CHARLESTON – The West Virginia Supreme Court of appeals has issued an opinion agreeing that birth defects from the drug Zoloft that have been sent to the Mass Litigation Panel fall under Michigan law.

M.M., through her mother, Jeanette M., appealed an order entered Aug. 30, 2016, by the Mass Litigation Panel.

By its order, the panel granted summary judgment to Pfizer, Roerig and Greenstone, upon its conclusion that there existed no genuine issue of material fact and that Pfizer was entitled to judgment as a matter of law.

On appeal to this court, M.M. assigns error to the panel’s order and contends that disputed issues of material fact preclude summary judgment, the panel applied the wrong state’s law under its choice of law analysis and the asserted claims are not preempted by federal law.

“Upon our review of the parties’ arguments, the pertinent authorities, and the record designated for consideration on appeal, we conclude that the panel correctly determined that the respondents are entitled to summary judgment,” the opinion states. “Accordingly, we affirm the August 30, 2016, order of the Mass Litigation Panel.”

Justice Robin Jean Davis authored the majority opinion. Justice Menis Ketchum did not participate in the decision. Putnam Circuit Judge Joseph Reeder participated by special assignment.

M.M. is a minor and one of 19 minor plaintiffs who have alleged that they sustained birth defects as a result of their mothers’ use of Zoloft during pregnancy.

Jeanette M. filed her complaint in Wayne County in 2012, alleging that the labeling on Zoloft did not warn prescribing physicians that the use of Zoloft in pregnancy was linked to an increased risk of birth defects and that women should use contraceptives while taking Zoloft.

In 2015, the panel concluded that Michigan law governs M.M.’s claims, that federal law operates to preempt the exception to Michigan’s failure to warn immunity where Zoloft received FDA approval. M.M. then appealed to the state Supreme Court.

“While M.M. attempts to rely upon the fraud on the FDA exception set forth in subsection (b), such an exception is valid only if the FDA, itself, acknowledges the perpetration of such fraud, which M.M. has not alleged here,” Davis wrote. 

M.M.’s remaining claims are also thwarted, whether they are governed by Michigan law or West Virginia law, according to the opinion.

“Ordinarily, M.M.’s strict liability and negligence claims would be governed by Michigan law insofar as the alleged injuries occurred in Michigan,” Davis wrote. “Under this standard, M.M.’s claims fail because both the strict liability and negligence claims allege that Pfizer improperly failed to include contraceptive and/or birth defect warnings on its labeling, which, again, constitute allegations that Pfizer failed to warn of the dangers of Zoloft.”

However, assuming that West Virginia law governs M.M.’s claims given that the panel denied Pfizer’s forum non conveniens motion because no other available forum existed in which to try M.M.’s substantive claims, M.M. still cannot prevail on the additional claims of strict liability and negligence set forth in the infant’s amended complaint under West Virginia substantive law.

“With respect to claims alleging strict liability, we have recognized that ‘a defective product may fall into three broad, and not necessarily mutually exclusive, categories: design defectiveness; structural defectiveness; and use defectiveness arising out of the lack of, or the inadequacy of, warnings, instructions and labels,’” Davis wrote. “Counsel for M.M. concedes that, with regard to strict liability, he is not alleging that the Zoloft in question was, itself, defective but rather that Pfizer inadequately warned of the potential harm when used by pregnant women. However, this is merely a restatement of M.M.’s failure to warn claim which…is governed, and foreclosed, by Michigan law.”

Finally, with respect to M.M.’s negligence claim, the Supreme Court  has previously held that there first must exist a duty, and a breach of that duty, to hold a defendant liable for negligence.

“Again, though, the duty M.M. alleges that Pfizer breached is the duty to provide adequate warnings about the potentially harmful effects of Zoloft if used by pregnant women, which is merely a reiteration of M.M.’s failure to warn claim,” Davis wrote. “To recognize such a claim under West Virginia law where the same already is foreclosed in the same case by the law of another jurisdiction, however, would contradict the full faith and credit due our sister jurisdictions.”

Thus, while M.M. may have established a question of fact sufficient to overcome summary judgment as to the asserted claim of negligence, because the failure to warn claim is subject to and precluded by Michigan law, Pfizer, and not M.M., is entitled to judgment as a matter of law as to the negligence claim.

“In other words, because M.M.’s failure to warn claim is governed by Michigan law, and the governing Michigan statutes provide that a manufacturer cannot be held liable where it has complied with the FDA reporting, disclosure, and labeling requirements, there exists no duty that could have been breached so as to establish a claim for negligence,” Davis wrote.

The court affirmed the Aug. 30, 2016, order of the panel.

W.Va. Supreme Court of Appeals case number: 16-0927

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