Tag Archives: fda

plaintiffs don’t have to use full FDA methods for testing nutrients to avoid FDA preemption

Posted on July 2, 2025 by rtushnet

Scheibe v. ProSupps USA, LLC, — F.4th —-, 2025 WL 1730272, No. 23-3300 (9th Cir. Jun. 24, 2025) The FDA specifies testing methods for determining the amount of carbohydrates and calories in a food, as well as a sampling process … Continue reading →

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FDA preclusion doesn’t work as often after Pom Wonderful (or Loper Bright?)

Posted on February 27, 2025 by rtushnet

Pacira BioSciences, Inc. v. Ventis Pharma, Inc., 2025 WL 576549, No. 2:24-cv-07554-MRA-RAO, (C.D. Cal. Jan. 17, 2025) Pacira alleged that its competitor (here Ventis) violated the Lanham Act by making claims about its drugs relating to (1) exemption from FDA … Continue reading →

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distinguishing false establishment claims from lack of substantiation claims

Posted on February 21, 2025 by rtushnet

Kurin, Inc. v. ICU Medical, Inc., 2024 WL 5416672, No. 8:24-cv-00564-FWS-ADS (C.D. Cal. Nov. 8, 2024) The parties compete in the market for medical devices aimed at addressing blood culture contamination (BCC) in hospitals. BCC is both medically and financially … Continue reading →

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Claims that “non-drowsy” is false aren’t preempted by FDCA

Posted on October 17, 2024 by rtushnet

Calchi v. Topco Assoc., LLC, 2024 WL 4346420, No. 22-cv-747 (N.D. Ill. Sept. 30, 2024) Is there any circuit style more distinctive than the Seventh Circuit style? (Cf.) This is one of a number of lawsuits against purportedly non-drowsy cold … Continue reading →

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FDCA doesn’t preclude lawsuit based on allegedly false claims about compounding drugs

Posted on August 28, 2024 by rtushnet

Pacira Biosciences, Inc. v. Nephron Sterile Compounding Center, LLC, No. 3:23-5552-CMC, 2024 WL 3656489 (D.S.C. Jul. 15, 2024) Pacira, which sells non-opioid pain management products, including Exparel, sued Nephron for false advertising. Exparel is “bupivacaine suspended in multivesicular liposomes,” and … Continue reading →

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“same” claim was literally false where probiotics had different strains and different profiles

Posted on May 2, 2023 by rtushnet

ExeGi Pharma, LLC v. Brookfield Pharmaceuticals, LLC, — F.Supp.3d —-, 2023 WL 3142311, No. 20-CV-192-JPS (E.D. Wis. Mar. 21, 2023) ExeGi sued Brookfield for state and federal false advertising/tortious interference. The court here resolves only the Lanham Act claims, partially … Continue reading →

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two melatonin class actions alleging higher doses than needed survive

Posted on March 20, 2023 by rtushnet

Mack v. Amazon.com, 2023 WL 2538706, No. C22-1310-JCC (W.D. Wash. Mar. 16, 2023) Plaintiffs alleged they bought and used Solimo, a melatonin supplement manufactured and sold by Amazon. Each product purports to provide a specific dose of melatonin per serving … Continue reading →

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“fit” on snack bars isn’t implied nutrient or “healthy” claim

Posted on March 13, 2023 by rtushnet

Seljak v. Pervine Foods, LLC, 2023 WL 2354976, No. 21 Civ. 9561 (NRB) (S.D.N.Y. Mar. 3, 2023) Plaintiffs sought to represent a class of purchasers of FITCRUNCH Whey Protein Baked Bar products or FITBAR energy bar products. They contain high … Continue reading →

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Failure to include adjusted protein percentage on protein-touting products can be misleading

Posted on March 13, 2023 by rtushnet

Rausch v. Flatout, Inc., — F.Supp.3d —-, 2023 WL 2401452, No. 22-cv-04157-VC (N.D. Cal. Mar. 8, 2023) I love a good summary: When a manufacturer advertises the amount of protein in a product on its package, the Food and Drug … Continue reading →

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“virologist developed” etc. plausibly implies disease prevention

Posted on October 25, 2021 by rtushnet

Corbett v. PharmaCare U.S., Inc., 2021 WL 4866124, No. 21cv137-GPC(AGS) (S.D. Cal. Oct. 19, 2021) This is a putative class action for violations of consumer fraud statutes in the sale of Sambucol, a dietary supplement that contains a “proprietary extract” … Continue reading →

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