Case
Wyeth v. Levine
215 published works
Drug & Device Law
Yesterday’s News, Today’s “Newly Acquired Information” — The First Circuit’s CBE Time Warp
Here is a question the First Circuit has now answered the wrong way — can a scientific paper published before the FDA approved a drug nonetheless qualify as “newly acquired…
Truth on the Market
Certified Uncertain: Why AI Safety Needs Assurance Tests, Not Permission Slips
OpenAI put tens of thousands of artificial-intelligence (AI) agents through a safety test and told them to work alone. Instead, some found one another, organized against the evaluator, and learned…
Drug & Device Law
Claims Can Still Be Preempted If The Drug Is Later Withdrawn
Long ago, it seemed that large-scale drug or device litigation was usually spurred on by a recall, market withdrawal, or major labeling change describing a new risk or limiting the…
Consumer Finance Monitor
Former FDIC Board Members Gruenberg and Cordray File Amicus Brief Supporting Colorado in Tenth Circuit DIDMCA Opt-Out Litigation
By Alan S. Kaplinsky, Burt M. Rublin
On July 15, 2026, former Federal Deposit Insurance Corporation (FDIC) Chairman Martin J. Gruenberg and former Consumer Financial Protection Bureau Director and FDIC Board Member Richard Cordray filed an amicus…
Pro Te: Solutio
From the Courtroom to Capitol Hill: State Legislative Action on Failure-to-Warn Claims
By Butler Snow
When a company brings a new product to market, who has the authority to approve the product’s label and associated warnings? In most instances involving pharmaceutical drugs or medical devices,…
Drug & Device Law
Plaintiffs Reduce Loper Bright To Absurdity
By Bexis
We read a brief from the other side recently that claimed that Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), abolished implied preemption altogether. We kid you not. Under…
Drug & Device Law
Defense Amici – Who Ya Gonna Call?
By Bexis
Back in 2008, when Blog was less than two years old, we wrote a practical post entitled “Defense Amici – One Stop Shopping.” It arose from blogposts we wrote examining…
Drug & Device Law
A Painful Preemption Decision
By Bexis
The flimsy decision in In re Acetaminophen − ASD-ADHD Products Liability Litigation, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022), leaves us scratching our heads. First, it claims to find “helpful…
Drug & Device Law
Failure-to-Warn Claim Targeting Branded Drug Held Preempted: Litigation-Driven Expert Analysis Is Not “Newly Acquired Information” for Purposes of the “Changes Being Effected” Regulation
Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally…
Mass Tort Defense
MDL Judge Decides Important Preemption Issues
By Sean Wajert
Worth our note is a recent preemption decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 2022 WL 855853 (D.N.J. March 23, 2022). The case is noteworthy because it…