Statute
FDCA
242 published works
Drug & Device Law
PREP Act Preemption Scorecard
By Bexis
We’ve discussed decisions applying preemption under the Public Readiness & Emergency Preparedness Act (hereafter “PREP Act”), 42 U.S.C. §247d-6d, on several occasions since the COVID-19 pandemic began. At this point,…
Food, Drug & Agriculture
FDCA Preemption: A Powerful Tool for Defending Class Actions
Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense…
Business and Commercial
FDCA Preemption: A Powerful Tool for Defending Class Actions
Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense…
Drug & Device Law
The Expanding Breadth Of Nexus
Back in 2020, we noted the possible broad implications of a Buckman preemption decision in a somewhat unusual economic loss case that turned on whether a compounded pharmaceutical needed FDA…
Food Safety News
Court Enjoins California food company from manufacturing and distributing adulterated food
By News Desk
A federal court has enjoined a California company to stop manufacturing and distributing adulterated food products that violate the Federal Food, Drug, and Cosmetic Act (FDCA). In a civil complaint…
Drug & Device Law
FDA and Off-Label Communication – Getting Closer to Truth
By Bexis
In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label…
Drug & Device Law
Drug Manufacturer’s Claims Against Compounding Pharmacy Held Impliedly Preempted by S.D. Tex. Notwithstanding Fifth Circuit’s Spano Decision
This post is solely from the non-Reed Smith side of the Blog. A court within the Fifth Circuit has held that the FDCA impliedly preempts unfair-competition and consumer-protection claims asserted…
Drug & Device Law
Preemption Ends Appeal Of Dyspeptic Supplement Case
We have often characterized preemption as one of the most powerful tools in product liability defense lawyers’ toolboxes. It also gets utilized effectively by lawyers defending against a variety of…
Drug & Device Law
Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted
As defense attorneys who represent drug and device companies, we generally cheer when a state-law claim is held preempted by the FDCA. We are, however, not sure whether to cheer…
Drug & Device Law
Plaintiff’s Expert Doesn’t Measure Up
If a court tells you your only non-preempted claim is one based on a theory that your labeling does not comply with the Federal Food, Drug & Cosmetic Act (“FDCA”),…