Albert Einstein supposedly said, “Insanity is doing the same thing over and over again and expecting different results.” He may not have, but the point is well taken. We often think the same thing – particularly about plaintiffs that sue manufacturers of FDA premarket-approved (“PMA”) medical devices with vague, boilerplate complaints. Haven’t they heard about
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.
Guest – Frankenstein’s Monster: Limiting Reliance on the Park Doctrine
Here’s another quasi-guest post by Reed Smith’s blogger-in-training Dean Balaes. This one provides a critique of the scary Park doctrine, aptly described here as “Frankenstein’s Monster,” that allows imposition of criminal liability on corporate officers for illegality they didn’t even know about.
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In 1816, Mary Shelley and Lord Byron entered into a wager to…
How the Other Side Views Albrecht
We recently came across the law review article, E. Lindenfeld, “Clear Evidence Clarified,” 75 Food & Drug L.J. 346 (2020). Since it cited and critiqued a number of our blogposts, we thought it was appropriate to reply.
Our initial impression is that the Lindenfeld article is comparatively reasonable – that is, compared to some prior…
Guest Post – Florida Adopts Practical And Fair Summary Judgment Standard
Today’s guest post is from Wendy Lumish and Daniel Rock of Bowman & Brooke. We sought them out because they wrote a successful amicus curiae brief in the case they discuss. That case is a major win for all Florida defendants, bringing Florida summary judgment practice into the Twenty-First Century. As always our guest…
Following up on a Recent Bottom Ten Decision
Late last year we awarded our #10 spot on our Worst of 2020 post to In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 18, 2020) (“VLI”). At that point the decision was brand new, and we promised a more in-depth analysis. Here it is.
VLI fits…
Ninth Circuit Trims No Injury Class Action Claims
Purported class actions on behalf of people who haven’t really suffered any injury are one of the banes of our existence. While not limited to California or courts in the Ninth Circuit, some of the worst (most of which we haven’t covered because they are adverse non-drug/device cases) decisions certainly hail from there.
Recently, however…
Guest Post – Discovery Of Trade Secrets: Part II
This guest post comes to you courtesy of Christian Saucedo, an associate in Reed Smith‘s LSHI group. He was inspired to follow up on a post we wrote earlier about confidential ediscovery involving computerized product design information. It’s a serious topic, involving the “crown jewels” of product manufacturing. As always our guest poster…
Newly Acquired Precedent on Newly Acquired Information
Particularly since Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), we have written numerous posts about preemption and “newly acquired information” in prescription drug product liability litigation. None of them, however, has involved federal appellate authority – until now.
In Knight v. Boehringer Ingelheim Pharmaceuticals, Inc.,…
Zantac Rulings – Bare Bones
This post is from the non-Dechert side of the Blog.
There were four opinions issued in the Zantac MDL on New Years Eve. We would like to tell you all about them, but we have to seek internal client approvals, and that will take time given the number of defendants. They are important, and overwhelmingly…
Tort Pandemic Countermeasures − The Ten Best Prescription Drug/Medical Device Decisions of 2020
With 2020 mercifully coming to an end, it is once again time for the Drug & Device Law Blog’s top ten decisions of the year. In keeping with COVID-19’s dominance of 2020, we present our top ten in the context of countermeasures against another social ill – the tort pandemic raging across much of the…