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JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. 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 LiinkedIn page is here.

Donald Rumsfeld once justified attacking Iraq without firm evidence that his target possessed the ultimately apocryphal “weapons of mass destruction” by citing fear of the unknown:

Reports that say that something hasn’t happened are always interesting to me, because as we know, there are known knowns; there are things we know we know.  We also

We had been waiting for the Utah Supreme Court’s decision in Burningham v. Wright Medical for some time.  As we pointed out in a blogpost when Burningham was first certified by the district court (Utah is one of the few courts allowing district court certification), over a year ago, “[p]ractically no court has . . 

We’ve blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors like Form 483s).  We’ve cited precedent, FDA internal manuals, FDA’s own position taken in formal briefing, and learned treatises on FDA law.  That an FDA warning letter has no binding legal effect (indeed,

Somebody asked Bexis the other day whether he thought that the increasing reliance on “telemedicine” – physician consultations taking place online, perhaps followed by the prescription of a drug or medical device – posed any risks to the learned intermediary rule.

Bexis said, “no.”  Would you expect other answer?

That response was based largely on

Here is the third and final part of our 50-state opus on precedent supporting the principle that plaintiffs asserting claims dependent on propositions that ordinary people aren’t expected to know must come forward with expert opinions for those propositions.  As mentioned previously, this project arose from something we read about in the Mirena litigation –

What follows is the second part of our extensive 50-state of cases precluding plaintiffs from proceeding with claims in the absence of admissible expert support.  Part One was last week.  In most states such rulings originated in medical malpractice and workers’ compensation actions, with the relevant principles broadening to encompass product liability and toxic torts.