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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.

At least try to do something different.

As we discussed before, because his prescription drug warning claims collided with federal preemption, the plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519 (C.D. Cal. Jun. 22, 2022), needed to plead what the FDA didn’t know, not what it did, to avoid dismissal.  His second try wasn’t any better than the first.

Continue Reading When at First You Don’t Succeed…

This is a guest post by Kelly Jones Howell, of Harris Beach and it’s for a good cause.


DRI’s Drug and Medical Device Committee will hold its annual Seminar on May 3-5, 2023, at the Hilton New Orleans Riverside, in New Orleans, Louisiana.  The Seminar is a preeminent program for practitioners who represent

When we last visited the Zostavax MDL last December, over a thousand plaintiffs, all claiming shingles as an injury, had been dismissed because none of them could produce results from the only medical test that could establish causation.  We ended that post with:

The only claims left allege that Zostavax caused a hodge-podge of other injuries.  But it’s safe to say the nucleus of this MDL pretty much self-destructed.

Continue Reading Zostavax − Dredging the Dregs

One of the most fundamental limitations on tort liability – all tort liability – is that a plaintiff must suffer an injury before s/he can bring a lawsuit.  As Judge (later Justice) Benjamin Cardozo, held “[p]roof of negligence in the air, so to speak, will not do.”  Palsgraf v. Long Island Railroad Co., 162 N.E. 99, 99 (1928) (citation omitted).  Or, as Professors William Prosser and Page Keeton, put it in their treatise:

Continue Reading Live Free, or at Least Have a Present Injury

The recent decision of the Hawai’i Supreme Court in State ex rel. Shikada v. Bristol-Myers Squibb Co., ___ P.3d ___, 2023 WL 2519857 (Haw. March 15, 2023), isn’t all bad by any means – but it’s bad enough, and it carries with it the prospect of liability based on a virtually limitless number of individualized genetic traits, so you can bet we’re not very happy after reading it.

You’d be right.

Continue Reading Trouble in Paradise

Time and time again, we have opposed efforts by one side of a scientific dispute – typically involving a prescription medical product – to attempt to sue the other side of that dispute into silence.  We came to that position through the crucible of litigation, since plaintiffs in the Bone Screw litigation sought to sue a variety of medical societies because they supported the (at the time) off-label use of bone screws for pedicle fixation.  We have tried to be consistent.

Continue Reading Agree To Disagree – Don’t  Sue the Other Side of a Scientific Dispute into Silence

We read a couple of recent articles in the local Philadelphia legal press questioning whether lawyers participating in depositions really had any idea what the “usual stipulations” for their depositions even were.  Between the two articles, they cited three cases.  The issue also prompted some discussion among us bloggers, with one of us commenting that, “for decades,” he has rejected reference to “usual stipulations” in depositions, in favor of the phrase “applicable rules and orders.”

Continue Reading What Are the “Usual Stipulations” for Discovery Depositions, Anyway?

At some point, early in the pelvic mesh litigation, some genius on the other side decided it would be a good idea to include a stand-alone claim for “defective product” in at least one of the plaintiffs’ standard complaints.  “Defective product” was pleaded as some generic form of strict liability, separate and apart from the three accepted theories of manufacturing, design, and warning defect.  We have no idea where this concept of “defective product” came from.  It’s not adopted by the law of any state as far as we can tell.

Continue Reading Defective Claims for “Defective Product”