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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.

Last July we published a “Here’s Hoping” post that maybe the terrible decision in Atchley v. AstraZeneca UK Ltd., 22 F.4th 204 (D.C. Cir. 2022), allowing drug companies to be sued for purportedly “aiding and abetting” international terrorists (see our takedown of Atchley here), would fall in light of the Supreme Court’s

Beyond the Supreme Court’s rolling out the red carpet to forum shopping plaintiffs, the decision in Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023), was further disturbing to us in that Mallory suggested that a state could deem, through a “consent statute,” grounds for “consent” to general personal jurisdiction that were much less than the “at home” standard previously required for such broad jurisdiction.  Id. at 145-46 (“attach[ing] jurisdictional consequences to what some might dismiss as mere formalities” such as completing a registration form and recognizing jurisdiction from “actions . . . that may seem like technicalities”).  Those other examples, however, all involved limited “special” jurisdiction issues, not the far broader expanse of general personal jurisdiction.Continue Reading Post Mallory Limits to Deeming Personal Jurisdiction

We recently discussed how “failure-to-recall” claims essentially don’t exist – outside of a couple of limited fact patterns that plaintiffs asserting such claims in litigation involving FDA-regulated products can almost never allege.  Today’s post adds the constitutional defense of preemption to good, old-fashioned state-law failure to state a claim.Continue Reading Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant

The title is ridiculous, but unfortunately true.

Muldoon v. DePuy Orthopaedics, Inc., is a suit over “hip-replacement surgery conducted in 2007.”  2024 WL 1892907, at *1 (N.D. Cal. April 30, 2024) (“Muldoon II”).  Suit was not filed, however, until 2015 – undoubtedly Muldoon is another example of the flotsam and jetsam dredged up by MDL lawyer solicitation.Continue Reading 15 Years After the Fact, This MDL Remand Case Is Still at the Pleading Stage

It’s been a little less than a year since the Supreme Court’s rolling out the red carpet to forum-shopping plaintiffs in Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023).  Mallory was, in places 5-4, and elsewhere 4-1-4, and everywhere extremely fact specific – to the point of including a defendant-specific image of its Pennsylvania contacts that, as far as we can tell, wasn’t even in the record, but rather was found on the Internet.  600 U.S. at 142-43.  The result – beyond the Dormant Commerce Clause flag waving in Justice Alito’s concurrence (discussed here) – was to punch this plaintiff’s one-time ticket against the Norfolk Southern Railway.  “To decide this case, we need not speculate whether any other statutory scheme and set of facts would suffice to establish consent to suit.”  Id. at 136.Continue Reading Mallory in the States – A Year After the Deluge

Late last Friday, we learned of Hickey v. Hospira, Inc., ___ F.4th ___, 2024 WL 2513487 (5th Cir. May 24, 2024) (thanks, Dick!), becoming the first appellate decision holding that preemption applies to FDA approved prescription drugs that came on the market via the so-called “paper NDA” process.  See 21 U.S.C. §355(b)(2).  Hickey arises out of the Taxotere MDL, which has produced defense-friendly decisions in a number of areas.Continue Reading Preemption and “Paper NDAs” – Perfect Together

It seems like once every couple of weeks, we see a story about some plaintiff (such as this one) suing, or threatening to sue, a defendant product manufacturer over some product that, according to the plaintiff, “the company should have recalled sooner.”

That’s garbage.

There is no such claim.  Rather failure-to-recall theories are

Over the last month, Bexis attended both the Hollingsworth Firm’s annual toxic tort litigation defense seminar and the Lawyers for Civil Justice spring meeting.  Both meetings featured discussions on how the new amendments to Fed. R. Evid. 702 were faring in court.  We’ve also written several blogposts (links below) about favorable applications of the new rule, which became effective December 1, 2024.  The amendments having been in effect now for several months, we decided to see whether they were having the Rules Committee’s desired effect of toughening up judicial consideration of expert testimony under Rule 702.  So we’re taking a more systematic look at the judicial response to the 2023 amendments.Continue Reading How Are the Recent Rule 702 Amendments Faring in Court?

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

As we’ve discussed, such as here, Fed. R. Civ. P. 702 was amended in late 2023, because the Civil Rules Advisory Committee concluded that too many courts were erroneously admitting expert testimony that proponents had not established was reliable.  It does appear that at least some courts are cracking down.  Here’s one from an Eighth Circuit court, which is significant since the Eighth Circuit was one of the worst offenders under the prior version of Rule 702.Continue Reading Frequent Flier P-Side Expert Excluded Under Amended Rule 702