The Sixth Circuit has just affirmed 99.9% of the defendants’ wins in the Darvocet litigation.  The result is the biggest one-two punch (generic preemption/no non-manufacturer liability for the innovator drug) decision to date.  The opinion involves 68 plaintiffs and the law in 22 states.  

Here’s a link to the opinion, which is encaptioned In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, Nos. 12-5368, et al. (6th Cir. June 27, 2014).

Here’s a quick summary:

Wins for generic preemption – and be aware that this is a 12(b)(6) motion to dismiss, so plaintiffs are out of court relatively quickly and inexpensively (by MDL standards anyway):

  • So-called “parallel misbranding” claims were not pleaded, because no “new information” sufficient to change the FDA’s mind was ever alleged under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2477 n.4 (2013).  All the information the plaintiffs mentioned was considered and rejected by the FDA as a basis for any administrative action.  The information that the FDA acted upon was not available to the generic defendants.  Darvocetslip op. at 11-14.  Plaintiffs could not avoid preemption even if a “parallel claim” exception existed after Bartlett and even if there were a state-law basis for it.
  • Plaintiffs failed to establish any factual basis for a failure to update claim – demonstrating the very limited nature of this sort of allegation.  “On information and belief” pleading can’t establish plausibility under TwIqbal, nor do blanket allegations against all defendants collectively. Darvocetslip op. at 14-17.
  • Failure to communicate claims – magically timed Dear Doctor letters − are preempted.  They would violate the duty of sameness.  Darvocetslip op. at 17-18.
  • FDA designation of a generic manufacturer’s product as a “reference listed drug” doesn’t change preemption at all.  A generic RLD is still a generic drug bound by the statute’s sameness requirement.  The FDA said so in a publication first discussed here on the blog on the day it came out.  A drug has either an ANDA or an NDA, and there’s no switching between the two. Darvocetslip op. at 18-20.
  • Express and implied warranty claims are preempted.  To the extent they’re based on the continued marketing of the drugs, these claims are disguised stop selling claims preempted by Bartlett.  Darvocetslip op. at 20-21.
  • Fraud, misrepresentation, and consumer fraud claims are preempted because they all challenge the labeling. Darvocetslip op. at 21-22.
  • Statutory misbranding/adulteration claims – which the plaintiffs called “negligence” are preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  They are premised  on violations of the FDCA, as to which can only be enforced by the government.  Darvocetslip op. at 23.

The innovator defendants won because the court concluded, in light of “overwhelming” precedent,  Darvocetslip op. at 25, that no state would hold an innovator manufacturer liable for “misrepresentations” with respect to a generic product that those defendants never sold to the plaintiffs.  The court goes right to our favorite Erie principle – the one we’ve been evangelizing about for almost eight years:

[F]ederal courts must be cautious when making pronouncements about state law and when 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.

Darvocetslip op. at 24 (citations and quotation marks omitted).

To the extent that a state would construe a non-manufacturing “misrepresentation” claim as a product liability claim, the claim fails for lack of product identification:

In the twenty-two states implicated by the Brand Manufacturers’ motion to dismiss, it is well-settled law that the threshold requirement of any products-liability claim is that the plaintiff assert that the defendant’s product caused the plaintiff’s injury. This is known as the “product identification requirement.”  Because Plaintiffs did not ingest the Brand Manufacturers’ drugs, their “misrepresentation” claims would fail if a state’s highest court would construe them as product liability claims under applicable state law.

Darvocetslip op. at 25 (citations and quotation marks omitted). To the extent the misrepresentation claims are considered something other than product liability, Darvocet predicted no state would impose a duty on a competing manufacturer:

[E]ven if a state’s highest court would not construe Plaintiffs’ claims as “product liability” claims, the claims were still properly dismissed if we predict that such courts would hold that the Brand Manufacturers do not owe users of generic drugs a duty that can give rise to liability.

Id.  The minority position, represented by Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), was acknowledged, but rejected.  Darvocetslip op. at 26.

First, the generic consumers’ injuries are not the foreseeable result of the brand manufacturers’ conduct, but of the laws over which the brand manufacturers have no control.  Congress made the public policy decisions to lower barriers of entry for generic drugs, as has the [relevant] state legislature in enacting laws to require certain prescriptions be filled with available generics.  Using these laws as the basis of supplying the duty element for tort liability stretches foreseeability too far.  Additionally, the [minority position] fail[s] to properly account for the magnitude of brand manufacturers’ burden of guarding against the injury; and the consequences of placing that burden on the brand manufacturers.  Courts in the majority note the traditional reticence against imposing liability on a manufacturer for injuries caused by their competitor’s products.  Further, there are grave health policy consequences associated with recognizing brand manufacturer liability in these situations including higher priced brand name drugs and fewer innovative drugs.

Darvocetslip op. at 34 (citations and quotation marks omitted).

The court undertook a state-by-state analysis of all 22 states – Arkansas, Connecticut, Florida (citing a case we sent to Westlaw), Georgia, Illinois (rejecting Dolin v. SmithKline Beecham Corp., 2014 WL 804458 (N.D. Ill. Feb. 28, 2014)), Indiana, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington, and West Virginia.  These are not two-liners, either.  Rather the appendix is the kind of multi-state survey that we like so much on the blog.  See Darvocetslip op. at 30-48.

Finally, ten plaintiffs alleged that they actually consumed the innovator drug.  Some of them couldn’t prove it.  Others only consumed those products after the innovator defendant had sold its NDAs and thus couldn’t change warnings anymore.  Still others alleged that the innovator defendant produced product under contract to a generic manufacturer.  Some relied solely on “information and belief” pleading.  Dismissal of all of these claims was affirmed.  Darvocetslip op. at 27-29.  Of particular importance is the dismissal of the post-NDA-sale claim:

After the divestiture, [defendant innovator manufacturer] had no more power to change the label than did [a generic manufacturer].  Because [it] was no different than the other Generic Manufacturers at the point the . . .  plaintiff allegedly may have taken their product, the district court did not err in dismissing their claim.

Darvocetslip op. at 27-28.  This defendant was not a generic manufacturer, so Darvocet has recognized at Mensing/Bartlettapplies outside of the purely generic sphere to any manufacturer that lacks “power” under the FDCA to make a change demanded by a plaintiff independently of the FDCA – something we’ve been advocating all along.

One lonely plaintiff – who pleaded ingestion of a branded product and injury – survived, because the court found a traditional product liability claim adequately pleaded.  Darvocetslip op. at 29.

Darvocet is the biggest one-two punch yet.  Twenty-two states including our own Pennsylvania.

A well-deserved tip of the hat to Hank Bullock of Mayer Brown both for successfully arguing the case for the innovator defendants and then thinking enough of us to send the decision along.