M.M., a Minor, By and Through Her Mother, etc. v. Pfizer, Inc. , 239 W. Va. 876 ( 2017 )

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).
i
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).
1
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.
3
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
5
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
7
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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