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Until now, the Bair Hugger MDL was known (at least to us) for two things:  First, was the Eighth Circuit’s horribly lax application of the Fed. R. Civ. P. 702 standards for expert admissibility – a decision that we consider the worst drug/device decision of 2021.  However, since then the federal judiciary’s Civil Rules Committee has adopted changes to Rule 702 that will, as of this December, overturn the Eighth Circuit’s weak approach to Rule 702.  Second, the manner in which the Bair Hugger litigation began was unusually sketchy, as we detailed here and here.

Recently, however, the tawdry manner of Bair Hugger’s origin was matched by a specious attempt to disqualify the MDL judge.  It’s obvious to us what is going on here.  Both sides know that plaintiffs’ free pass on Rule 702 expires this December, when the rule amendments take effect.  Assuming the expert testimony doesn’t change, the defendant essentially gets a do-over.  So the Bair Hugger plaintiffs desperately desired that do-over to be decided by a different judge.…

Continue Reading Plaintiffs’ Judge Shopping Ploy Fails in Bair Hugger MDL

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Beginning – at least − with the awful decision in Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448, 465 (W.D. Pa. 2019) (discussed here), plaintiffs seeking to overturn the longstanding Pennsylvania (since the 1940s) prohibition against strict liability in prescription medical product liability litigation have been systematically attacking the precedential weight…

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“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…

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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

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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

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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.

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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

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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….

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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…

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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