This post is not from the Dechert side of the blog, since they are involved in Reglan litigation.
Last evening, just before quitting time on the East Coast, we found the Sixth Circuit’s affirmance of the Rule 12 dismissal (that means no expensive discovery necessary) of seven Reglan cases under Tennessee Law. See Strayhorn v. Wyeth Pharmaceuticals, Nos. 12-6195, et al., slip op. (6th Cir. Dec. 2, 2013). The court also affirmed summary judgment against another set of defendants – affiliated with the original innovator manufacturer.
Because of that, we call this type of result a “one–two punch” case. That means that the plaintiffs – who took the generic version of the drug only – are: (1) knocked out of the box against the generic manufacturer by preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013); and (2) barred from suing the original innovator manufacturer of the drug by the very simple and basic fact that the plaintiff never used that defendant’s product.
First, the generic side:
Plaintiffs had filed the usual kitchen-sink type complaint alleging everything from design defect to consumer fraud. Plaintiffs abandoned consumer and unjust enrichment claims, but appealed dismissal of everything else. Strayhorn, slip op. at 7.
Strayhorn is significant because it confirms what we thought – after Mensing and Bartlett there’s very little left that’s unpreempted in generic drug litigation, unless the FDA manages to thread the statutory needle and nullify these results in the absence of congressional intervention, which we recently discussed here. But even that wouldn’t be of any use to plaintiffs, like those in Strayhorn, who took generic drugs labeled under the current regulatory scheme.
The failure to warn claims were easy. They were Mensing personified. The plaintiffs’ “narrow” reading of Mensing was
rejected, in accordance with what the court viewed as unanimous precedent (citing appellate decisions in the Fifth, Eighth, Ninth, Tenth, and Eleventh Circuits). Strayhorn, slip op. at 14. If the result would be a different or additional warning of some sort, then the claim, whatever the plaintiffs called it (and here they called it strict liability, negligence, express and implied warranty, fraud, and conspiracy), was preempted. Id. Claims asserting a duty to send “Dear Doctor” letters fail because such letters are also labeling that defendants can’t use without prior FDA approval. Id. at 24-25.
The court found nothing peculiar about Tennessee law to distinguish it from all the other cases. Yes, Tennessee did apply (in part, as an alternative) a consumer expectation approach to product liability. But the consumer expectation approach did not apply to “complex products.” Id. at 16. Significantly, and rightly in our opinion (see here), Strayhorn rejected the “reasoning” (if it could be called that) of the Pennsylvania Superior Court’s Reglan trilogy. Id. at 17-18. Those “outlier” cases were supported by “virtually no” precedent and their reasoning was “unpersuasive.” Id. at 18. Under the FDCA, warranty claims are plainly based on labeling:
Because such advertising and promotional materials are considered labeling, and because labeling is limited by federal law to the information contained in the brand-name drug’s labeling, all of the warranty claims against the Generic Manufacturers based on these materials are preempted under Mensing.
Id. at 19. The express warranty claims also failed under TwIqbal. Id. at 20-21. TwIqbal and the fact that the claims also related to warnings similarly defeated conspiracy claims, Id. at 28.
The Pennsylvania Superior Court’s treatment of fraud claims was likewise deficient. Strayhorn, slip op. at 22-23. Fraud claims are no different than other claims attacking the sufficiency of drug labeling. They “boil down to an alleged duty to provide additional information about [the] generic [drug].” Id. at 23.
As for design claims, they fail under Bartlett. A “consumer expectations” theory made no difference since that theory does not apply to prescription drugs.
[T]he [prudent manufacturer] test would appear to be the appropriate choice in this case because the ordinary consumer would not have the medical knowledge necessary to have a reasonable expectation about the safety of [a prescription drug].
Strayhorn, slip op. at 23 (citation omitted). The prudent manufactured prong employed a risk/utility test explicitly barred by Bartlett. Id. at 23-24.
Finally, while plaintiffs’ failure to update claims (that defendants did not change their label when the FDA told them to) could survive preemption, TwIqbal comes to the rescue. Plaintiffs didn’t allege which defendants’ warnings weren’t updated and they didn’t allege that they took the drug of a defendant during the period the labels weren’t what the FDA had ordered. Strayhorn, slip op. at 26-27. Plaintiffs couldn’t amend their complaints on appeal, and appellate courts “should not assume facts that were not pled.” Id. at 27.
Plaintiffs’ claims against the innovator manufacturers failed because Tennessee law does not allow product-related claims against defendants that didn’t sell anything the plaintiffs used. Tennessee has a product liability statute “contain[ing] multiple references to manufacturers and sellers.” Strayhorn, slip op. at 32. The claims plaintiffs attempted to assert – negligent and fraudulent misrepresentation, and express and implied warranties – did not exist separately from the statute. Id. at 31-32. All forms of marketing (plaintiffs alleged “advertising, promotions, in-office and group presentations, sponsored education and continuing education programs and seminar speakers, the planning, sponsorship, ghost-writing, and arranged publication of non-scientific and misleading medical research”) were covered by the statute. Id. at 32. All claims concerning product promotion “are based on these defendants’ status as the manufacturers of [the drug].” Id. at 33. There was no separate duty. Id. at 34.
Since the statute circumscribed the scope of product liability claims, and no Tennessee precedent had allowed product liability claims against non-manufacturers, the innovator claims failed. Id. at 34. Mere “foreseeability” isn’t enough. “[S]imply because a particular harm is foreseeable is not dispositive in determining the existence of a legal duty.” Id. at 34-35 (citation and quotation marks omitted). Applying our favorite Erie principle, the Sixth Circuit in Strayhorn found “no basis to conclude . . . that the Tennessee Supreme Court would overrule its prior decisions holding that a manufacturer owes no duty of care to consumers of products made by others.” Id. at 36.
The plaintiffs have presented no authority indicating that manufacturers of a brand-name drug have a duty under Tennessee law to consumers of the brand-name manufacturers’ competitors, and we are loath to expand Tennessee’s substantive law without direction from the Tennessee Supreme Court. 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.
Id. (citation and quotation marks omitted).
As for the minority (Conte) position, Conte was an “outlier”; Kellogg was “contrary to Tennessee law”; and Weeks had been withdrawn and was subject to reconsideration. Strayhorn, slip op. at 37-38. Every federal appellate court has rejected innovator drug liability where the plaintiff took a competing generic product. Id. at 37.
That’s two. Like Jack Dempsey once did to Luiz Firpo, the Strayhorn plaintiffs were knocked completely out of the box.
There’s also another one-two combination at work here. In addition to Strayhorn, our innovator liability scorecard includes Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011), also from the Sixth Circuit. We also list numerous decisions in the Darvocet MDL that dismiss similar claims. Since any Darvocet appeals would also go to the Sixth Circuit, the one-two punch of Strayhorn and Smith would seem to bode well for the right side of the “v.” in that litigation as well.