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Industry: Medical Devices

In False Ad Dispute Between Inhaler Companies, Court Grants PI Enjoining Unsupportable Clinical Superiority Claims

In its recent decision granting a preliminary injunction in GlaxoSmithKline v. Boehringer Ingelheim Pharmaceuticals, No. 19-5321, the United States District Court for the Eastern District of Pennsylvania enjoined a pharmaceutical company from making certain marketing claims of clinical superiority that the Court found did not match up with the study results purportedly supporting them. In doing so, the Court offered instructive guidance on the proof required to show falsity under the Lanham Act and on the showing necessary to justify preliminary injunctive relief.

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Liability Immunity Under The PREP Act: A Potent New Defense Against COVID-Related False Advertising Claims

Our national response to the COVID-19 pandemic has been made more difficult by a shortage of personal protective equipment and lifesaving drugs and medical devices.  Some evidence suggests that manufacturers’ fear of lawsuits has exacerbated these shortages. Seeking to allay these concerns, in March 2020, the Secretary of the Department of Health and Human Services (HHS) issued a Declaration providing manufacturers, distributors, health professionals, and other “qualified persons” immunity against certain claims relating to COVID-19 “countermeasures.”  See 85 Fed. Reg. 15198 (Mar. 17, 2020).  In mid-April, HHS followed up with an Advisory Opinion clarifying the scope of liability immunity under the Declaration.

Much has been written about the Declaration’s potential as a shield against product liability suits.  But does the Declaration also provide immunity from false advertising suits, including Lanham Act, common-law, and statutory consumer protection claims?  There’s not yet any judicial precedent on this question, but the answer appears to be “yes”—at least in many cases.

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FDCA Preclusion: When Can a Manufacturer Defeat a Competitor’s Lawsuit by Complying with FDA Regulations?

As many readers probably know, when a food or beverage manufacturer gets a consumer class action alleging that its labeling violated state law, one of the first things it should do is consider whether the disputed aspect of the labeling is covered by the federal Food, Drug and Cosmetic Act (“FDCA”).  Many provisions of that statute—and, by extension, their implementing regulations—expressly preempt non-identical state-law regulations.  If a putative class of consumers is asking a manufacturer to do something different with its labeling than those provisions do, there is a strong argument that the case is preempted:  federal law (the FDCA) trumps state law (the relevant consumer protection statute).

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