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Category: FDA/FDCA

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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Ninth Circuit Endorses RICO Claims For Prescription Pharmaceutical Promotion

Ninth Circuit Endorses RICO Claims For Prescription Pharmaceutical Promotion

The Racketeer Influenced and Corrupt Organizations Act (RICO) was meant to help take down the Mafia.  For years, however, plaintiffs have attempted to contort it into a federal false advertising regime for prescription pharmaceuticals, complete with treble damages and attorney’s fees.  The Ninth Circuit recently gave plaintiffs a boost in that effort, permitting RICO claims to proceed against pharmaceutical companies based on allegedly improper labeling and promotion of their prescription medications. 

Patterson partner and Misbranded contributor Jonah Knobler recently critiqued the Ninth Circuit’s decision—and pharmaceutical RICO suits generally—at Drug and Device Law.  Check out that post here.

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Misbranded Editors Present Webinar On “Hot Topics in Consumer False Advertising Litigation”

Last month, Misbranded co-editors Josh Kipnees, Jonah Knobler, and Jane Metcalf presented a live-streamed webinar via Bloomberg Law titled “Hot Topics in Consumer False Advertising Litigation.”  The free hour-long webinar, now available on demand, covers the following subjects, some of which should be familiar to regular readers of this blog:

  • “Natural” / “no artificial ingredients” claims

  • “No preservatives” claims

  • Ingredient claims (“made with [X]”)

  • Geographic origin claims (e.g., “Made in the USA”)

  • Slack-fill claims

  • Claims involving nondisclosure of morally troubling/offensive facts

  • What’s next in consumer false advertising litigation?

We encourage you to check it out (and obtain some CLE credit in the process).

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Cognitive Claims Draw FTC’s Focus

The promise of improved cognitive capability or memory appeals to almost everyone.  So it’s no surprise that the market for such enhancements is broad, ranging from “brain training” apps for your phone to dietary supplements promising memory boosts.

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“Slack-Fill” Cases Coming Up Empty

Unless you were born yesterday, you know that packaged goods usually contain some empty space in the box, bottle, or bag.  This has been true for as long as there have been packaged goods.  What is relatively new is that consumers—or, rather, a small cadre of specialized plaintiff’s lawyers—are suing over it.  But as Newton said, for every action, there is an equal and opposite reaction.  And the more that lawyers have inundated courts with these suits, the more aggressively courts have responded to shut the silliness down. This post examines the regulatory underpinnings of these so-called “slack-fill” suits and the many bases that courts have found for letting the air out of them.

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Acids Lawsuits with No Base

Many recent consumer class actions against food and beverage manufacturers have related to label claims that a particular category of ingredient is not used in the product—e.g., “No Preservatives,” “No Artificial Flavors.”  These lawsuits follow a predictable formula:  the plaintiff, relying on the product’s ingredient list, alleges that a particular ingredient in the product functions as an artificial flavor and/or chemical preservative, and that the “no preservatives” or “no artificial flavors” claim is therefore false.

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