Tag Archives: fda

Lanham Act covers ads that drug is FDA-approved/has ANDA

Arbor Pharmaceuticals, LLC v. ANI Pharmaceuticals, Inc., 2018 WL 3677923, No. 17-4910 (D. Minn. Aug. 2, 2018) Arbor sells prescription erythromycin ethylsuccinate for oral suspension, allegedly the only FDA-approved products of their kind on the market. ANI announced the launch … Continue reading

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make your own sexual reference: 9th Circuit partially reinstates male enhancement lawsuit

Sandoval v. PharmaCare US, Inc., No. 16-56301, No. 16-56710, — Fed.Appx. —-, 2018 WL 1633011 (9th Cir. Apr. 5, 2018) Sandoval brought a putative class action claim based on PharmaCare’s statements about its “male enhancement” product IntenseX. The court of … Continue reading

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Supplement maker can’t enjoin database changes, but avoids anti-SLAPP dismissal

Exeltis USA Inc. v. First Databank, Inc., 2017 WL 6539909, No. 17-cv-04810 (N.D. Cal. Dec. 21, 2017) This is an interesting case about the FDA/Lanham Act interaction. Exeltis sells prenatal vitamins that contain 1 mg of folic acid.  They aren’t … Continue reading

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Another court declines to apply GNC where plaintiff alleges only negative studies

Yeldo v. MusclePharm Corp., 2017 WL 5499588, Case No. 17-11011 (E.D. Mich. Nov. 16, 2017) Yeldo brought a putative class action alleging that MusclePharm used misleading marketing practices to promote its glutamine dietary supplement, whose label and online ads indicate … Continue reading

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When the specifics are misleading: medical test stats draw false advertising claim

Quidel Corp. v. Siemens Med. Solutions USA, Inc., 2017 WL 4654644, No. 16-cv-3059 (S.D. Cal. Oct. 16, 2017) Quidel is a “diagnostic healthcare manufacturer” that “developed, promotes and sells the Thyretain TSI Reporter BioAssay,” which is “intended for the qualitative … Continue reading

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Reading list: consequences of 1A protections for off-label promotion

Patricia J. Zettler, The Indirect Consequences of Expanded Off-Label Promotion, Ohio State Law Journal, Forthcoming  The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five … Continue reading

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“unapproved drug” claims fail post-Pom, but not challenge to “natural” claim

Hi-Tech Pharmaceuticals, Inc. v. Hodges Consulting, Inc., 2016 WL 8856671, No. 16-cv-00906 (N.D. Ga. Dec. 13, 2016) Hi-Tech and Hodges compete in the dietary supplement market for body builders.  Hi-Tech sued for patent infringement, as well as for false advertising. … Continue reading

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