Tag Archives: fda

labeling grandfathered drug in standard format doesn’t misrepresent it as FDA-approved

Belcher Pharms., LLC v. Hospira, Inc., — F. Supp. 3d –, No. 8:17-cv-2353-T-30AAS, 2020 WL 102744 (M.D. Fla. Jan. 7, 2020) “Epinephrine—a drug that is a medical necessity—has been in short supply on and off for nearly a decade.” Hospira … Continue reading

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court enjoins bar on “fake meat” labels; implications for FDA standards of identity?

Turtle Island Foods SPC v. Soman, No. 4:19-cv-00514-KGB (E.D. Ark. Dec. 11, 2019) Unsurprisingly, the court here enjoins provisions of Arkansas law that tried to restrict the use of “meat” terms for meatless alternatives. The worrying part is that the … Continue reading

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implied claims of FDA approval actionable under Lanham Act

Kurin, Inc. v. Magnolia Medical Technologies, Inc., 2019 WL 5422931, No.: 3:18-cv-1060-L-LL (S.D. Cal. Oct. 23, 2019) Kurin developed the Kurin Lock, a “specimen diversion device that reduces the risk of blood culture contamination and associated false positive blood culture … Continue reading

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pharmaco gets summary judgment against compounder on falsity/unlawfulness

Allergan USA, Inc. v. Imprimis Pharmaceuticals, Inc., 2019 WL 4545960, No. 17-cv-01551-DOC-JDE (C.D. Cal. Mar. 27, 2019) The parties compete in the market for ophthalmic drugs. Imprimis sells its ophthalmic drugs pursuant to Sections 503A and 503B of the FDCA … Continue reading

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coconut milk could mislead by claiming “no cholesterol” where it’s too high fat for that label

Marshall v. Danone US, Inc., No. 19-cv-01332-RS, 2019 WL 4509045, — F. Supp. 3d — (N.D. Cal. Sept. 13, 2019) Marshall brought a putative class action alleging false advertising (the usual California claims) against Silk coconut milk, which on its … Continue reading

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She don’t lie, but the pharmaco might: cocaine false advertising case continues

Genus Lifesciences Inc. v. Lannett Company, Inc., 2019 WL 1981186, No. 18-cv-07603-WHO (N.D. Cal. May 3, 2019) Genus competes with Lannett in the market for cocaine hydrochloride nasal spray. It sued Lannett for false advertising and maintaining a monopoly related … Continue reading

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false advertising claim based on alleged misbranding of drug as supplement fails

Amarin Pharma, Inc. v. Int’l Trade Comm’n, Nos. 2018-1247, 2018-114, 2019 WL 1925649, — F.3d – (Fed. Cir. May 1, 2019) The court of appeals upheld the ITC’s decision not to institute an investigation into Amarin’s complaint of an unfair … Continue reading

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