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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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One of us (Bexis) was updating a book chapter on “What Litigators Need to Know About the FDA,” and wanted to cite to the CDER (Center for Drug Evaluation and Research) Handbook concerning its definition of “untitled letter.” But the link to the CDER Handbook wasn’t active on the FDA’s website. Well, that prompted an…

Posted in FDA

Although even the academic critics of Twombly/Iqbal have agreed with us that vague “you violated the FDCA” pleadings should not survive a motion to dismiss, apparently there are still lawyers on the other side who think they should be able to get away with violation claims that do not identify what statute/rule/regulation was…

New Jersey Vioxx plaintiffs weren’t going to let a little thing like losing in the New Jersey Supreme Court keep them from trying to certify their nationwide consumer fraud class action. But yesterday, Judge Higbee, the trial judge assigned the Vioxx mass tort in New Jersey, saw it differently. She denied class certification for a…

Back in January, we put up a short post noting the filing of a petition for extraordinary (“King’s Bench”) review in the case of Commonwealth v. Janssen Pharmaceutica, Inc., No 0108002818 (Pa. C.P. Phila. Co.). It’s a case involving alleged off-label promotion of Risperdal, a widely prescribed “atypical” anti-psychotic medication. We posted a copy…

We were in the middle of the debate about Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), when the decision came down a couple of months ago. (For our relatively early posts about the case, which in turn link to responses to our arguments, click here and here.)
With the passage of time, we…

We just ran across Bracco Diagnostics, Inc. v. Amersham Health, Inc., ___ F. Supp.2d ___, 2009 WL 1743699 (D.N.J. June 30, 2009). Yeah, we know, it’s over a month old — ancient by blawg standards. In our defense, all we can say is that it’s a Lanham Act case, and we pay more attention…

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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