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Industry: Drugs

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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