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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.

This is rather state specific, but it’s big news in Pennsylvania, and Bexis insists it’s important enough to warrant inclusion here. Brickbats to Bexis, then.
Yesterday, the Pennsylvania Supreme Court entered an order, accepting allocatur (that’s Pennsylvanian for “appeal”) to answer the following question:
“Whether this Court should apply §2 of the Restatement (Third) of

Less than three weeks ago (it seems a lot longer) we posted about the FDA’s position that expert witnesses shouldn’t be allowed to opine on the meaning of FDA regulations during trial. Such opinions, the Agency argued, were legal – not factual – opinions. Thus they were the province of the court to decide, and

A little over a week ago (in other words, an eternity in the blogosphere), the FDA announced new draft guidelines that slightly relaxed some aspects of the Agency’s prohibitions concerning promotion of off-label uses by manufacturers of FDA-regulated products. See 73 Fed. Reg. 9342 (FDA Feb. 20, 2008).
We were busy at the time –

Google Analytics lets us track our viewers, although at a fairly high level of abstraction.

First the good news: We’re pleased to report that we’ve had more than 25,000 pageviews in the last thirty days — a new high for us. Thanks very much for your interest.

Now the bad news: We see some of

Many, but perhaps not all, of our readers know that the FDA offers automatic e-mail alerts of certain Agency publications and actions.

For those who may be interested, but were previously unaware of this service, here’s a link to the registration page. (Don’t worry; it’s easy. Even the two of us, blogging luddites that

The Supreme Court has formally extended the briefing schedule in Wyeth v. Levine, something we expected when the matter was deferred to next term. The merits brief for petitioner Wyeth is now due on May 26, 2008. The merits brief for respondent Levine is now due on August 1, 2008 (over two months later).

A recent opinion crossed our desk: Independence County v. Pfizer, Inc., ___ F. Supp.2d ___, 2008 WL 398980 (E.D. Ark. Feb. 11, 2008). The opinion has generated a bit of interest because of the unusual nature of the claim – which is, we suppose, to be expected where, as here, a local government has

This guest post was prepared by Ted Frank, who blogs regularly at Point of Law, and who attended the oral argument this morning in Warner-Lambert v. Kent. This report is also being posted at that site. Needless to say, this report represents only Ted’s work. We thank him for providing this news from