M.M., a Minor, BY AND THROUGH Her Mother and Next Friend JEANETTE
No. 16-0927
Supreme Court of Appeals of West Virginia
Submitted: October 17, 2017 Filed: November 1, 2017
806 S.E.2d 800
by holding that venue for this lawsuit is proper in Marion County.
Writ Granted.
See also 235 W.Va. 151, 772 S.E.2d 336 and 233 W.Va. 457, 759 S.E.2d 200.
Benjamin L. Bailey, Ryan McCune Donovan, J. Zak Ritchie, Bailey & Glasser LLP, Charleston, West Virginia, Bert Ketchum, Greene Ketchum, Huntington, West Virginia, Attorneys for the Petitioner
Michael J. Farrell, Erik W. Legg, Megan Farrell Woodyard, Farrell, White & Legg PLLC, Huntington, West Virginia, Mark S. Cheffo, pro hac vice, Quinn Emanuel Urquhart & Sullivan, LLP, New York, New York, Attorneys for the
Davis, Justice:
The petitioner herein and plaintiff below, M.M.1 (“M.M.” or “the Petitioner“), a minor, by and through her mother and next friend Jeanette M., appeals from an order entered August 30, 2016, by the Mass Litigation Panel (“the Panel“). By its order, the Panel granted summary judgment to the respondents herein and defendants below, Pfizer, Inc.; Roerig, a division of Pfizer, Inc.; and Greenstone, LLC (collectively “Pfizer” or “the Respondents“) 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. Accordingly, we affirm the August 30, 2016, order of the Mass Litigation Panel.
I. FACTUAL AND PROCEDURAL HISTORY
M.M., an infant, by her mother, is one of nineteen minor plaintiffs who have alleged that they sustained birth defects as a result of their mothers’ use of the prescription medication Zoloft. In the case sub judice, M.M. alleges that she sustained in utero injuries and resultant birth defects when her mother ingested sertraline hydrochloride while she was pregnant with M.M. Respondent Pfizer manufactures and markets sertraline hydrochloride as the antidepressant drug, Zoloft; Respondent Roerig is a former division of Pfizer, while Respondent Greenstone is a wholly owned subsidiary of Pfizer that sells an authorized generic version of this medication. More specifically, M.M., who, through her mother, filed her complaint in the Circuit Court of Wayne County in 2012, contends that the 2009 labeling information for 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.
Since the action‘s filing, the Respondents repeatedly, but unsuccessfully, have attempted to remove the subject litigation to federal court; the case has been referred to the Mass Litigation Panel; and this Court has decided several procedural issues in the ongoing litigation. See State ex rel. J.C. ex rel. Michelle C. v. Mazzone, 235 W. Va. 151, 772 S.E.2d 336 (2015) (forum non conveniens); State ex rel. J.C. v. Mazzone, 233 W. Va. 457, 759 S.E.2d 200 (2014) (assigning matter consolidated case number instead of individual case numbers). In 2015, M.M. filed an amended complaint asserting specific claims for strict liability, failure to warn, and negligence. Thereafter, the Respondents filed a motion for summary judgment, which the Panel granted by order entered August 30, 2016. In short, the Panel concluded that Michigan law governs M.M.‘s claims; federal law operates to preempt the exception to Michigan‘s failure to warn immunity where the subject
II. STANDARD OF REVIEW
The case sub judice comes to this Court on appeal from the Panel‘s order granting summary judgment to the Respondents. We previously have held that this Court will apply a plenary review to a summary judgment ruling. See Syl. pt. 1, Painter v. Peavy, 192 W. Va. 189, 451 S.E.2d 755 (1994) (“A circuit court‘s entry of summary judgment is reviewed de novo.“). In determining whether a moving party is entitled to summary judgment, we have held that “[a] motion for summary judgment should be granted only when it is clear that there is no genuine issue of fact to be tried and inquiry concerning the facts is not desirable to clarify the application of the law.” Syl. pt. 3, Aetna Cas. & Sur. Co. v. Federal Ins. Co. of New York, 148 W. Va. 160, 133 S.E.2d 770 (1963). Accord
III. DISCUSSION
On appeal to this Court, M.M. assigns error to the circuit court‘s ruling and contends that genuine issues of material fact preclude summary judgment; West Virginia, not Michigan, law applies to M.M.‘s claims; and, even if Michigan law applies, such law is not preempted by federal law. More specifically, M.M. argues that the Panel erred by granting summary judgment to Pfizer because there remain genuine issues of material fact so as to preclude summary judgment because, counsel 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. Based on these facts, M.M. contends that a jury should be allowed to determine whether Pfizer was negligent or strictly liable for its failure to adequately warn of the possibility of birth defects linked to Zoloft usage by women of childbearing age.
Pfizer responds that the Panel correctly determined that, while worded as three separate and distinct claims for relief, i.e., strict liability, failure to warn, and negligence, M.M.‘s claims essentially all seek to impose liability for the same alleged shortcoming of Pfizer: failure to warn. Moreover, Pfizer argues that, under either Michigan or West Virginia law, M.M. cannot prevail because Michigan statutory law expressly forecloses a failure to warn claim where the medication in question has been approved by the FDA and the exception thereto is preempted by federal law. Furthermore, even if West Virginia law governs M.M.‘s claims, the infant still is not entitled to relief insofar as there is no alleged duty with which Pfizer has failed to comply (negligence claim) and failure to warn is the only theory of strict liability advanced by M.M., which is foreclosed by Michigan statutory law. Accordingly, Pfizer contends that the Panel‘s order granting summary judgment in its favor should be affirmed.
In the infant‘s amended complaint, M.M. has asserted three causes of action against Pfizer: strict liability, failure to warn, and negligence. Pursuant to
(Emphasis added). Here, there is no dispute that the injuries alleged by M.M. and the infant‘s mother all occurred in the State of Michigan. Thus, M.M.‘s failure to warn claim is governed by Michigan law, which forecloses such a claim if the drug was approved by the FDA and the manufacturer complied with the FDA‘s labeling requirements:
(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration‘s approval at the time the drug left the control of the manufacturer or seller. However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval. This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:
(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301 to 321, 331 to 343-2, 344 to 346a, 347, 348 to 353, 355 to 360, 360b to 376, and 378 to 395, and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.
(b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.
M.M.‘s remaining claims also are thwarted, whether they are governed by Michigan law or West Virginia law. Ordinarily, M.M.‘s strict liability and negligence claims would be governed by Michigan law insofar as the alleged injuries occurred in Michigan. That is so because, “[i]n general, this State adheres to the conflicts of law doctrine of lex loci delicti.” Syl. pt. 1, Paul v. National Life, 177 W. Va. 427, 352 S.E.2d 550 (1986). Accord McKinney v. Fairchild Int‘l, Inc., 199 W. Va. 718, 727, 487 S.E.2d 913, 922 (1997) (“Traditionally, West Virginia courts apply the lex loci delicti choice-of-law rule; that is, the substantive rights between the parties are determined by the law of the place of injury.” (citations omitted)). 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. Such a claim is foreclosed by
However, assuming arguendo 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,3 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. See Mills v. Quality Supplier Trucking, Inc., 203 W. Va. 621, 624, 510 S.E.2d 280, 283 (1998) (“We ... adhere to the rule that the doctrine of lex loci delicti will not be invoked where ‘the application of the substantive law of a foreign state ... contravenes the public policy of this State.‘” (quoting Paul, 177 W. Va. at 433, 352 S.E.2d at 556)).
This Court previously has held that, in West Virginia,
[p]roduct liability actions may be premised on three independent theories—strict liability, negligence, and warranty. Each theory contains different elements which plaintiffs must prove in order to recover. No rational reason exists to require plaintiffs in product liability actions to elect which theory to submit to the jury after the evidence has been presented when they may elect to bring suit on one or all of the theories.
Syl. pt. 6, Ilosky v. Michelin Tire Corp., 172 W. Va. 435, 307 S.E.2d 603 (1983). In the case sub judice, M.M. alleges all three of these theories of product liability: strict liability, negligence, and failure to warn. As noted above, M.M.‘s failure to warn claim is governed by the law of the place of injury, i.e., Michigan, and is foreclosed thereby. See
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.” Morningstar v. Black & Decker Mfg. Co., 162 W. Va. 857, 888, 253 S.E.2d 666, 682 (1979). 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, as noted above, is governed, and foreclosed, by Michigan law. See
Finally, with respect to M.M.‘s negligence claim, we have held that there first must exist a duty, and a breach of that duty, to hold a defendant liable for negligence. “In order to establish a prima facie case of negligence in West Virginia, it must be shown that the defendant has been guilty of some act or omission in violation of a duty owed to the plaintiff. No action for negligence will lie without a duty broken.” Syl. pt. 1, Parsley v. General Motors Acceptance Corp., 167 W. Va. 866, 280 S.E.2d 703 (1981). See also Syl. pt. 2, Sewell v. Gregory, 179 W. Va. 585, 371 S.E.2d 82 (1988) (“In the matters of negligence,
Thus, while M.M. may have established a question of fact sufficient to overcome summary judgment as to the asserted claim of negligence,4 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. See
Accordingly, the August 30, 2016, order of the Mass Litigation Panel granting Pfizer‘s motion for summary judgment as to M.M.‘s claims of strict liability, failure to warn, and negligence is affirmed because no genuine issues of material fact require resolution and Pfizer, and the remaining Respondents, are entitled to judgment as a matter of law. See
IV. CONCLUSION
For the foregoing reasons, the Mass Litigation Panel‘s August 30, 2016, order granting summary judgment to Pfizer and the remaining Respondents is hereby affirmed.
Affirmed.