Category Archives: fda

IPSC: Other IP

Other IP  [Insert wry commentary about “fringe” fields like advertising law]   Sarah Burstein, The University of Oklahoma College of Law Reviving Ornamentality    Fed. Cir. killed the doctrine.  Statute says new, original, and ornamental designs can get a design … Continue reading

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False claims of FDA approval actionable under Lanham Act and state law

Innovative Health Solutions, Inc. v. DyAnsys, Inc., 2015 WL 2398931, No. 14-cv-05207 (N.D. Cal. May 19, 2015)   IHS sells a medical device called P–STIM.  DyAnsys used to be the distributor of P-STIM in the US, but after it lost … Continue reading

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FDA pre-approval doesn’t bar Lanham Act false advertising claim against device

Church & Dwight Co. v. SPD Swiss Precision Diagnostics, GMBH, No. 14 Civ. 00585, 2015 WL 2359467 (S.D.N.Y. Mar. 24, 2015)   Earlier discussion.  SPD argued that the FDCA barred Lanham Act false advertising claims against it because the FDA … Continue reading

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Primary jurisdiction didn’t warrant dismissal of "natural" claims, 9th Cir. says

Astiana v. Hain Celestial Group, Inc., No. 12-17596 (9th Cir. Apr. 10, 2015)   As the court of appeals introduced the case:   A product labeled “all natural” or “pure natural” likely evokes images of ground herbs and earth extracts … Continue reading

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post-POM claim based on false implication of FDA approval survives

Par Sterile Products, LLC v. Fresenius Kabi USA LLC, 2015 WL 1263041, No. 14 C 3349 (N.D. Ill. Mar. 17, 2015)   Par’s vasopressin injection product, Vasostrict, is a FDA-approved pharmaceutical. Fresenius’s vasopressin injection product is not.  Vasopressin is a … Continue reading

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9th Circuit reverses preemption finding in consumer protection case

Reid v. Johnson & Johnson, 2015 WL 1089583, No. 12–56726, — F.3d – (9th Cir. Mar. 13, 2015)   Reid sued defendants (here J&J) based on claims about Benecol, a vegetable oil-based spread sold as a healthy substitute for butter … Continue reading

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the intersection of FTC US origin guidelines and the Lanham Act

A.P. Deauville, LLC v. Arion Perfume and Beauty, Inc., No. C14-03343, 2014 WL 7140041 (N.D. Cal. Dec. 12, 2014) Deauville sued Arion for false advertising and unfair competition, and Arion counterclaimed.  This opinion granted in part Deauville’s motion to dismiss. … Continue reading

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Consumer suit against juice name preempted

Bell v. Campbell Soup Co.,  No. 4:14cv291, 2014 WL 6997611 (N.D. Fla. Dec. 11, 2014) The facts are essentially the same as in Pom Wonderful v. Coca-Cola, but the result is that only competitors, not consumers, can sue for false … Continue reading

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Insufficient deviation from FDA label and lack of materiality doom false ad claims

Apotex Inc. v. Acorda Therapeutics, Inc., 2014 WL 5462547, No. 11 Civ. 8803 (S.D.N.Y. Oct. 23, 2014) Zanaflex tablets and capsules (active ingredient tizanidine) are approved by the FDA to treat spasticity.  Somnolence is one of the most common side … Continue reading

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FTC challenges Gerber allergy-protection claims in court

Read the FTC’s explanation.  The FDA approved an extremely limited claim about very sketchy scientific evidence, and Gerber converted that into “the first and only infant formula that meets the criteria for a FDA Qualified Health Claim,” with accompanying gold … Continue reading

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