- Whether Michigan law applies to the plaintiffs' West Virginia products liability claim involving a mother's ingestion of Zoloft in Michigan and the birth of her child, who was born with birth defects, in Michigan.
- Whether summary judgment for the defendant manufacturer, Zoloft, was appropriate where the manufacturer knew of the possibility of birth defects from ingesting Zoloft while pregnant.
On July 11, 2012, the mother of a minor plaintiff filed a civil action in the Circuit Court of Wayne County, West Virginia, arising out of the minor's birth defects allegedly caused by the mother's ingestion of the prescription medication sertraline hydrochloride, trade name Zoloft®. The plaintiffs alleged that they were citizens of Michigan. The plaintiffs did not allege that the Zoloft was adulterated or that the labeling was not in compliance with the FDA.
It was undisputed that the plaintiffs were residents of Michigan; the mother was prescribed Zoloft by a physician in Michigan and ingested Zoloft in Michigan; that the minor plaintiff was born in Michigan and received treatment for her alleged injuries in Michigan. The plaintiffs' discovery responses did not identify any witnesses who were located in, or any events that took place in, any other state.
The defendants moved to dismiss on the grounds of forum non conveniens and also moved to dismiss under Michigan law. On October 21, 2014, the Mass Litigation Panel ("the Panel") denied the defendants' motion under Michigan law as premature.
Subsequently, the plaintiffs filed an amended complaint alleging three causes of action: (1) strict liability; (2) failure to warn; and (3) negligence. However, the Mass Litigation Panel found that no matter how the plaintiffs labeled their causes of action or characterized the evidence, the only claim they asserted was a strict liability claim based on failure to warn. The Panel further found that the plaintiffs based their strict liability and negligence claims on the theory that defendants failed to warn the medical community and public about the risks of taking Zoloft.
The Panel held that because the gravamen of plaintiffs' claims was for failure to warn, Michigan law applied. Michigan's products liability statute provides that a "drug is not defective if the drug was approved by the food and drug administration, and the drug and its labeling were in compliance with the food and drug administration's approval." Mich. Comp. Laws § 600.2946(5). The Michigan statute allows a product liability action to proceed only if the manufacturer "intentionally withholds from or misrepresents to the food and drug administration information required and the drug would not have been approved, or the food and drug administration would have withdrawn approval if the information were accurately submitted."
The plaintiffs asserted that this exception applied, but the Panel found that the plaintiffs cited only vague allegations that the defendants represented to the FDA that Zoloft was safe and effective and concealed knowledge that Zoloft can cause birth defects. The Panel determined this was insufficient to meet the plaintiffs' burden of proof and held that the plaintiffs had to offer "concrete evidence" that would support a verdict in their favor.
The Panel further concluded that the plaintiffs had not shown that the defendants withheld any relevant and material information from the FDA. The Panel took note that uncontroverted evidence showed that foreign labels and the International Product Document for Zoloft, all of which contained language that contraception should be used by sexually active patients taking Zoloft, were provided to the FDA before Zoloft was approved.
The Panel also found that the FDA exception to the Michigan statute is preempted by federal law and, therefore, unavailable unless the FDA itself "determine[d] that a fraud ha[d] been committed on the agency during the regulatory-approval process"
Position of Petitioner (Plaintiffs):
The plaintiffs argue that the Panel erred by applying Michigan law and granting summary judgment in favor of the defendants. The Panel's decision improperly conflated the minor's strict products liability and negligence claims with her failure-to-warn claim, in direct contravention to the Supreme Court's long-held view that plaintiffs in products actions are not required to elect which theory of liability they decide to submit to a jury. The plaintiffs rely on Syllabus Point 6 of Ilosky v. Michelin Tire Corp., 172 W. Va. 435, 437, 307 S.E.2d 603, 605 (1983) as support for this argument.
The plaintiffs further contend that even under Michigan law, the Panel failed to recognize the significant weight of disputed evidence showing that the defendants had been made aware of the risks of Zoloft to women of childbearing potential, and yet failed to properly ensure that the product was not defectively manufactured or sold and that such information was brought to the attention of the FDA.
With respect to the Panel's finding that the Michigan fraud exception was preempted by federal law, the plaintiffs contend that under long-established principles of preemption, courts must presume "that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." For support, the plaintiffs cite to Wyeth v. Levine, 555 U.S. 555, 565 (2009). The plaintiffs also argue that the Panel refused to follow the leading federal court of appeals to have squarely addressed this issue, Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), which concluded that the same Michigan law at issue here was not preempted. Finally, the plaintiffs contend that the Panel failed to understand that the issue is not a State's ability to impose liability for the sale of defective medicines, but whether a State law can impose liability for "fraud on the FDA."
Position of Respondents (Defendants):
The defendants contend that at the time this action was commenced in 2012, W. Va. Code Â§ 55-8-16(a) required, as a matter of public policy, that the law of the place of injury govern failure-to-warn claims. The fact that the plaintiff could elect to recover between negligence and strict liability at trial does not change the nature of her claim from failure to warn.
The defendants rely heavily on their contention that the plaintiff did not show that any required information was withheld from the FDA or that such information would have changed the FDA's decision to approve Zoloft.
Regarding the fraud preemption issue, the defendants contend that the controlling law is Buckman Co. v. Plaintiffsâ€™ Legal Committee, 531 U.S. 341 (2001). In Buckman, the U.S. Supreme Court held that claims for "fraud on the FDA" were preempted by the Federal Food, Drug and Cosmetic Act ("FDCA"). The defendants further argue that numerous courts have held that, under Buckman, the FDCA likewise preempts "fraud on the FDA" exceptions in statutes such as the Michigan law at issue here because they make liability contingent on a state court jury determining that the FDA has been defrauded--a determination that federal law vests exclusively with the FDA.
The instant case is likely to have far-reaching implications on forum non conveniens, choice of law and preemption issues in West Virginia as they pertain to failure-to warn cases and perhaps, more broadly, to all products liability cases. The Supreme Court is likely to affirm the choice of law structure set forth in W.Va. Code Â§55-8-16(a). On the issue of preemption, the Court's decision could have broad application to future products liability cases. In this particular case, the preemption defense stems from Michigan products liability law, but it will be interesting to see whether the Court chooses to more broadly expand its ruling beyond the scope of Michigan law.