Search results for: PREP Act

Last week the Third Circuit became the first federal appellate court to decide the question of whether federal courts have jurisdiction over COVID-related tort litigation.  It concluded they did not.  Maglioli v. Alliance HC Holdings LLC, — F.4th –, 2021 WL 4890189 (3d. Cir. Oct. 20, 2021).  A decision directly at odds with…

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…

Back in March, we discussed the Administration’s declaration of tort immunity under the “PREP Act” (42 U.S.C. §§247d-6a, et seq.) for “countermeasures” combating the COVID-19 epidemic.  Today, we’re discussing the first cast that we know of to construe this declaration.

That case is Estate of Maglioli v. Andover Subacute Rehabilitation Center I, 2020…

We continue to be cautiously optimistic that the recent amendments to Fed. R. Evid. 702 – enacted because too many courts had been too flaccid for too long in admitting dubious “expert” testimony – will actually improve things in the courtroom.  Our latest data point is In re Paraquat Products Liability Litigation, ___ F. Supp.3d ___, 2024 WL 1659687 (S.D. Ill. April 17, 2024).  While Paraquat is not drug/device litigation (the substance is a widely used herbicide), the Rule 702 analysis has broad applicability – as demonstrated by the decision’s reliance (in part) on the Acetaminophen decision that we discussed here.Continue Reading Amended Rule 702 – Eradicates Invasive Experts on Contact

In 1919, J. Edgar Hoover described Communism as a “conspiracy so vast” that it was impossible for the populace to comprehend it.  The Palmer Raids and the first Red Scare soon followed.

That phrase echoed in our minds when we first read In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2023 WL 1818922 (D.N.J. Feb. 8, 2023).  The Valsartan opinion was similarly mind-boggling in its scope.  It certified not one, not two − but four class actions:  one for economic loss, one for third-party payors (“TPPs”), and two for medical monitoring (“remedy” and “independent claim”).  Id. at *3.  Compare that to the state of class action precedent in product liability litigation not too long ago when we made this statement in 2007:

As far as we know, there has not been a single contested class action in product liability, personal injury litigation that’s been affirmed anywhere in the federal system in the decade since the Supreme Court put the kibosh on such things with its Ortiz and AmChem decisions.  That’s not limited to just pharmaceuticals, that’s every kind of product that’s made.

Four in a single MDL order?  These class certifications glommed together no less than 111 consumer and TPP subclasses.  Valsartan, 2023 WL 1818922, at *24.  These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions.  There’s no way on earth that common issues could predominate over individual ones, or that this morass could possibly be tried to a jury.Continue Reading An Abuse of Discretion So Vast….  Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications

Our immediate reaction to In re Bard IVC Filters Products Liability Litigation, ___ F.4th ___, 2023 WL 5441793 (9th Cir. Aug. 24, 2023) (hereafter, “Jones” (the plaintiff’s name)), was “popcorn time” – pull up a chair and watch the other side fight like drunken pirates over the MDL spoils.  But there’s more to Jones than that.  The MDL-related “participation agreements” that Jones enforced are something like third-party litigation funding, in that they introduce another party to the settlement mix, even in non-MDL cases.  Defendants thus have a need to know about those agreements when settlement is raised in those cases.Continue Reading Of MDLs, Settlements, and Common Benefit Contracts

Drug & Device Resources

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.
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