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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 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”

Starting with our comprehensive post lambasting Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448 (W.D. Pa. 2019), for ignoring 75 years of hitherto unbroken Pennsylvania precedent and allowing a “strict liability” design defect claim against an FDA-regulated prescription medical product, we have both chronicled and opposed the other side’s attempt to infiltrate strict liability into Pennsylvania litigation involving such products (primarily medical devices). That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 (Henderson) and 2014 (Lance), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) (Creazzo), all rejecting application of strict liability principles to prescription medical products.  For the gory details, see the prior post.

Continue Reading Pennsylvania Law, Federal Rules, and FDA Standards

What follows is from the non-Dechert side of the blog.

The history of the Zantac MDL has been one novel claim after another from the plaintiffs’ side.  Fortunately, the vast majority of those ideas have gotten nowhere.  That’s what most recently happened in In re Zantac (Ranitidine) Products Liability Litigation, ___ F.R.D. ___, 2023 WL 1797264 (S.D. Fla. Feb. 7, 2023).  The plaintiffs filed something entitled “Expedited Motion to Permit Multi-Plaintiff Complaints for Registry Claimants.”  This was the plaintiffs’ attempt to avoid paying filing fees for around 58,000 “registry claimants” − who are now obligated to make up their minds and file their complaints – or forever hold their peace.

Continue Reading Zantac MDL Zaps Crazy Consolidation Claims

A couple of our recent posts have mentioned the alternative compensation system created by the 1986 National Childhood Vaccine Injury Act (“Vaccine Act”), 42 U.S.C. §§300aa-10, et seq.

This Vaccine Program is the Act’s alternative to tort litigation, which addresses alleged injuries resulting from vaccines covered by the Vaccine Act.  The legal aspects of the

We’ve chronicled the path of the 2023 amendments to Fed. R. Evid. 702 pretty much from the beginning.  As we’ve discussed, those amendments reiterate what had always been (at least since 2000) the Rule’s requirements for analyzing the admissibility of expert witness testimony.  But courts had been ignoring critical elements – such as the burden of proof – that had been in comments rather than the black letter of Rule 702 itself.  So, as of December 2023, Rule 702 will provide that the proponent of expert testimony must meet all of the Rule’s substantive standards for admissibility by a preponderance of the evidence, and in particular that an adequate basis for such testimony is a prerequisite to admissibility. 

Continue Reading Don’t Wait – The Rule 702 Amendments Can Be Used Now

In updating chapter three of his book, on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions.  Quite a few states, as well as the Third Restatement of Torts, require plaintiffs alleging design defects to identify a “feasible” alternative design for the product as a prerequisite for asserting a design defect claim.  Even where an alternative product design is not mandatory, plaintiffs frequently offer such evidence. In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.”

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed.  Thus, as a matter of logic and semantics, “feasibility” would seem to demand that any proposed “alternative” to the existing design of a product subject to FDA scrutiny must likewise have passed the same level of FDA scrutiny.  For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims.

Continue Reading The FDA and Feasible Alternative Designs

Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible for crafting (and sometimes outright inventing, see fraud on the FDA) defenses for that then-unusual medical device-related mass tort.  One of the first post-MDL-remand Bone Screw cases involved a Louisiana statute, La. Stat. Rev. §9:2800.56, requiring that, for a product to be “unreasonably dangerous in design,” the plaintiff must establish that “[t]here existed an alternative design for the product that was capable of preventing the claimant’s damage” based on the statute’s risk/utility test.

Continue Reading A Primer on Alternative Design

One aspect of Pietrantoni v. Corcept Therapeutics Inc., ___ F. Supp.3d ___, 2022 WL 16857262 (D. Mass. Nov. 10, 2022), has troubled us ever since we first noticed the opinion.  But we recently noticed that Pietrantoni had been selected for publication, so we decided the issue was important enough to examine in depth.

Continue Reading The Problem with Pietrantoni – Unraveling Undertaking Liability

Today’s guest post by Reed Smith’s Kevin Hara arises indirectly from the Zantac MDL, but addresses a recurring preliminary question of federal jurisdiction − fraudulent joinder. That issue, in turn, involves product identification (another problem in MDLs) and a pointer for pharmacies that want to avoid being involved in pharmaceutical litigation. As always our guest