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
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.
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…
Non-Patent Implications of Supreme Court’s “Skinny Label” Hikma Decision
We don’t normally discuss patent/intellectual property issues on the Blog, even though they arise all the time in prescription medical product litigation. The reason is simple − our clients (and target audience) can be found on either side of the “v.” So, it’s best that we leave the offering of opinions on patent/IP issues to…
Preemption Is a Defense, Not a Basis for Jurisdiction
If preemption were an independent basis for federal subject matter jurisdiction, almost all of our drug, device, and vaccine product liability litigation would be in federal court. We’ve long been resigned that preemption is a defense, not grounds for jurisdiction. E.g., Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 811 (1986). A…
Supreme Court Roundup Decision: “Different From” and “In Addition To” Mean What They Say
Ever since we reviewed the Environmental Protection Administration’s (“EPA”) 2019 decision reaffirming its prior conclusion that glyphosate does not cause cancer and, therefore, the “Roundup” herbicide did not warrant any cancer warnings, we have been convinced that state-law claims demanding such warnings were (or should be) preempted – regardless of how pro-plaintiff decisions might seek…