Thursday, March 08, 2012

The New One-Two - Heavyweight Division

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.

The second blow fell on the claims against the branded manufacturers of Darvon/Darvocet.  With the original manufacturer having sold all its NDA rights for these drugs in 2002 – seven years before the FDA ordered it off the market, it’s unlikely (given the timing) that many plaintiffs ever consumed a product actually produced by the branded manufacturer.  Failure to plead use of the branded defendant's product, the court held, was fatal to all every claim that the plaintiffs pleaded.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL No. 2226, slip op. at 5-14 (E.D. Ky. Feb. 5, 2012):

In every state implicated by [the branded] motions, it is well-settled law that a threshold requirement of any products-liability claim is that the plaintiff assert that the defendant’s product caused the plaintiff’s injury.  There is no theory of product liability under which a defendant can be held liable for an injury caused by a product that it did not sell, manufacture, or otherwise supply to the plaintiff.

Id. at 5 (citatons, quotation marks and footnote omitted). So far, so good.

But are “misrepresentation theories” subject to the same limitation?  The court held that they were:
[C]ourts in many states have expressly rejected the argument that misrepresentation claims are distinct from product liability or failure-to-warn claims [page-long string citation omitted]. [A]ll claims arising from the use of a product are properly characterized as “product liability claims.” Therefore, plaintiffs must properly identify the entity responsible for the product at issue in order to proceed.

Slip op. at 9-10.

Not only that, the court held that product manufacturers do not owe any duties to persons who never used their products:

[T]o hold [the branded defendant] liable for misrepresentation in cases that do not allege the ingestion of [its] product, plaintiffs must establish that [it] owed them (or their prescribing physician) a legal duty. [discussion of Conte and Kellogg omitted]. Conte and Kellogg represent a minority position, with the overwhelming majority of courts instead adopting a rule that rejects the contention that a name brand manufacturer’s statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer’s drug [second page-long string citation omitted].

Slip op. at 10-13.

And finally, crowning blow – principles of federalism preclude the MDL court from adopting the expansive, minority view “in the absence of binding authority” to the contrary.  Id. at 14.  Neither Conte (an intermediate appellate decision not even binding on other California appellate courts) nor Kellogg (by a federal district court) warrant the description "binding."
A federal court should hesitate to expand the scope of state law without guidance from that state’s highest court. Instead, “‘given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.

Slip op. at 13-14 (citations and quotation marks omitted).

YESSSSSSSSS!

This federalist principle is something we’ve been pounding on since the beginning of the blog, and we’re pleased to see it invoked in this context.

Thus the Darvocet/Darvon/Propoxyphene litigation is listed in both our generic preemption and branded/generic scorecards.  Out of curiosity, we took a look to see what other cases might also have achieved this distinction. We found five other 1-2 knockouts so far.

Of course, there is Mensing itself, with generic preemption recognized by the Supreme Court, 131 S. Ct. 2567, and branded non-liability in Mensing v. Wyeth, Inc., 588 F.3d 603, 612-14 (8th Cir. 2009), reaffirmed after remand, 658 F.3d 867 (8th Cir. 2011).

Also there’s Smith v. Wyeth, Inc., 657 F.3d. 420 (6th Cir. 2011) (applying Kentucky law), which affirmed generic preemption and branded product identification dismissals in the same opinion.

Then there’s the peripatetic Moretti case.  First, in Moretti v. Wyeth, Inc., 2009 WL 749532 (D. Nev. March 20, 2009), a Nevada court dismissed the claims against the branded defendant on product identification grounds.  Later, after Mensing, a different court, in Minnesota, held the same plaintiff’s claims were preempted as against the generic manufacturer.  Moretti v. Mutual Pharmaceutical Co., 2012 WL 465867 (D. Minn. Feb. 13, 2012).

In Morris v. Wyeth, the court first granted the branded manufacturer’s product identification motion.  2009 WL 4064103 (W.D. La. Nov. 23, 2009).  Then, after the Supreme Court decided Mensing, the court granted the generic defendant’s preemption motion.  2011 WL 4973839 (W.D. La. Oct. 19, 2011).  At the same time, the court declined to reconsider its dismissal of the branded defendant.  2011 WL 4975317 (W.D. La. Oct. 19, 2011).

The Bell litigation was a lot like Morris – only more recent.  First the branded manufacturer was dismissed. Bell v. Pfizer, Inc., 2011 WL 904161 (E.D. Ark. March 6, 2011).  Later, after Mensing, the generic manufacturer got out as well.  Bell v. PLIVA, Inc., 2012 WL 640742 (E.D. Ark. Feb. 16, 2012).

All these cases share the same attribute – they're "win-win" for the defendants.  And that's just about as good as it gets.

1 comment:

Ron Miller said...

"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."

Yes, the safety of the drug did not change. But we all learned that it causes heart injuries to the point where someone thought it should be recalled. This is a pretty big deal. I'm not sure this fits cleanly under the "plaintiffs' lawyers, they sure are greedy" narrative.