Photo of Bexis

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.

We’ve read recently about a court taking the unprecedented step of ordering the off-label administration of an animal drug, ivermectin, to a seriously ill COVID-19 patient over the objections of that patient’s treating physicians and of the hospital in which the patient was being treated.

Off-label use is something we know a little bit about. 

Bexis has just returned from a week’s vacation in Acadia National Park in Maine.  After being rained out for a couple of days due to a stray hurricane, he climbed four mountains in three days – the Precipice Trail up Mt. Champlain; the West Face Cadillac Mountain trail up that mountain, and the Jordan Cliffs/Deer

We are watching the post-MDL-remand Bard IVC filter litigation with interest.  It bears some resemblance to the Bone Screw litigation of the late 1990s/early 2000s (except in Bone Screw, there was no MDL settlement) in that the targeted defendant is engaged skirmishes across the country.  In mass torts, the plaintiffs have the benefit of

Only five days after our recent post highlighting the possible no-private-right-of-action implications of the (to us, anyway) obscure Astra USA, Inc. v. Santa Clara County, California, 563 U.S. 110 (2011), case, the Fourth Circuit applied it along the lines we had speculated could be helpful to defendants.  Bauer v. Elrich, ___ F.4th ___,

Nearly six years ago, in 2015, the FDA attempted to slip a change to its “intended use” regulations (21 C.F.R. §§201.128, 801.4) – which had not been updated since the 1950s – through the administrative process by hiding it in a Federal Register notice about electronic cigarettes.  80 Fed. Reg. 57756 (FDA Sept. 25, 2015). 

Back in May, we discussed the latest amendments proposed by the Advisory Committee on Civil Rules to Fed. R. Evid. 702.  These amendments, while not changing the substance of Rule 702’s standards for admission of expert testimony – helpfulness, factual basis, reliability – are intended to reinforce other aspects of the Rule.  These

To find bloggable cases, we (well, Bexis) read a lot of cases that don’t turn out to be sufficiently significant to be bloggable.  Even those cases of lesser interest can alert us to trends, if the same issue or argument crops up repeatedly.  One of those is the TwIqbal concept of a “shotgun complaint” –

This is actually Rachel Weil’s post, but she is having password problems, so Bexis is doing the actual posting

***********

We spent last weekend in a shore house with extended family members (all vaccinated, of course) gathered to celebrate a cousin’s milestone birthday.  Since we had last gathered, babies had been born, the family matriarch