M.M., a Minor, By and Through Her Mother, etc. v. Pfizer, Inc.

IN THE SUPREME COURT OF APPEALS OF WEST VIRGINIA

September 2017 Term

FILED

November 1, 2017

released at 3:00 p.m.

No. 16-0927 EDYTHE NASH GAISER, CLERK

SUPREME COURT OF APPEALS

OF WEST VIRGINIA

M.M.,

A MINOR, BY AND THROUGH HER MOTHER

AND NEXT FRIEND Jeanette M.,

Plaintiff Below, Petitioner

V.

PFIZER, INC.;

ROERIG, A DIVISION OF PFIZER, INC.; AND

GREENSTONE, LLC,

Defendants Below, Respondents

Appeal from the Mass Litigation Panel

Circuit Court of Kanawha County

Honorable James P. Mazzone, Judge

In re Zoloft Litigation

No. 14-C-7000

Civil Action No. 12-C-149

AFFIRMED

Submitted: October 17, 2017

Filed: November 1, 2017

Benjamin L. Bailey Michael J. Farrell

Ryan McCune Donovan Erik W. Legg

J. Zak Ritchie Megan Farrell Woodyard

Bailey & Glasser LLP Farrell, White & Legg PLLC

Charleston, West Virginia Huntington, West Virginia

Bert Ketchum Mark S. Cheffo, pro hac vice

Greene Ketchum Quinn Emanuel Urquhart & Sullivan,

Huntington, West Virginia LLP

Attorneys for the Petitioner New York, New York

Attorneys for the Respondents

JUSTICE DAVIS delivered the Opinion of the Court.

JUSTICE KETCHUM, deeming himself disqualified, did not participate in the decision

of this case.

JUDGE REEDER, sitting by special assignment.

SYLLABUS BY THE COURT

1. “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.” Syllabus point 3, Aetna Casualty & Surety

Co. v. Federal Insurance Co. of New York, 148 W. Va. 160, 133 S.E.2d 770 (1963).

2. “If there is no genuine issue as to any material fact summary judgment

should be granted[.]” Syllabus point 4, in part, Aetna Casualty & Surety Co. v. Federal

Insurance Co. of New York, 148 W. Va. 160, 133 S.E.2d 770 (1963).

3. “In general, this State adheres to the conflicts of law doctrine of lex loci

delicti.” Syllabus point 1, Paul v. National Life, 177 W. Va. 427, 352 S.E.2d 550 (1986).

4. “Product 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.” Syllabus

point 6, Ilosky v. Michelin Tire Corp., 172 W. Va. 435, 307 S.E.2d 603 (1983).

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5. “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.”

Syllabus point 1, Parsley v. General Motors Acceptance Corp., 167 W. Va. 866, 280 S.E.2d

703 (1981).

ii

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.

1

Given that the instant proceeding involves an infant plaintiff, we will refer to

her, and her mother, by their initials rather than by their full names. See State ex rel. J.C. ex

rel. Michelle C. v. Mazzone, 235 W. Va. 151, 153 n.1, 772 S.E.2d 336, 338 n.1 (2015).

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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

2

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 drug has received

FDA approval; no genuine issues of material fact remained in the case; and the Respondents

are entitled to judgment as a matter of law. From this adverse ruling, M.M. now appeals to

this Court.

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.

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Federal Ins. Co. of New York, 148 W. Va. 160, 133 S.E.2d 770 (1963). Accord W. Va. R.

Civ. P. 56(c) (directing that summary judgment is proper when “there is no genuine issue as

to any material fact and . . . the moving party is entitled to a judgment as a matter of law”).

Thus, “[i]f there is no genuine issue as to any material fact summary judgment should be

granted[.]” Syl. pt. 4, in part, Aetna, 148 W. Va. 160, 133 S.E.2d 770. See also Syl. pt. 5,

id. (“The question to be decided on a motion for summary judgment is whether there is a

genuine issue of fact and not how that issue should be determined.”). Mindful of these

standards, we proceed to consider the parties’ arguments.

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

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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 W. Va. Code § 55­

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8-16(a) (2011) (Supp. 2011),2

[i]t is public policy of this state that, in determining the

law applicable to a product liability claim brought by a

nonresident of this state against the manufacturer or distributor

of a prescription drug for failure to warn, the duty to warn shall

be governed solely by the product liability law of the place of

injury (“lex loci delicti”).

(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

2

W. Va. Code § 55-8-16(a) (2011) (Supp. 2011) was amended in 2015, but we

apply the version of the statute that was in effect at the time of the events giving rise to the

case sub judice. See W. Va. Code § 55-8-16(b) (2011) (“This section shall be applicable

prospectively to all civil actions commenced on or after July 1, 2011.”). Cf. W. Va. Code

§ 55-8-16(a) (2015) (Repl. Vol. 2016) (“It is public policy of this state that, in determining

the law applicable to a product liability claim brought by a nonresident of this state against

the manufacturer or distributor of a prescription drug or other product, all liability claims at

issue shall be governed solely by the product liability law of the place of injury (lex loci

delicti).” (emphasis added)).

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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.

Mich. Comp. Laws Ann. §§ 600.2946(5)(a-b) (West 1995) (emphasis added). 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. See Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d

372, 381 (5th Cir. 2012) (holding that “a fraud-on-the-FDA provision . . . is preempted by

the FDCA unless the FDA itself finds fraud”); Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961,

966 (6th Cir. 2004) (concluding that fraud on the FDA exception is not preempted where “the

FDA itself determines that a fraud has been committed on the agency during the regulatory-

approval process” (emphasis in original; citation omitted)). In all other respects, operation

of this exception is preempted by federal law. See generally Buckman Co. v. Plaintiffs’

Legal Comm., 531 U.S. 341, 348, 121 S. Ct. 1012, 1017, 148 L. Ed. 2d 854 (2001)

(“hold[ing] that . . . state-law fraud-on-the-FDA claims conflict with, and are therefore

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impliedly pre-empted by, federal law” (footnote omitted)). Thus, Michigan law forecloses

M.M.’s failure to warn claim.

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 Mich. Comp. Laws Ann.

§§ 600.2946(5)(a-b).

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

8

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

3

See generally W. Va. Code § 56-1-1a(a)(1) (2008) (Repl. Vol. 2012)

(including, within forum non conveniens analysis, consideration of “[w]hether an alternate

forum exists in which the claim or action may be tried”); Syl. pt. 9, Mace v. Mylan Pharms.,

Inc., 227 W. Va. 666, 714 S.E.2d 223 (2011) (“In considering ‘whether an alternate forum

exists in which the claim or action may be tried’ pursuant to West Virginia Code § 56-1­

1a(a)(1) (Supp. 2010), an alternate forum is presumed to ‘exist’ where the defendant is

amenable to process. Such presumption may be defeated, however, if the remedy provided

by the alternative forum is so clearly inadequate or unsatisfactory that it is no remedy at all.

In such cases, the alternate forum ceases to ‘exist’ for purposes of forum non conveniens, and

dismissal in favor of that forum would constitute error.”).

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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 W. Va. Code

§ 55-8-16(a); Mich. Comp. Laws Ann. §§ 600.2946(5)(a-b).

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 W. Va. Code

§ 55-8-16(a); Mich. Comp. Laws Ann. §§ 600.2946(5)(a-b).

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

10

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, liability attaches to a wrongdoer, not because of a breach of a contractual

relationship, but because of a breach of duty which results in an injury to others.”). 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. See Syl. pt. 3, Ilosky, 172 W. Va. 435, 307

S.E.2d 603 (“For the duty to warn to exist, the use of the product must be foreseeable to the

manufacturer or seller.”). 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. See, e.g., Syl. pt. 1,

Johnson v. Huntington Moving & Storage, Inc., 160 W. Va. 796, 239 S.E.2d 128 (1977)

(“Under Section 1, Article IV of the Constitution of the United States, the judgment or decree

of a court of record of another state will be given full faith and credit in the courts of this

State, unless it be clearly shown by pleading and proof that the court of such other state was

without jurisdiction to render the same, or that it was procured through fraud.”); Syl. pt. 2,

International Harvester Co. of America v. Solazo, 116 W. Va. 34, 178 S.E. 429 (1935)

(“Under the full faith and credit clause of the federal constitution, the courts of this state may

not refuse to enforce a judgment of another state because it involves some contravention of

11

the public policy of this state.”).

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 W. Va. Code § 55-8-16(a);

Mich. Comp. Laws Ann. §§ 600.2946(5)(a-b). 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.

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

W. Va. R. Civ. P. 56(c); Syl. pt. 3, Aetna, 148 W. Va. 160, 133 S.E.2d 770.

4

See Syl. pt. 4, Ilosky v. Michelin Tire Corp., 172 W. Va. 435, 307 S.E.2d 603

(1983) (“The determination of whether a defendant’s efforts to warn of a product’s dangers

are adequate is a jury question.”).

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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.

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