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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.

Today, we chronicle two more decisions from the Zantac MDL.  Once again, kudos to this MDL transferee judge for outstanding willingness to tackle legal issues, and decide them, at an early stage of the litigation.  Because we’ve gone through these issues before, here and here, we discuss these latest rulings in one post.

Chronicle

Have you ever had a plaintiff dead to rights with a dispositive motion, and instead of opposing the motion, the plaintiff moves for voluntary dismissal?  We have, and it can be annoying as hell, especially if the judge is one of those who would rather not decide anything – and grants the plaintiff’s motion.

What

We recently decried the Eighth Circuit’s continuing disregard of the expert gatekeeping function imposed by F.R. Evid. 702 in In re Bair Hugger Forced Air Warming Devices Products Liability Litigation, ___ F.4th ___, 2021 WL 3612753 (8th Cir. Aug. 16, 2021).  Well, only four days later, the Fourth Circuit delivered a counterpoint in Sardis

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