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242 published works
Drug & Device Law
The FDCA Preempts California’s Sherman Law, Ninth Circuit Holds
We have always been flummoxed by California’s Sherman Law. That is the California statute that purports to incorporate by reference the Food, Drug, and Cosmetic Act, supposedly making violations of…
Drug & Device Law
Government Concedes Botched Off-Label Use Instruction in FCA Case
By Bexis
The billion-dollar-plus verdict in United States ex rel. Penelow v. Janssen Products, LP, 2025 WL 937504 (D.N.J. March 28, 2025), epitomizes everything that is wrong about the False Claims Act…
Drug & Device Law
How Not To Create “Newly Acquired Information”
By Bexis
Bexis is updating (probably for the last time) the preemption chapter of his drug and device product liability treatise, so expect blogposts like this on preemption-related topics. Briefly, preemption in…
Food, Drug & Agriculture
What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics
By Dominick DiSabatino, Audrey Mercer
Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”)[1] for allegedly…
Napoli Shkolnik Blog
Parents Sue Colgate: When Children’s Products Become Dangerous
#gap-1627989915 { padding-top: 50px; } The recent class action lawsuit against Colgate-Palmolive over their Hello Kids Fluoride Rinse represents a disturbing trend in corporate America where profit margins take precedence…
Drug & Device Law
Medical Device Manufacturers Are Not Health Care Providers, Right?
For the decades that we have been handling drug and medical device product liability cases, it has been a given that we wanted to make it clear that our clients…
Drug & Device Law
Preemption Round Up – Failure to Report
By Bexis
Recently, when putting together our “Staple Suit Cropped” blogpost about Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), we realized that, while we had a…
Climate Solutions Legal Digest
Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages
By Megan Beebe, Lauren Petrin [Former Attorney]
On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to…
Drug & Device Law
DDL Blog Goes to the Dogs (And Cats)
Yes, we are the Drug and Device Law Blog. Yes, we at times stray into other areas when we think a decision has application to our DDL world. Yes, today’s…
Drug & Device Law
Double Shot Thursday: Express Preemption Based on an OTC Drug Monograph and The Delaney Clause and Personal Injury Litigation— FDA Delists Color Additive Red No. 3, But Will It Be Enough to Attract Even Dyed-in-the-Wool Plaintiffs Lawyers?
Like the radio stations of yore did with songs, we offer up two related posts back-to-back instead of the usual one. We cannot offer a “favorite artist” as the source…