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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.