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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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Now where were we before Riegel, and the Journal, and The Times so rudely interrupted?
(Sorry — we couldn’t resist. We just love typing those words.)
Oh, yeah. We were regaling you with tales from the Tulane Law Review Multidistrict Litigation Symposium.
One panel at the Symposium featured Dean Edward Sherman (of Tulane),…

We’ve (yes, there are two of us) finally been noticed by the newspaper of record, The New York Times, in today’s article on the immediate aftermath of Riegel in other litigation involving PMA devices.

So here’s a warm welcome to the Times’ readers. Look around. And prepare for cognitive dissonance, as the positions stated…

We’ve had an unusual number of plaintiffs’ side blogs link to our Riegel posts over the past several days. While we’re flattered that the other side thinks we’re worth noticing, the traffic from these links has produced quite a few comments trashing either the Supreme Court (especially Justice Scalia), the FDA, or both. We’ve returned…

Posted in FDA

We must be slipping. For the Riegel v. Medtronic oral argument we had two attendees offer to send us detailed reports, and one of them actually did. Nobody’s made us an offer for Monday’s oral argument before the Supreme Court in Warner Lambert v. Kent. So we’ll make everyone out there an offer.…

After yesterday’s decision in Riegel v. Medtronic, Eric Turkewitz, from the plaintiff’s side of the “v.,” finds himself quoting Ronald Reagan in today’s post.

Will wonders never cease?

Yeah, it was a hell of a party … but we’re sober now.
One of us even got almost hilariously misquoted in the press, when the reporter got the effect of the 2006 Preemption Preamble exactly backwards. As everyone reading this knows, in 2006 the FDA invigorated – not impeded – preemption.
But it’s time…

More on Riegel – this time from one of our recidivist guest posters, Adam Masin at Reed Smith.
He thinks there may be a silver lining for drug defendants in Justice Ginsberg’s anti-preemption dissent.
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Justice Ginsberg, the lone dissenter in Riegel, had a lot of relevant things to say about preemption in…

Now we’ve read it, and before we go off to celebrate (and maybe to look for new jobs as IP lawyers – that’s a joke, folks), we thought we’d tell our readers why that’s exactly what we’re doing.
The 7-1 Riegel decision definitively demolishes a lot of the arguments we’ve been seeing for years (if…

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