Misbranded Blog

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Misbranded is Patterson Belknap’s blog covering false advertising litigation—both consumer class actions and competitor suits—with a particular focus on FDA-regulated products (foods/beverages, pharmaceuticals, cosmetics, and dietary supplements).  Writing from the industry perspective, we provide timely updates on important cases, surveys of litigation trends, and in-depth analyses of “hot” legal issues.  Our firm pioneered the modern practice of false advertising law more than 40 years ago, bringing the first competitor suits under the Lanham Act.  In the decades since, we have continued to practice at the cutting edge, handling many of the field’s most groundbreaking cases on behalf of the nation’s best-known businesses.  Today, led by Steven A. Zalesin, our team advocates creatively, strategically, and efficiently on behalf of our clients at all phases of litigation, from pre-complaint demands to Supreme Court appeals.

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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And So It Begins: The Wave of CBD-Related Consumer Actions Has Arrived

It was only a matter of time.  As we anticipated last summer, the plaintiffs’ bar recently filed a slew of false advertising suits against manufacturers of products infused or made with cannabidiol, a/k/a CBD.  This development was a fait accompli, given the combination of a booming CBD market, a murky federal regulatory landscape, and a patchwork of state regulatory efforts at varying degrees of development.  This confluence of factors has paved the way for at least ten consumer lawsuits in the last six months against producers of CBD products.  We expect more suits to follow in the near future as copycat suits are filed, CBD products become increasingly mainstream, and more deep-pocketed players enter the CBD market.

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CBD: The Next Cure-All—and the Next Frontier for False Advertising Litigation?

Cannabidiol—better known as “CBD,” a cannabis-derived compound—is one of the latest crazes in the consumer packaged goods industry. CBD sales are expected to top $5 billion in 2019—a 700% increase from 2018—and reach $24 billion in sales by 2023.  Manufacturers have flooded the market with CBD-infused food, dietary supplements, cosmetics, pet food, and other animal health products.  CBD is being touted as a miracle chemical compound capable of treating a host of diseases and ailments in both humans and animals, such as anxiety, depression, joint issues, digestive issues, chronic pain, ADHD, Alzheimer’s disease, cancer, and heart disease.  CBD products are largely unregulated, but the days of unfettered marketing may be coming to an end:  The FDA has recently taken a keen interest in CBD products, and a slew of consumer protection actions may not be far behind.

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How Much Is Too Much Deference to FDA Warning Letters in Consumer Class Actions?

Consumer class actions involving goods regulated by the Food and Drug Administration (“FDA”) coexist in parallel with FDA enforcement efforts.  Consumers have no private right of action to enforce the Food, Drug, and Cosmetics Act—the statute the FDA is charged with implementing—and attempts to use state consumer protection laws that interfere with the FDA’s regulatory regime are preempted.  Even so, private litigants often invoke FDA guidance, rules, and statements regarding labeling practices as evidence that a manufacturer’s marketing claims are—or are not—susceptible to challenge as deceptive advertising under state law.

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