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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  His LinkedIn page is here.

We have no inclination to mess with Texas.  Heck, a state ornery enough to secede from two different countries in order to preserve slavery isn’t likely to care, anyway.  So if Texas wants to run its own power grid, not connect to the rest of us, and freeze in the dark when that system fails, we’re certainly not going to stand in the way.  Conversely, when Texas emphatically adopted the learned intermediary rule in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), we hailed it as the best decision of 2012.

But when Texas decides to mess with the rest of us….  Well, that’s different.

So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19.  The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic.  That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available.  The Texas Complaint also claims that, in various ways, the vaccine manufacturer violated certain mandatory FDCA provisions and FDA regulations (¶22), did not follow voluntary FDA guidance (¶¶25-31), supposedly committed fraud on the FDA by submitting misleading data (¶¶47, 117, 120-21), and mostly that it purportedly misled the public and/or the press (¶¶50, 55-91, 154-55, 157-59, 161-63, 165-66, 168-69).Continue Reading A Texas Mess

As readers of the Blog undoubtedly know, the amendments toughening up Fed. R. Evid. 702 became effective on December 1, 2023.  Here are the precise changes again:

Rule 702. Testimony by expert witnesses.

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that:

a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

b) the testimony is based on sufficient facts or data;

c) the testimony is the product of reliable principles and methods; and

d) the expert has reliably applied the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case.

New language in italics; deleted language struck out.Continue Reading New Fed. R. Evid. 702 – Use This Stuff To Update Your Briefs

Our recent fraudulent joinder post ended with the observation, “[h]aving found fraudulent or procedural misjoinder, the court ‘sever[ed] the action’ against the healthcare provider ‘so as to preserve [the manufacturer’s] right to removal in the remaining action.’” (quoting In re Stryker Rejuvenate & ABG II Hip Implant Products Liability Litigation, 2023 WL 6514996, at *3 (D. Minn. 2023)).

That started us thinking about other uses of severance of non-indispensable parties to preserve diversity – particularly, as in the Rejuvenate case, medical malpractice defendants in product liability litigation – to preserve federal diversity jurisdiction.  We have discussed several individual decisions that successfully employed Rule 21 in this fashion:  here (discussing Mayfield v. London Women’s Care, PLLC, 2015 WL 3440492 (E.D. Ky. May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 2746086 (S.D. Ill. July 11, 2011)); here (discussing Stone v. Zimmer, Inc., 2009 WL 1809990 (S.D. Fla. 2009)); here (discussing DeGidio v. Centocor, Inc., 2009 WL 1867676 (N.D. Ohio June 29, 2009)); and here (discussing Joseph v. Baxter International, Inc., 614 F. Supp.2d 868, 872 (N.D. Ohio 2009)).Continue Reading Removal, Severance & Rule 21

Some of us are participating in beta testing of generative artificial intelligence (“AI”) for legal applications in the law firm environment.  So far the verdict is – associates can breathe easy, at least for now.  Nothing we’ve seen is capable of replicating legal research even at a first-year level of quality.

But that doesn’t mean that AI won’t impact prescription medical product liability litigation.  In particular, we’re not surprised to learn that AI is being used in the context of FDA-required adverse event reporting, purported problems with which have become one of the other side’s go-to preemption dodges.  Just a few examples from a simple Google search:Continue Reading Musing about Discovery and Artificial Intelligence

Abuse of substantive law as a weapon to force settlement occurs so frequently in multidistrict litigation (“MDL”), that we’ve given it a name – “the MDL treatment.”  The linchpin of the MDL treatment is that plaintiffs are allowed to take way more liberties with state law than the Erie doctrine allows.  Readers can recall from our prior posts that both the Supreme Court and Third Circuit (to take the relevant example), view expansive federal court “predictions” of state law – and state tort law in particular – usurp the prerogatives of the states and are an abuse of power. Continue Reading CPAP MDL Overinflates Plaintiffs’ Claims