Biotin Supplement Suit Dismissed on Preemption Grounds

A California federal judge tossed a proposed class action against allegedly “worthless” biotin dietary supplements on preemption grounds earlier this week, citing the Ninth Circuit’s recent decision in Dachauer v. NBTY, Inc., 913 F.2d 844 (9th Cir. 2019).

In Greenberg v. Target Corp., et al., the plaintiff filed a putative class action alleging that labeling for Target’s Up & Up brand of biotin dietary supplements was misleading under California’s Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA).

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Final Drug Pricing DTC Advertising Rule to Take Effect July 9 – But Faces Challenges from Pharmaceutical Companies

This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would require pharmaceutical manufacturers to list prices in DTC advertising for drugs costing $35 for a 30-day supply.

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Labeling Preemption Questions are for the Court, not the Jury, Holds U.S. Supreme Court in Fosamax Decision That Clarifies the “Clear Evidence” Standard

A judge, and not the jury, is the better-positioned and appropriate decisionmaker to determine whether a failure-to-warn claim is federally preempted, the U.S. Supreme Court held today.

The Court also clarified the “clear evidence” standard governing an impossibility preemption defense to failure-to-warn claims.

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The Presumption of Regularity in Prescription Drug Cases

In products liability cases involving prescription medicines, defendants sometimes rely on a preemption defense that FDA would not have approved – or in some cases, already rejected – the warnings that plaintiffs argue were required by state law.  Where the evidence shows FDA considered and rejected plaintiffs’ proposed warnings, plaintiffs often argue that the Agency would have approved their proposed warnings were it not for some technical issue.  For example, that FDA rejected the warning because the manufacturer asked to put it in the wrong section of the label or FDA would have approved it had the manufacturer asked rather than some third party in a Citizen’s Petition.  In rejecting such arguments courts often point, explicitly or implicitly, to the presumption of regularity, which “presumes” government agencies have “properly discharged their official duties” unless “clear evidence” shows otherwise.  See United States v. Chem. Found., Inc., 272 U.S. 1, 14-15 (1926); see also Nat’l Archives & Recs Admin. v. Favish, 541 U.S. 157, 174 (2004) (requiring “meaningful evidentiary showing” to rebut presumption of regularity).

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Are You Sure You’ve Got Milk?

Alternatives to traditional food products have increased in availability, number, variety and popularity over the last decade.  So where does this leave consumers and the regulators who are tasked with ensuring food safety?  The Ninth Circuit has held that the reasonable consumer can digest the differences between almonds and cows.

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The Price for Natural Cosmetics

In a world where consumers are more health-conscious and eco-friendly than ever, products containing artificial ingredients have become less attractive. Consumers are looking for natural alternatives, and the cosmetics industry is no exception. The recent boom of all-natural products has coincided with a rise in litigation. Like the food industry, cosmetic companies are learning that marketing products as “natural” comes with a price.

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Impact of President Trump’s Opioid Legislation on Drug Manufacturers

President Trump recently signed the SUPPORT, or Substance-Use Disorder Prevention That Promotes Opioid Recovery and Treatment, for Patients and Communities Act (the “Act”), aimed at curbing the overuse of opioids in the United States. The Act is far-reaching, and it includes changes to Medicare, Medicaid and other public health efforts. Certain sections, especially those in Title III, “FDA and Controlled Substance Provisions,” will have a direct impact on manufacturers of certain products used to treat chronic pain.

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