Search results for: PREP Act

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

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal.  A draft of this article is now available on SSRN.

The core premise of Bexis’ article is very simple:  Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying “no” and trying to ban that same FDA-approved drug.  It doesn’t matter whether that drug is morphine, methadone, minoxidil – or mifepristone.Continue Reading Mifepristone Manufacturer Wins First Round in West Virginia

Bexis recently returned from speaking at the 2022 National Vaccine Law Conference.  As a veteran of both the DTP and thimerosal vaccine litigations, he was generally interested in vaccine-related product liability issues, so he stayed for the entire conference.  He was most interested in learning more about the compensation systems provided by the National Childhood Vaccine Injury Act and the PREP Act.  The Vaccine Act, 42 U.S.C. §300aa-10 et seq., seemed most relevant, since the layers of preemption imposed by the PREP Act make product liability litigation over use of PREP Act “covered countermeasures” (which include vaccines) extremely unlikely.Continue Reading Thoughts on a Vaccine Act MDL

To bring suit in federal court, a plaintiff must have “Article III standing.” That is to say, the plaintiff must have a personal stake in the suit’s outcome. This is true whether a plaintiff is suing individually or as a member of a class.

Late last week, in TransUnion v. Ramirez, — S. Ct.…

Drug & Device Resources

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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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