March 2012

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We’ve mentioned before how preemption is the strongest defense because (unlike Daubert or the learned intermediary rule) it bars claims without regard to their substantive merit.  When preemption applies in mass torts, such dismissals may occur on a wholesale basis.  In our prior post, “The New One-Two,” we described how potent preemption can be in generic drug cases when teamed with the traditional requirement of product identification as applicable to branded manufacturers.
The other day this “new one-two” scored a knockout in the heavyweight division, that is to say a federal multi-district litigation (“MDL”) – specifically the Darvon/ Propoxyphene MDL.  In two simultaneously issued opinions, the court disposed of what are likely to be the great bulk of the claims in the MDL.  Darvon is a drug that’s been around for decades, and which the FDA eventually decided to take off the market because newer drugs were, the agency believed, both safer and more effective.  That doesn’t mean that Darvon was any less safe than before, but anytime there’s a recall, it seems somebody takes a shot at a mass tort.
No longer – at least for Darvon.
First, preemption. In In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL No. 2226, slip op. (E.D. Ky. Feb. 5, 2012), the court dismissed a comprehensive set of claims against generic makers of propoxyphene (the generic equivalent of Darvon), finding that all of the claims are either preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), or inadequately pleaded. Specifically:

  • “Wrongful marketing” – that is, claims that the generic defendants should be liable for not removing their products from the markets altogether – are preempted because such allegations prove too much: “the idea that [defendants] should have simply stopped selling [the generic drug] is an oversimplified solution that could apply anytime the issue of impossibility preemption arises: avoid a conflict between state and federal law by withdrawing from the regulated conduct altogether.”  Slip op. at 7-8.
  • Failure to warn claims based upon alleged “failure to timely change the labeling” after the FDA ordered it strengthened were barred because plaintiffs had no facts to support “purely conjectural” “information and belief” pleading.  Slip op. at 8-10.
  • Likewise, no facts were alleged to support “Dear Doctor” letter-based claims.  In any event, such letters would involve new information, and thus labeling that was no longer the “same” as required by federal law.  Slip op. at 10 & n.9.
  • That certain defendants were designated by the FDA as “reference listed drug” holders did not prevent preemption, because “the FDA, not the RLD holder, controls label changes” once such a designation is made.  Slip op. at 10-11.
  • Claims for misrepresentation, fraud, consumer protection, and express warranty, were all preempted because they demanded labeling changes that were impossible under the federal “sameness” requirement.  Slip op. at 11-12.
  • Plaintiff’s “statutory negligence” claims were based solely on allegations of FDCA violations (“mostly relating to labeling or ‘misbranding’”) and were thus preempted under Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), because there is no private FDCA right of action.  Slip op. at 12.

Because the MDL complaints had already been amended, and plaintiffs were not entitled to speculative discovery under TwIqbal, all of the generic complaints were dismissed with prejudice and without leave to amend.  Slip op. at 12-13.
That’s one.Continue Reading The New One-Two – Heavyweight Division

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            It was the best of times . . . . No, our story isn’t nearly as significant as that classic.  Rather, it is a tale of two medical device cases that we thought offered an interesting comparison for their numerous similarities and one key difference – the result.  This brings to mind vague memories

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Over a decade ago, Bexis convinced the Fourth Circuit to predict that Virginia would reject cross-jurisdictional class action tolling – the notion that a meritless class action filed in one jurisdiction could suspend the running of the statute of limitations in another jurisdiction.  See Wade v. Danek Medical, Inc., 182 F.3d 281 (4th Cir.1999).  But what was won in Wade had a hard time staying won.  Some federal courts, deviating from their federalist duty to construe state law conservatively, nonetheless made conflicting predictions that, maybe Virginia law (despite not recognizing class actions at all) would allow cross-jurisdictional tolling.  See Torkie-Tork v. Wyeth, 739 F. Supp.2d 887 (E.D. Va. 2010); Shimari v. CACI International, Inc., 2008 WL 7348184 (E.D. Va. Nov. 25, 2008).
But not all courts.  In In re Fosamax Products Liability Litigation, 694 F. Supp.2d 253 (S.D.N.Y. 2010), the court followed Wade in another multidistrict litigation (Wade had followed an MDL remand).  The plaintiffs appealed, and the Second Circuit certified the question to the Virginia Supreme Court, which accepted the appeal.
Virginia’s highest court has now killed cross-jurisdictional class action tolling dead in that jurisdiction.  Casey v. Merck & Co., No. 111438, slip op. (Va. Mar. 2, 2012).  Good riddance, we say.  It was a long enough time coming – as was the underlying Fosamax class action decision.  The plaintiffs wanted over two years of tolling – just for filing a meritless complaint – because it took various courts (it was an MDL, after all) from September 15, 2005 until January 28, 2008 to dismiss the patently bogus personal injury class action.Continue Reading At Long Last – Virginia Definitively Rejects Class Action Tolling

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Those of us who graduated from the University of Chicago are just a wee bit tired of the “place where fun goes to die” epithet. It’s true that U of C is an intensely intellectual place, and it’s true that Hyde Park is a long way from Chicago’s hot spots, and it’s true that the Cubs will continue to disappoint, and it’s true that when the Winter wind (“the Hawk”) blows in off Lake Michigan one prays for death, but … what was our point, anyway? Right – intellectual combat can be a fascinating spectator sport. It can be a moveable feast. It can even be, yes, fun.
In mid-February, the Law School put on a “Manhood in Law and Literature” conference. Here is part of what the conference announcement promised: “The conference will include two dramatic performances by members of the University of Chicago law School. The first scene, from the Caine Mutiny Court Martial by Herman Wouk, will feature Judge Richard Posner as Lt. Commander Queeg … and Judge Diane Wood as Captain Blakely. The second scene, from The Little Foxes by Lillian Hellman, will feature Professor Martha Nussbaum as Regina Hubbard Giddens and Professor Douglas Baird as her husband Horace. A musical interlude will be provided by Jajah Wu, Gary de Turck, and Martha Nussbaum.”
Sounds like fun, right? It gets better. An article describing the conference reveals that Professor Nussbaum sang “Can’t Help Lovin’ Dat Man” from Show Boat. Mind you, this is the same Martha Nussbaum who is one of the country’s most daring and creative philosophers, who is a hero to the Drug and Device Law Daughter because of her position on animal rights, and whose analysis of Plato’s Symposium has been stuck to our brain for over 25 years. We are genuinely sorry we missed this performance. Author Joyce Carol Oates also spoke (but did not sing) at the conference. She talked about Hemingway and boxing. Oates’s writings on boxing have given it an unexpected intellectual heft.Continue Reading There’ll Always Be Posner: Hemingway, Boxing, and Sanctions

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PARISIAN TRANSCRIPTS 2.0
We had a number of people send us material after our first post with out list of deposition transcripts (and various other items) concerning the testimony of the extremely active plaintiffs’ side expert, Dr. Suzanne Parisian. We are still awaiting promised materials from certain other folks, who will remain nameless.
One anonymous benefactor sent us a 30-page disclosure list (no transcripts, unfortunately) of Dr. Parisian’s appearances in court or at trial prior to early 2010.
Another anonymous benefactor sent us a Westlaw print out containing additional Parisian-related materials. We’ve added the Westlaw citations, both to new items and to those we’ve already had.  We haven’t looked at them all, but we did review some, and we caution that a lot of the Westlaw materials contain extensive omissions and thus might not be particularly helpful.  The Westlaw materials also included some of Parisian’s expert reports, so we’ve created a second list – after the first – of those.  Those are only on Westlaw; they weren’t included in any materials we received.
We’ve tried to synthesize this material and compile it into a single list.  If you thought our prior Parisian post was boring – well this one’s just as boring, but even longer.  If we have the actual transcript of the testimony, then the item is listed in black, as before, with or without a Westlaw citation. If we don’t have any transcript, then we’ve also listed it, but in red.  A red colored entry with a Westlaw cite means we don’t have a copy of the transcript, but there’s something available on Westlaw.Continue Reading Parisian Transcripts 2.0

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So The Artist won.  Some of us (maybe only one of us) didn’t even know it was a silent movie.  Imagine going to that movie without knowing it was silent.  That’s failure to warn.  At least when Mel Brooks made Silent Movie you knew what you were getting.  And in his movie the French guy

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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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