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.