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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.

Plaintiffs’ lawyers, now used to soliciting litigation from municipal governments, labor union health and welfare funds, and Medicare assistance plans, have been trying the same thing with Indian tribes (note: we don’t care much for “Indian” as it reflects Columbus’ 500-year-old navigational error, so we opt for the more accurate Canadian term – “First Nations”). 

Once again we undertake our annual task of sorting through the worst decisions of the year in prescription medical product liability litigation.  These are the true superspreaders of litigation against our clients, extending the contagion of non-socially distanced litigation tourism and other infectious forms of attorney-solicited lawsuits far and wide, to the detriment of almost

Plaintiffs love to tell juries how horrible the defendant’s product is.  They’ll tell them how the product kills people – even though the plaintiff in the case didn’t die.  They’ll try to bring up purported cancer risks although the plaintiff doesn’t have cancer.  They’ll argue that, if the defendant’s device were to fail, they’d face

The same Missouri Supreme Court that couldn’t be bothered to review a 22-plaintiff consolidation that resulted in a ten-figure verdict in a talc case saw fit to review a defense verdict in a pelvic mesh case.  One wonders where justice stands among that court’s priorities.  At least the verdict was affirmed – if only barely,

In our personal jurisdiction posts, we’ve generally taken a dim view of plaintiffs who attempt to oppose Rule 12(b)(2) dismissal motions with requests for jurisdictional discovery.  Both our experience and our perspective leads us to view such requests as overwhelmingly likely to be fishing expeditions, designed more to delay and to increase the expense of

We’ve heard politicians advocate importing “cheaper” prescription medical products from Canada for years.  We’ve always thought the idea was ludicrous.  As we said, a little more than two years ago:

Think about it.  California alone has a greater population than Canada.  Any large-scale importation of cheaper Canadian drugs to the United States would almost immediately

We’ve already commented about the broad scope of tort immunity conferred by the March, 2020 Notice of Declaration under the Public Readiness & Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §247d-6d.  That original immunity covered all aspects of government-related or sponsored production and use of anti-COVID countermeasures.  It was, as one of our colleagues put

A little over a month ago, we blogged about the Pennsylvania Superior Court (the Commonwealth’s general intermediate appellate court deciding a test case, Zitney v. Wyeth LLC, 2020 WL 6129173 (Pa. Super. Oct. 19, 2020), that held, as a matter of first impression, that there was no separate duty for a prescription medical product

Perhaps the biggest conflict among the circuits in PMA preemption cases involves the extent to which plaintiffs can get away with pleading essentially nothing to support supposed “parallel” violation claims, on the one hand, or on the other must plead a particularized violation of an FDA regulation (usually a “Current Good Manufacturing Practice” or “CGMP”)