“To see a world in a grain of sand,
And a Heaven in a wild flower,
Hold infinity in the palm of your hand,
And eternity in an hour.”
– William Blake, Auguries of Innocence
We’ve long been enamored with the idea that sources of insight reside all around us. Before we did drug and
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
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
For several years, we have blogged about the controversy over whether the American Law Institute (“ALI”) should put its Restatement Third of Torts imprimatur on no-injury medical monitoring. Here’s the latest update, as that effort nears culmination. As reported by the ALI, on Monday May 22, at the Institute’s 100th Anniversary annual meeting:Continue Reading Always Liability Increases (ALI)? Not Yet with Medical Monitoring.
The Eleventh Circuit’s recent decision in Rosell v. VMSB, LLC, ___ F.4th ___, 2023 WL 3398509 (11th Cir. May 12, 2023), has nothing whatever to do with prescription medical product liability litigation, but defense counsel should know about it because is rejects one trick that plaintiffs in complex litigation use to claim appellate jurisdiction. Specifically, it rejects the concept of “partial dismissal” under Fed. R. Civ. P. 41(a), as a tool to create a final appealable order following partial dismissal of an action.Continue Reading Plaintiff Cannot Create Appellate Jurisdiction Through Partial Dismissal
Some things make sense only in the topsy-turvy, litigate-everything-to-death world of multidistrict litigation. One recent example is In re Taxotere (Docetaxel) Products Liability Litigation, 2023 WL 2982464 (E.D. La. March 8, 2023), where MDL-related considerations led a defendant to oppose a plaintiff’s motion for voluntary dismissal with prejudice.
Why? Think chess. In MDLs the other side treats plaintiffs like pawns, regularly sacrificing them in the hope of putting one or more defendants in zugzwang (a chess term for forcing an adverse move). That’s what happened in Taxotere. Continue Reading Only in an MDL….
The first thing you learn as an appellate clerk is the importance of the standard of review. If the review is de novo – purely legal issues – your judge will not defer at all to what happened below. It’s a whole new (hence, de novo) ballgame. If the review is for abuse of discretion
We have decried several times plaintiffs’ tendency in prescription medical product litigation, particularly mass torts, to try to sue into submission their opponents in scientific debates. This often takes the form of lawsuits alleging that journal articles, continuing medical education, and other forms of scientific discussion are actionable “misrepresentations.” We said some time ago:
In the coming weeks, there are sure to be many articles looking at what Judge Brown Jackson has written and what that might suggest about the future jurisprudence of the United States Supreme Court if she is confirmed. We will not predict what will happen in confirmation. We will, however, weigh in on what Judge
Great decision from the Paraquat MDL recently, rejecting public nuisance claims in the product liability context. In re Paraquat Products Liability Litigation, 2022 WL 451898 (S.D. Ill. Feb. 14, 2022), involved what, in the herbicide context, is the equivalent of a prescription drug. That product “is not available for purchase by the public or