A few weeks ago, we reported on Chong v. Kind LLC, 2022 WL 464149 (N.D. Cal. 2022), a decision holding that 21 U.S.C. § 337(a) as construed in Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. As
Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law
Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 337(a), which proclaims that all actions to enforce
Court Allows Fraud and Misrepresentation Claims to Proceed Despite the Learned Intermediary Doctrine
A federal court applying Florida law has refused to dismiss fraud and misrepresentation claims brought by a patient against a medical-device manufacturer, rejecting the manufacturer’s contention that such claims are categorically barred by the learned-intermediary doctrine.
It is perhaps telling that the decision, Pirlein v. Ethicon, Inc., Med. Devices Rep. ¶ 24,799 (S.D. Fla.
Court Tosses Claims Against Manufacturer and Distributor of a Generic Drug
Earlier this week a district court dismissed claims brought against the manufacturer and the distributor of a generic drug, holding that all of the claims were preempted by federal law and the several also failed under Florida law. The decision, Hernandez v. Aurobindo Pharma USA, Inc., 2022 WL 204401 (M.D. Fla. 2022), is long
First Circuit Asks Whether Massachusetts Recognizes a Duty to Report Adverse Events to the FDA
Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown
Pennsylvania Supreme Court: Registering to Do Business Does Not Constitute Consent to General Personal Jurisdiction
In law as in real estate, “location, location, location.” Where a case is filed is often outcome-determinative. Jury pools and jurisprudence vary from one jurisdiction to the next. In some states, any complaint written on paper is sufficient; in others, a plaintiff must actually plead facts to avoid dismissal. Similarly, juries in some places routinely
MDL Court: Pre-Approval Design-Defect Claim Not Preempted
In a ruling that is contrary to Supreme Court precedent, the district court presiding over the Zostavax MDL recently held that federal law does not preempt a state-law design-defect claim based on the manufacturer’s failure to seek FDA approval of a different, purportedly safer vaccine.
Zostavax, a shingles vaccine, received FDA approval in 2006. The
Hospital Cannot Be Forced To Grant Privileges To Doctor Who Would Administer Ivermectin
Four times in the past several months (here, here, here, and here), we have reported on cases in which plaintiffs have sought injunctions that would compel hospitals to administer the anti-parasitic drug ivermectin to COVID-19 patients. Today we report on another such case, Texas Health Huguley, Inc. v. Jones,
Generally Applicable Implied-Preemption Principle Illustrated By Off-Label Generic Drug Case
Federal law regulates medical devices differently from pharmaceuticals, and branded drugs differently from generic drugs. Whether a particular state-law tort claim is preempted often depends on whether the claim involves a medical device, a branded drug, or a generic drug. Often but not always. As today’s case illustrates, there is one implied-preemption principle that applies
Court Severs Product-Liability Claims Brought By Different Plaintiffs Involving Different Devices Implanted At Different Times By Different Doctors
Plaintiffs like to file complaints that join multiple plaintiffs in a single action. They think that doing so gives them added leverage in settlement discussions. They think that because they know that if they get to a jury, a jury is—no matter the evidence—more likely to find in favor of the plaintiffs and against the