LENTZ et al v. PFIZER INC. et al
MEMORANDUM AND/OR OPINION. SIGNED BY HONORABLE CYNTHIA M. RUFE ON 4/5/2016. 4/6/2016 ENTERED AND COPIES E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 1574 IN 12-MD-2342) (ems)
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE: ZOLOFT (SERTRALINE
: MDL NO. 2342
________________________________ : HON. CYNTHIA M. RUFE
THIS DOCUMENT RELATES TO: :
April 5, 2016
By Order filed April 17, 2012, the United States Judicial Panel on MultiDistrict
Litigation transferred to this Court, for coordinated or consolidated pretrial proceedings, cases
alleging that Zoloft (sertraline hydrochloride), “a prescription medication approved for the
treatment of depression and other ailments, causes birth defects in children when their mothers
ingest the drug while pregnant.”1 In rejecting arguments opposing centralization of the cases, the
Panel determined that “while the specific birth defects alleged vary somewhat among the
plaintiffs, all actions will share discovery relating to general medical causation; factual discovery
will overlap concerning Pfizer’s research, testing, and warnings; and expert discovery and
Daubert motions will overlap to some degree.”2 These events common to the litigation having
occurred, the Court now is presented with Defendants’ motion for summary judgment in all
pending cases.3 Plaintiffs, through the Plaintiffs Steering Committee (“PSC”), oppose the
Doc. No. 1 at 1.
Doc. No. 1 at 2. Daubert motions are the method in federal court by which the admissibility of expert
witnesses is determined. See Daubert v. Merrill Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Doc. No. 1521; Reply at Doc. Nos. 1561, 1563. The motion was filed by Pfizer, Inc., its former division
J.B. Roerig & Company, Pfizer International LLC, and Greenstone LLC. These Defendants may be referred to
collectively as “Pfizer.” The motion has been joined by Defendants Wolters Kluwer Health, Inc. and Wolters
motion.4 The motion puts the following two questions before the Court: First, have Plaintiffs
produced sufficient admissible evidence from which a reasonable factfinder could determine, by
a preponderance of the evidence, that Zoloft caused Plaintiffs’ injuries? Second, if they have
not, what next?
Early in the MDL, the parties agreed to a schedule to govern proceedings in the MDL.5
The schedule included discovery from Pfizer, the exchange of expert reports regarding general
causation and hearings as to the admissibility of the expert testimony pursuant to Daubert v.
Merrell Dow Pharmaceuticals.6 At the initial hearings, the PSC offered the testimony of four
expert witnesses7 on the issue of general causation in an effort to establish that Zoloft, when used
at therapeutic dose levels during human pregnancy, is a teratogen capable of causing a range of
birth defects.8 Plaintiffs primarily relied upon Dr. Anick Bérard, an epidemiologist.9 By opinion
dated June 27, 2014, the Court found that Dr. Bérard had failed to base her opinion upon
Kluwer United States Inc., which published patient education information and are named in a relatively small
number of cases. Doc. Nos. 1525, 1562.
The only opposition was filed by the PSC [Doc. Nos. 1544-49]. The Court expressly granted all
Plaintiffs’ counsel the opportunity to submit any non-duplicative arguments in opposition to the motion within two
weeks after receipt of the PSC’s motion. See Pretrial Order No. 95 [Doc. No. 1529]. No additional briefs were
See Joint Motion [Doc. No. 285]; Pretrial Order No. 15 [Doc. No. 287, entered November 16, 2012].
509 U.S. 579, 593-94 (1993). Although, as Plaintiffs note, Pfizer proposed the early determination of the
general causation issues, the schedule was agreed upon and included comprehensive discovery from Pfizer on
numerous issues. Plaintiffs did not argue that they were unprepared for the Daubert proceedings, and assured the
Court early on that they were “not scared of Daubert.” Tr. Status Conf. 10/17/12 at 81 [Doc. No. 280] (Statement of
Joseph J. Zonies, Esq.).
The PSC initially put forward additional expert witnesses but withdrew them before the hearings.
A teratogen is “[a]n agent that produces abnormalities in the embryo or fetus by disturbing maternal
health or by acting directly on the fetus in utero.” Reference Manual of Scientific Evidence (Third) at 628.
“Epidemiology is the field of public health and medicine that studies the incidence, distribution, and
etiology of disease in human populations.” Id. at 551.
scientifically valid methodology and reasoning such that it could not be considered by a jury.10
The Court determined that “Dr. Bérard’s methodology involved a rejection of the importance of
replicated statistically significant epidemiological findings demonstrating an association between
Zoloft and a pattern of birth defects, substituting a novel technique of drawing conclusions by
examining ‘trends’ (often statistically non-significant) across selected studies.”11 The Court also
held that Dr. Bérard failed to address adequately those epidemiological studies that did not
support her opinion.12
By opinion and order dated August 12, 2014, the Court excluded in part the opinions of
the PSC’s three other general causation witnesses, Dr. Robert Cabrera (a teratologist), Dr.
Michael Levin (a molecular developmental biologist), and Dr. Thomas Sadler (an embryologist).
The Court concluded that these experts could not testify that Zoloft caused birth defects in
humans but could testify as to the limited question of the existence of plausible biological
mechanisms by which altered concentrations of serotonin in a developing embryo could cause
birth defects.13 The Court held that “when epidemiological studies are equivocal or inconsistent
with a causation opinion, experts asserting causation opinions must thoroughly analyze the
strengths and weaknesses of the epidemiological research and explain why that body of research
does not contradict or undermine their opinion.”14 These experts did not address the
In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 26 F. Supp. 3d 449 (E.D. Pa. 2014).
Id. at 465.
Id. at 462.
In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 26 F. Supp. 3d 466, 473 (E.D. Pa. 2014).
Id. at 475.
epidemiological evidence, and because Dr. Bérard’s report and testimony had been excluded
they could not rely on her conclusions or testify as to human causation.15
The PSC filed a motion for partial reconsideration of the opinion excluding Dr. Bérard
only. The Court denied this motion by opinion and order dated January 23, 2015, rejecting the
argument that the Court erred by requiring replicated, statistically significant epidemiological
findings to establish general causation.16 The Court explained that:
medical experts, and especially physicians opining as to specific rather than
general causation, may rely on data other than statistical evidence from
epidemiological studies, such as a differential diagnosis, which is a “technique
generally accepted in the medical community.” In re Diet Drugs
(Phentermine/Fenfluramine/Dexfenfluramine) Products Liab. Litig., 890 F. Supp.
2d 552, 561 (E.D. Pa. 2012) (citing Heller v. Shaw Industries, Inc., 167 F.3d 146,
155 (3d Cir. 1999)). However, Dr. Bérard is an epidemiologist, not a physician,
and the Court has evaluated the reliability of her methods accordingly. Moreover,
the Court notes that, unlike the association at issue in In re Diet Drugs, which had
not been the subject of any epidemiological study, the use of Zoloft during
pregnancy has been the subject of many large epidemiological studies designed
with the goal of identifying any associations between maternal SSRI /Zoloft use
and a broad range of birth defects. Even so, the Court has evaluated Dr. Bérard's
methods according to the Daubert principles, and did not apply any bright-line
exclusionary rules to her causation analysis.17
While seeking partial reconsideration, the PSC also filed a motion for leave to introduce
Nicholas Jewell, Ph.D., a biostatistics professor, as an additional expert witness on general
causation with regard to cardiac defects.18 The PSC argued in support of its motion that “Dr.
Jewell’s testimony is critically important to the plaintiffs in this litigation. Proof of general
causation – that exposure to Zoloft was capable of causing plaintiffs’ injuries – is a prerequisite
Id. at 476 n.45.
In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., No. 12-md-2342, 2015 WL 314159, at * 2
(E.D. Pa. Jan. 23, 2015).
Id. at *2 n.6. It is important to note that in the Diet Drugs case, the parties did not dispute that the drugs
could cause the disease at issue; instead, the parties disputed the latency period between a plaintiff taking the drugs
and developing the disease. In re Diet Drugs, 890 F. Supp. 2d at 561-62.
Dr. Jewell was the only additional expert the PSC sought leave to introduce.
to recovery by every plaintiff herein.”19 By opinion and order dated January 7, 2015, the Court
granted the motion after balancing the interests of all parties to the MDL and weighing heavily
“the indisputable fact that the evidence is of critical importance to Plaintiffs.”20 After these
rulings, many cases alleging non-cardiac injuries were dismissed without prejudice by stipulation
of the parties.21
Defendants raised a Daubert challenge as to the admissibility of Dr. Jewell’s testimony
and report.22 After this motion was filed, the parties stipulated to the dismissal without prejudice
of additional cases, including some alleging both cardiac and non-cardiac defects.23 Defendants
also filed a motion to strike new expert reports by Dr. Levin and Dr. Sadler, arguing that
Plaintiffs were improperly attempting to re-litigate the admissibility of these experts’ reports and
testimony.24 These reports purported to be case-specific to the two trial-ready cases,25 although
Dr. Levin did not address any opinions specific to these Plaintiffs, and Dr. Sadler essentially
applied his earlier opinions to the individual Plaintiffs. By stipulation of counsel approved by
the Court, Plaintiffs agreed to withdraw the reports and reserved “the right to file supplemental
reports from Dr. Levin and/or Dr. Sadler at a later date to address any new evidence relevant to
Doc. No. 1054-1 at 13. These statements likely constitute judicial admissions. See Berckeley Inv.
Group, Ltd. v. Colkitt, 455 F.3d 195, 211 n.20 (3d Cir. 2006) (“Judicial admissions are concessions in pleadings or
briefs that bind the party who makes them.”).
In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., No. 12-md-2342, 2015 WL 115486, at * 2
(E.D. Pa. Jan. 7, 2015).
The Court had granted all Plaintiffs asserting non-cardiac injuries an opportunity to submit their own
expert reports as to general causation. Pretrial Order No. 83 [Doc. No. 1165].
Doc. No. 1210. At the same time, the PSC filed a motion to exclude the testimony of defense expert Dr.
Robert Gibbons, see Doc. No. 1212; that motion was later dismissed as moot. Doc. No. 1498.
See Pretrial Order No. 97 [Doc. No. 1565].
Doc. No. 1372.
The trial-ready cases, which were the cases in which full discovery regarding the Plaintiffs was
conducted, are Long v. Pfizer, Civil Action No. 12-2595, and Goulet v. Pfizer, Civil Action No. 12-2441.
their opinions which may come to light, and the right to offer their testimony” in the cases set for
initial trials.26 Defendants reserved “all of their rights to file objections or motions challenging
any report and/or opinion of” these experts.27
By opinion and order dated December 2, 2015, the Court excluded Dr. Jewell’s report
and testimony pursuant to Federal Rules of Evidence 403 and 702.28 The Court concluded after
hearing testimony over several days that Dr. Jewell failed to consistently apply the scientific
methods he articulated, deviated from or downplayed certain well-established principles of his
field, and inconsistently applied methods and standards to the data so as to support his a priori
opinion.29 Significantly, the Court found that Dr. Jewell failed to address adequately all of the
available epidemiological studies, particularly more recent studies that did not replicate the
results in earlier studies, even though these studies included and expanded upon the populations
in the earlier studies.30 The Court also concluded that Dr. Jewell improperly attempted to rely
upon internal Pfizer documents because such partial literature reviews are not the kinds of
information generally relied upon by statisticians, and because to the extent that the documents
expressed Pfizer’s preliminary concerns about product safety, warranting further investigation,
and were not final conclusions drawn by Pfizer (as Pfizer argued), Dr. Jewell’s use of them
would potentially be misleading to a jury.31 Pfizer moved for summary judgment immediately
after this ruling.
Doc. No. 1452.
In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., No. 12-md-2342, 2015 WL 7776911 (E.D.
Pa. Dec. 2, 2015).
Id. at *16.
Id. at *7.
Id. at *12.
A court will award summary judgment on a claim or part of a claim where there is “no
genuine dispute as to any material fact and the movant is entitled to judgment as a matter of
law.”32 A fact is “material” if resolving the dispute over the fact “might affect the outcome of the
suit under the governing [substantive] law.”33 A dispute is “genuine” if “the evidence is such that
a reasonable jury could return a verdict for the nonmoving party.”34
In evaluating a summary judgment motion, a court “must view the facts in the light most
favorable to the non-moving party,” and make every reasonable inference in that party’s favor.35
Further, a court may not weigh the evidence or make credibility determinations.36 Nevertheless,
the party opposing summary judgment must support each essential element of the opposition
with concrete evidence in the record.37 “If the evidence is merely colorable, or is not
significantly probative, summary judgment may be granted.”38 This requirement upholds the
“underlying purpose of summary judgment [which] is to avoid a pointless trial in cases where it
is unnecessary and would only cause delay and expense.”39 Therefore, if, after making all
reasonable inferences in favor of the non-moving party, the court determines that there is no
genuine dispute as to any material fact, summary judgment is appropriate.40
Fed. R. Civ. P. 56(a).
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
Hugh v. Butler County Family YMCA, 418 F.3d 265, 267 (3d Cir. 2005).
Boyle v. County of Allegheny, 139 F.3d 386, 393 (3d Cir. 1998).
Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).
Anderson, 477 U.S. at 249-50 (internal citations omitted).
Walden v. Saint Gobain Corp., 323 F. Supp. 2d 637, 641 (E.D. Pa. 2004) (citing Goodman v. Mead
Johnson & Co., 534 F.2d 566, 573 (3d Cir. 1976)).
Wisniewski v. Johns–Manville Corp., 812 F.2d 81, 83 (3d Cir. 1987).
In ruling on the summary judgment motion, the Court has determined that it is not
required to apply the law of any particular jurisdiction. Although Plaintiffs argue at various
points in their opposition that the Court should apply the state or federal law applicable to the
states where the trial-ready Plaintiffs live, Plaintiffs have not cited cases from any jurisdiction
holding that the complex scientific question of whether a prescription drug is a teratogen can be
answered without expert testimony or based on circumstantial evidence, and the legal principles
upon which the Court has relied tend to be consistent across jurisdictions.41
Defendants argue that having failed to produce an expert who can establish general
causation, Plaintiffs cannot prevail on any of their claims. Plaintiffs argue that there is
substantial evidence of causation, including reports of adverse events, internal Pfizer documents
that Plaintiffs say admit to a positive association between maternal use of Zoloft and cardiac
defects, the evidence of biological plausibility from Dr. Levin and Dr. Sadler, differential
diagnoses performed by a pediatric cardiologist that can establish both general and specific
causation on a case-by-case basis, and an expert opinion by the former commissioner of the Food
and Drug Administration (“FDA”). Although the Court has considered Plaintiffs’ evidence in
full, the Court will not engage in an ad hoc third round of Daubert proceedings, as to do so
would provide Plaintiffs “with an open-ended and never-ending opportunity to meet a Daubert
See W. Ertmer, Just What the Doctor Ordered: The Admissibility of Differential Diagnosis in
Pharmaceutical Product Litigation, 56 Vand. L. Rev. 1227, 1258 (2003) (Although “state law varies considerably
with respect to the quantum of evidence required to support a finding of causation . . . the general rule across
jurisdictions is that satisfaction of the causation element requires evidence of both general and specific causation.”
(footnotes omitted)). Cf. In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 751 (3d Cir. 1994) (“If the [state-court] rule
conflicts with federal rules and is rationally capable of classification as procedural rather than substantive, then, as a
federal court, the district court ignores the rule and applies federal rules instead. But the determination of whether a
particular evidentiary ruling involves federal procedural law or state substantive law, can be difficult. Often
admissibility issues overlap with substantive concerns such as standards of proof.” (internal quotation marks and
challenge until [they] ‘get it right.’”42 Plaintiffs essentially attempt to proceed as if general
causation has not already been litigated extensively, as if the motion for leave to present Dr.
Jewell was superfluous, and as if the withdrawal of the supplemental reports of Dr. Sadler and
Dr. Levin was of no effect. The Court rules within the full context of the MDL proceedings,
mindful of all prior rulings and procedural orders.
A. Can Plaintiffs Establish General Causation?
“Causation has two levels, general and specific, and a plaintiff must prove both. General
causation is whether a substance is capable of causing a particular injury or condition in the
general population, while specific causation is whether a substance caused a particular
individual’s injury. Sequence matters: a plaintiff must establish general causation before moving
to specific causation. Without the predicate proof of general causation, the tort claim fails.”43
Plaintiffs proffered four experts on general causation in the first round of Daubert
proceedings: Dr. Bérard, Dr. Cabrera, Dr. Levin, and Dr. Sadler. The Court concluded that not
one of these experts could testify that Zoloft is capable of causing birth defects in humans. In the
second round of Daubert proceedings, Plaintiffs with leave of Court proffered Dr. Jewell and
without leave of Court submitted supplemental reports by Dr. Levin and Dr. Sadler. Plaintiffs
withdrew the supplemental reports and the Court held after an extensive hearing that Dr. Jewell
could not testify that Zoloft causes birth defects in humans. The Court must determine whether
Plaintiffs are able to establish general causation without the excluded expert testimony.
In opposing Pfizer’s motion, Plaintiffs have presented the Court with a prodigious record.
The Court has reviewed the 405 asserted statements of material facts (to which Pfizer has
In re TMI Litig., 199 F.3d 158, 159 (3d Cir 2000), amending, 193 F.3d 613 (3d Cir. 2000).
Wells v. SmithKline Beecham Corp., 601 F.3d 375, 277-78 (5th Cir. 2010) (internal quotations and
responded) and the nearly 200 exhibits contained in six banker’s boxes produced by Plaintiffs.
The quantity of the evidence is not, however, coterminous with the quality of evidence with
regard to the issues now before the Court. Aside from issues such as the submission of
duplicative exhibits44 and untranslated foreign-language documents,45 statements and documents
relating to the development, marketing costs, and profitability of Zoloft46 are irrelevant to the
question of whether Zoloft can cause birth defects. Plaintiffs have also submitted again the
epidemiological studies that, pursuant to the Court’s rulings with regard to Dr. Bérard and Dr.
Jewell, fail to support claims of causation.47 In addition, the PSC recently filed a supplemental
submission that purports to be an “important epidemiology recent study,” but which appears to
be a statement by statisticians as to p-values and statistical significance that has been accepted
for publication but not yet published.48 This document, whatever its provenance, is not relevant
to the issues on summary judgment; the Court will not belatedly revisit the Daubert rulings.
The Role of Epidemiological Evidence
Plaintiffs argue that epidemiological evidence is not required to establish general
causation.49 Although the legal concept is more nuanced than Plaintiffs present, nevertheless,
See, e.g., Robinson Decl. Exs. 112, 117, 127, and 129. The Court also notes that the description of the
documents in the declaration does not always match the documents as tabbed.
See Robinson Decl. Ex. 93 (a document from Honduras in Spanish).
See PSC’s Statement of Controverted and Disputed Facts in Opposition to the Pfizer Defendants’
Motion for Summary Judgment at ¶¶ 4-7.
Robinson Decl. Exs. 153-63. The copy of the Louik (2007) study appears to be the original, inaccurate
study, not the version corrected by the study authors as required by the New England Journal of Medicine in 2015.
Robinson Decl. Ex. 153.
Doc. No. 1569.
See Rider v. Sandoz Pharms. Corp., 295 F.3d 1194, 1198 (11th Cir. 2002) (“It is well-settled that while
epidemiological studies may be powerful evidence of causation, the lack thereof is not fatal to a plaintiff’s case.”).
See also Glasteller v. Novartis Pharms. Corp., 252 F.3d 986, 992 (8th Cir. 2001) (holding that the absence of
epidemiological evidence does not doom a plaintiff’s case, but its absence limited the available tools with which the
plaintiff may prove causation). But see Wade-Greaux v. Whitehall Labs., Inc., 874 F. Supp. 1441, 1453 (D.V.I.
this Court has not held to the contrary. Instead, the Court’s rulings have followed the accepted
principles that “epidemiology is the best evidence of general causation in a toxic tort case” and
that “where epidemiology is available, it cannot be ignored.”50 As this Court held in the opinions
on the biological experts:
Several courts have held that positive human epidemiological studies are required
to reach reliable conclusions as to whether an agent is teratogenic in humans, and
causation opinions based primarily upon in vitro and live animal studies are
unreliable and do not meet the Daubert standard. The Court agrees that reliable
expert opinions about human causation generally should be supported by positive
and replicated epidemiological studies, but reaches a narrower holding here.
Specifically, the Court holds that when epidemiological studies are equivocal or
inconsistent with a causation opinion, experts asserting causation opinions must
thoroughly analyze the strengths and weaknesses of the epidemiological research
and explain why that body of research does not contradict or undermine their
Zoloft has been on the market and used during pregnancy for approximately
twenty years, and a great deal of epidemiological research has been conducted
and published. Therefore, the Court holds that any litigation experts on human
causation in this MDL must address the epidemiological research. Where that
body of research does not support the conclusions drawn by the experts, the
experts must endeavor to reconcile the inconsistent epidemiological data with
In other words, in order to successfully opine on general causation (i.e., that Zoloft can
cause birth defects), any expert must account for the findings reached in the full universe of
epidemiological studies.53 In arguing against this determination, Plaintiffs rely on a case that
1994), aff’d 46 F.3d 1120 (3d Cir. 1994) (“Absent consistent, repeated human epidemiological studies showing a
statistically significant increased risk of particular birth defects associated with exposure to a specific agent, the
community of teratologists does not conclude that the agent is a human teratogen.”).
Norris v. Baxter Healthcare Corp., 397 F.3d 878, 882 (10th Cir. 2005) (citing cases).
In re Zoloft, 26 F. Supp. 2d at 475 (footnotes omitted).
Id. at 476.
Richardson v. Richardson-Merrell, Inc., 857 F. 2d 823, 830 (1988) (“These three types of studies then --chemical, in vitro, and in vivo, cannot furnish a sufficient foundation for a conclusion that Bendectin caused the birth
arose in a different context, one in which epidemiological studies had not been published. The
plaintiff in Heller v. Shaw Industries, Inc.,54 sought recompense for respiratory illnesses
allegedly caused by volatile organic compounds that emanated from carpeting manufactured by
the defendant and installed in the plaintiff’s home.55 The Third Circuit rejected the notion that “a
medical expert must always cite published studies on general causation” because to do so “would
doom from the outset all cases in which the state of research on the . . . alleged causal agent was
in its early stages,” and would unacceptably impose a bright-line standard.56 The decision in
Heller does not stand for the proposition that existing epidemiological studies are irrelevant or
need not be addressed and reconciled with an expert’s opinions on causation. Plaintiffs cannot
prevail by ignoring the epidemiological evidence.
Dr. Sadler and Dr. Levin
In opposing summary judgment, and in addition to the reports previously litigated in the
Daubert proceedings, Plaintiffs have submitted reports that were the subject of the earlier motion
to strike and were withdrawn pursuant to stipulation and order, and additional declarations dated
2016, relating to the Long and Goulet cases.57 Pfizer has filed a motion to strike, arguing that
defects at issue in this case. Studies of this kind, singly or in combination, are not capable or proving causation in
human beings in the face of the overwhelming body of contradictory epidemiological evidence.”).
167 F.3d 146 (1999).
Id. at 149.
Id. at 155. Accord Milward v. Acuity Specialty Prods. Group, Inc., 639 F.3d 11, 24 (1st Cir. 2011)
(distinguishing a case in which there was a lack of statistically significant epidemiological evidence from cases in
the available epidemiological studies found no causal link).
Robinson Decl. Ex. 164 (Dr. Levin’s report of June 15, 2015); Fox Decl. Ex. 2 (Dr. Sadler’s report in
Goulet dated June 15, 2015); Smith Decl. Ex. 4 (Dr. Sadler’s report in Long dated June 15, 2015); Plffs.’ Ex. 8 (Dr.
Sadler’s declaration in Goulet dated Jan. 12, 2016); Plff.s’ Ex. 10 (Dr. Sadler’s declaration in Goulet dated January
these submissions violate the Court’s order approving the stipulation to withdraw the reports.58
Pfizer also argues that the expert submissions address no new evidence and simply restate
opinions excluded by the Court’s second Daubert ruling. Plaintiffs argue that Pfizer was on
notice that the experts would submit declarations specific to the Long and Goulet cases in
opposition to summary judgment, and that a Daubert challenge could have been raised then, and
that the submissions do not contravene the parties’ Court-approved stipulation.
Plaintiffs cannot bring in new opinions by these experts or resurrect those previously
excluded. The Court has ruled that neither Dr. Levin nor Dr. Sadler can testify that Zoloft, used
in conventional doses, can cause birth defects in humans. As this opinion is inadmissible as to
people in general, it must be inadmissible as to any particular Plaintiff.
The opinions that the Court previously held admissible remain admissible, and to the
extent that Dr. Levin and Dr. Sadler have elaborated upon the bases for the admissible opinions,
they are not barred from supplementing, but the Court will not allow its ruling to be
circumvented under the guise of addressing specific causation or discussing new evidence. Nor
will the Court sanction Plaintiffs’ tactics in submitting reports, then withdrawing them without
prejudice when challenged, only to bring them forth in opposing summary judgment. There was
an appropriate time to offer these reports which may have withstood contest, but it is too late
The Court’s Daubert ruling remains in effect: these experts cannot testify as to the
ultimate issue of human causation. And because animal studies cannot overcome the contrary
results of human epidemiological studies, the opinions do not support general causation, even in
combination with the differential diagnoses by Dr. Abdulla.
Doc. No. 1558.
Plaintiffs argue that differential diagnoses performed by Ra-Id Abdulla, M.D., with
regard to the trial-ready Long and Goulet cases provide substantial evidence of general
causation.59 Dr. Abdulla, a pediatric cardiologist, is not a treating physician of either of the
minor Plaintiffs, and was never designated as an expert on general causation. Therefore, it is
procedurally improper, pursuant to the Court’s pretrial scheduling orders, for Plaintiffs to tender
him now, even as an expert on general causation as to individual Plaintiffs, and his opinions
cannot be used to support general causation. Substantively, Dr. Abdulla’s reports are also
A differential diagnosis assumes that general causation has been established.61 Although
“there may be a case where a rigorous differential etiology is sufficient to help prove, if not
prove altogether both general and specific causation,”62 these are not such cases. “To properly
perform a differential diagnosis, an expert must perform two steps: (1) ‘Rule in’ all possible
causes of [the injury] and (2) ‘Rule out’ causes through a process of elimination whereby the last
remaining potential cause is deemed the most likely cause” of the injury.63 The expert must use
scientifically valid methodology to rule in and rule out the potential causes.64 However, reliable
Smith Decl. Ex. 1; Fox Decl. Ex. 3.
Cf. Fed. R. Civ. P. 16(b)(4) (“A schedule may be modified only for good cause and with the judge’s
Norris, 397 F.3d at 885 (quotation marks and citation omitted).
C.W. v. Textron, Inc., 807 F.3d 827 (7th Cir. 2015) (emphasis omitted) (citing Ruggiero v. WarnerLambert Co., 424 F.3d 249, 254 (2d Cir. 2005)).
Feit v. Great West Life and Annuity Ins. Co., 271 F. App’x 246, 254 (3d Cir. 2008).
Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 254 (2d Cir. 2005). A physician performing a
differential diagnosis need not “rule out all alternative possible causes.” Heller, 167 F.3d at 156 (internal quotation
methods for making a differential diagnosis “cannot sanitize an otherwise untrustworthy
conclusion,” and “good grounds” must exist for the physician to reach his conclusion.65
In his declarations dated January 28, 2016, Dr. Abdulla addresses “ruling in” potential
causes of cardiac birth defects in the briefest possible fashion, simply stating that he “analyzed
the relevant, publicly available scientific literature on the causes and risk factors for congenital
heart disease including the review of experimental and human data related to serotonin (5HT)
and selective serotonin reuptake inhibitors (SSRIs), including Zoloft, and abnormal cardiac
development.”66 This bald statement does not constitute a scientific analysis for purposes of
ruling in Zoloft as a cause of congenital heart disease. In his June 15, 2015 opinions, Dr.
Abdulla opines that:
As stated above, while there are studies which report a positive association which
is not statistically significant but with a 95% Confidence Interval show an odds
ratio reflecting increased risk and others which do not report a positive
association, these [sic] are a variety of reasons these studies did not find statistical
significance or increased risk, including lack of power for specific exposureoutcome analysis and/or the rarity of the defect to detect associations, which in
my opinion does not refute the statistically significant and clinically important
increase in risk for cardiac malformations demonstrated in the above peerreviewed journals. Thus, considering the available evidence, it is my opinion that
there is sufficient scientific evidence that Zoloft (sertraline) can cause a clinically
important increase in the risk of congenital cardiac defects in infants exposed
during the first trimester of gestation.67
Dr. Abdulla states reasons why a particular study may not have found a positive
association, but this falls far short of establishing causation. Dr. Abdulla adds nothing new to the
discussion of the epidemiological studies that neither Dr. Bérard nor Dr. Jewell could reliably
interpret to establish general causation. Dr. Abdulla does discuss the difference between what is
Heller, 167 F.3d at 156.
Pls.’ Exs. 7& 9 at ¶ 15. Dr. Abdulla also stated that he considered “epidemiological evidence” and “all
relevant scientific and medical literature.” Pls.’ Ex. 7 at ¶ 18.
Smith Decl. Ex. 1 at 14; Fox Decl. Ex. 3 at 14.
clinically important (or significant) and what is statistically significant,68 but clinical significance
goes to the decisions made by the individual doctor and patient; it does not bear on general
causation. Dr. Abdulla’s specific causation opinion essentially assumes that general causation
has been established; otherwise statements declaring, for example, that septal ventricular defects
“have been encountered at a higher frequency in children exposed to SSRIs in-utero,”69 put the
rabbit in the hat, requiring the Court to simply take Dr. Abdulla’s word for it.70 Dr. Abdulla’s
reports do not provide “independently reliable evidence that that the allegedly dangerous drug or
substance had harmful effects.”71
It is important to note in this regard that birth defects “can be caused by a variety of
factors, including genetic and chromosomal abnormalities and environmental agents.”72 Indeed,
the etiology of many birth defects is currently unknown.73 Congenital heart defects are the most
common type of birth defects, occurring in as many as 1% of live births and affecting 40,000
infants in the United States each year.74 Dr. Abdulla stated that he ruled out “maternal diabetes,
family history of genetic or congenital heart diseases, arrhythmia, or sudden cardiac death,
exposure to other medications (except prenatal vitamins),” environmental exposures, and
Smith Decl. Ex. 1 at 11; Fox Decl. Ex. 3 at 11.
Smith Decl. Ex. 1 at 15; Fox Decl. Ex. 3 at 15. Dr. Abdulla’s reference to SSRIs generally creates
additional problems of lack of fit.
Hendrix ex rel. G.P. v. Evenflo Co., 609 F.3d 1183, 1201 (11th Cir. 2010).
Hollander v. Sandoz Pharms. Corp., 289 F.3d 1193, 1210 (10th Cir. 2002).
Wade-Greaux v. Whitehall Labs., Inc., 874 F. Supp. 1441, 1447 (D.V.I. 1994), aff’d, No. 94-7199, 1994
WL 16973481 (3d Cir. Dec. 15, 1994).
DeLuca v. Merell Dow Pharms., Inc., 911 F.2d 941, 945 (1990).
See Centers for Disease Control and Prevention, Congenital Heart Defects (CHD), Data and Statistics,
http://www.cdc.gov/ncbddd/heartdefects/data.html (last accessed March 11, 2016).
maternal use of tobacco, alcohol, and illicit drugs.75 Dr. Abdulla also conducted genetic tests to
detect known chromosomal anomalies.76 But the ruling-out process, by itself, cannot establish
causation.77 Because Dr. Abdulla cannot rule in Zoloft as a potential cause of the birth defects,
the evidence suffers from too large an analytical gap between the data and the opinions offered.78
Plaintiffs submit the expert report of David A. Kessler, M.D., a former Commissioner of
the FDA.79 As with Dr. Abdulla, Plaintiffs did not put forth Dr. Kessler as an expert on general
causation and the Court will not allow him to offer such opinions in disregard of the course of
proceedings in this MDL. Moreover, Dr. Kessler fails to create a material issue as to general
causation. He states that “[w]hile I leave it to other epidemiologists to discuss the strengths and
limitations of each study, none of the limitations negate the fact that the study results represent
positive evidence.”80 In this litigation there is no admissible testimony from “other
epidemiologists,” and Dr. Kessler’s own statement demonstrates that he has not conducted the
analysis that the Court has explained in its earlier opinions that Daubert requires in this
litigation.81 Dr. Kessler’s opinion that “the existence of studies that do not show a statistically
Plffs.’ Ex. 7 at ¶ 19.
Plffs.’ Ex. 7 at ¶ 15.
Cf. Hendrix, 609 F.3d at 1202 (holding that because the expert failed to reliably rule in his theory of
causation, the court did not need to “venture into the quagmire of attempting to define the parameters of a reliable
process of ‘ruling out’ other possible causes” of the disease in question).
See General Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997) (holding that “nothing in either Daubert or the
Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only
by the ipse dixit of the expert).
Robinson Decl. Ex. 24. The report is dated June 15, 2015.
Id at ¶ 202.
However, given the discussion of the epidemiological studies in the report, it appears that Dr. Kessler
does recognize the importance of such evidence in establishing causation.
significant risk does not negate the statistically significant positive studies that indicate a risk,”
would serve to confuse a jury, particularly given that there is no evidence that Dr. Kessler
himself has reconciled the contrary studies using scientifically acceptable methodology.82
Therefore, the Court declines to consider Dr. Kessler’s testimony for purposes of establishing
general causation. The Court does not reach Dr. Kessler’s opinions with regard to the
sufficiency of the warnings on the Zoloft labels, the actions Pfizer should have taken, and the
applicable regulatory issues, as these opinions cannot speak to the issue of whether Zoloft could
have caused Plaintiffs’ injuries.
Case Studies and Adverse Event Reports
Plaintiffs cite reports in which doctors or patients reported adverse events that were
perceived to occur after using Zoloft, including incidents of birth defects.83 These reports are
certainly relevant to the generation of study hypotheses, but are insufficient to create a material
question of fact on general causation. “Although a court may rely on anecdotal evidence such as
case reports, courts must consider that case reports are merely accounts of medical events. They
reflect only reported data, not scientific methodology.”84 Once again, the importance of the
epidemiological studies cannot be ignored: “in the face of controlled, population-based
epidemiological studies which find otherwise, these case studies pale in comparison.”85 This is a
Dr. Kessler’s report includes two schedules entitled “Summary of Zoloft Epidemiological Study Results
Concerning Birth Outcomes” (Schedule 11) and “Zoloft Epidemiological Studies – List of Strengths and
Weaknesses and Cohort Summary” (Schedule 12); the report notes that all of the schedules “were prepared by staff
from legal counsel at my request and subject to my review.” Id. at 6. The Court therefore cannot conclude that
these schedules represent analysis by Dr. Kessler, rather than by unknown staff employed by Plaintiffs’ counsel.
See, e.g., Robinson Exs. 110, 152.
Rider, 295 F.3d at 1199 (citing Allison v. McGhan Med. Corp., 184 F.3d 1300, 1316 (11th Cir. 1999)).
Allison, 184 F.3d at 1316 (citations omitted). Accord Glastette , 252 F.3d at 989-90 (noting that case
reports do not screen out alternative causes for the adverse event and often lack analysis).
particularly salient point in the context of birth defects, which have many potential causes,
known and unknown.86
Pfizer documents and foreign labels
Plaintiffs have produced a plethora of internal Pfizer documents, including discussions
among Pfizer’s own epidemiologists and other scientists analyzing certain epidemiological
studies. The Court has ruled that statements set forth in Pfizer company documents such as
literature reviews of published studies are not typical of documents that experts would generally
rely upon in a causation analysis, in part because “[t]he cited studies themselves are a better
source of information regarding the methods used and the results of studies of the association of
interest, and it is the methods, data, and results that a statistical expert . . . is called upon to
interpret.”87 The internal documents demonstrate that Pfizer employees raised questions about
associations between Zoloft and birth defects and discussed possible changes to the product
label, generally without reaching conclusive findings.88 The documents may be relevant to
questions of Pfizer’s knowledge and actions if Zoloft were found to cause birth defects, but do
not raise a genuine issue of material fact as to causation. Pfizer’s epidemiologists and others
reviewed the same epidemiological studies that Plaintiffs’ own experts unsuccessfully attempted
to use to establish causation. Neither these documents, nor draft product documents or foreign
product labels containing language that advises use of birth control by a woman taking Zoloft
The adverse event reports as to Zoloft are of a markedly different character from those in the In re:
Neurontin Marketing, Sales Practices, and Products Liability Litigation, 612 F. Supp. 2d 116, 153 (D. Mass. 2009),
as the reports in those cases included “dechallenge and rechallenge events,” in which the adverse event stops when
the patient stops taking the drug and reoccurs when the patient resumes taking the drug, as well as reports from
clinical trials, which cannot be conducted with pregnant women.
In re Zoloft, 2015 WL 7776911, at *12.
See, e.g., Robinson Decl. Exs. 148, 149.
constitute an admission of causation, as opposed to acknowledging a possible association.89 In
addition, as the FDA has listed Zoloft as a Category C drug, foreign labels provide at best
Is Summary Judgment for Defendants Warranted?
The Court has carefully considered the evidence that Plaintiffs argue creates a material
issue of disputed fact on causation. Without admissible expert testimony based on the
epidemiological evidence, Plaintiffs instead have cobbled together evidence of biological
plausibility, specific causation opinions based on an assumption that general causation has been
established, and anecdotal evidence.91 Taken together, Plaintiffs’ potentially admissible
evidence supports no more than an association between Zoloft and certain birth defects, and can
only establish that much by ignoring the full universe of epidemiological evidence and
See Meridia Prods. Liab. Litig. v. Abbott Labs., 447 F.3d 861 F.3d 861, 866 (6th Cir. 2006) (holding that
a label that was the product of discussion between the FDA and the regulated party and warned that the drug
“substantially increases blood pressure in some patients” constituted an admission in light of the strong language of
“substantially increases” in contrast to “milder warning language such as ‘is associated with.’”) (capitalization
omitted). This is consistent with the Court’s prior rulings that establishing causation requires a “true” association:
In general, before concluding that there is a “true” association between maternal medication use
and birth defects, the teratology community requires repeated, consistent, statistically significant
human epidemiological findings, and studies which address suspected confounders and biases.
Epidemiological studies alone can only inform scientists that two events (e.g., medication
exposure and a birth defect) are associated. . . . To infer a causal relationship from an association,
scientists look at well-established factors sometimes referred to as the Bradford-Hill criteria.
These include: the strength of the association between the exposure and the outcome; the temporal
relationship between the exposure and the outcome; the dose-response relationship; replication of
findings; the biological plausibility of such an association; alternative explanations for the
association; the specificity of the association (i.e., does an outcome have only one cause, or
several); and the consistency with other scientific knowledge.
In re Zoloft, 2015 WL 7776911, at * 3 (footnote omitted).
The FDA has established five categories to indicate the potential of a drug to cause birth defects if used
during pregnancy; Category C means that animal reproduction studies have shown an adverse effect on the fetus,
but there are no adequate and well-controlled studies in humans, and so pregnant women should weigh the potential
benefits against the potential risks. In re Zoloft, 26 F. Supp. 3d at 453 n.7.
Plaintiffs also present excerpts from the depositions of Defendants’ experts, who did not conclude that
Zoloft can cause birth defects, for the uncontroverted medical fact that Zoloft crosses the placenta. See Robinson
Decl. Exs. 36, 37.
disregarding the Court’s substantive and procedural rulings on general causation. Causation
must be based upon more than a possibility.
As Plaintiffs have not produced sufficient admissible evidence from which a reasonable
factfinder could determine, by a preponderance of the evidence, that Zoloft could have caused
Plaintiffs’ injuries, the Court therefore turns to the second question implicated by Defendants’
motion for summary judgment: Where does the litigation go from here?
Plaintiffs’ Request to Delay or Deny Summary Judgment Pending
Plaintiffs argue that summary judgment should be denied in all cases except Long and
Goulet pursuant to Federal Rule of Civil Procedure 56(d) so that all Plaintiffs have the
opportunity to conduct discovery in their individual cases and to obtain differential diagnoses to
support their claims.92 However, Plaintiffs have failed to comply with the plain language of the
Rule, as the argument is unsupported by affidavit or declaration. No individual plaintiff has
sought to introduce his or her own expert as to general causation, and as discussed above, a
differential diagnosis is insufficient to establish general causation.93 It is also worth
emphasizing, again, that the path to establishing general causation was fully laid out in pretrial
orders and the Court’s rulings, and the Court will not allow Plaintiffs to disregard the entire
course of the MDL proceedings.94
The Rule provides that “[i]f a nonmovant shows by affidavit or declaration that, for specified reasons, it
cannot present facts essential to justify its opposition, the court may: (1) defer considering the motion or deny it; (2)
allow time to obtain affidavits or declarations or to take discovery; or (3) issue any other appropriate order.” Fed. R.
Civ. P. 56(d).
See Garner v. City of Ozark, 587 F. App’x 515, 518 (11th Cir. 2014). This is not a case in which a party
filed for summary judgment before expert reports were due. See LaBarre v. Bristol-Myers Squibb Co., 544 F. App’x
120, 124 (3d Cir. 2013).
After the Court allowed the PSC to present Dr. Jewell as an additional expert on general causation, the
Court advised Plaintiffs’ counsel at a general status conference that cases could be subject to a summary judgment
motion even though it had not been selected as a trial case and individual discovery had not been conducted. Hr’g
Tr. Feb. 23, 2015 at 26-28 [Doc. No. 1158]. Although the PSC’s memorandum vaguely alludes to due process
Plaintiffs’ Request for Dismissal without Prejudice
Plaintiffs forcefully argue that if, as the Court has determined, summary judgment is
warranted, the cases should instead be dismissed without prejudice pursuant to Federal Rule of
Civil Procedure 41(a)(2).95 Dismissal under this Rule is within the sound discretion of the Court
and the primary purpose in requiring court approval is to protect the other party from unfair
treatment.96 The Court considers factors such as “the defendant’s effort and expense of
preparation for trial, excessive delay and lack of diligence on the part of the plaintiff in
prosecuting the action, insufficient explanation for the need to take a dismissal, and whether a
motion for summary judgment has been filed by the defendant.”97
This MDL has been extensively litigated for more than three years through substantial
discovery from Pfizer and two rounds of Daubert hearings on five experts, at what must have
been considerable expense. Plaintiffs did not seek Court approval to dismiss the cases without
prejudice until after Defendants moved for summary judgment in the wake of the exclusion of
Dr. Jewell’s testimony. Plaintiffs argue that they should have the opportunity to bring the cases
at a later time should the claims become viable, and that the interests of the minor Plaintiffs
should be protected by preserving their right to sue in the future. The Court is not persuaded that
the cases upon which Plaintiffs rely in support of these arguments augur in favor of dismissal
without prejudice in this MDL.
concerns, the argument is not developed. The Court is satisfied that all Plaintiffs had notice and opportunity to bring
evidence on general causation before the Court, or to seek dismissal without prejudice of any individual cases, if
they so chose.
The Rule provides in relevant part that “an action may be dismissed at the plaintiff’s request only by
court order, on terms that the court considers proper. . . . Unless the order states otherwise, a dismissal under this
paragraph (2) is without prejudice.” Fed. R. Civ. P. 41(a)(2).
Grover v. Eli Lilly and Co., 33 F.3d 716, 718 (6th Cir. 1994) (citation omitted).
In In re Paoli R.R. Yard PCB Litigation,98 the Third Circuit held that several plaintiffs in
a multi-plaintiff litigation stemming from exposure to toxic substances who asserted both
property damage and personal injury claims should be permitted to dismiss without prejudice the
personal injury claims because they were not presently suffering injuries, but could manifest
harm from exposure in the future.99 Significantly, the court found that there was no indication
that defendants had litigated the personal injury claims, having focused on issues of causation,
exposure, and non-physical injury.100 Here, all Plaintiffs allege that the injury has occurred and
the reason Plaintiffs seek to keep the litigation gates open—that they may at some point in the
future be able to establish general causation—is precisely the issue that has been exhaustively
The New York district court in In re Agent Orange Products Liability Litigation,101
granted dismissal without prejudice to minor plaintiffs who lacked evidence at the time to
support their claims because the scientific evidence may not have been fully developed.102
Importantly, the court concluded that the plaintiffs’ attorneys had done little to advance the case
while it was pending, and thus no substantial burden had been placed on the defendant.103 Here,
the issue of general causation has been thoroughly litigated, with the result that Plaintiffs cannot
prevail despite having multiple opportunities to produce the required expert testimony. All of
the minor Plaintiffs’ lawsuits were brought by those legally authorized to pursue claims on their
916 F.2d 829 (3d Cir. 1990).
603 F. Supp. 239 (E.D.N.Y. 1985).
Id. at 247.
Id. at 248.
behalf and there is no principled basis for distinguishing the cases that happened to be selected as
initial trial cases from the other cases in the MDL, as the failure to establish general causation
affects all Plaintiffs equally. Dismissal without prejudice under the circumstances of this MDL
and in the face of this essential defect of proof would work against the fair administration of
justice. The Court recognizes that the final scientific verdict as to whether Zoloft can cause birth
defects may not be delivered for many years. Nevertheless, Plaintiffs chose when to file their
cases, and the Court concludes that for the Plaintiffs who have continued to pursue their claims,
the litigation gates must be closed.104
Throughout the course of this MDL, the Court’s goal has been to ensure that all parties
had a full and fair opportunity to develop their claims and defenses. At the end of the day,
Plaintiffs have failed to raise a jury question on the necessary predicate to success in any case:
that Zoloft was capable of causing their injuries. Consequently, Defendants’ motion will be
granted. An appropriate order will be entered.
Plaintiffs do not argue that there is any basis for liability against the Wolters Kluwer Defendants in the
absence of liability against Pfizer.
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