Food and Drug Cases to Watch in 2024

The Contributors

As always, our panel of contributors has assembled some key ongoing cases to keep an eye on for the balance of the year 2024.

Takahashi-Mendoza v. Coop. Regions of Organic Producer Pools

The plaintiff in the putative class action Takahashi-Mendoza v. Coop. Regions of Organic Produce Pools alleges that Organic Valley, an organic dairy seller, falsely claims that its products are made with the highest standards of animal care practices, despite engaging in allegedly inhumane treatment of dairy cows.^[1] The defendant’s primary argument in its motion to dismiss was that the challenged packaging statements were non-substantive romance copy that is puffery and communicates no actionable claims. Judge Jon Tigar of the Northern District of California dismissed some claims, but found that claims that the defendant was “committed to the highest organic standards and animal care practices” were not puffery and were actionable. The parties have started discovery in this case and are preparing for a summer mediation. It will be interesting to see what happens in this case as it could greatly impact ESG food and beverage litigation.

United States v. Vepuri

As reported in FDLI’s Food and Drug Law Journal, the Third Circuit Court of Appeals in 2023 decided a case that “potentially allows any firm manufacturing a copycat drug to market it without FDA approval and without fear of FDA enforcement action under 21 U.S.C. § 355(a), provided the copycat has the same chemical composition and labeling as a drug specifically approved by FDA pursuant to a new drug application (NDA) or an abbreviated new drug application (ANDA).”^[2] The court overturned the criminal convictions of a drug company and its executives for defrauding FDA in connection with its unauthorized substitution of a supplier of the active ingredient in its product from a facility not listed in the company’s ANDAs or otherwise approved by FDA. At issue was the interpretation of FDCA § 355(a), which prohibits the introduction of a “new drug” into interstate commerce without a current application. The basis for the Third Circuit’s decision was its conclusion that a drug does not become a “new drug” with a new “composition” merely because the source of the active ingredient is changed. Although this case was dismissed in April 2024 pursuant to the Third Circuit’s ruling, commentators are closely watching the government’s next move to attempt to close the loophole created by the decision.

Vanda Pharmaceuticals v. United States

In January of this year, the U.S. Court of Federal Claims granted in part and denied in part a motion to dismiss a case brought against FDA by Vanda, alleging a Fifth Amendment taking and a breach of implied-in-fact contract based on FDA’s alleged disclosure of trade secrets and confidential information of Vanda during the approval process for generic drug equivalents of Vanda’s product.^[3] Vanda alleged that FDA had disclosed proprietary information about dissolution specifications, impurities analysis, and micronization to four generic drug companies that had filed ANDAs seeking to make generic versions of Vanda’s Fanapt and Hetlioz branded drugs for treatment of schizophrenia and sleep disorders, respectively. The Fifth Amendment count survived the motion to dismiss, and the continuing case will be watched closely for its implications for FDA and other government agencies.

Winkelbauer v. Welch Foods Inc. & Promotion in Motion, Inc.

Winkelbauer v. Welch Foods Inc. and Promotion in Motion, Inc. is a putative class action filed in the Northern District of California, alleging that Welch Foods misrepresents fruit snacks as containing no preservatives although the ingredient statement discloses the presence of citric and lactic acids.^[4] This is one of many recent cases in which acids and other additives in foods, which are acknowledged potentially to serve multiple functions in the food, are alleged to be serving one particular function in contradiction of some labeling claim—most often either “no preservatives” or “no artificial flavors.” Someday down the line, plaintiffs presumably would bear the burden of proving that the additive actually serves that function in the product. For purposes of a motion to dismiss, however, many courts require little more of plaintiffs than to allege that the ingredient could serve the alleged purpose or that it sometimes does so in other foods. Winkelbauer is one such case, and having survived a motion to dismiss in May 2023, it is currently in the process of litigating a motion for class certification. The case has been relatively hotly litigated, with the defendants succeeding in dismissing one named plaintiff who refused to show up for a deposition, and with motions to strike allegedly late-produced factual evidence and expert testimony before the court for hearing in June.

Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration

We would be remiss in not mentioning the widely watched mifepristone case, whose appeal is styled FDA v. Alliance for Hippocratic Medicine, argued before the Supreme Court on March 26, 2024.^[5] In this case, anti-abortion groups challenged FDA’s approval of expanded access in 2016 and 2021 to drugs commonly used in medication abortions, as well as the drugs’ original approvals in 2000. The appeal is from the Fifth Circuit, which upheld the plaintiffs’ restrictions relating to the 2016 and 2021 FDA actions. The Justices’ questioning during argument focused on Article III standing, including the sufficiency of the alleged underlying injury. They also expressed concern whether the nationwide injunction against the drugs would be an appropriate remedy, even if FDA’s actions were found to be arbitrary and capricious in violation of the Administrative Procedure Act. Attention will continue to be focused on this case, given both its legal significance and political sensitivity.

[1]   No. 22-cv-5086-JST (N.D. Cal.).

[2]   74 F.4th 141 (3d Cir. 2023); see Donald Ashley, Kalah Auchincloss & Elizabeth Oestreich, Implications of Recent Third Circuit Court of Appeals Decision for FDA Drug Approval Framework, 78 Food & Drug L.J. 257 (2023), https://www.fdli.org/2023/12/implications-of-recent-third-circuit-court-of-appeals-decision-for-fda-drug-approval-framework-open-access/.

[3]   No. 23-629C (Ct. Fed. Claims).

[4]   No. 3:22-cv-7028-JD (N.D. Cal.).

[5]   No. 23-235 (S.Ct.).