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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.

We’ve bashed the horrible decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), more times than we care to count.  This time we’re taking a look precedent contrary to Bausch’s statement that “[t]here are no special pleading requirements for product liability claims.”  Id. at 558.  While that is true as a platitude, the fact of the matter is that TwIqbal does not recognize legal conclusions such as “X violated the FDCA” unless they are supported by facts that plausibly establish the purported violation.  Plaintiffs “cannot simply incant the magic words [defendant] violated FDA regulations in order to avoid preemption.”  Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1224 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015)

Thus, in the specific context of allegations of “parallel” claims that seek to evade preemption, most courts have recognized that “[p]arallel claims must be specifically stated in the initial pleadings.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).Continue Reading Preemption, Plausibility, and Parallel Claims

The billion-dollar-plus verdict in United States ex rel. Penelow v. Janssen Products, LP, 2025 WL 937504 (D.N.J. March 28, 2025), epitomizes everything that is wrong about the False Claims Act – and that’s just about everything.  A private plaintiff (“relator”), purporting to act as a self-appointed agent of the United States government, claimed that

To all in-house counsel working in the pharmaceutical, medical device, biotech, and digital health industries: if you’re looking to complete a few final CLE hours before the end of 2025, we invite you to attend Reed Smith’s annual Virtual Life Sciences CLE Week, taking place from November 3 through November 7, 2025.

This week-long event

We recently received a couple of links from old friends that we thought we’d pass along.  Decades ago, Bexis and some of our other bloggers worked with Peter Grossi – then a senior partner at Arnold & Porter – defending fen-phen cases in Philadelphia and elsewhere.  Peter is retired now, but he still teaches law

Add Connecticut to the list of Zantac multi-plaintiff losses, following the Florida multidistrict litigation (our “Zantac Chronicles” series of posts, and the Delaware Supreme Court).  Only this time the several hundred Connecticut plaintiffs that were dismissed never even reached the absurd causation allegations that doomed the MDL and Delaware cases.  Rather, these Connecticut plaintiffs didn’t even have a means to establish personal jurisdiction over the non-Connecticut defendants they sued.  Bacher v. Boehringer Ingelheim Pharmaceuticals, Inc., 2025 WL 2463143 (Conn. Super. Aug. 22, 2025).Continue Reading Hundreds of Non-Resident Zantac Plaintiffs Run Out of Connecticut

As we’ve discussed earlier several times, there is a lot of lawyer advertising on television and in other media, and it can have adverse effects.  A lot of it also is of questionable accuracy, giving “the false impression that they reflect medical or governmental advice,” using phrases such as “consumer medical alert,” “health alert,”

In what we view as a game-changing submission, on September 3, Lawyers for Civil Justice filed a 20-page analysis of no fewer than nine third-party litigation funding (“TPLF”) contracts that, one way or another, have become public.  This analysis rips away the veil of secrecy that has surrounded TPLF, analyzes why and how specific TPLF

Have you ever heard of the “Presentment Clause” to the United States Constitution?  U.S. Const. Art. I §, cl. 2.  While we can’t say that we had never heard of it – we are aware of presidential vetoes, pocket vetoes, and such – we had never had occasion to consider it in the context of the legal work we do defending prescription medical product liability litigation.  That changed with In re Gardasil Products Liability Litigation, ___ F.4th ___, 2025 WL 2535105 (4th Cir. Sept. 4, 2025), which we recently discussed, here.Continue Reading Presenting the Presentment Clause

Several of our Reed Smith bloggers are planning to be in New York on December 3–4 for ACI’s 30th Annual Conference on Drug and Medical Device Litigation. We’re looking forward to hearing Bexis’ participation on a 30-year retrospective panel and other insightful content, while also enjoying valuable networking opportunities and hopefully the chance to connect