authorizes it to establish the NAAQS--to "reconsider" a decision made in 2020 to not lower the PM2.5 standard; that the agency failed to take into account the cost and feasibility of a tightened standard; and that it failed to give a "reasoned explanation for key aspects of its decision."

The NAM filed an amicus brief in support of rehearing en banc by the 9th Circuit in one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. This case is part of a coordinated, national litigation campaign filed in carefully chosen states and federal circuits by agenda-driven lawyers and activists. The issue presented is whether putative state-law tort claims alleging harm from global climate change are removable because they arise under federal law. In April 2022, the 9th Circuit rejected federal-question jurisdiction and all other bases for subject matter jurisdiction and remand the case to state court. In support of rehearing, the NAM filed an amicus brief arguing that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws.

Unfortunately, on June 27, 2022, the 9th Circuit denied the petition for rehearing.

In 2015, the NAM filed an amicus brief in the U.S. Court of Appeals for the Fifth Circuit supporting a federal judge’s decision not to impose excessive penalties on ExxonMobil for various permit violations. On remand to the district court, the groups reduced their requested penalties from $642 million to about $40 million, and the district judge awarded them about $20 million, prompting Exxon’s appeal back to the Fifth Circuit. In 2018 and 2021, the NAM filed additional amicus briefs arguing that the Constitution and Clean Air Act limit citizen suits under the Clean Air Act and asking the Fifth Circuit to enforce the constitutional line that limits federal courts to deciding discrete cases and controversies and prevents them from acting as regulators or policymakers.

Unfortunately, on August 30, 2022, the Fifth Circuit affirmed the district court's latest decision imposing a $14.25M penalty on defendant-appellants (for 3,651 purported violations). On, October 20, 2022, the NAM filed an amicus brief in support of Exxon’s petition for the 5th Circuit to rehear en banc its appeal challenging the district court’s penalty award.

Happily, on February 17, 2023, the 5th Circuit granted the petition for rehearing en banc and vacated the panel decision. On March 27, 2023, the NAM filed an amicus brief asking the full 5th Circuit to reverse the panel’s decision to enforce the limits of federal courts’ jurisdiction. This case is important to manufacturers because courts should exercise discretion in determining civil penalties to prevent creating perverse incentives for plaintiffs.

The NAM sued the EPA in 2015 to challenge the EPA’s declaration that 36 states’ state implementation plans (SIPs) under the Clean Air Act are invalid because they allow air emissions in excess of permit limits during startup, shutdown or equipment malfunctions. That flexibility is important to manufacturers that might temporarily exceed permit limits for reasons beyond their control. The litigation has been held in abeyance since April 2017 while the EPA considers whether to revise or rescind the rule.

On June 25, 2018, the NAM moved to intervene in a case involving permitting requirements for manufacturers under the Clean Air Act. Environmental groups sued to challenge a guidance document from the U.S. Environmental Protection Agency (EPA) that streamlines Clean Air Act permits under the New Source Review program for facilities that expand or modify their operations. If the plaintiffs' claims are successful, facility modifications could be significantly delayed and rendered more expensive. The NAM's motion asks the court to allow the NAM to become a co-defendant in the case with EPA to bring the voice of manufacturers in defense of the EPA's sensible policy.

On July 13, 2018, the court held the case in abeyance pending the completion of an EPA rulemaking to implement the terms of the guidance document. The litigation is expected to reactivate when the final rule issues.

On May 7, 2024, the NAM filed an amicus brief urging the 10th Circuit to clarify the proper application of the economic substance doctrine, a tax doctrine found in the Internal Revenue Code. That doctrine allows the Commissioner of the IRS to disallow a tax benefit for engaging in a transaction not likely to produce economic benefits aside from reducing tax liability. In this case, the District of Colorado granted summary judgment to the government and determined that the economic substance doctrine applied to disallow Liberty Global Inc.’s $110 million tax refund claim based on its sale of stock in a controlled foreign corporation. In doing so, the district court misinterpreted the economic substance doctrine to apply to all transactions which is an overbroad view of the economic substance doctrine’s scope. Liberty appealed the decision to the 10th Circuit.

We will argue that the doctrine does not apply to transactions for which the tax code authorizes tax-beneficial treatment and courts are required to first determine whether the doctrine should apply before proceeding to apply it to disallow a tax benefit. Failing to first determine whether the economic substance doctrine is relevant to a transaction has the consequence of expanding the reach of the doctrine in ways that could nullify Congress’s policy judgment regarding which transactions should receive tax benefits that allow manufacturers to compete in a global economy.

The NAM filed an amicus brief in a case involving the state of Washington’s authority to prohibit certain exports from Washington’s coastal ports. Washington state denied several environmental permits necessary to construct a new coal export terminal near Longview, Washington. The denials were improperly based on concerns about the use of coal for electricity generation in foreign countries. The state’s actions have dangerous implications for the power of individual states to interfere with interstate and international trade. A federal district court rejected the plaintiffs’ claims. On appeal to the 9th Circuit, the NAM’s amicus brief explained how state and local interference with foreign trade undermines a uniform foreign policy and is harmful to the national economy. Moreover, we argued that Washington’s actions violate the foreign commerce clause and that allowing the state’s actions to stand would give a green light to state and local interference with foreign trade policy.

On February 6, 2018, the EPA issued a final rule that adds an applicability date of February 6, 2020, to the EPA’s 2015 rule governing jurisdictional “Waters of the United States” under the Clean Water Act (2015 WOTUS rule). A coalition of environmental groups sued EPA to challenge the rule, arguing that EPA lacks the statutory authority to impose an applicability date. The applicability date rule is important to manufacturers because it precludes application of the 2015 WOTUS rule while EPA develops and issues a sensible replacement WOTUS rule. The 2015 WOTUS rule asserts federal jurisdiction over millions of acres of landscape features throughout the United States, triggering permitting requirements that will slow development and increase permitting costs on manufacturers. The rule’s vague and ambiguous terms also create confusion and increase the risk of inadvertent violations. The NAM intervened in the litigation to help EPA defend the applicability date rule to allow EPA the necessary time to develop and issue a new WOTUS rule.

On 2/16/17, the NAM and other associations moved to intervene in a case brought by North Dakota challenging the EPA's latest action on its Clean Power Plan (CPP). The agency rejected a petition to reconsider the rule, and that decision is now being challenged in court. The case is likely to be affected by the court's soon-to-be-issued ruling in our main challenge to the CPP rule, since the procedural and substantive defects in the petition for reconsideration overlap significantly with the issues raised in the case already before the court. A motion to hold the case in abeyance pending EPA reconsideration was granted, and the case remains in abeyance.

The NAM sought review in the U.S. Court of Appeals for the D.C. Circuit of the Environmental Protection Agency’s (EPA) 2015 Clean Power Plan rule governing New Source Performance Standards (NSPS) for greenhouse gases from electric utilities. The rule is an attempt to address emissions from new, modified and reconstructed electric generating units. This case is important for manufacturers because EPA should not rely on policy preferences rather than the rule of law.

The NAM sued the EPA with a broad industry coalition to challenge the NSPS rule. We seek to invalidate the rule to pave the way for a sensible alternative. Our briefs argue that the rule is unlawful because EPA’s conclusions are arbitrary and capricious, not supported by substantial evidence, and fail to make the requisite endangerment findings. In 2017, the D.C. Circuit held the rule in abeyance while the current administration considers whether to revise or rescind the rule.

Upon promulgation of the EPA's 2015 rule defining jurisdictional "Waters of the United States" (WOTUS) under the Clean Water Act, a coalition of states led by North Dakota sued the EPA in federal district court in North Dakota to challenge the rule. The states then moved for preliminary injunction against the rule, which the court granted within the territorial boundaries of the plaintiff states (North Dakota, Alaska, Arizona, Arkansas, Colorado, Idaho, Missouri, Montana, Nebraska, New Mexico, Nevada, South Dakota, and Wyoming). Soon thereafter, however, the U.S. Court of Appeals for the Sixth Circuit claimed authority to consider all challenges to the WOTUS rule—to the exclusion of the North Dakota district court and several other district courts in which lawsuits had been filed, including an NAM coalition lawsuit in the U.S. District Court for the Southern District of Texas. In January 2018, however, the U.S. Supreme Court ruled that the Sixth Circuit lacked jurisdiction to consider the various WOTUS challenges. This reactivated the North Dakota case, allowing the court to proceed to the states’ merits challenges to the 2015 rule. On June 8, 2018, the NAM filed an amicus brief on behalf of the states that explains how the rule was promulgated without required procedure and how the rule violates the Clean Water Act and the U.S. Constitution.

Oklahoma and a coalition of business groups sued to challenge the EPA's 2015 rule governing jurisdictional "Waters of the United States" under the Clean Water Act. The rule adversely impacts manufacturers by asserting federal jurisdiction and permitting requirements over millions of acres of dry land throughout the country and by imposing unclear rules on land development. Oklahoma sought a preliminary injunction to stop the rule. A district court denied that injunction, and Oklahoma appealed. In support of their appeal, the NAM filed a coalition amicus brief that explains the impact of the rule on manufacturers and other sectors of the economy and supports an injunction in Oklahoma.

The NAM filed an amicus brief in the U.S. Court of Appeals for the First Circuit to overturn the city of South Portland, Maine’s ban on crude oil exports from the city’s harbor. The city council claimed it enacted the ban for health and safety reasons, but various public statements revealed a political opposition to the planned transportation of Canadian crude oil by pipeline to the harbor for export. The pipeline owner sued the city, arguing the ban violates the U.S. constitution’s commerce clause. A federal district court sided with the city. If such local energy export bans are allowed to stand, energy production and transportation would be restricted, shutting some products out of some markets, and increasing energy prices for many manufacturers. On appeal to the First Circuit, the NAM’s amicus brief explains the importance of the free trade of energy for manufacturers and argues that the city’s interference with free trade violates the U.S. constitution. On January 10, 2020, the court "sidestepped" the federal constitutional questions and certified three questions to Maine’s high court concerning potential preemption of the ordinance by state law.

On January 22, the NAM filed an amicus brief in an appeal to the 9th Circuit challenging a lower court finding that an Idaho land exchange between a manufacturer and the federal government violated federal law. In this case, Shoshone-Bannock Tribes of the Fort Hall Reservation v. DOI, Simplot acquired federal land from the Bureau of Land Management in accordance with the Federal Land Policy and Management Act (FLPMA) to build new gypstacks containing waste products from fertilizer in exchange for Simplot land. Nevertheless, the trial court agreed with a local tribe that the exchange was precluded by a 1900 law that restricted the potential uses of exchanged federal land.

We argue in our brief that the exchange is authorized by both the 1900 Act and FLPMA. FLPMA is a comprehensive land management statute that must be read to allow for all federal land dispositions to satisfy business expectations and foster resource development on public lands in the United States, which are crucial to supply chain and energy security for American manufacturing.

On May 2, 2024, the NAM filed an amicus brief urging the 6th Circuit to recognize wildfires as an exceptional event properly excluded by EPA when determining compliance with National Ambient Air Quality Standards. In this case, Sierra Club challenges EPA’s redesignation of the Detroit area from nonattainment to compliant with the 2015 ozone NAAQs. In making this determination, EPA excluded from its calculations monitoring data on two days that the Detroit area was adversely affected by wildfires. We argue that EPA properly excluded the data influenced by wildfires, which are exceptional events that need not be included in state reporting data under the Clean Air Act. Excluding exceptional events from determinations of whether areas have attained the NAAQS standard provides needed relief for business from the costly and burdensome requirements to limit their emissions based on circumstances beyond a state or businesses’ control.

In June, 2014, the Sierra Club challenged 9 EPA Clean Air Act rules in court, alleging that provisions in each rule are no longer valid as a result of a decision in April by the U.S. Court of Appeals for the D.C. Circuit. The provisions at issue allows companies an affirmative defense to civil penalties for exceeding emissions limits that are caused by malfunctions. A company must prove that the malfunction was sudden, infrequent, not reasonably preventable and not caused by poor maintenance or careless operation, and that it took steps to correct the malfunction and minimize resulting emissions.

In April, the court decided in Natural Resources Defense Council v. EPA to vacate portions of a Portland cement industry rule pertaining to the affirmative defense, finding that the EPA lacked the authority to create a defense applicable in federal court. This Sierra Club suit attempts to remove the defense from 9 other rules in which it arises, involving various industries and kinds of equipment. Challenges to regulations must be brought within 60 days of their promulgation unless the petition "is based solely on grounds arising after such sixtieth day . . . ." The suit claims that the NRDC case decision constitutes grounds arising after the rules were promulgated.

In July, the NAM and 13 other business associations filed a motion to intervene in the suit. Manufacturers will be negatively impacted if the suit is successful, since it could make them liable for permit violations arising from unavoidable equipment malfunctions. That liability can arise both from EPA citations and from citizen suits around the country.

The rules at issue govern chemical manufacturing, pulp and paper mills, steel pickling, marine tank vessel loading operations, industrial steam-generating units, nitric acid plants and others.

On July 25, the court ordered the case held in abeyance while the EPA decided on a pending administrative petition from the Sierra Club to revise the rules. The EPA granted the petition, and on December 17, 2014, the court held this case in abeyance until the EPA completes the rules revision process. As of July 30, 2019, the EPA has not yet completed its administrative process.

The MCLA intervened in an environmental group’s legal challenge to the EPA’s rescission of the prior administration’s 2015 “Waters of the United States” rule. The EPA rescinded the 2015 rule because the rule’s lack of clarity resulted in regulatory uncertainty and confusion. Additionally, because some federal courts invalidated the 2015 rule in some parts of the country and not others, manufacturers faced a regulatory patchwork that made compliance across different states very difficult. The EPA’s rescission of the 2015 rule restored regulatory consistency and clarity. A coalition of environmental groups sued to challenge the rescission, arguing that the EPA exceeded its authority in doing so. The NAM and other leading industry trade associations intervened in the case to help defend the rule and to represent the interests of our members in the litigation.

On February 6, 2018, the EPA issued a final rule that adds an applicability date of February 6, 2020, to the EPA’s 2015 rule governing jurisdictional “Waters of the United States” under the Clean Water Act (2015 WOTUS rule). A group of states led by New York sued EPA to challenge the rule, arguing that EPA lacks the statutory authority to impose an applicability date. The applicability date rule is important to manufacturers because it precludes application of the 2015 WOTUS rule while EPA develops and issues a sensible replacement WOTUS rule. The 2015 WOTUS rule asserts federal jurisdiction over millions of acres of landscape features throughout the United States, triggering permitting requirements that will slow development and increase permitting costs on manufacturers. The rule’s vague and ambiguous terms also create confusion and increase the risk of inadvertent violations. The NAM intervened in the litigation to help EPA defend the applicability date rule to allow EPA the necessary time to develop and issue a new WOTUS rule.

On October 17, 2024, the NAM filed an amicus brief urging the D.C. Circuit to vacate EPA’s flawed rule for conducting risk evaluations of chemical substances under the Toxic Substances Control Act. The rule—which was challenged by a union and several industry groups—requires EPA to take a “whole chemical” approach to risk evaluation under which EPA makes a single risk determination for all conditions of use of a chemical. This approach potentially subjects all uses of a chemical to regulation, even if all but one of the chemical’s uses poses no risk. The rule also requires EPA to assume that workers do not use personal protective equipment when dealing with chemical substances in manufacturing.

We argue in our brief that EPA’s “whole chemical” approach is contrary to both the text of TSCA and the case-by-case approach to risk determinations endorsed by EPA for decades. The new rule will lead to complex risk revaluations that cannot be completed within statutory deadlines. We further argue that EPA’s PPE presumption is inconsistent with industry practice and ignores existing legal requirements.

On February 18, 2022, the NAM filed an amicus brief urging the U.S. Supreme Court to review and reverse a 9th Circuit decision which sanctions a patchwork system of local regulation of healthcare and retirement benefits in square conflict with ERISA’s expansive preemption provision. This case, ERISA Industry Committee (ERIC) v. City of Seattle, involves a challenge to a Seattle ordinance requiring certain employers to make monthly healthcare expenditures to employees at Seattle-specific thresholds. The 9th Circuit rejected the challenge even though Congress intended for federal law—the Employee Retirement Income Security Act of 1974 (ERISA)—to provide a single uniform national scheme for the administration of healthcare and retirement plans without interference from states or municipalities. Indeed, the 1st and 4th Circuits have held that similar laws are preempted under well-established ERISA preemption principles.

The NAM filed an amicus brief in support of Supreme Court review explaining that ERISA preemption plays a critical role in making benefits possible for employees, and state and local rules that conflict with ERISA’s national uniformity must be struck down. As a practical matter, state and local mandates like this one harm workers, forcing employers to divert resources away from providing quality health coverage, and instead spend money to comply with a complex and mismatched patchwork of state and local rules. Already, localities across the country have begun to adopt similar ordinances with varied minimum benefit rates, timelines, definitions, and recordkeeping requirements—a completely unworkable, fragmented regulatory regime. Supreme Court intervention is sorely needed.

Unfortunately, on November 21, 2022, the Supreme Court denied cert.

The NAM filed an amicus brief urging the U.S. Supreme Court to review and reverse a deeply flawed Eighth Circuit opinion applying an erroneous standard to the admissibility of expert testimony and usurping the gatekeeping role of the trial court. This multidistrict litigation involves allegations that 3M’s Bair Hugger patient warming device causes surgical site infections. After conducting a thoughtful and thorough review of plaintiffs’ general causation experts’ opinions—a faithful application of Fed. Rule of Evidence 702—the district court found that the opinions included large analytical gaps and were not generally accepted, and, accordingly, granted summary judgment in favor of 3M.

The Eighth Circuit reversed, applying a pre-Daubert standard. Under that standard, it is an abuse of discretion to exclude expert testimony unless the experts’ opinions are “so fundamentally unsupported” that they’re of no help to a jury. This obsolete standard essentially abrogates any discretion a district court has to exclude expert testimony.

The NAM filed an amicus brief urging the Court to grant 3M’s cert petition to resolve the widespread confusion in the courts on applying Rule 702 and safeguard the scientific underpinnings of the American health care system. The Eighth Circuit’s liberal admissibility standard threatens to adversely affect those who rely on the benefits of a medical device or drug—approximately 50,000 people per day. Such critical products, which are subject to substantial scientific analysis and review by the federal government, should not be deemed defective by juries applying an erroneous, overly permissive admissibility standard.

Unfortunately, on May 16, 2022, the Supreme Court denied cert.

On February 28, 2023, the NAM filed an amicus letter requesting that the California Supreme Court review and reverse a California Court of Appeal decision affirming the trial court’s admission of unreliable expert testimony that equated talc with asbestos. In this case, the plaintiff-appellee maintained that the defendants’ cosmetic talc products were contaminated with asbestos and that her exposure thereto caused her mesothelioma. A California trial judge allowed, over defendants-petitioners’ objection, the admission of expert testimony proffered by the plaintiff-appellee that equated talc’s and asbestos’ effects on DNA--a novel theory excluded in other talc trials. After a jury returned a verdict in the plaintiff-appellee’s favor, a California Court of Appeal affirmed the trial judge’s evidentiary ruling on the ground that the appellants-petitioners did not invoke a particular case name to support their challenge. In fact, the appellants-petitioners validly challenged the admissibility of the disputed testimony as an unsupported and unreliable scientific theory not accepted within the scientific community.

In our letter brief, we argue that review is necessary to clarify how to challenge a novel scientific technique--the Court of Appeal’s holding sows confusion in how to preserve expert challenges and creates an artificial, distinct standard for evaluation of certain expert testimony that is not supported by the relevant case law or California’s evidentiary rules. Unfortunately, on April 12, 2023, the California Supreme Court denied the petition for review.

On October 2, 2024, the NAM filed an amicus brief urging the 7th Circuit to affirm a trial court decision excluding the plaintiffs’ expert’s testimony. In this multidistrict litigation, over 5,000 plaintiffs sued manufacturers alleging that they developed Parkinson’s disease due to their exposure to the herbicide paraquat. The Southern District of Illinois granted summary judgment for the defendants after carefully evaluating and rejecting the opinions of plaintiffs’ sole general causation expert. Plaintiffs have appealed that decision to the 7th Circuit.

We argue that the district court properly performed its gatekeeping function in excluding the plaintiffs’ expert testimony. We ask the Court to take this opportunity to reaffirm the court’s gatekeeping role and the standards under the amended Rule 702 for admissibility of expert testimony—namely, the proponent must establish by a preponderance of the evidence that the expert’s opinion meets the applicable indicia for reliability, which the plaintiffs did not due in this case. All manufacturers have an interest in keeping junk science out of the courtroom.

On June 17, 2024, the NAM filed an amicus brief asking the Delaware Superior Court to certify its problematic decision admitting unreliable expert testimony in a mass tort action for interlocutory appeal to the Delaware Supreme Court. In this case, plaintiffs have brought more than 70,000 lawsuits against pharmaceutical companies alleging that the heartburn and acid reflux drug ranitidine—widely sold under the name Zantac—caused them cancer. The Delaware Superior Court denied the defendants’ request to exclude the plaintiffs’ unreliable expert testimony from trial which, if granted, would have resulted in the dismissal of the plaintiffs’ case. The court’s ruling is contrary to a federal court’s ruling in the Zantac multidistrict litigation which dismissed all cases alleging similar cancer claims in 2022.

In our brief, we argue that the Delaware Superior Court improperly interpreted the Delaware rule governing the admission of expert testimony as more lenient than federal law and that Delaware Supreme Court review is required to stop the forum shopping that the court’s opinion will encourage.

Unfortunately, on July 1, 2024, the Delaware Superior Court refused to certify its decision for interlocutory appeal.

On December 9, 2022, the NAM filed an amicus brief urging the Supreme Court of Wisconsin to review and reverse a trial court’s failure to exercise its gatekeeping duty to exclude unreliable expert testimony. In this case, Vanderventer, et al. v. Hyundai Motor America, et al., the plaintiffs allege that the defective design of a driver seat caused one of the plaintiffs to experience enhanced injuries from a car accident. Over the defendant’s objection, the trial court admitted the testimony of plaintiffs’ expert witnesses and the jury returned a verdict of $38 million in the plaintiffs’ favor.

Our coalition brief argues that the Supreme Court of Wisconsin should grant the petition to clarify Wisconsin trial courts’ gatekeeping obligation to ensure that expert testimony is the product of reliable principles and methods prior to admission into evidence. The trial court failed in this regard by allowing (1) plaintiffs’ expert witnesses—a biomechanical engineer and a medical doctor—“to extend their [causation] testimony beyond their specific fields of expertise”; and (2) the plaintiff’s biomechanical engineer to give design defect testimony without his ever testing the actual car seat at issue under conditions similar to those that occurred during the accident. All manufacturers have an interest in ensuring that trial courts closely scrutinize the factual foundation of expert testimony, as that testimony tends to have an outsized influence on juries.

Unfortunately, on February 21, 2023, the Supreme Court of Wisconsin denied the petition for review.

On June 9, 2022, the NAM filed an amicus brief in the 9th Circuit arguing that, where a business acts in accordance with an objectively reasonable interpretation of an ambiguous government regulation, the business’s conduct does not fall within the ambit of the False Claims Act (FCA.) Originally enacted in 1863 in response to defense contractor fraud during the Civil War, the FCA is a federal statute used to combat fraud against the government. In this case, U.S. ex rel. Island Industries, Inc. v. Sigma Corp., a company brought a FCA suit against its competitor based on the purported failure to pay required antidumping duties. In a separate proceeding before the Court of International Trade, however, the court ruled that the antidumping duty order at issue was ambiguous and based upon the publicly available information, it was not clear whether the defendant’s product was subject to the duty. Further, the Department of Commerce thereafter agreed that the order was ambiguous, and as a result, held that no duties were owed. Nonetheless, a C.D. Cal. jury found the defendant liable for failing to pay the duties, returning an $8M verdict, before trebling.

The NAM filed a brief arguing that exposing companies to this type of draconian penalty for behaving in conformance with reasonable interpretations of legal requirements would create untold liability traps and unmoor the FCA from its narrow fraud-prevention purpose. Where, as here, a company takes an “objectively reasonable” position regarding a regulation or contract term that it was not warned away from by authoritative guidance, the FCA’s scienter—or knowledge—requirement simply is not satisfied. Further, a reasonable interpretation of an ambiguous regulation defeats any claim that there is an obligation to pay the government, or that the failure to adhere to a different reasonable interpretation is material to any payment to the government. Allowing the judgment to stand would transform the FCA into a blunt enforcement instrument and would impose unwarranted risks and uncertainties on manufacturers and other businesses that must navigate complex regulatory terrains.

On December 22, 2023, the NAM filed an amicus brief asking the 7th Circuit not to impose False Claims Act liability where a defendant subjectively believes that it is following a legal obligation based on an objectively reasonable interpretation of an ambiguous statutory, regulatory or contract provision. In this case, a drug manufacturer participated in the federal government’s Medicaid drug rebate program which requires manufacturers to pay a rebate back to the state and federal government for each drug sold to the program based on the Average Manufacturer's Price for the drug. The plaintiff-relator alleged that Lilly miscalculated the rebate it was required to provide under the program by miscalculating the AMP even though Lilly based its calculation on a reasonable interpretation of an ambiguous term and informed the government of its interpretation without the government taking any action. The relator obtained a verdict of over $61 million, which the district court subsequently trebled.

We joined other business groups in arguing that the plaintiff failed to satisfy the falsity and knowledge requirements necessary to impose False Claims Act liability. We explained that those requirements are not satisfied where, as here, a party’s legal obligations are unclear, and the party acts in accordance with its genuinely held reasonable interpretation. Expanding False Claims Act liability to situations like this would expose government contractors to protracted litigation and potential liability any time a relator comes up with an alternative interpretation to a manufacturer’s interpretation of an ambiguous legal obligation.

On October 7, 2024, the NAM filed an amicus brief urging the Illinois Supreme Court to maintain the doctrine of intrastate forum non conveniens. That doctrine allows an Illinois trial court to transfer a case to another court in the state that would be more convenient for the parties or to better serve the ends of justice. In this case, a store in Madison County sued the Illinois Attorney General challenging the constitutionality of a new state consumer protection law. The AG sought to transfer the case pursuant to a state law that requires constitutional challenges to state laws be filed in Cook County (Chicago) or Sangamon County (Springfield). However, relying in part on the forum non conveniens doctrine, a Madison County Circuit Court Judge struck down the state law as unconstitutional citing concerns over plaintiffs’ due process rights. The AG appealed to the Illinois Supreme Court.

On appeal, the AG and Illinois Trial Lawyers Association, as amicus curiae, invite the court to use the case as a vehicle for abandoning the longstanding doctrine of intrastate forum non conveniens even though doing so is not necessary to deciding the constitutionality of the law at issue. We argue that the doctrine is still needed to curtail plaintiffs from forum shopping to courts where they expect a more favorable outcome.

The NAM filed an amicus brief to oppose overbroad government investigations intended to chill corporate scientific inquiry, debate, and discussion. ExxonMobil sued the attorneys general of New York and Massachusetts to challenge overbroad subpoenas and civil investigative demands seeking more than 40 years of communications between the company and other parties involving the topic of climate change. On appeal to the U.S. Court of Appeals for the Second Circuit, the NAM’s brief explains that corporations contribute to important policy discussions involving economic, scientific and other issues of public concern and that expansive use of government investigatory powers can chill corporations’ contributions to the free exchange of ideas.

The NAM filed an amicus brief in support of the pharmaceutical industry's challenge to the Trump administration's Most-Favored Nation (MFN) Rule. The rule, which bypassed the notice and comment process that agencies must ordinarily follow before making rules effective, creates a new payment model for Medicare Part B drugs, tying payments for certain drugs (a set of 50 that encompass a high percentage of Medicare Part B drug spending) to the lowest price paid by other wealthy countries. In this case, the NAM filed an amicus brief in the Northern District of California in support of plaintiffs'--the Biotechnology Innovation Organization (BIO) and two California-based biotechnology organizations--motion for preliminary injunction. A near-identical case was filed in the District of Maryland by the Pharmaceutical Research and Manufacturers of America (PhRMA) and groups representing cancer treatment providers. The NAM's brief argues that the MFN rule is yet another fatally flawed attempt by the government to use the COVID-19 pandemic as the basis for an end-run around the Administrative Procedure Act's (APA) notice and comment procedures. The NAM's members have a vital institutional interest in ensuring that the federal government is held to the procedural safeguards provided in the APA.

Happily, oOn December 28, 2020, the district court granted the plaintiffs' motion for a preliminary. Injunction .

On June 24, 2024, the NAM filed an amicus brief urging the 8th Circuit to vacate the SEC’s final climate disclosure rule. Back in March, the SEC voted to approve the final rule instituting new climate disclosure requirements on public companies. As requested by the NAM, the final rule omitted the onerous and unworkable Scope 3 supply chain emissions reporting mandate the SEC included in its original proposal. Although the final rule is significantly more workable for manufacturers than the proposal, questions remain about the SEC’s authority to adopt it in the first place. In this case, several groups sued challenging the final rule as exceeding the SEC’s authority and those cases were consolidated in the 8th Circuit.

We argue in our amicus brief that even though the SEC has authority to require a public company to disclose information that would be material to a reasonable investor and climate information can be material, provisions of the rule suggest the SEC is prescribing climate policy. The EPA, not the SEC, has authority to make climate policy.

On April 29, 2024, the NAM filed an amicus brief urging the 8th Circuit to vacate the FCC’s digital discrimination rule. Under the Infrastructure Investment and Jobs Act of 2021, FCC was required to promulgate rules prohibiting intentional discrimination in the deployment of broadband based on a protected classification—such as income level, race, or religion. The FCC’s digital discrimination rule, however, goes further. It prohibits broadband providers from implementing practices or policies that “differentially impact consumers” access to broadband internet access. Accordingly, business trade groups sued the FCC in multiple circuits, challenging the rule as exceeding the FCC’s authority and those actions were consolidated in the 8th Circuit.

We argue in our amicus brief that the IIJA only prohibits intentional discrimination in the deployment of broadband. The disparate impact standard unliterally imposed by the rule will deter investment in critical broadband infrastructure necessary for manufacturers to innovate and compete in the global economy.

The NAM filed an amicus brief urging the U.S. Supreme Court to review and reverse the lower courts’ dismissal of a challenge to a California ballot initiative that regulates the conduct of farmers, manufacturers, and producers nationwide. Proposition 12 bans the sale of imported pork and veal in California unless farmers and producers outside of California meet strict animal confinement standards set by California voters. The NAM argued in the brief that Proposition 12 violates the Commerce Clause by regulating conduct beyond California’s borders, impinging on other states’ sovereign authority to legislate within their own jurisdictions, and, substantially burdening out-of-state pork producers absent a sufficient and legitimate local interest.

On May 28, 2022, the Supreme Court granted the cert. petition. On June 17, the NAM filed an amicus brief asserting the same arguments included in its amicus brief filed in support of the U.S. Supreme Court granting review. This litigation is important to all manufacturers because if upheld, Proposition 12 may embolden other states to regulate out-of-state conduct, resulting in a complex web of inconsistent and competing extraterritorial regulations in the agriculture and food industries, and beyond.

Unfortunately, on May 11, 2023, the Supreme Court affirmed the 9th Circuit's decision affirming the lower court's dismissal of the case.

The NAM filed an amicus brief in the Ninth Circuit in support of PhRMA’s constitutional challenge to California’s Senate Bill 17, a drug pricing law that allows California to control wholly out-of-state prices and directly regulate conduct outside its borders. SB 17 effectively freezes a prescription drug’s wholesale acquisition cost (WAC)—the uniform, nationwide list price, akin to the sticker price for a car— nationwide for 60 days before it can be raised. As the NAM’s brief explains, by freezing a nationally uniform pricing benchmark, SB 17 impermissibly regulates the price of wholly out-of-state drug transactions. Further, upholding SB 17 threatens the success of the national common market by encouraging every state to find and manipulate pricing benchmarks in hopes of influencing downstream prices.

Unfortunately, on July 25, 2022, the Ninth Circuit affirmed the district court's decision, concluding that it did not err in finding that issues of fact exist regarding whether "SB 17's practical effect is to directly regulate transactions in interstate commerce."

On May 14, 2024, the NAM filed an amicus brief urging the Northern District of Texas to stay the FTC’s sweeping ban on noncompete agreements—a rule that threatens to hamstring innovation in the manufacturing sector and damage the competitiveness of American industry. In January 2023, the FTC proposed an across-the-board rule that would flatly prohibit employers, as an unfair method of competition prohibited under Section 5 of the Federal Trade Commission Act, from entering into a noncompete clause with a worker, and would also retroactively invalidate any existing noncompete agreements. The NAM opposed the rule as proposed, and submitted comments detailing the harms to manufacturers that would result. In April 2024, the FTC finalized a comprehensive noncompete ban with only two limited exceptions (for the sale of a business and for existing non-compete agreements with senior executives).

Ryan, a Texas accounting firm, sued the FTC in the Northern District of Texas, challenging the FTC’s authority to issue the rule and seeking a stay of the rule pending the district court’s decision on the merits. We argue in support of that stay that noncompete agreements are essential for protecting manufacturers’ trade secrets and other proprietary information. Effective protection for confidential commercial information is critical to maintaining incentives for manufacturers to make capital-intensive investments in R&D that ultimately power innovation and American economic competitiveness.

Our brief debunks the FTC’s assertion that trade secret misappropriation litigation and nondisclosure agreements are adequate alternatives for protecting companies’ proprietary information. Misappropriation suits are costly, slow and extraordinarily difficult to prosecute, requiring knowledge of a rival’s misappropriation by improper means. NDAs are similarly difficult to prove as there is no ready way to determine if the agreement has been breached, and litigation is slow and expensive. Further, the final rule’s “functional” definition of noncompete clauses will deem many—if not most—NDAs to be non-compete clauses, thus barring them wholesale. And both misappropriation litigation and NDAs function only retrospectively, attempting to compensate for detected and completed wrongdoing rather than preventing it in the first place. Although these concerns were raised by the NAM and many other commenters, the FTC failed to meaningfully respond to them. We argue, accordingly, that the agency acted arbitrarily and capriciously and that the final rule must therefore be set aside.

On July 3, 2024, the district court issued an order barring implementation and enforcement of the rule against the named plaintiffs.

The NAM filed an amicus brief seeking to enjoin the federal government from publicly disclosing sensitive risk assessment and hazard modeling documents associated with Sunoco's pipeline operations. Sunoco initiated this lawsuit in the U.S. District Court for D.C. after the Pipeline and Hazardous Materials Safety Administration—which had historically protected this type of information from public disclosure under the Freedom of Information Act (FOIA) given its sensitive nature—reversed course and sought to disclose the information publicly within a matter of days. Our amicus brief argues that risk assessment and hazard modeling documents provided to the federal government to help protect against a major physical or cyber-attack are critical to maintaining pipeline operations and should be protected from disclosure under FOIA for both security and commercial reasons. Manufacturers in the oil & gas industry and beyond customarily protect the type of information at issue in this case from public disclosure due to significant threats to disruption of operations and public safety from bad actors seeking to exploit potential vulnerabilities. The government's decision to disregard the applicable FOIA exemptions presents grave concerns regarding the treatment of similar information that manufacturers routinely provide to regulators.

Citing the COVID-19 pandemic as a pretext for emergency rulemaking, the Departments of Labor and Homeland Security issued two rules in mid-October 2020 creating a series of new restrictions on the H-1B visa program that would have slammed the door on talented workers in hard to fill specialty and technical roles. The rules were especially unsound because they were directly issued as final rules, with no notice or opportunity to provide comment on their harmful impacts despite cost estimates that put these rules among the most expensive federal rules ever issued. The NAM joined with a coalition of business groups, health care organizations and prominent universities to challenge the rules, filing a lawsuit against the Trump administration arguing that they were unlawful and hugely detrimental to American competitiveness. On December 1, 2020 a federal judge agreed and handed manufacturers a crucial victory that immediately vacated both rules and protected the H-1B program.

In July 2020, the NAM filed a lawsuit in the Northern District of California against the Trump administration’s unlawful restrictions to a wide range of nonimmigrant work visas. The restrictions, which were part of a June 22 Presidential Proclamation that essentially shut off the flow of high-skilled workers for hard-to-fill jobs in the manufacturing sector, were the subject of intense member interest and concern. The restrictions were so disruptive that they quickly began to inflict irreparable harm on our members, and we argued that they lacked legal basis because economic policy–the justification for the Proclamation—is a uniquely Congressional domain, and the Proclamation exceeds the President’s constitutional authority by rewriting existing law. On October 1, 2020, Judge White granted our request for a preliminary injunction. The Justice Department has appealed that decision to the Ninth Circuit for review.

The NAM filed an amicus brief in the U.S. District Court for the District of Columbia supporting employers in their efforts to retain highly skilled workers. Spouses of H-1B skilled workers who have been approved for permanent residence can apply for and receive H-4 visas allowing them to work in the United States. If this rule were invalidated, manufacturers would lose access to leading talent, harming their ability to remain competitive in the global economy. A federal district court ruled that the plaintiffs lacked standing to bring the case, but the D.C. Circuit reversed and remanded the case for further proceedings. Now, following cross-motions for summary judgment, the NAM filed an amicus brief urging the court to preserve H-4 employment authorization. The NAM’s brief details the devastating impact that eliminating H-4s would have on affected employees and their families, employers, and the health of the overall economy.

Happily, on March 28, 2023, the district court upheld the rule allowing H-4 visa-holders to apply for employment authorization.

On February 1, 2024, the NAM joined a coalition amicus brief urging the 5th Circuit to uphold DHS’s new Deferred Action for Childhood Arrivals rule. DACA is a program that allows undocumented immigrants who were brought to this country as children to apply for protection from deportation and permission to work in the United States. In this case, the 5th Circuit affirmed a district court ruling that DHS lacked authority to adopt DACA. The 5th Circuit remanded the case to the district court for consideration of whether DHS may accept new and renewal DACA applications based on DHS's promulgation of a new DACA rule. On remand, the district court invalidated the new rule, and barred DHS from approving new DACA requests.

Alongside 55 other businesses and trade associations, we argue in our brief that invalidating DACA will harm the economy because (1) businesses rely on DACA recipients as employees, customers, and job creators; and (2) DACA recipients fill jobs that would otherwise remain vacant. Moreover, DACA is a lawful exercise of executive authority.

On October 2, 2023, the NAM filed an amicus brief urging the New Jersey Supreme Court to affirm the Appellate Division’s determination that Merck’s insurers improperly denied coverage for losses arising out of a cyberattack. In this case, Merck sought coverage for losses from the 2017 NotPetya cyber event under its "all risk" property policies. The policies contained an express grant of coverage for electronic data corruption or destruction, including broad business interruption coverage. Nevertheless, the insurers denied coverage, contending that standard-form “war” exclusions—developed by the insurance industry years before cyber-risks emerged—barred coverage. The trial court and Appellate Division agreed with Merck that, by its plain language, the war exclusion was limited to situations involving the use of armed forces, and therefore did not apply. The instant appeal followed.

The NAM’s amicus brief underscores the significant threat posed by cyber risks to businesses of all sizes and across all industrial sectors. By developing and employing consistent rules of interpretation, New Jersey courts have created an environment in which policyholders can conduct business and prepare for cyber risks in a predictable and reasonable manner. The NAM further explains that the result advocated for by the insurance industry would undermine core principles of insurance policy interpretation that are critically important to manufacturers seeking coverage under policies purchased at considerable expense.

The case was resolved by the parties prior to oral argument.

The NAM led a group of associations in filing two World Trade Organization (WTO) statements because Thailand failed to abide by its WTO commitments on customs valuation and now threatens a company with fines of more than $2 billion and imprisonment of several individuals. Proper valuation is important because many manufacturers operate through interconnected commercial relationships and supply and production chains with producers and suppliers throughout the United States and foreign countries. The statements emphasize the importance of the WTO’s customs valuation rules to international trade, which allow companies to produce goods as efficiently as possible and to access international consumers in the global marketplace.

On September 22, 2023, the NAM filed an amicus brief urging the 5th Circuit to decline to extend Texas personal jurisdiction to an out-of-state manufacturer who never sold the product at issue in a lawsuit to consumers, advertised it to consumers, or directed anyone else to sell or advertise it to consumers. In this case, the plaintiff claims that a Samsung-manufactured 18650 lithium-ion battery in the plaintiff’s e-cigarette exploded in his pocket, causing severe burns. Although the plaintiff claimed that he purchased the battery on Amazon.com from a third-party seller, he sued Samsung in Texas state court asserting contract and tort claims. The defendants removed the case from state to federal court and the federal district court granted the defendants’ motion to dismiss for lack of personal jurisdiction, concluding that Samsung’s contacts with Texas were insufficient for it to exercise personal jurisdiction. Although Samsung provided batteries to companies in Texas engaged in manufacturing or repairing products, Samsung did not authorize the sale of its battery by a third-party to the plaintiff or sale of its batteries to be used in an e-cigarette.

We argue in our brief that there is an insufficient basis to exercise personal jurisdiction where a claim arises independent of a defendant’s deliberate efforts to serve a market. And exercising personal jurisdiction in this case would create unpredictability for the business community.

On September 21, 2023, the NAM filed an amicus brief in support of energy manufacturers’ petition seeking U.S. Supreme Court review of a lower court’s remand order in a case asserting state liability claims related to climate change. This is a case seeking to hold oil and gas companies liable for the impacts of climate change in Minnesota. The 8th Circuit upheld the federal district court’s decision to remand the case to state court for lack of subject matter jurisdiction. In our brief, we argue that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. This case has important implications for all manufacturers because of the growing trend among plaintiffs’ lawyers of using public nuisance and consumer deception claims to seek monetary damages from manufacturers for broad, societal issues that are ill-suited for consideration by a patchwork of state court determinations and should be addressed in the policy process.

Unfortunately, on January 8, 2024, the U.S. Supreme Court denied the energy manufacturers' petition.

On February 9, 2024, the NAM joined 15 other leading business groups in filing an amicus brief urging the court to reject the National Labor Relations Board’s decision that does away with the longstanding policy of protecting workers’ rights to secret ballots in union organizing efforts. This case involved a bargaining unit of approximately 366 cement truck drivers who voted against representation by the International Brotherhood of Teamsters. Following this “no” vote, the Union accused the employer of unfair labor practices—specifically, that the employer engaged in coercive conduct to dissuade employees from voting in favor of Union representation—and asked that the results of the election be set aside, and that the employer be ordered to bargain with the Union. Although an Administrative Law Judge recommended that a new election be held, the NLRB’s Democratic majority instead used the case to announce a troubling new framework for determining when employers are required to bargain with unions without a representation election. The NLRB determined that if a union claims to have majority support and demands recognition, an employer must either (1) grant recognition without the benefit of a secret ballot election, or (2) file its own NLRB petition seeking an election. If the employer fails to take either step, the union can file an unfair labor practice charge, and the NLRB will order mandatory union recognition unless the employer proves the union did not have majority support in an appropriate bargaining unit. And, perhaps most worrying, even if the employer files a petition for election, the NLRB may cancel the election and issue a bargaining order if the employer commits virtually any unfair labor practice during the period preceding the election—this would include seemingly innocuous conduct like having a “workplace civility rule” in an employee handbook.

Our coalition argues that the Cemex decision is contrary to congressional intent by defaulting union representation to card check rather than via secret ballots and puts the burden on employers to call for an NLRB-supervised election, rather than the union as currently required. The brief also argues that the decision violates Supreme Court precedent by making any unfair labor practice sufficient to support the issuance of a bargaining order against the employer, forcing the employer to recognize a union that may not have majority support from the workforce.

On Wednesday, December 28, the NAM filed an amicus brief in support of energy manufacturers’ petition seeking U.S. Supreme Court review of the lower courts’ remand order in a case asserting “public nuisance” claims related to climate change. This case, Chevron Corporation, et al. v. San Mateo County, California, et al., is one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. The 9th Circuit upheld the district court’s decision to remand the case to state court for lack of subject matter jurisdiction.

In our brief, the NAM argues that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. This case has important implications for all manufacturers because of the growing trend among plaintiffs’ lawyers of using public nuisance and consumer deception claims to seek monetary damages from manufacturers for broad, societal issues that are ill-suited for consideration by a patchwork of state court determinations and should be addressed in the policy process.

Unfortunately, on April 24, 2023, the Court denied the energy manufacturers' petition.

On September 12, 2023, the NAM joined a coalition brief in the 5th Circuit concerning removal under federal officer jurisdiction. This case is one of over 40 cases filed by a group of Louisiana parishes seeking relief for alleged damage to Louisiana’s coastal environment. The plaintiffs allege that the defendants--energy producing companies--violated the Louisiana State and Local Coastal Resources Management Act by violating or failing to obtain a use permit for oil production activities on the Louisiana coast. Defendants are authorized to remove cases against them from state to federal court for actions taken while “acting under” an officer of the United States. The defendants removed this case, in part, based upon acts taken to assist the Allies in World War II, pursuant to Shell Oil Company’s contracts with the government to refine oil. The district court found that Shell Oil Company’s contracts were insufficient to establish "acts under" a federal officer because the defendants failed to show that Shell Oil Company was "acting under" a federal officer in carrying out a specific directive to engage in the activity that provides the basis for the plaintiff’s suit.

In our amicus brief, we argue that Shell Oil Company "acted under" a federal officer because oil production was how the companies fulfilled their contractual obligation to produce refined oil to the government. Ensuring that courts properly apply federal-officer removal jurisdiction is important to all manufacturers who provide goods or services to the United States government pursuant to a contract and face potential liability claims in state courts. Unfortunately, on May 29, 2024, the 5th Circuit affirmed the trial court's decision.

On July 10, 2024, the NAM filed an amicus brief requesting that the full 5th Circuit rehear the case. We argued that full 5th Circuit review is necessary to correct the panel’s interpretation of the federal officer removal statute which is inconsistent with circuit precedent and narrower than the interpretation employed by other circuits. Further, if left uncorrected, the panel’s decision will create forum uncertainty and will discourage private companies from aiding the federal government.

The case concerns a group of Louisiana parishes, supported by the Louisiana Department of Natural Resources and the Louisiana Attorney General as intervenors, seeking relief for alleged damage to Louisiana’s coastal environment based on acts committed during World War II that were controlled, directed, and regulated by the federal government. After learning of the WWII connection to plaintiffs’ claims via the plaintiffs’ 2018 expert report, the defendant oil companies sought to remove 42 related cases to federal court. In the defendants' first appeal, the Fifth Circuit held that removal was untimely because the defendants should have ascertained the federal question earlier based on vague references buried in an exhibit to the plaintiffs’ complaint. On September 15, 2020, the NAM filed an amicus brief in support of the defendants’ petition for rehearing en banc, arguing that the court's decision created uncertainty in all forms of removal, forcing defendants to file protective removal notices for fear that even equivocal and uncertain statements by plaintiffs may start the 30-day removal clock. The NAM maintained that the decision undermined the purpose of the removal statute to the detriment of both litigants and courts. On August 5, 2021, the court agreed with the defendants that their removal based on federal-officer jurisdiction was timely, but remanded the case for consideration of whether federal question jurisdiction exists.

On remand, the district courts found federal questions jurisdiction wanting, which the Fifth Circuit affirmed. The panel held that the defendants failed to present evidence that they acted pursuant to a federal officer's directive in the absence a contract that made them accountable to the federal government. On November 16, 2022, the NAM filed an amicus brief in support of the defendants' petition for a panel rehearing or, in the alternative, rehearing in banc, arguing that the panel decision conflicts with Congress's expressive directive, Supreme Court precedent, and other Circuits' case law, which do not require evidence of an express contract to establish "guidance or control" by the federal government for removal purposes.

Unfortunately, on November 29, 2022, the Fifth Circuit the petition.

On January 5, 2023, the NAM filed an amicus brief in support of energy manufacturers’ petition seeking U.S. Supreme Court review of the lower courts’ remand order in a case asserting “public nuisance” claims related to climate change. This case is one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. The 1st Circuit upheld the district court’s decision to remand the case to state court for lack of subject matter jurisdiction.

In our brief, the NAM argues that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. This case has important implications for all manufacturers because of the growing trend among plaintiffs’ lawyers of using public nuisance and consumer deception claims to seek monetary damages from manufacturers for broad, societal issues that are ill-suited for consideration by a patchwork of state court determinations and should be addressed in the policy process.

Unfortunately, on April 24, 2023, the Court denied the energy manufacturers' petition.

On January 5, 2023, the NAM filed an amicus brief in support of energy manufacturers’ petition seeking U.S. Supreme Court review of the lower courts’ remand order in a case asserting “public nuisance” claims related to climate change. This case is one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. The 9th Circuit upheld the district court’s decision to remand the case to state court for lack of subject matter jurisdiction.

In our brief, the NAM argues that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. The NAM also argues that the petitioners plainly satisfy the requirements for federal officer removal by asserting they are “person[s]” in a “civil action” “for or relating to” acts performed while “acting under” federal officers and “raise[d] a colorable federal defense”—which are the only requirements Congress and the Court have established for when the statute provides a right of removal. This case has important implications for all manufacturers because of the growing trend among plaintiffs’ lawyers of using public nuisance and consumer deception claims to seek monetary damages from manufacturers for broad, societal issues that are ill-suited for consideration by a patchwork of state court determinations and should be addressed in the policy process.

Unfortunately, on April 24, 2023, the Court denied the energy manufacturers' petition.

On November 22, 2023, the NAM filed an amicus brief urging the Pennsylvania Superior Court to review and reverse a trial court decision finding Pennsylvania’s consent by registration statute—which conditions the privilege of doing business in the State on an out-of-state corporation’s submission to general personal jurisdiction—constitutional. In this case, the plaintiffs assert that they developed Parkinson’s disease from exposure to Syngenta’s herbicide and sued Syngenta in Pennsylvania state court even though a majority of the plaintiffs’ claims and Syngenta itself have no significant connection to the state. Syngenta objected to the trial court’s exercise of jurisdiction on the ground that Pennsylvania’s consent by registration statute violates the U.S. Constitution. The trial court, however, denied Syngenta’s request to dismiss the case for lack of personal jurisdiction.

We argue that the Pennsylvania Superior Court should hear the case to address a question left unresolved by the U.S. Supreme Court in Mallory v. Norfolk Southern Railway Co., 143 S. Ct. 2028 (2023): whether Pennsylvania’s consent by registration statute violates the dormant Commerce Clause. We maintain that the statute violates the dormant Commerce Clause by interfering with the efficiency of company operations and forcing companies to defend suits in locations where alleged injuries did not occur and neither party is a resident. In addition, Pennsylvania’s exercise of jurisdiction over residents of another state in cases asserting claims unconnected to the State raises federalism concerns as that conduct should be rightfully policed by some other State. Pushing back against expansion of a state court’s jurisdiction to hear such cases is important to prevent plaintiffs from forum shopping to plaintiff-friendly jurisdictions.

Unforturnately, on August 8, 2024, the court denied the request to hear the case.

On August 26, the NAM filed an amicus brief urging the National Labor Relations Board to reject General Counsel Jennifer Abruzzo’s radical proposal to overturn longstanding and established precedent by awarding prospective, compensatory make-whole relief for the period when an employer refuses to bargain while challenging a union’s certification in court. The traditional remedy for cases where an employer unlawfully refuses to bargain with the chosen bargaining representative of its employees is a bargaining order whereby the NLRB commands the employer to stop its unlawful refusal and bargain with the representative. Over 50 years ago, in Ex-Cell-O Corp., the Board explicitly rejected make-whole relief—in that case raises for employees—as too speculative. The Board concluded that compelling employers “to accede to terms never mutually established by the parties” would violate the plain language of the National Labor Relations Act and Supreme Court precedent.

In this case, Arrmaz Prods. And Internat’l Chem. Workers Union, GC Abruzzo asked the Board to “make the bargaining unit employees whole for the lost opportunity to engage in collective bargaining” during the period when the employer refuses to bargain in order to test the union’s certification in the courts.” As the NAM’s brief explains, this inherently speculative and arbitrary remedy would chill the protected rights of every employer to petition a court to review certification of a union as the exclusive representative of the employer’s employees. Further, section 8(d) of the National Labor Relations Act flatly states that the obligation to bargain collectively “does not compel either party to agree to a proposal or require the making of a concession.” Here, the proposed make-whole remedy cannot be calculated without presuming an agreement that the Board is not entitled to presume or to compel. Employers and employees alike rely on the Board to maintain labor relations stability. Such reliance interests are severely undermined when longstanding and established precedents are overturned without adequate justification, as is threatened in this case.

On December 8, 2022, the Board held that respondent ArrMaz Products, Inc. violated the National Labor Relations Act by refusing "to recognize and bargain with the Union as the exclusive collective-bargaining representative of the employees in the appropriate unit." The Board did not address make-whole relief. The Board has severed this issue and plans to issue a supplemental decision regarding a make-whole remedy at a later date.

The IRA includes provisions to lower prescription drug prices for people with Medicare by requiring manufacturers of certain drugs covered under Medicare Part D (starting in 2026) and Part B (starting in 2028) to negotiate prices with the government. That drug negotiation program would establish an upper limit for the maximum “fair” price for a given drug according to the government. That is, the program establishes price controls for certain prescription medications that will preclude manufacturers of those medications from receiving fair market value. And in June 2023, the Centers for Medicare and Medicaid Services—a component of the Department of Health and Human Services—issued guidance on the agency’s plans for implementing the program.

In this case, Bristol Meyers Squibb and Jassen Pharmaceuticals, Inc.—whose drugs are two of the 10 initial drugs subject to the drug negotiation program—challenged the constitutionality of the program in the District of New Jersey. The drug manufacturers allege that the program violates: (1) the First Amendment by compelling them to agree to a drug price the government states is “fair”; (2) the Fifth Amendment’s Takings Clause by not providing just compensation for their drugs; and (3) the unconstitutional conditions doctrine—a doctrine that limits the government’s ability to condition the receipt of a benefit on the waiver of a constitutional right. Unfortunately, the district court granted judgment for the government, concluding that the program neither affects a taking nor violates the unconstitutional conditions doctrine because participation in the program is voluntary and that the program regulates conduct, not speech. The drug manufacturers appealed the district court’s decision to the 3rd Circuit.

On July 19, 2024, the NAM filed an amicus brief in support of the appeal arguing that the program violates the Fifth Amendment’s Takings Clause and unconstitutional conditions doctrine by forcing manufacturers to transfer title in their drugs to third parties for less than fair market value. The “option” to exit the Medicaid and Medicare program is only hypothetical considering the government’s dominant share of the market for prescription drugs and devastating effects an exit would have on drug manufacturers. Further, forcing manufacturers of selected drugs to sell their products for less than fair market value will cause research and development of new drugs to stagnate, depriving patients of new therapeutic options.

On May 21, 2024, the NAM sued OSHA in the Western District of Texas, challenging the agency’s final walkaround rule that would allow labor organizers, community activists, plaintiffs’ attorneys or even disgruntled former employees to accompany OSHA compliance officers during workplace safety inspections. The OSH Act, the 1970 law that created OSHA, authorizes an employee representative to accompany OSHA during a walkaround inspection. Since OSHA’s inception over half a century ago, that representative had to be an employee of the employer absent a few narrow exceptions. The new walkaround rule makes a radical change to that paradigm by permitting non-employee third parties to serve as the employee representative.

On summary judgment, we argued that the rule exceeds OSHA’s authority as Congress did not authorize third-party access to non-union workplaces or non-union third parties to represent unionized employees during OSHA inspections. The rule also violates the Fifth Amendment’s takings clause—which protects employers’ right to exclude third parties from their private property—by requiring third party access to employers’ property. And the rule is otherwise arbitrary and capricious in violation of the Administrative Procedure Act because OSHA failed to (1) reasonably explain its policy change from only allowing employees of an employer to accompany OSHA inspectors during an inspection; (2) consider all important concerns about the rule raised during the comment process like how employers can protect trade secrets and confidential business information; (3) consider alternatives to third-party access (e.g., allowing OSHA inspectors to retain experts and consultants); and (4) consider all the costs the rule imposes on employers.

On April 15, 2024, the NAM filed an amicus brief asking the 1st Circuit to reverse a district court decision that requires employers to hire a “surrogate” employee as a reasonable accommodation under the Americans with Disabilities Act. In this case, an employee suffered from severe anxiety that made it difficult for her to perform her essential, public-facing job functions. She requested from her employer the accommodation of a “surrogate” to perform those essential functions, which her employer denied as unreasonable. The plaintiff subsequently sued her employer in the District of Massachusetts alleging that her employer violated the ADA by failing to grant her request for accommodation. The district court, over the employer’s objection, instructed the jury that an example of a reasonable accommodation included “qualified readers” which the plaintiff’s counsel equated to a “surrogate” during closing arguments at trial. Thereafter, a jury returned a verdict of $24 million in damages for the employee, which the district court refused to overturn—the employer appealed the decision to the 1st Circuit.

We argue in our amicus brief that the ADA does not require employers to hire someone else to perform the essential functions of an employee’s job. Unlike a surrogate, a “reader’ helps an employee perform the essential functions of the job himself; readers do not do the job for that employee. Expanding the notion of reasonable accommodation to include job surrogates is a misguided approach that imposes an unreasonable burden on employers.

On April 1, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to resolve a circuit split regarding the proper legal framework to apply for determining whether time spent putting on and taking off personal protective equipment (“donning and doffing” time) is compensable under the Fair Labor Standards Act. In this case, the plaintiff oil rig workers sued their employer under the FLSA for failure to compensate them for time spent donning and doffing generic PPE—fire retardant overalls, steal-toe boots, hard hats and safety glasses—at the beginning or end of their workday. The district court held that the time is not compensable, but the 3rd Circuit reversed on appeal. The 3rd Circuit rejected the test applied by the lower court—also adopted by the 2nd Circuit—and embraced a different, more plaintiff-friendly test to govern compensability determinations.

We argue that review is necessary to resolve the circuit split and provide certainty to manufacturers regarding their compensability determinations. If the U.S. Supreme Court does not agree to hear the case, manufacturers will be harmed by the 3rd Circuit’s test which not only calls standard compensation practices into question, but potentially expands the workday to include activities commonly completed at home and could spur a flood of litigation.

Unfortunately, on June 3, 2024, the Court denied the petition for certiorari.

On March 21, 2022, the NAM filed an amicus brief urging the National Labor Relations Board to adhere to U.S. Supreme Court and Board precedent by preserving the validity of employment arbitration agreements. In Epic Systems v. Lewis, the Supreme Court held that the Federal Arbitration Act prevents the NLRB from challenging enforcement of arbitration agreements between employers and employees. Building on that holding, the NLRB ruled in 2020 that an arbitration agreement explicitly and prominently assures employees that their right to file charges with the Board does not interfere with employee rights under the National Labor Relations Act.

Despite this clear precedent, the current NLRB is seeking to abrogate its prior holdings and reconsider whether arbitration agreements interfere with employees’ right to file Board charges or otherwise access the Board’s processes. The NAM filed an amicus brief urging the Court to adhere to its current standard. Our brief highlights the Court’s holding in Epic Systems—that Congress does not alter the fundamental details of one statutory scheme (the FAA) through vague pronouncements in another (the NLRA). Any action by the Board to overrule its prior precedent and impose liability on an employer for enforcing its arbitration agreement would violate the FAA and lead to another confrontation with the Supreme Court. Many NAM members rely on lawful, voluntary arbitration agreements with their employees to reduce litigation costs and reach timely resolution of employment disputes through neutral fact finding and decision making, consistent with the FAA.

On October 30, 2023, the NAM filed an amicus brief urging the U.S. Supreme Court to review the 4th Circuit’s refusal to reverse a National Labor Relations Board decision that eviscerates the long-standing prohibition on secondary boycotts (where a union coerces a neutral employer to cease doing business with an employer with whom a union has a labor dispute). In this case, the South Carolina State Ports Authority operates the Port of Charleston by employing state workers to run lift-equipment and having International Longshoremen’s Association members perform the other longshoreman work there. After SCSPA opened another terminal at the port in 2022 and attempted to use the same division of labor, ILA sued the United States Maritime Alliance (USMX), a multi-employer association of carriers that deliver and pick up containers at the ports, and two of its carrier-members, alleging that they were violating the parties’ collective bargaining agreement by using state employees to perform port work. USMX, the State of South Carolina and SCSPA countered by filing unfair labor charges, maintaining that the lawsuit sought to obtain an illegal secondary objective in violation of the NLRA’s secondary boycott provision. The NLRB disagreed and the 4th Circuit refused to reverse the NLRB’s decision on appeal.

We argue in our amicus brief that the union’s actions in this case constitute a quintessential secondary boycott: the union is coercing neutral parties (the carriers) to stop doing business at a port unless a different party—the South Carolina State Ports Authority—accedes to the union’s demands. All manufacturers have an interest in limiting this type of coercive and intimidating conduct by unions. Unfortunately, on February 20, 2024, the U.S. Supreme Court declined to hear the case.

On November 6, 2023, the NAM filed an amicus brief urging the U.S. Supreme Court to review a lower court decision granting preliminary relief in favor of a union—including forcing the employer to reinstate terminated employees—while the Board’s adjudication process remains ongoing. Under the National Labor Relations Act, federal district courts are empowered to grant preliminary relief at the NLRB’s request while an NLRB adjudication remains pending. In this case, the 6th Circuit affirmed a district court’s grant of preliminary relief—which is considered an extraordinary remedy reserved for extreme cases—under an unduly permissive standard. Specifically, the 6th Circuit, along with the 3rd, 5th, 10th and 11th Circuits, has held that the NLRB is entitled to preliminary relief upon a showing of reasonable cause to believe that the unfair labor practice alleged has occurred and that preliminary relief is just and proper. By contrast, other circuit courts have applied the traditional, and more stringent, four factor test to determine whether the NLRB is entitled to preliminary relief. Under that test, the NLRB must establish that (1) that it is likely to succeed on the merits of its claim, (2) that it is likely to suffer irreparable harm in the absence of preliminary relief, (3) that the balance of equities tips in its favor, and (4) that an injunction is in the public interest.

We argued in our amicus brief that the Court should grant Starbuck’s petition to resolve the circuit split and that the 6th Circuit’s lenient standard places unreasonable burdens on employers subject to unfair labor practice proceedings. Happily, on January 12, 2024, the Court granted the petition.

We filed another amicus brief on February 28, 2024, urging the Court to reverse the 6th Circuit's unsupported watered-down injunction standard that the Board has leveraged to interfere with American business. On June 13, 2024, the Court reversed the 6th Circuit's decision and made clear that the traditional, and more stringent, four-factor test used for determining a party’s entitlement to a preliminary injunction applies to the NLRB.

The NAM filed an amicus brief supporting safety incentive programs and post-incident drug testing. Since 2016, the NAM has fought the U.S. Occupational Safety and Health Administration's (OSHA) overreaching "injury and illness" rule, which sought to restrict employers' ability to administer drug tests to employees after safety incidents. The rule also limited incentive programs that encourage safe workplaces. The incoming presidential administration in 2017 announced it would reconsider the rule, then OSHA issued guidance to clarify that post-incident drug testing and safety incentive programs are not prohibited. This case is important because a favorable ruling will help preserve pro-safety measures and keep a future administration from easily reinstating the guidance that was so harmful to manufacturers. The NAM’s brief asks a federal judge to invalidate the regulatory provisions underpinning OSHA's 2016 restrictions on post-incident drug testing and safety incentive programs.

The NAM filed an amicus brief urging the U.S. Supreme Court to grant cert to reinforce the preemptive authority of the federal government to regulate pharmaceutical drug labeling. Federal law bars drug manufacturers from unilaterally changing drug labels to include warnings for off-label uses; in fact, manufacturers can face potential criminal liability for “misbranding” a drug if the label includes information about unapproved uses. Yet in this case, Janssen Pharm., et al. v. A.Y., et al., a Philadelphia jury awarded plaintiffs $70 million in damages because the manufacturer did not include a warning about an off-label use of the drug Risperdal. There are over 10,000 nearly identical cases still pending against the company in Pennsylvania state court. Manufacturers across federally regulated industries are subject to carefully calibrated federal labeling regimes that provide the certainty and predictability needed to operate. As the NAM’s brief argues, the use of state tort law to undermine federal labeling requirements will, if allowed to continue, create a confusing and ultimately destructive “dual track” system where federal agencies and state tort law will conflict and ultimately undermine the federal goal of targeting labeling to a specific audience.

Unfortunately, on May 17, 2021, the Supreme Court denied cert.

The NAM filed an amicus brief to argue that the 6th Circuit should hold that businesses that hire independent trucking companies to transport goods are not liable for the negligent acts of those independent truckers. An individual was injured in a traffic collision involving a trucking company hired by a freight broker. The injured person argued that the broker was negligent in selecting the trucking company because it knew or should have know about the company’s prior regulatory infractions. The freight broker responded that the hiring directly concerns the services a freight broker provides under the Federal Aviation Administration Authorization Act of 1994, and therefore preempts state law, including state common law for negligence. The district court agreed. On appeal to the 6th Circuit, the NAM’s amicus brief explained the careful balance that congress struck in regulating drivers under the Act, and why the plaintiffs’ theory of liability is unworkable in practice.

On September 26, 2024, the NAM filed an amicus brief urging the full 6th Circuit to consider whether the Clean Air Act preempts plaintiffs’ state law consumer protection claims. In this case, plaintiffs allege that Defendants are liable under state law for failing to disclose to consumers that auxiliary emission control devices (AECDs) constitute a prohibited defeat device—a device that reduces the effectiveness of an emissions control system. A split 6th Circuit panel held that plaintiffs’ claims are not preempted by the CAA.

We argue that plaintiffs are attempting to relitigate EPA’s determination that GM’s AECDs are not prohibited defeat devices. The 6th Circuit should rehear the case as claims that seek to second-guess EPA’s decision making, purport to rebalance Congress’s objectives and risk broader destabilization of the vehicle approval regime are plainly preempted by federal law.

The NAM filed an amicus brief in the Second Circuit seeking to uphold a summary judgment ruling in favor of the manufacturing defendants in a helicopter design defect case based on the doctrine of implied field preemption. The case arose from a fatal crash of a U.S. Army helicopter. The decedents’ estates brought design defect and manufacturing defect claims against the manufacturers of the helicopter, even though the Army required that the Federal Aviation Administration (FAA) approve all aspects of the helicopter’s design. The trial court rejected the plaintiffs’ claims after finding clear congressional intent to occupy the entire field of aviation safety, including aviation product liability cases. The NAM joined the General Aviation Manufacturers’ Association (GAMA) in filing an amicus brief arguing for affirmance of the trial court’s ruling. As the NAM’s brief explains, the FAA exercises pervasive authority to establish aviation design standards and approve compliance with those standards. The FAA also retains ultimate, exclusive authority over changes to approved designs and monitors aviation products throughout their lives in service to address any safety issues. This federal regulatory scheme requires preemption to prevent an unworkable array of conflicting requirements that would jeopardize the safety and viability of the aviation industry—in the United States and globally.

On April 1, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to review a Hawaii Supreme Court decision allowing plaintiffs to pursue claims under state law that seek to hold energy companies liable for climate change. In this case, the trial court denied the defendants’ motion to dismiss the plaintiffs’ state law claims, arguing that the claims are preempted by federal common law or the Clean Air Act. The Hawaii Supreme Court affirmed that decision, reasoning that neither federal common law nor the CAA preempt the plaintiffs’ state law claims. Our brief urges the Court to grant the petition because the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature—such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws.

The NAM filed an amicus brief supporting BNSF and underscoring the importance of the freight rail network for manufacturers that rely on it to efficiently move materials. The plaintiff seeks an unprecedented injunction restricting the type and quantity of goods that can be shipped over an interstate railway that crosses its land, particularly hazardous materials. Such an injunction would disregard the exclusive federal regulatory scheme governing interstate rail transportation, would undermine shippers’ common-carriage rights and would obstruct interstate commerce in economically critical products. The NAM’s brief explained why the court should not allow the obstruction of commerce of lawful products by giving landowners an unprecedented ability to veto the quantity or types of cargo being shipped through interstate commerce.

On September 5, 2023, the NAM filed an amicus brief arguing to the Ohio Supreme Court that commercial general liability (CGL) insurance policies cover public nuisance claims. In this case, a California trial court held Sherwin-Williams liable for public nuisance claims, alleging that it contributed to a public health crisis by promoting lead paint for interior and exterior use despite knowing the use of lead was hazardous to human beings. The parties subsequently settled the case and Sherwin-Williams sought insurance coverage for monies paid to abate the conditions created by interior residential lead paint in 10 California jurisdictions. An Ohio court of appeal held that Sherwin-Williams' insurance policies provide coverage for the monies Sherwin-Williams had to pay, and the Ohio Supreme Court granted the insurers’ request to hear the case.

In our brief, we argue that the monies Sherwin-Williams was ordered to pay to abate the public nuisance are “damages” and that the Insurers’ CGL policies cover public nuisance claims. Further, knowledge of the risk of harm a product poses at the time of manufacturing and selling the product is not a sufficient basis to deny coverage under the clause in CGL insurance policies that excludes damages that are “expected or intended.” That exclusionary clause only applies to allow an insurance company to deny coverage when a company that is insured intends for a resulting harm or injury to occur. This case is important to prevent insurance companies from being able to deny coverage under their insurance policies any time a manufacturer has knowledge that a product might cause harm.

On July 23, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to hear 19 Republican State Attorneys General’s complaint seeking to block five states—California, Connecticut, Minnesota, New Jersey and Rhode Island—from pursuing climate change litigation against energy manufacturers. The Constitution authorizes the Court to hear disputes between states. In this case, the 19 State AGs contend that the States that have brought climate change litigation are attempting to regulate interstate GHG emissions through tort actions against energy producers—actions that violate the “horizontal separation of powers, usurp federal authority over a federal issue, and violate the prohibition on extraterritorial regulation embodied in the Commerce Clause.”

We argue in our brief that review is necessary because the subject matter and remedies sought in the climate change lawsuits are inherently national, as well as legislative and regulatory in nature—such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws. Further, state courts have thus far been split on whether a state can sue energy manufacturers for emissions that occur outside their borders. The Court’s review is needed now to provide guidance.

On August 5, 2024, the NAM filed an amicus brief in support of the petitioners’ request that the Colorado Supreme Court overturn the lower court’s refusal to dismiss climate change litigation brought by Boulder County and the City of Boulder. We argue that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature—such complex policy matters should not be decided by state courts under state liability laws.

The NAM filed an amicus brief in the U.S. Court of Appeals for the Second Circuit to oppose misguided efforts to impose “public nuisance” liability on energy manufacturers. The city of New York sued several energy companies to seek damages for local impacts of climate change, arguing that the defendants’ sale of fossil fuels is a public nuisance that entitles the city to financial compensation. This theory of liability poses a grave risk for manufacturers because it would impose liability on manufacturers despite a plaintiff’s inability to prove the manufacturer actually caused the plaintiff’s injuries. A federal district court dismissed the lawsuit. On appeal to the Second Circuit, the NAM’s amicus brief explains how Supreme Court precedent forecloses such lawsuits by recognizing the federal legislature as the appropriate branch of government to set national energy policy, including addressing climate change. Our brief also highlights the extensive technological innovations that manufacturers have already deployed to reduce carbon emissions, and which they will continue to pursue to address climate change and other environmental challenges.

On November 2, 2023, the NAM filed an amicus brief asking the Maine Supreme Court to affirm a trial court decision rejecting public nuisance claims brought by various hospital operators based on the manufacturing defendants' marketing or distribution of opioid medications. In this case, the hospital operators allege that marketing and distribution of opioids contributed to the opioid epidemic and increased operating costs to treat impacted patients.

We argue in our amicus brief that the trial court's decision is consistent with longstanding public nuisance liability principles and to reverse the decision would threaten open ended, industry-wide liability for a variety of products that may also have foreseeable risks or inherent externalities, including pharmaceuticals, oil and gas, and household chemicals. This case is important for all manufacturers because if the lower court's ruling is reversed, manufacturers could be subject to industry-wide liability in Maine for selling and marketing products with known risks of harm with few, if any, defenses.

On March 12, 2023, the NAM filed a coalition amicus letter urging the California Supreme Court to review a Court of Appeal decision endorsing a novel theory of liability where plaintiffs do not have to prove that a product is defective or unreasonably dangerous, but rather can assert that a company is liable for researching and developing another product that it “knew” was “safer” and failing to bring that product to market. In this case, the plaintiffs concede that the product at issue—a medication used to prevent and treat HIV/AIDS—is useful and not defective. Nevertheless, the Court of Appeal agreed with the plaintiffs that the manufacturer of the product can be held liable for the delay in bringing to market a different product the plaintiffs contend is safer.

We will argue that the decision conflicts with longstanding law and will result in a flood of litigation if left in place. The negligence theory that the Court of Appeal accepted could be repurposed against any manufacturer, not just a drug maker. And it will not be hard for enterprising plaintiffs’ lawyers to plead a claim under this new theory of negligence. California Supreme Corut review is necessary to clarify the scope of manufacturer liability and to bring California law back in line with the general and sound rule that a manufacturer can be held liable only for the products it made and sold, not products it could have made and sold.

Happily, on May 2, 2024, the California Supreme Court agreed to hear the case.

On December 19, 2022, the NAM filed an amicus brief urging the 7th Circuit to stay or enjoin ongoing mass tort litigation against a manufacturer’s solvent parent to allow the manufacturer to resolve its overwhelming tort liabilities through bankruptcy. Debtor Aearo Technologies LLC sought chapter 11 relief and, on the same day, requested, under relevant provisions of the Bankruptcy Code, a stay or injunction of all pending and future actions seeking to hold Aearo and 3M (its parent) liable for alleged injuries related to military earplugs manufactured by the companies. Litigation over the earplugs’ alleged defective design and marketing has become the largest multidistrict litigation in history, with over 290,000 claims. The bankruptcy court denied Aearo’s request, finding that the Bankruptcy Code only authorized it to enter orders to protect the “debtor, not non-bankruptcy co-debtors like 3M. The bankruptcy court further determined that a stay of pending litigation and an injunction against future actions were unwarranted because, ultimately, under the terms of their funding agreement, 3M will fully fund any liability incurred by Aearo” related to the earplugs. The instant appeal followed.

Our brief argues that bankruptcy, unlike MDL, is well equipped to resolve mass-tort lawsuits of this magnitude in an efficient manner. Further, unlike in the MDL context, bankruptcy promotes global resolution of a company’s liabilities, by sweeping in even future claims based on injuries that have not yet manifested. We urge the 7th Circuit to clarify that a bankruptcy court can and should do what is necessary and appropriate to enable a bankruptcy proceeding’s success—including staying parallel mass-tort litigation against a related entity whose liabilities redound to the debtor.

The NAM filed an amicus brief in the Texas Supreme Court to seek reversal of a Texas appellate court decision that improperly imposed liability on a manufacturer for its alleged failure to adequately warn of risks from one of its commercial air conditioners. An experienced HVAC repairman was injured when an HVAC compressor released pressurized fluids. The repairman sued the manufacturer, claiming the warning of such releases was insufficiently descriptive. A Texas jury found in the plaintiff’s favor, and an appeals court affirmed. In support of review by the Texas Supreme Court, the NAM filed an amicus brief that argued against the court of appeals’ unsupported expansion of the duty of a manufacturer to warn licensed professionals of known risks. The NAM’s brief also asks the court to clarify the jury instructions in failure-to-warn cases such as this.

The court granted review in June 2020. On April 16, 2021, the court affirmed the jury verdict, however the court took a giant leap forward by agreeing with NAM and Emerson's position that a jury in a design-defect case can be instructed on the five risk-utility balancing factors commonly used in other jurisdictions. The court failed to address the court of appeals’ unsupported expansion of the duty of a manufacturer to warn licensed professionals of known risks, deeming the issue waived based on Emerson's failure to object to a particular jury instruction. The NAM filed an amicus brief in support of Emerson's petition for rehearing on that issue, arguing that the court should have requested supplemental briefing before disposing of a case on an issue not raised or briefed by the parties.

Unfortunately, on September 3, 2021, the Texas Supreme Court denied the petition for rehearing.

The NAM filed an amicus brief urging the U.S. Supreme Court to review California’s imposition of over $300 million in civil penalties under California’s Unfair Competition Law (UCL) and False Advertising Law (FAL) without providing fair notice of the conduct that gave rise to those penalties and the scope of the potential punishment. In this case, the trial court imposed $344 million in civil penalties under the UCL and FAL—an amount 50 times greater than the largest penalties previously awarded under those statutes and larger than all other reported UCL and FAL awards combined—based on communications about FDA-approved pelvic mesh products. A California court of appeal reduced the civil penalty award to approximately $302 million but rejected the defendants-appellants’ argument that the trial court’s imposition of over $300 million in penalties violated their Fourteenth Amendment due process rights. The Supreme Court of California denied review.

We argue in our amicus brief that California’s—as well as many other states’—unfair, deceptive, and abusive practices statutes have failed to provide fair notice of the conduct that gives rise to civil penalties and the scope of the potential punishment. We urge the Supreme Court to grant the defendants-appellants’ petition for certiorari to (1) articulate the constitutional bounds for civil penalties; (2) establish principles states can use to ensure their civil penalties are objective and rational; and (3) draw from the principles the Court applies in the punitive damages and civil forfeiture contexts to place similar bounds on the aggregation of “per violation” civil penalties.

Unfortunately, on February 22, 2023, the Supreme Court denied the petition for certiorari.

The NAM filed an amicus brief in support of an application to the U.S. Supreme Court to stay a remand order transferring litigation involving “public nuisance” claims related to climate change to state court. Twenty-six energy company defendants in the case filed the stay request to allow appeals to progress on the question of which court has proper jurisdiction over the claims. The case is part of a coordinated, national litigation campaign involving over two dozen public nuisance cases filed in carefully chosen states and federal circuits by agenda-driven lawyers and activists. This issue is important to energy producers and all manufacturers because public nuisance claims involving climate change implicate federal questions and the preemption of federal laws that are appropriately heard by federal courts rather than state courts. The NAM’s amicus brief explained to the court the broader context of the plaintiffs’ legal strategy and that these suits implicate federal issues and therefore should be in federal court. Unfortunately, Chief Justice Roberts denied the stay petition. Thereafter, following the Fourth Circuit's decision to remand the case to state court, the NAM filed an amicus brief in support of BP's petition for cert. pressing the high court to resolve the circuit split regarding the scope of appellate review of remand orders involving the federal officer removal statute. Happily, on October 2, 2020, the Court granted review.

On November 23, the NAM filed an amicus brief on the merits in support of removal jurisdiction in this case, asking the Court to ensure that lower courts evaluate all grounds for removal prior to issuing remand orders.

On May 17, 2021, in a 7-1 decision with Justice Gorsuch writing for the majority, the Court reversed the Fourth Circuit’s denial of full federal appellate review of the important jurisdictional issues raised by this case and remanded the case for the Fourth Circuit to consider those issues in the first instance. Unfortunately, on April 7, 2022, the Fourth Circuit affirmed the district court's remand order, holding that none of the asserted basis for removal permit the Court to exercise jurisdiction.

On November 17, 2022, the NAM filed an amicus brief in support of the petitioners' petition to the U.S. Supreme Court for cert. The NAM's brief again argues that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws.

Unfortunately, on April 24, 2023, the Court denied the petition.

The NAM filed an amicus letter urging the California Supreme Court to review a lower court decision that eviscerates the rational boundaries for liability under California’s Unfair Competition Law (UCL) and False Advertising Law (FAL). In this case, the trial court imposed $344 million in civil penalties under the UCL and FAL—an amount 50 times greater than the largest UCL or FAL award previously reported and larger than all other reported UCL and FAL awards combined—based on the defendant’s communications about its FDA-approved pelvic mesh products. To reach this extraordinary result, the court refused to judge the communications from the perspective of their target audiences: trained physicians who treat pelvic floor conditions and the patients whom those physicians consent prior to prescribing mesh products. Instead, the court ruled that medical device risk disclosures must include all potential risks, no matter whether they are already known to physicians or likely to mislead prospective patients.

The NAM’s amicus letter emphasizes that proper application of the “likely to deceive” standard under the UCL and FAL is vital to protect against speculative allegations of deceit that are not grounded in the real-world context in which the communications were made. The UCL and FAL have already spawned a number of product lawsuits premised on idiosyncratic readings of existing representations or demands that every conceivable malfunction be disclosed prominently before purchase. Ensuring that any omission of risk information is assessed through a rigorous “likely to deceive” standard keeps the most highly speculative UCL and FAL lawsuits from clogging the judicial system

Unfortunately, on July 13, 2022, the California Supreme Court denied the petition for review.

On May 22, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to review a 1st Circuit decision allowing Mexico to proceed on claims attempting to hold firearms manufacturers liable for cartel violence in Mexico. In this case, the 1st Circuit reversed a District of Massachusetts decision dismissing Mexico’s tort claims against firearm manufacturers under the Protection of Lawful Commerce in Arms Act’s general prohibition of tort suits against firearms manufacturers. The 1st Circuit reversed, however, after finding Mexico’s claims exempt from the PLCAA because Mexico alleged that the defendants proximately caused it harm (expenditure of money to combat cartel violence).

We argue that the PLCAA’s proximate cause requirement incorporates traditional notions of proximate cause that have served to protect manufacturers engaged in lawful commerce of products with inherent risks from unprincipled liability. U.S. Supreme Court review of the 1st Circuit’s decision is necessary to (1) resolve the circuit split created by the 1st Circuit’s erroneous conclusion that foreseeability alone could satisfy proximate cause; (2) reaffirm that foreseeability is insufficient to establish proximate cause; and (3) ensure that no government—foreign or domestic—can use the civil justice system to regulate lawful products by imposing untenable liability costs on their continued production and sale.

On July 8, the NAM filed an amicus brief asking the U.S. Supreme Court to grant cert in one of over two dozen public nuisance cases seeking to drive national energy policy on climate change. The case, Suncor Energy Inc., et al v. Board of Cnty. Commissioners of Boulder Cnty., et al., is part of a coordinated, national litigation campaign filed in carefully chosen states and federal circuits by agenda-driven lawyers and activists. The issue presented is whether putative state-law tort claims alleging harm from global climate change are removable to federal court because they arise under federal law. On the few occasions where federal courts have reached the substance of these claims, the courts have concluded that the claims arise under federal common law and are displaced by the Clean Air Act.

Earlier this year, the 10th Circuit agreed with the plaintiffs’ novel argument that their claims became viable under state law and could not be removed because Congress exercised its authority and displaced the federal common law by enacting the Clean Air Act—a theory that the Second Circuit referred to in a related case as “too strange to seriously contemplate.” Further, the 10th Circuit concluded that under the well-pleaded complaint rule, federal courts are not permitted to look behind the veneer of the claims’ state law labels even when the labels are clearly masking federal law claims. In support of Supreme Court review, the NAM filed an amicus brief arguing that the subject matter and remedies sought through this litigation are inherently national, as well as legislative and regulatory in nature, and that such complex policy matters should not be driven by individual state judges in individual state courtrooms applying (or misapplying) various state liability laws.

Unfortunately, on April 24, 2023, the Court denied the petition for cert.

On April 16, the NAM filed an amicus brief urging the 6th Circuit to affirm a lower court dismissal of a no-injury class action. The plaintiffs in this case instituted a putative class action against Whirlpool in the Western District of Michigan alleging that the company engaged in fraud and violated various state consumer protection laws by selling ranges without disclosing a latent product defect—control knobs susceptible to unintentional actuation that create a risk of hazardous conditions. Although the district court agreed with the plaintiffs that their “benefit of the bargain” theory of harm—that they would have paid less for the ranges or purchased another brand had they known of the alleged defect—established the requisite injury necessary to support standing to sue, the court granted Whirlpool’s motion to dismiss for failure to state a claim. The court concluded that the plaintiffs failed to allege that Whirlpool had presale knowledge of the safety risk presented by the defect, a necessary element of the plaintiffs’ claims. The plaintiffs appealed that decision to the 6th Circuit.

We explain in our amicus brief that to state a claim and establish a concrete injury to support Article III standing, plaintiffs must allege that they were harmed by the alleged defect. Claims of injury premised on an overpayment for a product require plaintiffs to provide an objective measure against which their claims may be measured. The plaintiffs here, however, do not specify the value of the range they contend they bargained for versus the value of the range they actually received, i.e., how much the ranges diminished in value to them given the knobs’ “defect.” We further argue that enforcing the pleading standards will prevent plaintiffs from masking their allegations of product defect as consumer fraud class actions.

On May 1, 2023, the NAM filed an amicus brief urging the Alabama Supreme Court to review and reverse a lower court order extending Alabama’s law of public nuisance to the marketing and distribution of legal and highly-regulated products—FDA-approved medications. In this case, Ex Parte Janssen Pharmaceuticals, Inc., Alabama hospitals sued the manufacturers and distributors of opioid medications in Alabama state court alleging that the defendants’ activities created a public nuisance—the opioid epidemic—that caused them to incur increased operational costs. Notably, however, public nuisance law in Alabama—as in other states—is a land and water use cause of action, directed at resolving local disturbances that interfere with the right of the public to use a public road, communal space, or local waterway.

We argue in our brief that the trial court’s decision departs from long-standing public nuisance liability principles and threatens open-ended, industry-wide liability for a variety of products that may also have foreseeable risks or inherent externalities, including pharmaceuticals, oil and gas, and household chemicals. This case is important for all manufacturers because if the trial court’s ruling can stand, manufacturers could be subject to industry-wide liability in Alabama for selling and marketing products with known risks of harm with few if any defenses.

Unforturnately, on June 2, 2023, the Alabama Supreme Court denied the request for review.

On June 26, 2024, the NAM filed an amicus brief in this take home asbestos exposure case. In this case, a worker worked around asbestos-containing molding compounds used to make finished plastic products. The worker’s family member sued Schneider and Union Carbide alleging that her mesothelioma diagnosis derived from exposure to asbestos from her father’s contaminated work clothes. The trial court granted summary judgment for Schneider and Union Carbide, concluding that they had no duty to protect against secondary exposure to asbestos. Kentucky’s intermediate appellate court, however, reversed on appeal and recognized a duty “to household members who regularly and repeatedly came into close contact with an employee's asbestos-contaminated work clothes over an extended period.” We argue that no such duty exists under Kentucky law.

This case was brought in the 5th Circuit by activist group NCPPR accusing the SEC of applying its Rule 14a-8 in an inconsistent and politically motivated manner. Under SEC Rule 14a-8, public companies are required to include certain shareholder proposals on their proxy ballot. Historically, companies could exclude proposals that encroached on the company’s "ordinary business operations." However, in November 2021, the SEC released new guidance (SLB 14L) making proposals that raise issues with "broad societal impact" presumptively non-excludable. And activist groups from across the ideological spectrum are increasingly using shareholder proposals to inject contentious ideological policy fights into corporate governance. In May 2023, we intervened in this case to push back on this troubling trend.

On July 21, 2023, we filed our opening brief arguing that Rule 14a-8 violates the First Amendment by compelling a company to include shareholder-selected proposals unrelated to the company’s core business or the creation of shareholder value on the company’s own proxy statement at the company's own expense. Aside from these constitutional concerns, the SEC lacked authority to issue Rule 14a-8. Congress only authorized the SEC to enact rules prohibiting deceptive or misleading statements by corporations when they solicit shareholder-proxy votes. Rule 14a-8, however, does not address such statements.

On October 3, 2023, we filed our reply brief urging the 5th Circuit to reject the SEC's jurisdictional and procedural arguments and hear this important challenge to the SEC's authority to dictate which proxy ballot items investors should consider. We explain in our reply brief that, contrary to the SEC's assertions, there are no jurisdictional or procedural barriers preventing the 5th Circuit from holding that the SEC lacks authority to compel companies to include and subsidize shareholder speech within the company's own proxy statement. And in addition to the SEC's failure to clear the First Amendment barrier to its compelled subsidized speech regime, the SEC fails to identify a clear statement from Congress giving it the authority to hijack a corporation's own speech in contravention of state corporation law that does not enable shareholders to insert their speech or voting proposals onto a corporation's own proxy statement.

This case was brought in the 5th Circuit by activist group NCPPR challenging an SEC no-action letter--stating that it would not recommend enforcement action against Kroger if Kroger excluded NCPPR's proposal from its proxy ballot--and accusing the SEC of applying its Rule 14a-8 in an inconsistent and politically motivated manner. Under SEC Rule 14a-8, public companies are required to include certain shareholder proposals on their proxy ballot. Activist groups from across the ideological spectrum are increasingly using shareholder proposals to inject contentious ideological policy fights into corporate governance. We intervened in this case to raise two arguments not addressed by the parties: (1) Rule 14a-8 violates the First Amendment by compelling a company to include shareholder-selected proposals unrelated to the company’s core business or the creation of shareholder value on the company’s own proxy statement at the company’s own expense; and (2) the SEC lacks authority to compel company speech on its own proxy statement.

On April 5, 2024, the NAM filed an amicus brief urging the U.S. Supreme Court to enforce the robust pleading standards required by the Private Securities Litigation Reform Act to assert a securities fraud claim. Public companies, including many NAM members, are often the targets of frivolous securities litigation. The PSLRA created a heightened pleading standard for bringing securities fraud suits. Nevertheless, a 9th Circuit panel allowed the plaintiffs in this case to rely on an expert’s post hoc analysis to support their securities fraud claim without alleging with particularity the contents of any internal report or data source that would have put the defendant’s executives on notice that their public statements about who was purchasing the company’s gaming processing units were false or misleading when made.

We argue in our amicus brief that Supreme Court review is needed to resolve a circuit split on the pleading standards under the PSLRA. The panel’s decision will also create a playbook for securities plaintiffs to evade the PSLRA’s stringent pleading requirements by pointing to post-hoc, made-for-litigation expert opinions resting on unreliable assumptions and devoid of any basis in internal company data. Happily, on June 17, 2024, the Court granted the petition for certiorari.

On August 20, 2024, the NAM filed an amicus brief urging the Supreme Court to reverse the 9th Circuit's decision. We argue that affirming the 9th Circuit’s decision would undermine the PSLRA’s pleading standard by allowing plaintiffs to point to post-hoc, made-for-litigation expert opinions instead of particularized factual allegations. Affirming would also hamper the economic competitiveness of domestic industry by creating excessive litigation risk.

On February 16, 2023, the NAM filed an amicus letter seeking intervention by the California Supreme Court in a case involving a party’s ability to challenge agency action under the California Environmental Quality Act (CEQA). This case arises from the California Department of Toxic Substances Control (the Department) listing spray foam systems as a priority product under California’s "Green Chemistry" law. This listing subjects the spray foam industry in California to potential restrictions or ban on the sale of its product. The petitioners--American Chemistry Council (ACC) and General Coatings Manufacturing Corp--sued the Department challenging the listing as a violation of the CEQA. The trial court found for the petitioners on their CEQA claim. On appeal, however, the Department maintained that the petitioners’ claim should have been dismissed as untimely under CEQA’s 180-day statute of limitations. In turn, the petitioners argued that their claim was timely because the statute of limitations period began to run after ACC fully exhausted the Department’s administrative appeals process under relevant regulations implementing the Green Chemistry law. The Court of Appeal agreed with the Department, concluding that litigants do not need to exhaust administrative remedies before initiating CEQA claims unless the underlying administrative review process specifically references CEQA--here, the relevant regulations make no reference to CEQA. We argued in our amicus letter that review is necessary because the Court of Appeal’s decision provides little guidance as to what level of detail is required to incorporate CEQA claims into administrative exhaustion procedures enumerated in other statutory schemes. Allowing the Court of Appeal’s decision to stand will undermine three key tenants of the California judicial system: (1) the efficiency and conservation of resources that administrative exhaustion affords; (2) legal clarity that precludes agencies from shielding their decision-making from judicial review; and (3) a preference for resolving disputes on the merits instead of on technicalities. All manufacturers involved in CEQA litigation would benefit from clear rules regarding what steps are required before CEQA litigation can be initiated. Unfortunately, on March 29, the California Supreme Court denied theh petition for review.

On February 22, 2023, the NAM filed an amicus brief urging the Federal Circuit to reverse the lower court’s dismissal of over $19M in breach of contract claims against the federal government as barred by the statute of limitations for submitting a claim to a contracting officer, a prerequisite to pursuing litigation. In this case, a contracting officer denied Textron’s claim for payment of pension costs recoverable under government contracts as time-barred under the applicable six-year statute of limitations for submitting a claim. Textron promptly filed a complaint against the government in the U.S. Court of Federal Claims, which granted summary judgment in favor of the government based on the statute of limitations, holding that Textron’s claim had accrued more than six years before July 2020 (when Textron submitted the claim).

We argue in our brief that the trial court failed to apply the proper claim accrual standard. Textron’s request for the government to pay its share of pension costs following a segment closing should not be considered a "claim"--it is a routine submission that is not in dispute when submitted and the government must be afforded sufficient time to conduct its administrative review of the submission before the request can be considered a claim. Even assuming a request for payment of pension costs after a segment closing could be considered a claim, the trial court misapplied the remaining elements of claim accrual. Textron did not experience an injury and was unable to present its claim until the government denied payment. Claim accrual can only commence when all events have transpired to fix the government’s liability. All manufacturers who are government contractors subject to administrative adjustments between contracting partners have an interest in an efficient, collaborative, and non-litigious framework for the claim accrual standard.

On February 14, 2024, the NAM filed an amicus brief urging the 8th Circuit to reverse the IRS’s increase of a manufacturer’s taxable income by more than $23 million. In this case, 3M v. Commissioner, 3M licensed certain intellectual property to a Brazilian subsidiary who was barred by Brazilian law from paying 3M the arms-length price for use of the IP. The Tax Court erroneously endorsed the IRS’s view that it could increase the company’s taxable income to reflect a hypothetical arms-length transaction even though foreign law precluded the company from receiving the arms-length price in the transaction.

We argue in our brief that the IRS’s actions contradict controlling precedent and that allowing the IRS to increase 3M’s revenue would upend the public’s settled expectations upon which businesses rely to make investment decisions. We will also argue that the 8th Circuit should not allow the IRS to flout its Administrative Procedure Act obligations by relying on a rule for its actions that did not go through the notice and comment process.

On March 31, 2022, the NAM filed an amicus brief urging the Seventh Circuit to reverse the Tax Court’s misapplication of tax code regulations which rendered a taxpayer’s valid research expenditures ineligible for the R&D tax credit. This case is of critical importance to manufacturers as the manufacturing sector leads all others in performing private sector R&D. Here, after finding that the taxpayer (a manufacturer of oil tankers and dry docks) undertook the type of research that the credit was intended to incentive, the Tax Court nonetheless denied the claimed credit after concluding that the taxpayer failed to prove that “substantially all” (80%) of its development activities “constitute[d] elements of a process of experimentation.” To reach this erroneous conclusion, that Tax Court distinguished costs incurred for employees engaging in qualified research from costs incurred for those directly supporting or supervising qualified research—a distinction not supported by the tax code or the relevant Treasury regulations.

The NAM’s brief explains that the Tax Court’s approach is inconsistent with the text, structure, history, and purpose of the Tax Code and with the relevant implementing regulations. Fabrication of prototypes or pilot models used in testing can be essential to the development of new products, particularly in the manufacturing sector. And, as was true in this case, the labor costs for such fabrication can be substantial. The Tax Court’s reasoning inexplicably penalizes manufacturers who, in performing legitimate and potentially important R&D, incur substantial costs to test new designs or concepts. If affirmed, that reasoning will undermine Congress’ efforts to encourage increased investments in domestic R&D, including increased spending on employees who directly support R&D efforts—results completely at odds with the purpose of the law.

On March 7, 2023, although the Seventh Circuit affirmed the Tax Court's decision, it clarified that both support time and supervision time as well as the costs of building and testing a prototype can be elements of a process of experimentation for purposes of the R&D tax credit.

On April 17, 2023, the NAM filed an amicus brief urging the U.S. Supreme Court to review and reverse a North Carolina Supreme Court decision disregarding precedent that precludes a state from taxing the sale of goods that occurs outside its borders. Quad Graphics is a Wisconsin-based commercial printer that prints books, magazines, catalogs, and direct-mail items for customers throughout the United States, including in North Carolina. The North Carolina Department of Revenue imposed a sales tax on Quad for sales to North Carolina residents even though those sales were consummated in Wisconsin by passing title to the merchandise (and risk of loss) when the merchandise arrived at a common carrier’s shipping dock outside of North Carolina for shipping. The North Carolina Supreme Court upheld the tax, concluding that subsequent U.S. Supreme Court precedent implicitly overruled McLeod v. J.E. Dilworth Co., 322 U.S. 327 (1944), which precludes taxing out-of-state sales.

We argued in our amicus brief that review is necessary for manufacturers to have clear rules about where and when taxes will be imposed. Further, the U.S. Supreme Court should grant the petition because the Commerce Clause precludes a state regulating conduct outside its borders. All manufacturers have an interest in limiting a state’s ability to regulate conduct occurring outside its borders as well as reducing the untenable risk of double taxation.

Unfortunately, on June 20, 2023, the Court denied the petition for certiorari.

The NAM filed an amicus brief in the U.S. District Court for the Western District of Washington supporting protection of confidential communications between taxpayers and their non-attorney tax advisors. Federal law under the “tax Privilege” generally makes such communications confidential, but an exception exists for communications relating to “the promotion of the direct or indirect participation” in a “tax shelter.” While a tax shelter is broadly defined, “promotion” is not, and the government wants to remove routine tax advice and common tax planning from the protections of the tax privilege, which would make it more difficult for manufacturers access to important tax advice. The NAM filed an amicus brief arguing that Congress did not intend such a broad interpretation, tax policy favors the free flow of information between taxpayers and their advisors, and routine advice should not make a tax advisor a promoter of a tax shelter. The court refused to consider NAM's or any other amici briefs and the case was closed in 2017.

This white paper explores the First Amendment implications of mandatory product disclosures and transparency initiatives, when such disclosures compel manufacturers to disparage their own products, or to in-effect take sides in controversial public policy debates they might otherwise avoid. Such mandates raise important free speech concerns under the First Amendment, and as a result courts should apply strict scrutiny when reviewing them.

The First Amendment prohibits public officials from wielding the coercive power of the government to silence private organizations—including corporations—with differing or opposing viewpoints on controversial issues of public concern. Corporations, either alone or through their participation in trade associations, and in conjunction with other third parties, make substantial and important contributions to issues of public debate contributing their industry knowledge, experience and research to enhance understanding of important issues of public concern.

This white paper argues that in order to safeguard these rights, Government officials and courts must cautiously evaluate motives for subpoenas and investigative demands that target activities relating to legitimate participation in the public policy process and must guard against the use of these powers to silence or censure particular points of view.

This white paper explains how regulatory actions can impinge on core First Amendment rights and identifies fundamental principles that should inform agency action and judicial review of such action to ensure that agencies properly recognize the First Amendment as a limitation on government power.