What follows is another of our occasional guest posts, this time by fellow Reed Smith attorney Danielle Devens. As always with our guest posts, the author gets all the credit, and any blame, for the contents of his/her work.
This week, a panel of the Missouri Court of Appeals issued an opinion allowing a plaintiff to maintain a small subset of warning-related claims against a generic drug manufacturer. It also dismissed the claims against the brand name manufacturers, albeit reluctantly, pointing out the “inherent unfairness” of the supposedly “unjust result.” Finally, same opinion reversed the trial court decision dismissing plaintiff’s claims against a publisher of information disseminated by pharmacies, but only on statute of limitations grounds. The case is Franzman v. Wyeth Inc., No. ED100312, slip op. (Mo. App. Aug. 26, 2014) [ed note: Now at 2014 WL 4210207, as of this morning].
The plaintiff allegedly took generic version of the drug Reglan from March 2002 through October 2005, at which point she allegedly developed tardive dyskinesia, a known risk of this drug. She brought claims against the brand-name manufacturers, generic manufacturers, and a publisher. In a prime example of litigation tourism, plaintiff is a Kentucky resident pursuing claims under Kentucky law who filed her suit in the notoriously plaintiff-friendly St. Louis, Missouri. [Slip Op. at 2]
But even St. Louis was not that friendly to this plaintiff. The trial court knocked out plaintiff with a one-two-three combination, dismissing all claims against: (1) the generic manufacturers based on Mensing preemption; (2) the brand name defendants based on lack of legal causation because they did not make the product the plaintiff took; and (3) the publisher based on the Kentucky one-year statute of limitations. Plaintiff appealed each ruling.
As to the publisher, it is worth noting that the only issues litigated pertained to the statute of limitations. The trial court’s determination that plaintiff’s claims were barred by the statute of limitations was reversed as the court held that when plaintiff acquired knowledge of her legal injury is a question of fact to be decided by the jury. The underlying question of whether any claims lie against publishers was not raised. [Slip Op. at 24-27] This blog has highlighted this simple truth several times before − publishers do not make or sell drugs. Even though publishers do not owe plaintiffs any duty of care, unfortunately, these claims sometimes survive.
As to the generic manufacturer, plaintiff offered the predictable argument that preemption is not applicable where state law duties do not conflict with federal law. The appellate court largely agreed, making its attitude clear in the section of its opinion titled, “Mensing does not provide blanket immunity to the Generic Defendants.” [Slip Op. at 15 - 18] Even though the court agreed that all of plaintiff’s claims sounded in failure to warn regardless of how they were framed, it did a distinct analysis under Mensing to determine whether requirements of federal law preempt the manufacturer’s state law duties for each claim plaintiff asserted. [Id.] In 2004, the brand name labeling was updated to include bold language stating, “Therapy should not exceed 12 weeks in duration.” Plaintiff claimed that the defendants took too long to copy this change in their labels. The court held that this claim involved only state law duties and was not preempted. “While the Generic Defendants were limited with respect to the warnings they could provide by their ‘federal duty of sameness’ . . . federal law did not prohibit the Generic Defendants from updating their label to conform to the 2004 Reglan label revision.” [Slip Op. at 17]
So, the issue is whether a generic manufacturer is responsible for making its product labeling the same as that of the brand manufacturer, right? And “sameness” is a federal law requirement, right? And private causes of action attempting to enforce federal law are prohibited by the FDCA, right? The court somehow escapes this conclusion that this was a private attempt to enforce the FDCA by reliance upon “parallel claim” analysis drawn from express preemption cases involving medical devices, even though the statutory language allowing that exception did not apply to generic drugs. [Slip Op. at 19]. The blog has discussed this concept here.
When given an opportunity, the court took the pro-plaintiff route. Citing Fulgenzi, which is discussed here, the court held that plaintiff’s claim that the generic defendants breached their state law duty by failing to update their warning labels to match the 2004 brand-name Reglan revision stems from the independent duty under Kentucky law to warn of foreseeable risks. [Slip Op. at 19] But that’s all. The court also determined that claims that the generic labeling should have had stronger warnings than the brand labels are clearly preempted by federal law, and thus the plaintiff is “limited to arguing that the Generic Defendants’ label was inadequate to the extent that it did not include the language contained in the updated 2004 brand-name Reglan label.” [Slip Op. at 19-20]
So in the span of a few paragraphs, the court first acknowledges that plaintiff’s entire argument depends on whether the labels were the same, not on the adequacy of the warnings themselves, while conveniently ignoring that “sameness” is a duty which comes only from federal law, which is why there is preemption in the first place. These points would seem to support a different conclusion, that state law has nothing to do with whether generic and brand labels are required to be the same, and allowing plaintiffs to file state law claims related to “sameness” circumvents the FDCA proscription on using state law claims to enforce federal law.
While the court dismissed all claims against brand-name manufacturers, it nonetheless editorialized about the one-two punch packed into this kind of case. Bound to apply Kentucky law, the court held that plaintiff’s claims were all subsumed by the Kentucky Product Liability Act (“KPLA”). The KPLA requires the plaintiff to prove that the brand defendants’ product was the legal cause of her injury. [Slip Op. at 21] As plaintiff conceded that she ingested only generic Reglan, summary judgment was affirmed. [Slip Op. at 20] The court went out of its way, however, to bemoan the supposed unfairness of the one-two punch, describing generic consumers as “cut adrift in a sea of hopelessness.” [Slip Op. at 23] Lost was the fact that, by taking generic drugs, plaintiff saved quite a bit of money, which is the point of both federal Hatch-Waxman and state substitution statutes concerning these drugs. Given the court’s comments, it was just as well that this panel was applying settled Kentucky law. Sometimes litigation tourism has a downside for plaintiffs.
Missouri is historically a tough jurisdiction for defendants in drug/device litigation. The defendants here did about as well as could be expected, with the court's rhetoric indicating its inclination to cut plaintiffs every break it could.