Tag Archives: fda

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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competitor succeeds in enjoining sale of competing but non-FDA-cleared medical devices

Posted on October 7, 2021 by rtushnet

Telebrands Corp. v. Vindex Solutions LLC, 2021 WL 534361, No. 21-cv-00898-BLF (N.D. Cal. Feb. 12, 2021) Telebrands sells stuff, including the Hempvana Rocket, a handheld transcutaneous electrical nerve stimulation (TENS) unit, “a pain-relieving pen that uses TENS therapy in the … Continue reading →

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infant/child painkiller case dismissed as preempted

Posted on September 13, 2021 by rtushnet

Youngblood v. CVS Pharmacy, 2021 WL 3700256, No. 2:20-cv-06251-MCS-MRW (C.D. Cal. Aug. 17, 2021) Another infant/children acetaminophen consumer protection case. This one dismisses the claims as completely preempted by the FTCA. Plaintiffs argued that their claims are consistent with the … Continue reading →

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Pom Wonderful applies to pharmaceuticals, but “implied FDA approval” claim still fails

Posted on August 30, 2021 by rtushnet

Belcher Pharms., LLC v. Hospira, Inc., 1 F.4th 1374 (11th Cir. 2021) Belcher alleged that the labels for two of Hospira’s drugs falsely implied that the products and their uses were FDA-approved. The district court rejected that claim on the … Continue reading →

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“implied gov’t approval” claims don’t work

Posted on August 25, 2021 by rtushnet

ImPACT Applications, Inc. v. Concussion Management, LLC, 2021 WL 978823, No. GJH-19-3108 (D. Md. Mar. 16, 2021) ImPACT provides training and software, including a proprietary evaluation system. Immediate Post-concussion Assessment and Cognitive Testing “provides a neurocognitive test battery that offers … Continue reading →

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no preemption of state claims where FDA didn’t regulate cosmetic talc at all

Posted on August 11, 2021 by rtushnet

Johnson & Johnson v. Fitch, No. 2019-IA-00033-SCT, — So.3d —-, 2021 WL 1220579 (Miss. Apr. 1, 2021) The Mississippi AG sued J&J under the Mississippi Consumer Protection Act for selling talcum powder products, alleging that J&J failed to warn of … Continue reading →

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prescription and OTC products can directly compete; many non-FDCA-based claims survive

Posted on August 9, 2021 by rtushnet

Scilex Pharmaceuticals Inc. v. Sanofi-Aventis U.S. LLC, 2021 WL 3417590, — F.Supp.3d —-, 2021 WL 3417590, No. 21-cv-01280-JST (N.D. Cal. Aug. 5, 2021) Scilex sells an FDA-approved, prescription-strength topical analgesic self-adhesive patch, ZTlido (lidocaine), which is allegedly often prescribed off-label, … Continue reading →

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