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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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As we head past Halloween, your Reed Smith bloggers wanted to offer our loyal readers a treat: Reed Smith is once again offering its virtual “Life Sciences CLE Week” starting Monday, November 7. (See the end of this post for information on jurisdictions in which credit is offered. You can register for the webinars here.)

And we will now mix our holiday references to note that yes, Virginia, there is an Ethics Credit session.

Bexis will be kicking things off on Monday, November 7, at 2 p.m. ET with a presentation on “The Ebb and Flow of the Law – A Year of Drug, Medical Device, and Vaccine-Related Preemption Developments,” which will discuss significant preemption-related developments over the last twelve months, both favorable and unfavorable, in product liability litigation involving prescription drugs (including generics), medical devices, vaccines, and OTC drugs.

Next up, on Tuesday, November 8 at 12 p.m. ET, our colleagues Dave Cohen and Selina Coleman will discuss “Ethics and E-Discovery: Lessons Learned from the Alex Jones Cases and Others.” Dave and Selina will use the Alex Jones cases as a starting point for discussing Model Rules 1.1, 1.6, 3.1, 3.3, and 3.4 and other recent matters where sanctions or major fines were issued relating to discovery or information governance.

Continue Reading Shameless Plug: Reed Smith’s Virtual Life Sciences CLE Week

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

We’re happy to report on a couple of favorable decisions involving some of the COVID-19-related issues that the Blog has been covering.  We have one each on ivermectin injunctions, Shoemaker v. UPMC, ___ A.3d ___, 2022 WL 4372772 (Pa. Super. Sept. 22, 2022), and vaccine mandates, Children’s Health Defense, Inc. v. Rutgers, 2022 WL 4377515 (D.N.J. Sept. 22, 2022).Continue Reading Two Recent COVID-19 Wins

A few months ago, we reported on what we believed—and still believe—was an abusive application of offensive non-mutual collateral estoppel, Freeman v. Ethicon, Inc., 2022 WL 3147194 (C.D. Cal. 2022), which precluded those defendants in one of their numerous pelvic mesh cases from disputing at a jury trial certain factual findings entered by a…

Today’s guest post is from Reed Smith‘s Micah Brown. He discusses a recent appellate decision that we think is counterproductive, in that it interprets the federal Anti-Kickback statute to preclude drug manufacturers from alleviating the high expense of breakthrough drugs that treat relatively rare medical conditions. As always our guest bloggers deserve 100% of the credit (and any blame) for what they have to say.

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Illustrating the principle that hard cases make bad law, a panel of the Second Circuit in July unanimously upheld a Department of Health and Human Services Office of Inspector General (“OIG”) advisory opinion that a drug manufacturer’s plan to offer significant cost-sharing support for Medicare beneficiaries who use a life-saving, but expensive, drug was unlawful.  The Second Circuit agreed with the OIG that the manufacturer’s proposal could constitute prohibited remuneration under the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b (“AKS”).  Pfizer, Inc. v. United States HHS, 42 F.4th 67 (2d Cir. 2022).  The manufacturer sought to cover Medicare patients’ Part D cost-sharing obligations for the drug – which were estimated at approximately $13,000 per year – but the OIG said “no thanks,” and the Second Circuit has affirmed that outcome.Continue Reading Guest Post – Second Circuit Rejects Manufacturer’s Plan to Share Cost of Expensive Drug with Medicare Part D Beneficiaries

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

Bexis recently returned from speaking at the 2022 National Vaccine Law Conference.  As a veteran of both the DTP and thimerosal vaccine litigations, he was generally interested in vaccine-related product liability issues, so he stayed for the entire conference.  He was most interested in learning more about the compensation systems provided by the National Childhood Vaccine Injury Act and the PREP Act.  The Vaccine Act, 42 U.S.C. §300aa-10 et seq., seemed most relevant, since the layers of preemption imposed by the PREP Act make product liability litigation over use of PREP Act “covered countermeasures” (which include vaccines) extremely unlikely.Continue Reading Thoughts on a Vaccine Act MDL

A little over a year ago, we discussed one of the best decisions we had ever read on why comparative risk claims – premised on a manufacturer’s alleged failure to warn that a competing product was supposedly “safer” – are both statistically invalid and practically impossible.  That decision, Nelson v. C.R. Bard, Inc., 553 F. Supp.3d 343 (S.D. Miss. 2021), explained at length both how product “comparisons,” if based on the FDA’s voluntary “MAUDE” adverse event reporting system are inherently suspect due to “informational bias,” id. at 355, and, if based on non-public information, would require access to unavailable information about competitors’ products.  Id. at 354-55.Continue Reading More on Comparative Warnings

This is a guest post by Luther Munford, Butler Snow LLP, who comes to us fresh from the pelvic mesh wars.  He is grateful to Jin Yoshikawa of that firm for his help with this post. As always, our guest posters do their own work and thus deserve 100% of the credit (and any blame) for what they write.

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As previously stated, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices.  The 1982 world it describes disappeared decades ago.  This author’s article in the Food and Drug Law Journal, L. Munford, “Courts v. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. 6 (2021), provides the details, and it is hardly alone in its conclusions.Continue Reading Guest Post − No One Should Ever Rely on What Lohr Says about FDA Device Clearance

Drug & Device Resources

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.
Learn more about this book