Order Regarding Defendants' Motion For Summary Judgment

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IN THE CIRCUIT COURT OF KANAWHA COUNTY, WEST VIRGINIA
IN RE: ZOLOFT LITIGATION CIVIL ACTION NO. 14-C-7000
THIS DOCUMENT APPLIES TO:
M.M., a minor by and through her mother and next
friend Jeanette Maskill v. Pfizer, Inc., et al. Civil Action No. 12-C-149 WNE
ORDER
On August 8, 2016, the Panel heard arguments on Defendants’ Motion for Summary
Judgment. Having reviewed and maturely considered the briefs and evidence submitted by the
parties, and the arguments presented by counsel, and having conferred with one another to insure
uniformity of their decision, as contemplated by Rule 26.07(a) of the West Virginia Trial Court
Rules, the Presiding Judges unanimously GRANT Defendants’ motion for summary judgment
for the reasons set forth below.
FINDINGS OF FACT
1. On July 11, 2012, Plaintiff Jeanette Maskill and M.M. (the “Minor Plaintiff”)
filed this civil action in the Circuit Court of Wayne County, West Virginia, arising out of injuries
allegedly caused by the prescription medication sertraline hydrochloride, trade name Zoloft®.1
Plaintiffs alleged that they are citizens of Michigan. (Compl. ¶ 10 (Transaction ID 54957463);
Am. Compl. ¶ 9 (Trans. ID 57945570).)
2. Plaintiffs further alleged that the Minor Plaintiff sustained birth defects as a result
of the Mother Plaintiff’s ingestion of sertraline during pregnancy. (Compl. ¶¶ 64-65; Am.
Compl. ¶ 9.)
3. Plaintiffs asserted a number of products liability and derivative claims arising out
of this allegation. Plaintiffs do not allege that the Zoloft or sertraline the Mother Plaintiff
ingested was adulterated or that the labeling with which it was sold was not in compliance with
the FDA-approved labeling for the product. (Compl. ¶¶ 116-178.)
1 As used herein, “Zoloft” includes its generic form, sertraline.
EFiled: Aug 30 2016 11:23AM EDT
Transaction ID 59488864
2
4. On September 20, 2013, the Maskill Plaintiffs provided interrogatory responses
confirming they are residents of Michigan; the Mother Plaintiff was prescribed Zoloft or
sertraline by a physician in Michigan and ingested Zoloft in Michigan; and the Minor Plaintiff
was born in Michigan and received treatment for her alleged injuries in Michigan. The Maskill
Plaintiffs’ discovery responses do not identify any witnesses who are located in, or any events
that took place in, any other state. (Def. Ex. 1.)
5. On July 9, 2014, Defendants moved to dismiss this action and twenty others
brought by non-resident plaintiffs on the grounds of forum non conveniens. (Trans. ID
55708149.)
6. Defendants also moved to dismiss this action under Michigan law. (Trans. ID
55706714.)
7. On October 21, 2014, the Panel denied the motion to dismiss under Michigan law
as premature (Transaction ID 56225190), and granted in part and denied in part Defendants’
motion to dismiss on forum non conveniens grounds (Transaction ID 56224960).
8. Among other things, the Panel determined that it is required by W.Va. Code § 558-16(a)(2011) to apply the law of the place of injury to the Maskill Plaintiff Family’s failure to
warn claims. See (Transaction ID 56224960), paragraph 57 (“the Panel is required by statute to
apply the law of the location of injury to each of the subject Plaintiff Families’ failure to warn
claims”); paragraph 60 (Maskill Plaintiff Family’s public policy argument is rendered academic
insofar as it applies to failure to warn claims by § 55-8-16(a)); and paragraph 62 (because
Maskill Plaintiff Family filed complaint after effective date of § 55-8-16 the Panel is bound to
apply the law of the state of injury to failure to warn claims).
9. Pursuant to the Court’s Second Case Management Order (Transaction ID
57813632), Plaintiffs filed an Amended Complaint on September 30, 2015. The Amended
Complaint contains the same core factual allegations as the original complaint, but omits certain
causes of action, among other changes. Plaintiffs now plead three causes of action: (1) strict
3
liability; (2) failure to warn; and (3) negligence. They also seek punitive damages. (Am. Compl.
¶¶ 95-132.)
10. The following facts are undisputed: (1) Zoloft was approved for safety and
efficacy by the United States Food and Drug Administration (“FDA”); (2) Plaintiffs do not allege
that the Zoloft Mrs. Maskill took was adulterated or that its labeling was not in compliance with
the FDA-approved labeling for the product; and (3) the FDA has not ordered Zoloft removed
from the market and it has not withdrawn approval for Zoloft.
11. Plaintiffs have not alleged with specificity any misrepresentations made to the
FDA. Nor do they plead that any such representations were intentionally false or concerned
information that was required to be submitted to the FDA. Plaintiffs have also made no
allegation that, if proven, would establish that any such alleged, but unidentified,
misrepresentations to the FDA would have caused the FDA to not approve Zoloft or to withdraw
its approval for Zoloft. Nor do Plaintiffs allege that the FDA has ever made a determination of
fraud regarding Zoloft or sertraline.
12. The FDA has promulgated regulations governing the content and form of
information to be submitted to it, both pre- and post-marketing. See, e.g., 21 C.F.R. 314.50
(governing the content and form of a new drug application); 21 C.F.R. 314.70 (governing
supplements and changes to an application); 21 C.F.R. § 314.80 (governing postmarketing
reporting of adverse drug experiences); 21 C.F.R. § 314.81 (governing other postmarketing
reports). Plaintiffs have not shown that the data and information described in their exhibits were
required to be submitted to the FDA or that required information (rather than specific
documents) was withheld from the FDA.
13. Plaintiffs cite to various animal studies and toxicology reports prepared by Pfizer,
providing their own interpretations of those complex, scientific documents, without expert
testimony to support their interpretations. (Plaintiffs’ Amended Response to Defendants’
Memorandum of Law in Support of Their Motion for Summary Judgment (“Am. Resp.”) (Trans.
ID 58950879) at 2, 13.) This is mere speculation and allegation by the Plaintiffs. More
4
importantly, Plaintiffs have not shown that the results of animal studies conducted by Pfizer were
not reported to the FDA in accordance with its regulations. The record shows that the FDAapproved Zoloft label summarizes the animal studies, describes the adverse effects seen in those
studies, states that there was no evidence of teratogenicity, and ends with the statement: “The
clinical significance of these effects is unknown. There are no adequate and well-controlled
studies in pregnant women. ZOLOFT (sertraline hydrochloride) should be used during
pregnancy only if the potential benefit justifies the risk to the fetus.” (Pl. Ex. A at 25.)
14. Plaintiffs also refer to evaluations of adverse event reports, again offering their
own speculative, non-expert interpretation of such documents. (Am. Resp. at 2-3.) However,
the FDA has specific requirements and forms governing the reporting of such information to it.
See 21 C.F.R. § 314.80. Plaintiffs have not shown that Pfizer failed to submit any required
adverse event report to the FDA.
15. Plaintiffs further cite to a statement in Pfizer’s Core Data Sheet and foreign labels
that “[w]omen of childbearing potential should employ an adequate method of contraception if
taking sertraline,” again offering their own interpretation of the referenced documents. (Am.
Resp. at 3-4, 8-9. 13-14.). However, Plaintiffs have not shown that any required information
(rather than a specific document) was withheld from the FDA. To the contrary, Pfizer has
submitted unrebutted evidence that the FDA requested copies of foreign labels during the
approval process for Zoloft. In response, Pfizer provided the FDA with copies of foreign labels
for the United Kingdom and Ireland, as well as the International Product Document (“IPD”)
which was used as the basis for labels in other countries. (Def. Ex. 15.) Each of these
documents contained the contraception language cited by Plaintiffs. (Id.) Thus, it appears the
FDA was aware of the contraception language when it approved Zoloft.
16. Litigation against Pfizer involving allegations that Zoloft causes birth defects has
been pending in various jurisdictions since 2011, and there has been a fair amount of publicity
about the litigation. There have been two trials (each resulting in a defense verdict). (Def.
Exs. 5 & 6.) Shortly before trial in a third case began, a Pennsylvania state court excluded the
5
Plaintiffs’ experts and entered summary judgment in favor of Pfizer. (Def. Exs. 7 & 8.) In the
federal multidistrict litigation (“MDL”), there have been two Daubert hearings, each resulting in
the exclusion of plaintiffs’ proffered expert testimony on human causation.2 As a result of those
rulings, the MDL court granted Pfizer’s motion for summary judgment as to all cases then
pending in the MDL, dismissing the claims of more than 300 plaintiff-families.3 Significantly,
the plaintiffs in the federal MDL sent their most recent general causation expert report to the
FDA. (Def. Ex. 9.) Yet, despite years of public airing of plaintiffs’ allegations against Pfizer in
the courts and media, Zoloft remains on the market and continues to be widely prescribed. The
FDA has not withdrawn approval for Zoloft or removed Zoloft from the market.
17. In September 2014, the Organization of Teratology Information Specialists
(OTIS), responding to the question “Can taking [Zoloft] during my pregnancy cause birth
defects?” explained that “[Zoloft] is one of the better studied antidepressants during pregnancy.
There are reports of over 2000 pregnancies exposed to [Zoloft] during the first trimester.” The
organization further explained to mothers wondering whether Zoloft is safe during pregnancy
that, while “[s]ome studies have found associations between [Zoloft] use during pregnancy and
particular birth defects[,] . . . most studies have not found that women taking [Zoloft] during
pregnancy are more likely to have a baby with a birth defect than women not taking [Zoloft].
Overall, the available information does not suggest that [Zoloft] increases the risk for birth
defects above the 3-5% background risk that is seen in the general population.” (Def. Ex. 3,
emphasis added.)
18. More recently, the Centers for Disease Control (“CDC”) summarized the findings
of a study conducted by CDC investigators published in the British Medical Journal (“BMJ”):
2 See In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 26 F. Supp. 3d 449, 465 (E.D. Pa. 2014),
reconsid. denied, 2015 WL 314149 (E.D. Pa. Jan. 23, 2015); In re Zoloft (Sertraline Hydrochloride)
Prods. Liab. Litig., 26 F. Supp. 3d 466, 481 (E.D. Pa. 2014); In re: Zoloft (Sertraline Hydrochloride)
Prods. Liab. Litig., 2015 WL 7776911, at *16 (E.D. Pa. Dec. 2, 2015).
3 See In re: Zoloft (Sertraline Hydrochloride) Products Liab. Litig., 2016 WL 1320799, at *11 (E.D. Pa.
Apr. 5, 2016).
6
In this CDC study published in The BMJ, researchers re-assessed several
previously reported links between SSRI use and birth defects using more recent
data. These results reflect not only the new data, but also incorporate results from
previously published independent studies. . . .
* * *
Reassuringly, researchers did not confirm links between [Zoloft], the SSRI used
most often, and any of the birth defects observed in previous studies.
(Def. Ex. 4; See also Def. Ex. 13.)
CONCLUSIONS OF LAW
I. Legal Standard
19. Summary judgment is appropriate if “there is no genuine issue as to any material
fact and that the moving party is entitled to a judgment as a matter of law.” W. Va. R. Civ. P.
56(c); accord Fleet v. Webber Springs Owners Ass’n, 235 W. Va. 184, 188, 772 S.E.2d 369, 373
(2015)(“[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
application of the law”)(internal citation omitted). “A material fact is one that has the capacity to
sway the outcome of the litigation under the applicable law.” Syl. Pt. 5, Jividen v. Law, 194
W. Va. 705, 461 S.E.2d 451 (1995).
20. “If the moving party makes a properly supported motion for summary judgment
and can show by affirmative evidence that there is no genuine issue of material fact, the burden
of production shifts to the nonmoving party who must either (1) rehabilitate the evidence
attacked by the moving party, (2) produce additional evidence showing the existence of a
genuine issue for trial, or (3) submit an affidavit explaining why further discovery is necessary as
provided in Rule 56(f) of the West Virginia Rules of Civil Procedure.” Syl. Pt. 3, Williams v.
Precision Coil, Inc., 194 W. Va. 52, 459 S.E.2d 329 (1995).
21. “[T]he party opposing summary judgment must satisfy the burden of proof by
offering more than a mere ‘scintilla of evidence,’ and must produce evidence sufficient for a
reasonable jury to find in a nonmoving party’s favor.” Painter v. Peavy, 192 W. Va. 189,
192-93, 451 S.E.2d 755, 758-759 (1994).
7
22. “Summary judgment is appropriate where the record taken as a whole could not
lead a rational trier of fact to find for the nonmoving party, such as where the nonmoving party
has failed to make a sufficient showing on an essential element of the case that it has the burden
to prove.” Id. at 193, 759 (citations omitted). The nonmoving party may not rely on speculation
and unsupported allegations to oppose summary judgment, but must offer “‘significant probative
evidence tending to support the complaint.’” Id. (citations omitted).
II. Choice of Law
23. Defendants argue that the Maskill Plaintiffs’ claims are barred by Michigan law.
As an initial matter, this Panel must determine whether Michigan law applies to the Maskill
Plaintiffs’ claims.
24. The version of West Virginia Code section 55-8-16(a) in effect when this lawsuit
was filed provided that:
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 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”).
W. Va. Code § 55-8-16(a) (2011).4
25. Plaintiffs argue that the Panel should decline to apply Michigan law as a matter of
public policy and, in doing so, misconstrue the Panel’s prior ruling. Because the applicable
version of W. Va. Code § 55-8-16(a) applied only to failure to warn claims, the Panel determined
that it was not precluded from applying West Virginia public policy considerations to Plaintiffs’
other claims when deciding Defendants’ motion to dismiss on grounds of forum non conveniens.
4 The statute was revised in 2015 to state, “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 delecti’).” W. Va. Code § 55-8-16(a)
(2015)(emphasis added). The amendments to the statute apply “prospectively to all civil actions
commenced on or after July 1, 2015.” Id. at § 55-8-16(b). Because the Maskill civil action was
commenced in 2012, the 2011 version of the statute applies. See § 55-8-16(b) (2011).
8
(Court’s Order entered October 21, 2014, Transaction ID 56224960 ¶ 63).5 However, while the
Panel left open the possibility of applying law other than Michigan to Plaintiffs’ non-failurewarn claim, the Panel’s decision was clear that Michigan law applied to Plaintiffs’ failure to
warn claims.
26. “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.” Syl. Pt. 6, Ilosky v. Michelin Tire Corp., 172 W.Va. 435, 307 S.E.2d
603 (1983). Additionally, in strict liability actions, a defective product may fall into three
categories: (1) design defect; (2) structural or manufacturing defect; and (3) use defect arising
out of inadequate warnings. Morningstar v. Black and Decker Mfg. Co., 162 W. Va. 857, 88889, 253 S.E.2d 666, 682 (1979).
27. As ordered by the Panel, Plaintiffs’ filed an amended complaint on September 30,
2015. Their amended complaint alleges three causes of action: (1) strict liability; (2) failure to
warn; and (3) negligence (Am. Compl. ¶¶ 95-132). However, no matter how Plaintiffs label their
causes of action or characterize the evidence, the only claim they are asserting is strict liability
based on failure to warn.
28. Plaintiffs’ argument that their strict liability and negligence claims survive under
West Virginia law makes it clear that their only claim is failure to warn. (Am. Resp. at 7-8) (“In
a use defectiveness, or failure to warn, case, ‘the focus is not so much on a flawed physical
condition of the product, as on its unsafeness arising out of the failure to adequately label,
instruct or warn.’”)(internal citations omitted); Id. (“A strict liability claim brought on failure to
warn theory ‘covers situation when a product may be safe as designed and manufactured, but
which becomes defective because of the failure to warn of dangers which may be present when
the product is used in a particular manner.’” )(internal citations omitted); Id. at 8 (“Here,
5 Defendants argue that the only state other than Michigan whose law could constitutionally be applied to
Plaintiffs’ non-failure-to-warn claims is New York, citing Phillips Petroleum Co. v. Shutts, 472 U.S. 797,
822 (1985)). Because Plaintiffs have made clear that they are not pursuing claims other than failure to
warn, the Panel need not resolve this issue.
9
Plaintiffs base their strict liability and negligence claims on the theory that Defendants failed to
warn the medical community and public about the risks of taking Zoloft during pregnancy
despite knowing that such risks existed.”)(emphasis added); Id. (“if the Panel determines that
Plaintiffs must demonstrate that a feasible alternative design was available, notwithstanding that
West Virginia (and New York) common law only require such a showing where the Plaintiff has
claimed that a design defect existed in the product at issue, Plaintiffs contend that the feasible
alternative design was to provide adequate labeling information that warned of the risks of the
use of Zoloft in pregnant women or women of childbearing age.”)(emphasis added)
29. During oral argument, Plaintiffs’ counsel argued that Plaintiffs had made a case
for defective design. However, his argument was premised entirely on failure to warn:
And under West Virginia law - whether you call it a failure
to warn case or a defective design case - it’s really looking at the
same thing: What -- what are we talking about, right? And on a
defective design case, where you have a product with an
inadequate label, then you have a -- you’ve made a case for
defective design.
If you have a pipe that is only rated for a certain pressure
but that pipe doesn’t have information about what it’s rated for, the
design is defective.
I know, Judge Swope, you’ve handled, you know, auto
product liability cases. If you have a tire, it doesn’t tell you how
much to inflate the tire, so that it’s either underinflated or
overinflated, that tire -- that tire is defective. Same here.
The drug is not just the molecule. The drug is in the
packaging that it goes in, including the warning label. And in this
case, the warning is inadequate. The warning in this case - and as
evidenced and you guys have seen it in the briefing - did not
contain essential information about the use of the product for
women of childbearing potential.
(August 8, 2016 Tr. at 37:1-38:1.)
30. Plaintiffs’ counsel has also argued that W. Va. Code § 55-8-16(a) says only that in
a failure to warn case, the duty will be governed by the place of injury. Id. at 35:22-36:2.
However, the Michigan statute at issue does not merely provide an affirmative defense to
manufacturers of prescription drugs. It states affirmatively that a drug approved by the FDA is
10
not defective, absent one of the exceptions. In other words, under Michigan law, a manufacturer
meets its duty to provide an adequate warning when it sells a drug accompanied by a label that
has been approved by the FDA. See Taylor v. SmithKline Beecham Corp., 658 N.W.2d 127, 131
(Mich. 2003).
31. The Maskill Plaintiffs are nonresidents and the place of their alleged injury is
Michigan, because that is where the Mother Plaintiff was prescribed Zoloft, ingested Zoloft, and
resided during her pregnancy. It is also where the Minor Plaintiff was born and treated for her
injuries. Because the gravamen of Plaintiffs’ claims is for is failure to warn, as the Panel has
previously determined, Michigan law applies pursuant to W. Va. Code § 55-8-16(a).
32. The Panel, therefore, finds that Michigan law governs Plaintiffs’ claims in this
action.
III. Summary Judgment
A. The Michigan Statute
33. The Michigan statute applicable to Plaintiffs’ claims provides, in relevant part:
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.
Mich. Comp. Laws § 600.2946(5). Michigan’s highest court has expressly confirmed that in
adopting this statute, “the [Michigan] Legislature . . . determined that a drug manufacturer or
seller that has properly obtained FDA approval of a drug product has acted sufficiently prudently
so that no tort liability may lie.” Taylor, 658 N.W.2d at 131 (emphasis added).
34. This action is “a product liability action against a manufacturer or seller.” Mich.
Comp. Laws § 600.2946(5). The Michigan statute defines a “[p]roduct liability action” broadly
to include “an action based on a legal or equitable theory of liability brought for the death of a
person or for injury to a person or damage to property caused by or resulting from the production
of a product.” Id. § 600.2945(h).
11
35. The elements of the Michigan statutory bar are satisfied because Zoloft was
“approved for safety and efficacy by the [FDA]” and “its labeling [was] in compliance with the
[FDA’s] approval at the time the drug left the control of [Pfizer].” Mich. Comp. Laws.
§ 600.2946(5).
36. Accordingly, in the absence of an exception to manufacturer’s immunity
(discussed below), the Michigan statute requires dismissal of the Maskill Plaintiffs’ claims. See
White v. SmithKline Beecham Corp., 538 F. Supp. 2d 1023, 1031 (W.D. Mich. 2008) (granting
judgment on the pleadings where “Plaintiffs have not alleged any fact which would invoke either
of the two exceptions contained within the statute”); Henderson v. Merck & Co., Inc., 2005 WL
2600220, at *11-12 (E.D. Pa. Oct. 11, 2005) (granting judgment on the pleadings under the
Michigan statute, and noting “because plaintiff’s complaint is devoid of allegations to trigger
these exceptions, discovery on this issue would be futile”), reconsid. denied, 2005 WL 2864752
(E.D. Pa. Oct. 31, 2005); See also Thurston v. Merck & Co., 415 F. App’x 585, 586 (5th Cir.
2011) (dismissal as a matter of law was warranted where plaintiff failed to “plead facts sufficient
to meet any of the exceptions” to the Texas statute).
B. Plaintiffs Have Failed to Meet Their Burden to Create a Triable Issue of
Material Fact as to the Fraud-on-the-FDA Exception to the Michigan Statute
37. The Michigan statute allows a product liability action against a manufacturer of
an FDA-approved medicine to proceed if the manufacturer:
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 . . . 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.
Mich. Comp. Laws § 600.2946(5)(a).6 Plaintiffs assert that this exception, also known as the
“fraud-on-the-FDA exception,” applies to their case.
6 The Michigan statute contains other exceptions, but Plaintiffs have not argued that they apply in this
case.
12
38. To successfully plead the fraud-on-the-FDA exception to the Michigan statute,
the Maskill Plaintiffs must establish that: (1) the manufacturer intentionally withheld from or
misrepresented to the FDA information concerning the drug; (2) the information was required to
be submitted under the federal Food, Drug and Cosmetic Act (“FDCA”); and (3) the drug would
not have been approved, or the FDA would have withdrawn approval for the drug if the
information were accurately submitted. Mich. Comp. Laws § 600.2646(5)(a).
39. Once Defendants met their burden to show that the Michigan statute applied and
barred Plaintiffs’ claims, the burden shifted to Plaintiffs to show that one of the exceptions
applied. Cf. Powderidge Unit Owners, 196 W. Va. 692, 699, 474 S.E.2d 872, 879 (1996) (once
defendant showed statute of limitations applied, plaintiff had burden of proving it was within the
discovery exception).
40. The nonmoving party cannot satisfy his or her burden with evidence that is
“conjectural or problematic. It must have substance in the sense that it limns differing versions
of the truth which a factfinder must resolve. The evidence must contradict the showing of the
moving party by pointing to specific facts demonstrating that, indeed, there is a ‘trialworthy’
issue.” Williams, 194 W. Va. at 60, 459 S.E.2d at 337. “A ‘trialworthy’ issue requires not only a
‘genuine’ issue but also an issue that involves a ‘material’ fact.” Id. (citations and footnotes
omitted); See also Powderidge Unit Owners, 196 W. Va. at 698, 474 S.E.2d at 878
(“Genuineness and materiality are not infinitely elastic euphemisms that may be stretched to fit
whatever preferrations catch a litigant’s fancy.”); Celotex Corp. v. Catrett, 477 U.S. 317, 317
(1986) (“[A] complete failure of proof concerning an essential element of the nonmoving party’s
case necessarily renders all other facts immaterial.”).
41. Here, Plaintiffs cite to vague allegations that Defendants represented to the FDA
that Zoloft was safe and effective and concealed knowledge that Zoloft can cause birth defects to
persons exposed in utero to support their argument that the fraud-on-the-FDA exception applies.
(Am. Resp. at 14-15.) However, the nonmoving party cannot satisfy his burden with vague
allegations, but most offer “concrete evidence” that would support a verdict in his favor.
13
Painter, 192 W. Va. at 193, 451 S.E.2d at 759. Mere allegations are insufficient to sustain the
non-moving party’s burden. Sergent v. City of Charleston, 209 W. Va. 437, 445, 549 S.E.2d
311, 319 (2001).
42. Plaintiffs also cannot meet their burden with evidence that, while disputed, is
immaterial to the issue at hand. For example, in Williams, the plaintiff argued that an employee
handbook constituted a contract of employment. Whether it did or not, the plaintiff failed to
show that he knew about the handbook and relied upon it. As a result, “the plaintiff failed to put
into dispute an essential element of his cause of action.” 194 W. Va. at 65-66, 459 S.E.2d at
342-43. Likewise, in Gibson v. Little Gen. Stores, Inc., 221 W. Va. 360, 655 S.E.2d 106 (2007),
the West Virginia Supreme Court affirmed summary judgment where the plaintiff failed to
produce competent evidence of product malfunction. Id. at 364, 655 S.E.2d at 110.
43. Plaintiffs’ approach to summary judgment is comparable to the approach rejected
by the West Virginia Supreme Court in Miller v. City Hosp., Inc., 197 W. Va. 403, 475 S.E.2d
495 (1996) (per curiam). In Miller, the Supreme Court affirmed summary judgment in favor of
an employer, when the plaintiff failed to produce sufficient evidence to create a material issue of
fact on the “deliberate intention” exception to employer immunity under West Virginia’s worker
compensation laws. See Id. at 405, 475 S.E.2d at 497. The Court noted that while an issue of
fact existed for some of the elements of the exception, the plaintiff failed to show that the
defendant violated a safety statute or standard. See Id. at 409, 475 S.E.2d at 501. The plaintiff
argued “that she ha[d] shown a violation of a safety statute or standard based on the general
knowledge of the ‘cause and effect between high stress and clinical depression and other
disorders.’” Id. Rejecting her argument, the Supreme Court explained that “a general allegation
is not a ‘specific unsafe working condition [which] was a violation of a state or federal safety
statute. . . .’ and neither does such an allegation automatically show a violation ‘of a commonly
accepted and well-known safety standard within the industry.’” Id. The Court further stated that
the plaintiff’s “statement about general knowledge of stress does not meet her burden of
14
production to fulfill W. Va. R. Civ. P. 56(e)’s explicit mandate for ‘specific facts.’” Id. at 410,
475 S.E.2d at 502.
44. Similar to Miller, Plaintiffs argue that Pfizer was aware of various risks associated
with the use of Zoloft during pregnancy and, therefore, the Zoloft label was inadequate. These
allegations are disputed by Pfizer; however, this dispute does not create an issue of material fact
precluding summary judgment. Plaintiffs have not met their burden because they have not
shown how any of the documents they rely on are relevant to the elements of the fraud-on-theFDA exception to the Michigan statute: (1) did Pfizer intentionally withhold from or
misrepresent to the FDA information concerning Zoloft; (2) was such information required to be
submitted under the FDCA; and (3) would such information have caused the FDA to refuse to
approve Zoloft or withdraw approval for Zoloft if it were accurately submitted?
45. As discussed in the Findings of Fact, Plaintiffs have not shown that any relevant
and material information (as opposed to specific documents) required to be submitted to the FDA
was withheld from the FDA. For example, Plaintiffs place great reliance on language regarding
use of contraception found in Pfizer’s Core Data Sheet for Zoloft.7 However, Plaintiffs have not
cited any regulation that requires a prescription drug manufacturer to provide a copy of a Core
Data Sheet to the FDA. At oral argument, Plaintiffs’ asserted that the Core Data Sheet should
have been provided to the FDA pursuant to the Code of Federal Regulations 314.50. (August 8,
2016 Tr. at 40:12-16.) However, 21 C.F.R. § 314.50 governs the content and format of a new
drug application and says nothing about Core Data Sheets. Moreover, the uncontroverted
evidence shows that foreign labels and the International Product Document for Zoloft, all of
which contained the contraception language, were provided to the FDA before Zoloft was
approved. (Def. Ex. 15.)
46. Finally, Plaintiffs have not introduced any evidence that any of the information
cited by Plaintiffs would have caused the FDA to refuse to approve Zoloft or to withdraw
7 Defendants contend that Plaintiffs have misinterpreted this statement in the Core Data Sheet. However,
the Panel need not resolve this dispute to decide this motion for summary judgment.
15
approval for Zoloft. As noted in the Findings of Fact, the FDA was aware of the results of
animal tests, adverse event reports and language regarding contraception use in Pfizer’s foreign
labels and International Product Document. Further, the allegations made by Plaintiffs in this
litigation have been made in other cases and have been the subject of significant publicity. The
record shows that plaintiffs in the federal multidistrict litigation sent a copy of their expert report
to the FDA. (Def. Ex. 9.) Thus, even though the FDA is aware of claims being made in
litigation similar to this action, and of the opinions of plaintiffs’ expert in the Zoloft federal
MDL, Zoloft continues to be marketed with FDA approval.
47. At oral argument, Plaintiffs’ counsel was asked whether the FDA had done
anything with this information, and he could not identify any action the FDA had taken in
response. (August 8, 2016 Tr. at 41:12-42:21.) He noted that the Zoloft label was undergoing
revision but conceded that process reflected a new FDA approach to pregnancy labeling. (Id. at
42:1-12.) Regardless, the Michigan statute requires more than a label change; it requires
evidence that the FDA would not have approved Zoloft or would have withdrawn approval for
Zoloft. Plaintiffs have not produced even a scintilla of evidence to support such a claim.
48. Whether there is a genuine issue of fact to prevent summary judgment is not
determined by the volume of submissions, but their relevance and materiality. Plaintiffs have
failed to produce any relevant and material evidence sufficient to satisfy their burden on the
applicability of the fraud-on-the-FDA exception to the Michigan statute.
C. Federal Law Preempts Reliance on the Fraud-on-the-FDA Exception
49. Even if Plaintiffs had presented evidence on all three elements of the fraud-onthe-FDA exception to the Michigan statute sufficient to create a genuine issue of fact, it would
still not save their claims because the exception is preempted by federal law. Under the U.S.
Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), a
claim that a manufacturer committed fraud on the FDA is impliedly preempted by the federal
Food, Drug, and Cosmetic Act. Id. at 348-53. The U.S. Supreme Court held that state law
causes of action that require evidence that a manufacturer submitted false or misleading
16
information to the FDA are impliedly preempted because “the federal statutory scheme
empowers the FDA,” not individual citizens, “to punish and deter fraud against the
Administration . . . to achieve a somewhat delicate balance of statutory objectives.” Id. at 348.
This balance “can be skewed by allowing fraud-on-the-FDA claims under state tort law.” Id.
50. In Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), the United
States Court of Appeals for the Sixth Circuit held that, under Buckman, the fraud-on-the-FDA
exception in the Michigan statute is preempted and, therefore, unavailable unless “the FDA itself
determines that a fraud has been committed on the agency during the regulatory-approval
process.” Id. at 966; accord Marsh v. Genentech, Inc., 693 F.3d 546, 551 (6th Cir. 2012); In re
Aredia & Zometa Prods. Liab. Litig., 352 F. App’x 994, 995 (6th Cir. 2009).8 Thus, a plaintiff
must plead and prove that the FDA itself determined that it was defrauded for immunity not to
apply to a manufacturer of an FDA-approved medicine. See Garcia, 385 F.3d at 966. The
United States Court of Appeals for the Fifth Circuit has likewise held that the fraud-on-the-FDA
exception to Texas’s analogous drug product liability statute is preempted unless “the FDA itself
finds fraud.” Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372, 381 (5th Cir.
2012) (emphasis added).9
51. Plaintiffs do not allege that the FDA has ever made a determination of fraud
regarding Zoloft or sertraline, much less that Defendants fraudulently obtained FDA approval for
Zoloft.10
8 See also Blair v. Genentech, Inc., 2011 WL 5088969, at *6 (W.D. Mich. Oct. 26, 2011) (holding that
under Garcia, the fraud-on-the-FDA exception to the Michigan Act was preempted because plaintiff
failed to allege a “federal finding of such fraud”); Duronio v. Merck & Co., Inc., 2006 WL 1628516, at *5
(Mich. Ct. App. June 13, 2006) (adopting holding in Garcia); In re Trasylol Prods. Liab. Litig., 763
F. Supp. 2d 1312, 1325-27, 1329-30 (S.D. Fla. 2010) (excluding evidence that a manufacturer provided
inadequate information to the FDA because the FDA itself had not reached that finding).
9 See also Solomon v. Bristol-Myers Squibb Co., 916 F. Supp. 2d 556, 571 (D.N.J. 2013); Eckhardt v.
Qualitest Pharms. Inc., 858 F. Supp. 2d 792, 799 (S.D. Tex. 2012), aff’d, 751 F.3d 674 (5th Cir. 2014);
Murthy v. Abbott Labs., 847 F. Supp. 2d 958, 976 (S.D. Tex. 2012).
10 A determination that the second exception is preempted, absent a finding of fraud by the FDA, does
not bar enforcement of the act. Under Michigan law, “[i]f any portion of an act or the application thereof
to any person or circumstances shall be found to be invalid by a court, such invalidity shall not affect the
remaining portions or applications of the act which can be given effect without the invalid portion or
17
52. In arguing against preemption, Plaintiffs confuse the critical distinction between
their failure-to-warn claims and the statutory exception they invoke. For example, Plaintiffs
state that “the United States Supreme Court has clearly recognized that plaintiffs’ claims are not
preempted by federal law” (Am. Resp. at 19), and Plaintiffs heavily rely upon Wyeth v. Levine,
555 U.S. 555 (2009), and Altria Group, Inc. v. Good, 555 U.S. 70 (2008) (Id. at 18-19). These
decisions are inapplicable here. As the Sixth Circuit recognized in Marsh, Plaintiffs’ view
“confuses the validity of [a] substantive claim with the validity of [an] argument that immunity
does not apply.” Marsh, 693 F.3d at 554. The Fifth Circuit has also rejected the arguments
Plaintiffs advance here with respect to an equivalent Texas statute, holding that to follow the
view advanced by Plaintiffs would be to deny that the “statute is what it is—a requirement to
prove fraud on the FDA.” Lofton, 672 F.3d at 377.
53. Indeed, the allegations that Plaintiffs advance here to support their reliance on the
fraud-on-the-FDA exception implicate precisely the concerns expressed by the Supreme Court in
Buckman. In Buckman, the Supreme Court explained that “fraud-on-the-FDA claims would also
cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the
Administration, will later be judged insufficient in state court. Applicants would then have an
incentive to submit a deluge of information that the Administration neither wants nor needs,
resulting in additional burdens on the FDA’s evaluation of an application.” 531 U.S. at 351.
54. As discussed above, Plaintiffs do not identify any information required to be
submitted to the FDA that was withheld. Instead they cite to various internal Pfizer documents
they contend should have been provided to the FDA, even though the FDA has specified the
information it needs and the format that it should be provided in. Allowing fraud-on-the-FDA
application, provided such remaining portions are not determined by the court to be inoperable, and to this
end acts are declared to be severable.” Mich. Comp. Laws § 8.5. Here the immunity provision can be
given effect because the fraud exception remains valid where the FDA itself has found fraud.
Accordingly, preserving, rather than voiding, the immunity statute is more faithful to the Michigan
Legislature’s concern that “unlimited liability for drug manufacturers would threaten the financial
viability of many enterprises and could add substantially to the cost and unavailability of many drugs.”
Garcia, 385 F.3d at 967.
18
claims to proceed, whether as a stand-alone claim or to support an exception to a statute such as
Michigan’s, risks causing the deluge of information to the FDA that the Supreme Court feared.
55. Plaintiffs ask this Panel to disregard Garcia, Marsh, Lofton, and their numerous
circuit and district court progeny and to instead follow the opinion in Desiano v. WarnerLambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by an equally divided court sub nom.,
Warner-Lambert Co. v. Kent, 552 U.S. 440 (2008). However, Desiano is inconsistent with more
persuasive and more recent decisions of the Fifth and Sixth Circuits and other courts interpreting
the Michigan Act and the similar Texas statute, which have held that, under Buckman, a plaintiff
must plead and prove that the FDA itself determined that it was defrauded. See Lofton, 672 F.3d
at 380; Marsh, 693 F.3d at 554; In re Aredia, 352 F. App’x at 995.
56. In addition, Desiano cannot be reconciled with Buckman. Under Desiano, for a
plaintiff to establish the fraud-on-the-FDA exception to the Michigan Act, a fact-finder would
have to make precisely the determination the Supreme Court held in Buckman was preempted –
that the FDA was defrauded by the defendant. See Buckman, 531 U.S. at 348-49; Garcia, 385
F.3d at 966 (“[S]tate tort remedies requiring proof of fraud committed against the FDA are
foreclosed since federal law preempts such claims”) (citation omitted); In re Aredia & Zometa
Prods. Liab. Litig., 2009 WL 2497229, at *2 (M.D. Tenn. Aug. 13, 2009) (under Buckman,
plaintiff could not present evidence that a manufacturer improperly obtained FDA-approval of a
drug to rebut a statutory presumption that the drug was not defective); In re Aredia & Zometa
Prods. Liab. Litig., 2008 WL 2944910, at *4 (M.D. Tenn. Jul. 25, 2008) (under a similar Texas
statute, “in order to establish that the FDA would have acted differently if Defendant had
submitted accurate information, Plaintiffs would have to ‘go behind’ the FDA processes, raising
the concerns sought to be avoided in Buckman”).
57. Neither Desiano nor its progeny are persuasive. Though West Virginia courts
have not addressed this issue, multiple courts analyzing Garcia and Desiano, including the Fifth
Circuit in Lofton, have held the Sixth Circuit’s reasoning in Garcia is more consistent with
Buckman. Desiano relies on a strained attempt to distinguish a stand-alone claim for fraud on
19
the FDA from proof that there has been fraud on the FDA. As the Fifth Circuit explained, that
“strain[ed]” and inconsequential distinction is not “faithful to Buckman” and “overlooks the
reality of trial practice and the precise statutory language.” Lofton, 672 F.3d at 380. “Either way
. . . a plaintiff must ‘establish’ a violation of FDA’s required disclosures. In so doing, the
plaintiff necessarily re-treads the FDA’s administrative ground both to conduct discovery and to
persuade a jury.” Id. at 380; See also In re Trasylol Prods. Liab. Litig., 763 F. Supp. 2d 1312,
1323-27 (S.D. Fla. 2010) (adopting Garcia over Desiano because “[t]he concerns expressed . . .
in Buckman hold true not only where there is a separate fraud-on-the-FDA claim but also where
a plaintiff seeks to prove fraud on the FDA in order to bring a traditional state-law torts suit”);
Grange v. Mylan Labs., Inc., 2008 WL 4813311, at *7 (D. Utah Oct. 31, 2008) (finding Garcia
“more persuasive” than Desiano).11
CONCLUSION
In light of the foregoing, the Panel unanimously GRANTS Defendants’ Motion for
Summary Judgment. Judgment is entered in favor of Defendants and the claims of the abovecaptioned Plaintiff Family are hereby DISMISSED WITH PREJUDICE. Any exceptions or
objections are noted and preserved for the record.
The Court FINDS upon EXPRESS DETERMINATION that this a final order available
for the proper application of the appellate process pursuant to Rule 54(b) of the Rules of Civil
Procedure and the Rules of Appellate Procedure. Accordingly, this order is subject to immediate
appellate review. The parties are hereby advised: (1) that this is a final order; (2) that any party
aggrieved by this order may file an appeal directly to the Supreme Court of Appeals of West
Virginia; and (3) that a notice of appeal and the attachments required in the notice of appeal must
be filed within thirty (30) days after the entry of this Order, as required by Rule 5(b) of the West
Virginia Rules of Appellate Procedure.
11 Hall v. Wyeth, Inc., 2010 WL 3860467 (E.D. Pa. Sept. 30, 2010), also cited by Plaintiffs (Am.
Resp. at 20) is not a persuasive decision for the same reasons as Desiano.
20
The Clerk is directed to close this case and place it among the cases ended. A copy of
this order is this day served on the parties of record via File & ServeXpress.
It is so ORDERED.
ENTER: August 30, 2016. /s/ James P. Mazzone
Lead Presiding Judge
Zoloft Litigation

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