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
Federal Officer Removal and Pharmacy Benefit Managers
We’ve posted twice recently about the potential jurisdictional benefits of the congressionally expanded “federal officer” basis for federal jurisdiction in tort litigation: 28 U.S.C. §1442 (a)(1). Our first post cited in passing Griffin v. Optum, Inc., ___ F.4th ___, 2026 WL 1239289 (8th Cir. May 6, 2026), as an example of courts already applying
OT – Bexis’ Hawai’ian Adventure
This post is off-topic – it has nothing to do with prescription medical product liability litigation, or even the law. Bexis recently took a vacation on the island of Kauai, in Hawai’i, for the sixteenth time. He hiked, for the tenth time, the first two miles of the Kalalau Trail, to Hanakapiai Beach. That’s nice
Say Good-Bye to CGMPs and Hello to ISO 13485
Recently, towards the end of a post about preemption and the FDA’s Current Good Manufacturing Practices (“cGMPs”) – also known as Quality Management System Regulations (“QMSRs”) − we noted a “significant change” last February. “[T]he FDA issued a final rule” that replaced all existing cGMPs “by incorporating by reference an international standard specific for device