Category: Regulatory

SCOTUS Denies Certiorari in Cases Concerning FCA Liability Requirement, Objective Falsity Circuit Split Remains Intact

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The United States Supreme Court denied certiorari without comment in two cases seeking to resolve a Circuit split regarding the proof required to establish that a claim for payment was false or fraudulent under the False Claims Act.

Two Petitioners asked the Court to decide whether the False Claims Act, 31 U.S.C. §§ 3729-3733, requires proof of “objective falsity”, or whether a plaintiff expert’s opinion that differs from the judgment of the defendant is sufficient to show a claim for payment was false or fraudulent under the FCA.  Both cases involved allegations that a physician’s certification of medical necessity for hospice services was false, and therefore sufficient to prove plaintiffs’ FCA claims.

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Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

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The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim.  The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA).  Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines.  The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL

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A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling and design defect claims against the makers, re-packagers, retailers, and distributors of generic forms for the popular heartburn medication Zantac were preempted by federal law.  The court subsequently dismissed these claims against 32 such Zantac generics makers and distributors.

The Zantac MDL was created by the United States Judicial Panel on Multidistrict Litigation on February 6, 2020.  The plaintiffs allege that ranitidine, the active ingredient in Zantac and its generic forms, breaks down into N-nitrosodimethylamine (“NDMA”), which is part of a group of compounds that have been shown to increase the risk of cancer. The plaintiffs allege a variety of product liability and related claims against the makers and distributors of Zantac and its generic forms under federal and state laws.

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Northern District of California Sours Plaintiff’s Claims against “Vanilla” Soymilk Maker

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The Northern District of California recently dismissed a Plaintiff’s claim that the term “vanilla” was misleading on the label of a soymilk product, but left the proverbial door open for the filing of an amended pleading.

In Clark v. Westbrae Natural, Inc., Case No. 20-cv-03221, Plaintiff alleged that Defendant’s use of the word “vanilla” on the label of its organic unsweetened soymilk misrepresented to consumers that the product’s vanilla flavor was derived exclusively from the vanilla bean plant. Gas chromatography‒mass spectrometry analyses showed that the flavor came from a non-vanilla source. Plaintiff alleged he would not have purchased the product had he realized the flavor was not derived from the vanilla bean, and asserted claims under California’s Unfair Competition Law, False Advertising Law, and Consumers Legal Remedies Act.  He argued that the product should be labeled “artificially flavored.”

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FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

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The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.

The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

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Preemption of Structure/Function Claims

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Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds strong bones,” “St. John’s Wort supports mood,” and “Vitamin E supports the immune system.”

The FDA defines and regulates structure/function claims, and FDA requirements generally preempt state-law requirements that are “not identical.” 21 U.S.C. § 343-1(a)(5). So, does compliance with FDA regulations for structure/function claims shield food and supplement manufacturers from lawsuits claiming their structure/function claims are false and misleading?

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