M.M., a Minor, By and Through Her Mother, etc. v. Pfizer, Inc., 806 S.E.2d 800

M.M., a minor, sued Pfizer (including Roerig and Greenstone) alleging in utero injuries from her mother’s use of Zoloft (sertraline) and that 2009 labeling failed to warn of birth-defect risks or advise contraceptive use.
Case filed in Wayne County, WV (2012); consolidated before the Mass Litigation Panel after multiple removal attempts and interlocutory rulings.
M.M. amended her complaint to assert strict liability, failure to warn, and negligence claims; Pfizer moved for summary judgment.
The Panel held Michigan law (place of injury) governs failure-to-warn claims under WV’s lex loci delicti statute and concluded Michigan statutory immunity for FDA‑approved drugs (with limited fraud-on‑FDA exception) precluded M.M.’s failure-to-warn theory.
The Panel ruled remaining strict‑liability and negligence theories were effectively failure‑to‑warn claims and thus also foreclosed; it granted summary judgment to Pfizer. WV Supreme Court affirmed.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Choice of law: which state’s product‑liability law applies	West Virginia law should apply	Lex loci delicti (place of injury—Michigan) governs under WV statute	Michigan law governs failure‑to‑warn claims (WV Code §55‑8‑16(a))
Preemption / Michigan statutory immunity for FDA‑approved drugs	Fraud‑on‑FDA exception applies because Pfizer withheld info and used different warnings in Europe	Michigan law immunizes FDA‑approved drug labeling; fraud-on‑FDA exception requires FDA finding; federal law preempts state claims beyond that	Michigan statute bars failure‑to‑warn claims for FDA‑approved drugs; fraud‑on‑FDA exception not satisfied; federal preemption applies
Adequacy of warnings / strict liability claim	Warnings were inadequate (including absence of contraceptive/birth‑defect warnings); issue for jury	Plaintiff’s strict‑liability theory is merely a failure‑to‑warn claim and is foreclosed by Michigan law	Strict‑liability theory based on inadequate warnings is precluded by Michigan law and fails
Negligence / duty to warn	Pfizer breached duty by failing to warn; factual disputes preclude summary judgment	Any alleged duty is the same failure‑to‑warn claim preempted by Michigan law; thus no actionable duty remains	Negligence claim fails because the underlying duty (adequate warnings) is precluded by applicable law; summary judgment proper

Aetna Cas. & Sur. Co. v. Fed. Ins. Co. of N.Y., 148 W. Va. 160, 133 S.E.2d 770 (W. Va. 1963) (standards for summary judgment)
Paul v. Nat’l Life, 177 W. Va. 427, 352 S.E.2d 550 (W. Va. 1986) (lex loci delicti choice‑of‑law rule)
Ilosky v. Michelin Tire Corp., 172 W. Va. 435, 307 S.E.2d 603 (W. Va. 1983) (product‑liability theories and duty to warn jury question)
Parsley v. Gen. Motors Acceptance Corp., 167 W. Va. 866, 280 S.E.2d 703 (W. Va. 1981) (negligence requires a duty)
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state law fraud‑on‑FDA claims impliedly preempted)
Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) (fraud‑on‑FDA exception requires FDA acknowledgement)
Garcia v. Wyeth‑Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) (fraud‑on‑FDA exception valid only when FDA finds fraud)
Morningstar v. Black & Decker Mfg. Co., 162 W. Va. 857, 253 S.E.2d 666 (W. Va. 1979) (categories of product defects)
Johnson v. Huntington Moving & Storage, 160 W. Va. 796, 239 S.E.2d 128 (W. Va. 1977) (full faith and credit principles)
Painter v. Peavy, 192 W. Va. 189, 451 S.E.2d 755 (W. Va. 1994) (de novo review of summary judgment)