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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

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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

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This post is from the non-Reed Smith side of the blog.

We don’t usually report on securities-law cases, but today we do. That is because the well-reasoned decision in question, In re Allergan PLC Securities Litigation, 2022 WL 17584155 (S.D.N.Y. 2022), has major implications for the parallel Textured Breast Implant MDL now pending in…

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The defendants in Mixson v. C.R. Bard, Inc., ___ F. Supp.3d ___, (N.D. Fla. Sept. 16, 2022) (“Mixson I”), and Mixson v. C.R. Bard, Inc., 2022 WL 7581737 (N.D. Fla. Sept. 23, 2022) (“Mixson II”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results.…

Continue Reading Mixson Somewhat Mixed, But We’ll Take It

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For a decision that affirmed not just a verdict, but an award of punitive damages, against a device manufacturer, Nicholson v. Biomet, Inc., 46 F.4th 757 (8th Cir. 2022), is not as bad as it could have been.  That’s because most of the decision was about evidentiary rulings that the court found to be “harmless” error, and one might even have some benefit for our clients in the long run.

Still, Nicholson was pretty darn depressing.…

Continue Reading Nicholson – Not So Harmless

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Federal Rule of Evidence 407, dealing with the inadmissibility of subsequent remedial measures, isn’t all that complicated – as Federal Rules go.  It’s only 73 words long:

When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove:

  • negligence;

…

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Counsel defending depositions have a decision to make – whether, after opponent’s the direct examination of the witness is complete, whether to “cross-examine” a witness aligned with our own client.  Usually, the answer will be “no,” because such questioning usually offers no advantages and could well undermine the witness (who may lose focus under friendly…

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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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