It’s been a been a while – some five years – since we discussed cross-jurisdictional class action tolling. That’s mostly because, aside from the occasional result-oriented atrocity that occurred in the Valsartan MDL, class actions are no longer a top-shelf problem in prescription medical product liability litigation. But it’s still nice to report on a
Getting Noticed – Receiving FDA-Related Judicial Notice
This post sort of got away from us. We started with the proposition that our prescription medical product clients frequently move to dismiss cases, and thus seek to get courts to take judicial notice of FDA-related documents in product liability litigation involving their products. Judicial notice in cases involving FDA regulated products can be of great assistance on pleadings-based motions (Rule 12(b)(6) and judgment on the pleadings) because judicial notice is an exception to the usual limitation of such motions to what plaintiffs plead – or, equally importantly, fail to plead – in their complaints. Not only do judicially noticeable documents fill in facts that plaintiffs deliberately omit, but they can also defeat contrary factual allegations that the documents establish are untrue. This is an important exception to the Rule 12 mantra that challenged allegations are to be taken as true. Instead, allegations in a complaint are not credited where contradicted by judicially noticeable documents. E.g., Fuqua v. Santa Fe County Sheriff’s Office, ___ F.4th ___, 2025 WL 3072794, at *4 (10th Cir. Nov. 4, 2025); Jeffery v. City of New York, 113 F.4th 176, 179 (2d Cir. 2024); Clark v. Stone, 998 F.3d 287, 298 (6th Cir. 2021); Massey v. Ojaniit, 759 F.3d 343, 353 (4th Cir. 2014); Kaempe v. Myers, 367 F.3d 958, 963 (D.C. Cir. 2004); Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). So judicial notice can overcome contrary pleadings.Continue Reading Getting Noticed – Receiving FDA-Related Judicial Notice
Once More Into the Breach on Off-Label Use
Some of us are old enough to remember when the Kessler-led FDA attacked off-label use of prescription medical products by using archaic language in the agency’s “intended use” regulations (21 C.F.R. §§201.128, 801.4) to claim that a regulated entity’s mere knowledge that its products were being used off-label by physicians meant that those products were
2025 Updates to Ediscovery for Defendants Cheat Sheet
Another two years have elapsed (since October, 2023) since we last updated our cheat sheet devoted to ediscovery for defendants. That’s because finding good, pro-defense ediscovery decisions is a hard and time-consuming task – and getting harder. Unlike most of our other cheat sheets and scorecards, cases involving defense discovery of plaintiffs’ social media
PMA Preemption of Negligent Testing Claims
As we’ve pointed out elsewhere, particularly in our duty to test cheat sheet, most states do not recognize any sort of separate negligence or strict liability claim for “duty to test” or “failure to test” separate and apart from the more usual sort of product liability claims involving the design and warnings of products. So defendants looking to file motions to dismiss against testing-based counts of their opponents’ complaints could do worse than to check out our cheat sheet.
Manufacturers of FDA pre-market approved medical devices, however, have a second option. They can also go after testing-based claims on preemption, because claims that manufacturers of such devices should have done more or different testing than the FDA considers necessary for approval are either “different from or in addition to” the FDA’s PMA criteria. Indeed, the seminal express preemption case, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), recognized that express preemption under 21 U.S.C. §360k(a) extends to “tort law, applied by juries under a negligence or strict-liability standard,” such as state tort claims alleging “negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of [a PMA device],” id. at 320, although the dismissed testing claims were not separately discussed by the Supreme Court in Riegel.Continue Reading PMA Preemption of Negligent Testing Claims
Guest Post – Radical Transparency and Product Liability Exposure – The New Frontier
Today’s guest post is by Howard Dorfman, a old friend of the Blog, who is now continuing to think important thoughts as an Adjunct Professor at Seton Hall Law School. This post concerns potential product liability implications of the FDA’s decision to release so-called “complete response letters (“CRLs”), apparently as a matter of future
FCA Dismissal Illustrates Pharmaceutical Promotion Done Right
Back in the bad old days of the Bone Screw litigation, we had to fight our way through a thicket of scurrilous allegations about how our clients supposedly promoted off-label use through continuing medical education seminars that the Bone Screw plaintiffs claimed were used to reward surgeons who regularly used our clients’ products with excessive speaker fees. Back then – in the mid 1990s – the plaintiffs’ preferred avenues for asserting such allegations were state-law based: negligence per se, fraud on the FDA, and conspiracy. By the time that the infamous Franklin False Claims Act (“FCA”) decisions came down (United States ex rel. Franklin v. Parke-Davis,147 F. Supp.2d 39 (D. Mass. 2001), and United States ex rel. Franklin v. Parke-Davis, 2003 WL 22048255 (D. Mass. Aug. 22, 2003)), we had won Buckman (and a lot of other things), so Bone Screw-related promotion allegations were never the subject of FCA litigation.
But the Bone Screw promotional allegations were close enough to what has been subsequently alleged ad nauseum in FCA litigation that we’ve followed similar FCA litigation ever since. Today’s case, United States v. Gilead Sciences, Inc., 2025 WL 2627686 (E.D. Pa. Sept. 11, 2025), does not involve off-label use, but does involve allegations of kickbacks – through speaker programs and donations to charitable organizations. We’re happy to say that the entire action was dismissed – on both sets of facts. We’re even happier to recommend the discussion in Gilead as providing useful guidance for how pharmaceutical companies can manage both types of programs in compliance with applicable law.Continue Reading FCA Dismissal Illustrates Pharmaceutical Promotion Done Right
California Design vs. Manufacturing Defects – Neer the Twain Shall Meet
Not long ago we published a blogpost, “New California Ranitidine Litigation Order Makes A Huge Mess Of Everything” about a California trial court decision that created, out of whole cloth, what it called a “hybrid theory” of strict liability that jumbled together elements of the long-established – and long separate – concepts of design and manufacturing defect, while sprinkling in the negligence concept of intent. See In re Rantidine Cases, 2025 WL 2796831 (Cal. Super. Sept. 15, 2025). As a result, the court allowed a “manufacturing” defect that was uniform across all units of the product, because it construed plaintiffs’ attack on the defendants’ manufacturing processes as a manufacturing defect.
In this post we will attempt to describe just how far out of bounds this “hybrid theory” really is.Continue Reading California Design vs. Manufacturing Defects – Neer the Twain Shall Meet
Recent Pennsylvania Appellate Decisions Can Combat Post-Mallory Forum Shopping
Not long ago we discussed Somerlot v. Jung, ___ A.3d ___, 2025 WL 2157391 (Pa. Super. July 30, 2025), as providing a potential antidote to some Mallory-inspired forum shopping. However, as we pointed out, Somerlot’s advantages were limited, because: (1) they required the pro-active use of forum selection clauses in advance of any litigation, and (2) would only be available to defendants who had the sort of relationship (directly or through distributors or doctors) with a plaintiff that would provide the opportunity to require such a clause. Thus, the Somerlot solution was not available to all, or even most, prescription medical product liability litigation.
However, over the last couple of months, Pennsylvania appellate decisions involving the more traditional concepts of forum non conveniens and venue have materially changed applicable law for the better, in terms of their availability as tools to combat post-Mallory forum shopping. Since Pennsylvania remains the only large state to allow general jurisdiction by consent in prescription medical product liability litigation, Pennsylvania law remains by far the most important for dealing with post-Mallory forum shopping.Continue Reading Recent Pennsylvania Appellate Decisions Can Combat Post-Mallory Forum Shopping
Another Shameless Plug – Calling All Life Sciences In-House Counsel: Wrap Up Your 2025 CLE Requirements with Us
If you’re an in-house counsel working in the pharmaceutical, biotech, medical device, or digital health space (and still looking to complete CLE hours before year-end) we invite you to join Reed Smith’s annual Virtual Life Sciences CLE Week, taking place November 3–7, 2025.
This week-long event will feature a series of live webinars