Tag Archives: fda

Reading list: the First Amendment and the FDA

Christopher Robertson, A Trojan Horse? How Expansion of the First Amendment Threatens Much More than the Regulation of Off-Label Drugs, forthcoming, __ Ohio State Law Journal __ (2017) Abstract: Scholars, advocates, and courts have begun to recognize a First Amendment … Continue reading

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Primary jurisdiction doesn’t defeat supplement false advertising claim

Nutrition Distribution LLC v. Custom Nutraceuticals LLC, No. CV-16-00173, 2016 WL 3654277 (D. Ariz. Jul. 8, 2016) The parties compete in the nutritional supplement market; defendant Custom sells Ostarine, a selective androgen receptor modulator (“SARM”) with effects similar to those … Continue reading

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Second Circuit narrowly interprets materiality for Lanham Act purposes

Apotex Inc. v. Acorda Therapeutics, Inc., — F.3d —-, 2016 WL 2848911, No. 14–4353–cv (2d Cir. May 16, 2016)   The parties compete to make tizanidine, a drug for treating spasticity. Apotex alleged that Acorda (i) filed a sham citizen … Continue reading

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Cal. court sensibly rejects Fourth Circuit’s GNC rule on consumer protection claims

Mullins v. Premier Nutrition Corp., 2016 WL 1534784, No. 13-cv-01271 (N.D. Cal. Apr. 15, 2016) This case revisits an issue with which courts have struggled: when consumer plaintiffs plead that a product advertised as clinically proven isn’t, is that a … Continue reading

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Flagging supplement case revived

ThermoLife Intern., LLC v. Gaspari Nutrition Inc., — Fed.Appx. —-, 2016 WL 1460171, No. 14–15180 (9th Cir.  Apr. 14, 2016)   ThermoLife sued Gaspari (GNI) false advertising under the Lanham Act and unfair competition under Arizona common law, based on … Continue reading

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announcing product launch and pricing can be false advertising if no launch occurs

Concordia Pharmaceuticals, Inc. v. Method Pharmaceuticals, LLC, 2016 WL 1271082, No. 3:14CV00016 (W.D. Va. Mar. 29, 2016)   Concordia bought the Donnatal line of pharmaceutical products from former plaintiff PBM. Donnatal is a prescription line of combination phenobarbital and belladonna … Continue reading

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What’s in a name? A false advertising suit against a generic drug maker

Endo Pharmaceuticals, Inc. v. Actavis, Inc., 2016 WL 1090356, No. 12-cv-7591 (D.N.J. Mar. 21, 2016)   Endo sued Actavis under federal and state law for allegedly falsely marketing a generic form of oxymorphone hydrochloride extended-release tablets. The court got rid … Continue reading

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Advertising law at Cardozo

Cardozo Law Conference: New Impressions of Advertising Law   Panel 1: False Advertising (herein of Pom Wonderful v. FTC) Moderator: Brett Frischmann | Professor and Director, Cardozo Intellectual Property & Information Law Program, Benjamin N. Cardozo School of Law   … Continue reading

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FDLI symposium: John Coates keynote on deconstitutionalizing corporate speech

John Coates, John F. Cogan, Jr. Professor of Law and Economics, Research Director, Center on the Legal Profession, Harvard Law School: Re-de-constitutionalizing Corporate & Commercial Speech   What I see as a mess in my space is even more of … Continue reading

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FDLI symposium part 2: First Amendment/Commercial Speech

Session 2: Constraints on Commercial Speech and the First Amendment   Moderator: Richard Cleland, Assistant Director, Federal Trade Commission, Bureau of Consumer Protection   Tracing the FTC’s Line Between Advertising and Free Speech Katie Bond, Senior Associate, Kelley Drye   … Continue reading

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