Today’s guest post is from friend-of-the-Blog Richard Dean of Tucker Ellis. For years he has been advocating greater defense use of the dormant Commerce Clause, and given the discussion of that constitutional defense in the pivotal Alito concurrence in the recent Mallory v. Norfolk Southern Railway Co., ___ S. Ct. ___, 2023 WL 41877494 (U.S. June 27, 2023), personal jurisdiction decision, he is back again. He’s too nice to say “I told you so,” but he’s earned the right. As always our guest bloggers deserve 100% of the credit, and any blame, for what they write.Continue Reading Guest Post − Let the Dormant Commerce Clause Challenge to Consent Statutes Go Forth
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.
Litigation Tourism Lives – Mallory Reversed
If Mallory v. Norfolk Southern Railway Co., slip op. (June 27, 2023), were a prescription medical product case, it would probably qualify as the worst judicial decision since the Blog was created – due to its potential scope. Since it’s not, Wyeth v. Levine, 555 U.S. 555 (2009), retains that title. But because it does not arise from what we do, Mallory is in certain ways worse. Not only does it give free reign to all litigation tourism in Pennsylvania, but it opens the door to any other state potentially to do the same thing.Continue Reading Litigation Tourism Lives – Mallory Reversed
A Preemption Two-Fer
It’s unusual when the same defendant wins two unrelated cases involving the same product in the same week – and on the same issue. But it does happen, and recently, in both Benn v. Medtronic, Inc., 2023 WL 3966000 (D.N.J. June 13, 2023), and Warmoth v. Medtronic, Inc., 2023 WL 3938464 (W.D. Okla. June 9, 2023), express medical device preemption carried the day, in decisions issued only four days apart.
That’s worth a blogpost – and two cheers. Hip hip!Continue Reading A Preemption Two-Fer
Taxotere Timing Troubles Persistently Plague Plaintiffs
We’ve blogged before about the plaintiffs’ self-defeating “injury” definition in the Taxotere mass tort litigation. Specifically, plaintiffs have defined their injury as being hair loss that persists more than six months after their cessation of treatment with the defendant’s cancer chemotherapy drug. But, because this litigation (like most product liability MDLs) only exists because of lawyer solicitation, such solicitation dredges up many plaintiffs who sat on their hands for much longer than the aforesaid six month period. Having a date certain as to when the injury exists greatly assists any defendant in winning dismissal of these stale claims on statute of limitations grounds.
That’s not just true in the Taxotere MDLContinue Reading Taxotere Timing Troubles Persistently Plague Plaintiffs
Final Report From One FCA Front – As Another Front Opens
Since 2018, we have blogged several times about the federal government’s crackdown on abusive False Claims Act (“FCA”) litigation via motions for dismissal, and how the abusive relators have tried to resist those efforts. Last week the Supreme Court ruled that, yes, the government does have the power to shut down rogue litigation ostensibly being conducted in the name of the United States of America.
All the federal government has to do is intervene and give a coherent reason why.Continue Reading Final Report From One FCA Front – As Another Front Opens
Dismissal of Experts-Turned-Plaintiffs’ FCA Case as Sanction Affirmed
We always thought that the decade-old Nargol v. DePuy False Claims Act litigation was a particularly abusive misapplication of the FCA for legal reasons. As discussed here, the primary allegations asserted the same sort of “fraud on the FDA” claim that, when brought as a common-law tort claim, were held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) – that the defendant purportedly misled the FDA to clear a §510(k) medical device, and that, as a result, every use of the device was ipso facto a false claim. No other causation needed. As the earlier post discussed, the First Circuit rightly put an end to that attack on FDA authority in United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017).
Then it turned out that a lot more was wrong with Nargol than just a bogus legal theory. The relators were p-side “experts,” Antoni Nargol and David Langton, who had access to documents from a couple of MDLs that targeted the defendant’s hip implant products. Critically:
Protective orders regarding confidential [defendant’s] product design information were issued in both of the multidistrict litigation cases (individually, the “ASR protective order” and the “Pinnacle protective order”; collectively, the “Protective Orders”).
United States ex rel. Nargol v. DePuy Orthopaedics, Inc., ___ F.4th ___, 2023 WL 3746534, at *1 (1st Cir. May 18, 2023).Continue Reading Dismissal of Experts-Turned-Plaintiffs’ FCA Case as Sanction Affirmed
Guest Post – More on Expert Gatekeeping in West Virginia
Shortly after we recently posted our 50-state survey of state law concerning expert “gatekeeping,” we received a thoughtful email from friend-of-the-Blog Tom Hurney, of Jackson Kelly, informing us that there were additional gatekeeping-related issues in West Virginia that our search – limited to cases using the word “gatekeeping” – did not reflect. His…
Medical Monitoring – 50-State Survey
As we mentioned in our recent American Law Institute (“ALI”) medical monitoring post, the other side is engaged in an ongoing attempt to ram recognition of a new tort for recovery of medical monitoring expenses by plaintiffs with no present injury (“no-injury medical monitoring” for short) through the ALI. One aspect of Bexis’ activity in opposition to that was to conduct detailed 50-state analysis of no-injury medical monitoring, once we determined that the ALI reporter’s material was both biased and incomplete. We stand behind our research and have nothing to hide. Thus, there’s no reason for us not to make this same information available to our blog readers, so that’s what we’re doing here. For long-time subscribers to the blog, please consider what follows to be an update to, and replacement of, our 2009 50-state survey on medical monitoring – ironically also prompted by ALI-related activity.
So here goes:Continue Reading Medical Monitoring – 50-State Survey
Another Decision Admitting Evidence of FDA §510(k) Clearance
Kelley v. C.R. Bard, Inc., 2023 WL 2565853 (N.D. Ga. March 17, 2023), reconsideration denied, 2023 WL 3032063 (N.D. Ga. April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible.Continue Reading Another Decision Admitting Evidence of FDA §510(k) Clearance
Supreme Court Eliminates Appellate Procedure Trap for the Unwary
Dupree v. Younger, ___ S. Ct. ___, 2023 WL 3632755 (U.S. May 25, 2023), has nothing whatever to do with drugs, or devices, or product liability, but we bring it to our readers’ attention because of what it has to say about federal appellate procedure. In Dupree, a §1983 action, the defendant sought summary judgment for the plaintiff’s alleged failure to exhaust administrative remedies – and lost. Then the defendant went to trial, and lost again. Id. at *2-3.
Then the defendant appealed. But – oops – the defendant did not raise the exhaustion issue in his post-trial motion under Fed. R. Civ. P. 50(a). Id. at *3. In the Fourth Circuit, failure to renew any issue, even a purely legal one like exhaustion, on a Rule 50(a) post-trial motion waived that issue. Varghese v. Honeywell International, Inc., 424 F.3d 411, 422-23 (2005).
Not anymore.Continue Reading Supreme Court Eliminates Appellate Procedure Trap for the Unwary