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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.

J.C. McElveen, of Jones Day, wrote the following guest post, for which we thank him. As is always true of guest posts, the two of us had nothing to do with what follows; JC gets all the credit. (We alone, however, are to blame for not knowing how to create subscripts in blog posts.

One of the questions we’ve been asking – but not finding answers – is where exactly do investigational medical devices (IDE) fit in to the preemption rubric after Riegel. Investigational devices, after all, are PMA, only their applications haven’t been approved yet. Since IDE devices are subject to the same regulations as PMA devices,

The two of us have been slaving over this blog, regularly producing substantive posts about cutting edge legal issues, for more than two years now.
And what do we get called out for (by name) over at Above the Law this morning?
The “bong water” case.
We’re speechless.

We’ve blogged before about the importance of both sides in personal injury litigation – and especially drug/medical device product liability litigation involving the learned intermediary rule – having equal rights to talk to treating/prescribing physicians. We’ve praised courts that have gotten this issue right – most significantly the New York Court of Appeals in the

The Third Circuit just issued its opinion in Gunvalson v. PTC Therapeutics (link here), the case in which a trial court issued an injunction requiring a drug company, PTC Therapeutics, to provide an experimental drug to a patient outside of the context of a clinical trial. (One of our many earlier posts on

We posted last year about the NY Court of Appeals excellent decision in Arons v. Jutkowitz, on defense interviews with treating physicians.
We’re doing it again. Here’s a copy of the Court of Appeals (that’s the state’s highest court) recent decision in Adamo v. Brown & Williamson holding that, where a product’s only function

The Financial Accounting Standards Advisory Council held a public meeting yesterday to discuss the proposed amendment to FAS 5, which deals with the disclosures that publicly traded companies must make about litigation. (We previously posted on that topic this summer.)
We’ve heard through the grapevine that FASB is now considering an alternative to

We were pleased to see that USPharmD included us in its list of the “Top 50 Medical Ethics Blogs.” Lord knows, we’re not medical ethicists, but the list includes other topics, such as “medicine and the law” and “pharmaceuticals,” so at least we’re in the neighborhood. More importantly, you may find the other blogs on

Herrmann’s book, The Curmudgeon’s Guide to Practicing Law, has a chapter about “couth” that discusses, among other things, communicating by e-mail.
He’s now had two reactions to that chapter that he just has to share.
First, right after the book came out, an inside counsel offered this rant about lawyers communicating with clients by e-mail: