Shortly after the Supreme Court decided Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), we predicted that that the other side would attempt to use that decision “for nefarious purposes.” We chronicled their first, “meat-axe” attempt here, where MDL plaintiffs argued that Loper Bright somehow abolished implied preemption in tort cases altogether.
JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee. He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee. He can be reached at jmbeck@reedsmith.com. His LinkedIn page is here.
The Continuing Demise of Market Share Liability
We published a 50-state survey on the widespread rejection of so-called market share liability back 2010, which we recently referenced in our post celebrating the demise of an “ultra processed” food strike suit in Pennsylvania. As that post discussed, one of the liability theories that failed was market share liability. That got us thinking that…
Recent FDA Development Warrants Revisiting Tampon Preemption
…[T]esting conducted by FDA laboratories and a toxicological risk assessment related to metals found in tampons . . . found that, while trace metals are present in
A British Hi-Tech Response to a Hi-Tech Problem
Novo Nordisk A/S v. British Telecommunications Plc, 2026 WL 01791875 (Ch. Div. June 23, 2026), is the first judicial decision from the United Kingdom that we have featured on the Blog. The high-tech solution that the court approved for combating proliferating fly-by-night websites that “in one way or another were involved in the sale…
DiToto Is a Total Mess
Our initial inclination was not to blog about DiToto v. Nevro Corp., 2026 WL 1425041 (D. Md. May 21, 2026), given that it was an adverse, poorly reasoned trial court level decision. But then we received an updated citation indicating that – for reasons that totally escape us – Thompson-Reuters/West had decided to publish…
Medical Monitoring and the Limits to Equity
We recently became aware of a legal podcast comment about the incompatibility of medical monitoring claims and the availability of equitable relief (at least in federal court) under Grupo Mexicano de Desarrollo S.A. v. Alliance Bond Fund, Inc., 527 U.S. 308 (1999).
Whodawhat?
That was our initial reaction. But we took a look anyway…
New WLF Paper on the First Amendment as a Defense to Public Nuisance
We first learned of the Washington Legal Foundations (“WLF”) back in the 1990s, when Bexis collaborated with WLF in pursuing what was then viewed as a rather radical proposition – that the First Amendment applied to FDA and other governmental constraints on off-label promotion of FDA regulated products. Eventually, the Supreme Court specifically held that…
Mistakes of Law as Fraud – A 50-State Survey
Not too long ago we wrote about McKenzie v. Progressive Treatment Solutions, LLC, 2026 WL 636741 (N.D. Ill. March 6, 2026). One of the things about McKenzie that caught our eye was the statement that, under Illinois law, “misrepresentations or mistakes of law cannot form the basis of a claim for fraud.” Id. at…
Rule 12(b)(6) Dismissal Where Judicially Noticed Facts Contradict the Complaint
Late last year, when we were putting together our massive post that collected and categorized every case that had ever judicially noticed an FDA document, we ran across the intriguing proposition that in deciding Rule 12 pleading-based motions, “allegations in a complaint are not credited where contradicted by judicially noticeable documents.” We cited several appellate…
Guest Post − Texas Supreme Court’s “One Step” Grants A Distributor Interlocutory Review Regarding Non-Manufacturing Seller Immunity Statute
Today’s guest post is by Kevin Hara, of Reed Smith, who is pinch-hitting for Steve Boranian. His post today discusses the Texas Supreme Court’s procedural reversal of a lower court’s refusal to hear an interlocutory appeal concerning application of a Texas distributor immunity statute arising in the context of an FDA-regulated drug. The…