Tag Archives: fda

allegedly false generic claims not actionable, but contributory liability possible

Concordia Pharm. Inc., S.À.R.L. v. Winder Laboratories, LLC, 16-CV-00004 (N.D. Ga. Mar. 15, 2017) Concordia makes Donnatal to treat irritable bowel syndrome and acute enterocolitis.  (There’s related litigation that ended badly for the defendant there.)  Concordia’s predecessor had conditional approval … Continue reading

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allegedly false generic claims not actionable, but contributory liability possible

Concordia Pharm. Inc., S.À.R.L. v. Winder Laboratories, LLC, 16-CV-00004 (N.D. Ga. Mar. 15, 2017) Concordia makes Donnatal to treat irritable bowel syndrome and acute enterocolitis.  (There’s related litigation that ended badly for the defendant there.)  Concordia’s predecessor had conditional approval … Continue reading

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Older case: placement of medical device on market isn’t representation of FDA approval

Intra-Lock International, Inc. v. Choukroun, 2015 WL 11422285, No. 14-cv-80930 (S.D. Fla. May 4, 2015) Old, but new in Westclip (why? It’s an algorithmic mystery), and presents an interesting fact pattern about FDA approval/the lack thereof and the relationship between … Continue reading

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kefir confusion: court finds definition of little-known product to be up for grabs

Lifeway Foods, Inc. v. Millenium Products, Inc., No. CV 16-7099-R, 2016 WL 7336722, — F. Supp. 3d – (C.D. Cal. Nov. 17, 2016) Before the case was dismissed on statute of limitations/laches grounds, the court denied a preliminary injunction. Lifeway … Continue reading

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Second Circuit will trust FDA on drug facts, not on misleadingness

Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmBH, 2016 WL 7131177, No. 15-2411, — F.3d – (2d Cir. 2016) (as amended on denial of reh’g Dec. 5, 2016) Original opinion discussed here; the court amended the opinion … Continue reading

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Republication of online articles was commercial speech and not protected by CDA

Western Sugar Coop. v. Archer-Daniels-Midland Co., 2015 WL 12683192, No. CV 11-3473 (C.D. Cal. Aug. 21, 2015) More belated blogging.  The sugar industry and the corn refining industry accused each other of falsely advertising  high-fructose corn syrup (HFCS).  Plaintiffs were … Continue reading

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Cheerios Protein name might be more bluff than buff

Coe v. General Mills, Inc., No. 15-cv-05112, 2016 WL 4208287 (N.D. Cal. Aug. 10, 2016) Plaintiffs alleged the name “Cheerios Protein” was misleading because it implied that the product is essentially the same as Cheerios, only with added protein. Cheerios … Continue reading

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