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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.

While putting together our recent Camp Lejeune post on deliberative process privilege, we came across another discovery dispute that we’ve seen in prescription medical product liability mass tort litigation – plaintiffs refusing to produce their social security numbers.  So we decided to take a look at what’s out there.  We found that “Courts have routinely

As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability.  That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their

Much of the Camp Lejeune litigation is rapidly becoming, in military parlance, FUBAR.  Even prominent plaintiff-side lawyers have started calling out the avalanche of fraudulent claims that MDL-style solicitation has been generating.  Congress permitted liability, so now the United States itself is being targeted by the same litigation practices that plague MDL defendants.

But the

In our recent post describing the best prescription medical product liability litigation decisions of 2023, no fewer than three of the opinions we discussed:  #4 In re Acetaminophen-ASD-ADHD Products Liability Litigation, ___ F. Supp.3d ___, 2023 WL 8711617 (S.D.N.Y. Dec. 18, 2023), #5 Onglyza Products Cases, 307 Cal. Rptr.3d 480 (Cal. App. 2023)

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