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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.

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Until now, the Bair Hugger MDL was known (at least to us) for two things:  First, was the Eighth Circuit’s horribly lax application of the Fed. R. Civ. P. 702 standards for expert admissibility – a decision that we consider the worst drug/device decision of 2021.  However, since then the federal judiciary’s Civil Rules Committee has adopted changes to Rule 702 that will, as of this December, overturn the Eighth Circuit’s weak approach to Rule 702.  Second, the manner in which the Bair Hugger litigation began was unusually sketchy, as we detailed here and here.

Recently, however, the tawdry manner of Bair Hugger’s origin was matched by a specious attempt to disqualify the MDL judge.  It’s obvious to us what is going on here.  Both sides know that plaintiffs’ free pass on Rule 702 expires this December, when the rule amendments take effect.  Assuming the expert testimony doesn’t change, the defendant essentially gets a do-over.  So the Bair Hugger plaintiffs desperately desired that do-over to be decided by a different judge.…

Continue Reading Plaintiffs’ Judge Shopping Ploy Fails in Bair Hugger MDL

Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation.  He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.”  FDA, “Medical Device Reporting (MDR): How to Report Medical Device Problems,” at MDR Data Files, Alternative Summary Reports (available here).  Bexis came across preemption cases mentioning ASR reporting with respect to surgical staplers, Bell v. Covidien LP, 2023 WL 3006175, at *2 (D. Mass. April 19, 2023), breast implants, e.g., Gravitt v. Mentor Worldwide, LLC, ___ F. Supp.3d ___, 2022 WL 17668486, at *3 (N.D. Ill. Dec. 14, 2022); D’Addario v. Johnson & Johnson, 2021 WL 1214896, at *3 (D.N.J. March 31, 2021), and contraceptive devices.  McLaughlin v. Bayer Essure Inc., 2019 WL 3764658, at *1 (E.D. Pa. May 9, 2019).  It appears that plaintiffs are attempting to turn various defendants’ use of this FDA-created and authorized program into a tort (variously described as warning defect or a variant of a misrepresentation claim).…

Continue Reading Thinking About the FDA’s Alternative Summary Reporting Program

As we’ve discussed before, the United States Supreme Court, in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), sent the presumption against preemption, in express preemption cases anyway, into the dustbin of history.

[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Id. at 125 (citations and quotation marks omitted).…

Continue Reading On the Erstwhile Presumption Against Preemption, the Third Circuit Sticks Out Like a Sore Thumb

Not too long ago we discussed post-remand Pennsylvania Supreme Court filings in the Mallory personal jurisdiction matter. After reviewing both sides’ filings, we observed: “[U]nless the Pennsylvania Supreme Court in Mallory were to act contrary to the positions of both sides, the DCC issue will be decided promptly, on this appeal.”

Well, that’s exactly what…

We closed our post on the terrible Supreme Court decision in Mallory v. Norfolk Southern Railway Co., 143 S. Ct. 2028 (2023), with this “stay tuned” message:

Finally, as all the Mallory opinions make clear, jurisdictional litigation in Mallory itself is not over.  The Pennsylvania Supreme Court’s interpretation of the Pennsylvania statute has not

…

Beginning – at least − with the awful decision in Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448, 465 (W.D. Pa. 2019) (discussed here), plaintiffs seeking to overturn the longstanding Pennsylvania (since the 1940s) prohibition against strict liability in prescription medical product liability litigation have been systematically attacking the precedential weight…

Over-the-counter (“OTC”) drugs are protected from civil liability by an express preemption provision that is even stronger than the medical device preemption clause interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  That provision is:

Except as provided in subsection . . . (e) . . ., no State or political subdivision of a State may establish

…

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators.  It’s an interesting topic; Eric recently wrote a paper on it, and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject.  From these exercises we concluded that a 50-state survey on intangibles as “products” for product liability purposes would be both doable and useful.…

Continue Reading How the Fifty States View Electronic Data as a “Product”

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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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