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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

Recently, in the context of an IVC filter case, the Third Circuit Court of Appeals certified two questions to the Pennsylvania Supreme Court:

1. Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may

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We are careful when discussing discovery sanctions, particularly spoliation, for a simple reason.  The companies we represent that make medical products tend to have allegations about failing to produce discoverable information in the course of the litigation against them.  Indeed, there is a style of litigating against drug and device companies, and other corporate defendants,…

Bexis just turned 65 (on 1/25/2021) – the classic retirement age.  That’s an occasion to look back and evaluate what’s gone on over the course of an entire legal career.  So how have we done, as defense lawyers, over the course of our entire careers, at our primary job – which is to prevail for…

Once again we undertake our annual task of sorting through the worst decisions of the year in prescription medical product liability litigation.  These are the true superspreaders of litigation against our clients, extending the contagion of non-socially distanced litigation tourism and other infectious forms of attorney-solicited lawsuits far and wide, to the detriment of almost…

As consumers, and connoisseurs, of personal jurisdiction precedent, we write today to consider the latest jurisdictional mess that has arisen, this time in talc litigation.  Two courts, deciding the same jurisdictional issue on the same set of facts in the same week, have reached diametrically opposed decisions.  The current contretemps concerns “Shimmer” – a minor…

Isn’t enough for standing that is.  And, likely not enough for plaintiff’s case to survive, but that question was left for another day.  We’ve done a few posts on “slack fill” which is defined by the FDA as the difference between the capacity of a container and the volume of product inside.  Slack fill lawsuits…

The opinion, Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019), recently “predicted” that Pennsylvania would allow strict liability design and warning defect claims in cases involving prescription medical products.  Id. at *11-13.  In so doing Schrecengost was not only wrong, but loud wrong.  First, without even a serious discussion, Schrecengost…

California courts continue to find ways to exercise personal jurisdiction over out-of-state defendants, even when there is little or no dispute that the Constitution and the United States Supreme Court’s opinion in Bristol-Meyers Squibb Co. v. Superior Court do not permit it.  “Resistance” is probably too strong a word, insofar as it calls up images…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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