Statute
FDCA
242 published works
Drug & Device Law
Trying To Make Some Sense Out of OTC Economic Loss Decisions
By Bexis
Over-the-counter (“OTC”) drugs are protected from civil liability by an express preemption provision that is even stronger than the medical device preemption clause interpreted in Riegel v. Medtronic, Inc., 552…
Drug & Device Law
A Preemption Two-Fer
By Bexis
It’s unusual when the same defendant wins two unrelated cases involving the same product in the same week – and on the same issue. But it does happen, and recently,…
Inside Class Actions
Federal Law Preempts Plaintiffs’ Challenges to the Label of a Glucosamine Dietary Supplement, Ninth Circuit Holds
The Ninth Circuit recently affirmed summary judgment in favor of a manufacturer of glucosamine dietary supplements, holding that plaintiffs’ state law claims sought to impose requirements different from those under…
Drug & Device Law
Mifepristone Manufacturer Wins First Round in West Virginia
By Bexis
Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom…
Drug & Device Law
Ninth Circuit: Call a Spray a Spray – Butter Substitute Labeling Claims Preempted by the FDCA
We start with the usual poodle report – actually with a comment that these may be drawing to a close, as Luca is only a few points from finishing his…
Gender and the Law Prof Blog
Danco Laboratories Seeks Stay of Preliminary Injunction from U.S. Supreme Court
By Jamie Abrams
Danco Laboratories filed its "Emergency Application for Stay of Preliminary Injunction Pending Appeal" in the Alliance for Hippocratic Medicine case. The Fifth Circuit’s unprecedented order has created regulatory chaos across the country. The…
Health Care and Life Sciences
FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration
By Dominick DiSabatino, Arushi Pandya
On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter[1] to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding and adulteration.…
Health Care and Life Sciences
FDA Expands Inspection Guidance to Apply to Device Manufacturers
On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” (the “Inspection…
Drug & Device Law
W.D. Kentucky Dismisses Amlodipine Claims on Preemption Grounds
Bexis has already plugged the Reed Smith Life Sciences CLE programs this week, so we won’t replug — except to remind you that Rachel Weil and the drudge/author of this…
Drug & Device Law
D. New Mexico Upholds Vaccine Employment Mandate
We listen to the This American Life show on National Public Radio most weeks, and it often reveals interesting things about, uh, this American life. On Saturday, as we drove…