The petitioner, M.M., an infant, by her mother, is one of nineteen minor plaintiffs who alleged that they sustained birth defects from their mother's use of the prescription anti-depressant Zoloft. The respondent, Pfizer, manufactures and markets Zoloft. The remaining respondents, Roerig and Greenhouse, are both affiliated with Pfizer. Roerig is a former division of Pfizer, while Greenstone is a wholly owned subsidiary of Pfizer that sells an authorized, generic Zoloft. In the case sub judice, M.M. contended that the 2009 labeling information for Zoloft did not warn prescribing physicians that the use of Zoloft during pregnancy was linked to an increased risk of birth defects and that women should us contraceptives while taking Zoloft.
Subsequent to its filing, the case was referred to the West Virginia Mass Litigation Panel. In 2015, M.M. filed an amended complaint asserting specific claims for strict liability, failure to warn, and negligence. Thereafter, the respondents moved for summary judgment. In considering the motion, the Panel concluded that Michigan law governed M.M.'s claims; that federal law operated to preempt the exception to Michigan's failure to warn immunity where the subject drug has received FDA approval; that no genuine issues of material fact remained in the case; and that the respondents were entitled to judgment as a matter of law. Accordingly, the Panel granted summary judgment to the respondents, by order entered August 30, 2016. It is from this adverse ruling that M.M. appealed to the Supreme Court.
1. Whether West Virginia, not Michigan, law applied to M.M.'s claims.
2. Whether Michigan law, if it applies, is preempted by federal law.
3. Whether the trial court erred by granting summary judgment where, as M.M. contends, Pfizer knew of the dangers of Zoloft use during pregnancy, generated reports suggesting contraceptive use while taking the medication, and realized the import of the possibility of birth defects by specifically including contraceptive warnings on its European packaging for the drug.
The Supreme Court began by noting that there was no dispute that the injuries alleged by M.M. and the infant's mother all occurred in the State of Michigan and, therefore, Michigan law governed M.M.'s failure to warn claim under the lex loci delicti provisions of W. Va. Code § 55-8-16(a) (2011). The Court then took note that Michigan law, specifically Mich. Comp. Laws Ann. §§600.2946(5)(a-b), forecloses a failure-to-warn claim if the drug is approved by the FDA and the manufacturer complied with the FDA's labeling requirements, which was the case here. The Court also addressed M.M.'s attempt to rely on the fraud exception to the Michigan statute, but concluded that M.M. had not alleged that the FDA itself had acknowledged perpetration of the fraud as required to meet the statutory fraud exception.
With respect to M.M.'s claims of strict liability and negligence, the Court upheld summary judgment regardless of whether those claims were governed by Michigan or West Virginia law. The factual underpinning for the Court's holding stemmed from the fact that M.M.'s claims of strict liability and negligence centered on Pfizer improperly failing to include contraceptive and/or birth defect warnings on its labeling. The Court held that this was simply a rehash of M.M.'s failure-to-warn argument and, therefore, under Michigan law, those claims would also be governed under 600.2946(5)(a-b).
The Court went on to hold that, even if West Virginia law governed under Mills v. Quality Supplier Trucking, Inc., 203 W. Va. 621, 624, 510 S.E.2d 280, 283 (1998), summary judgment was still proper with respect to strict liability and negligence because M.M. simply rehashed her failure-to-warn theories in support of those claims and, therefore, Michigan law applied under principles of lex loci delicti. With respect to negligence, the Court held that "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, would contradict the full faith and credit due our sister jurisdictions. The Court held that, "[i]n 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. Accordingly, the Court affirmed the Mass Litigation Panel's granting of summary judgment to the defendants.
This decision reiterates and reinforces the lex loci delicti provisions of W. Va. Code § 55-8-16(a) on product liability claims brought by nonresidents against manufacturers or distributors of prescription drugs. This decision seems to comport with a national trend towards restricting the locales and courts in which defective drug claims can be brought by nonresidents, and serves as a guidepost when considering how best to successfully pursue such claims--in West Virginia or perhaps in another, more appropriate jurisdiction.