176 F. Supp. 3d 483 | E.D. Pa. | 2016
OPINION
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.”
I. BACKGROUND
Early in the MDL, the parties agreed to a schedule to govern proceedings in the MDL.
By opinion and order dated August 12, 2014, the Court excludéd in part the opinions of the PSC’s three other general cau
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.
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 biosta-tistics professor, as an additional expert witness on general causation with regard to cardiac defects.
Defendants raised a Daubert challenge as to the admissibility of Dr. Jewell’s testimony and report.
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.
II. LEGAL STANDARDS
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.”
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.
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.
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 Dau-bert challenge until [they] ‘get[ ] it right.’”
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.”
'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 prodi
1. The Role of Epidemiological Evidence
Plaintiffs argue that epidemiological evidence is not required to establish general causation.
Several courts have held that positive human epidemiological studies are required to reach reliable conclusions as to whether an agent is teratogenie 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*493 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 opinion.51
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 their opinions.52
In other words, in order to successfully opine on general causation (ie., that Zoloft can cause birth defects), any expert must account for the findings reached in the full universe of epidemiological studies.
2. Expert Evidence
a. 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.
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 now.
The Court’s Dcmbert 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. Ab-dulla.
b. Dr. Abdulla
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.
A differential diagnosis assumes that general causation has been established.
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.”
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 exposure-outcome 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 peer-reviewed 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 clinically important (or significant) and what is statistically significant,
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.”
c. Dr. Kessler
Plaintiffs submit the expert report of David A. Kessler, M.D., a former Commissioner of the FDA.
3. Non-Expert Evidence
a. 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.
b. 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.”
B. 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.
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?
1. Plaintiffs’ Request to Delay or Deny Summary Judgment Pending Case-Specific Discovery
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.
2. 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).
In In re Paoli R.R. Yard PCB Litigation,
The New York district court in In re Agent Orange Products Liability Litigation,
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.
ORDER
AND NOW, this 5th day of April 2016, upon consideration of the Pfizer Defendants’ Motion for Summary Judgment [MDL Doc. No. 1521], in which the Wol-ters Kluwer Defendants have joined [MDL Doc. No. 1525], and the arguments in support thereof and in opposition thereto, and for the reasons explained in the accompanying opinion, it is hereby ORDERED that the Motion is GRANTED and:
1. Summary Judgment is ENTERED in favor of Defendants Pfizer, Inc., J.B. Roer-ig & Company, Pfizer International LLC, . and Greenstone LLC and against Plaintiffs in all cases listed on Exhibit A;
2. Summary Judgment is ENTERED in favor of Defendants Wolters Kluwer Health, Inc. and Wolters Kluwer United States, Inc. and against Plaintiffs in all cases listed on Exhibit B; and
3. The Clerk is directed to CLOSE all cases in which summary judgment is entered EXCEPT for those cases listed on Exhibit C, in which claims against other Defendants remain pending.
It is so ORDERED.
Attachment
EXHIBIT A
EXHIBIT B
EXHIBIT C
. Doc. No. 1 a£ 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. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (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.
. 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 filed.
. See Joint Motion [Doc. No. 285]; Pretrial Order No. 15 [Doc. No. 287, entered November 16, 2012],
. 509 U.S. 579, 593-94, 113 S.Ct. 2786, 125 L.Ed.2d 469 (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 útero.” 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.
. 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 Hydrocloride) Prods. Liab. Litig., 26 F.Supp.3d 466, 473 (E.D.Pa.2014).
. Id. at 475.
. Id. at 476 n. 45.
. In re Zoloft (Sertraline Hydrocloride) Prods. Liab. Litig., No. 12-md-2342, 2015 WL 314149, 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.
. 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.
. Doc. No. 1452.
. Id.
. In re Zoloft (Sertraline Hydrocloride) 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.
. Fed. R. Civ. P. 56(a).
. Anderson v. Liberty Lobby, Inc., 477 U.S, 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986),
. Id.
. 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, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
. Anderson, 477 U.S. at 249-50, 106 S.Ct. 2505 (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).
. 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
. 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 citations omitted).
. 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 Glastetter 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.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 dbes 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.3d 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 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 Deck Ex. 164 (Dr. Levin's report of June 15, 2015); Fox Decl. Ex. 2 (Dr. Sad-ler's report in Goulet dated June 15, 2015); Smith Deck Ex. 4 (Dr. Sadler’s report in Long dated June 15, 2015); Plffs.' Ex. 8 (Dr. Sad-ler’s declaration in Goulet dated Jan. 12, 2016); Plff.s’ Ex. 10 (Dr. Sadler's declaration in Goulet dated January 21, 2016).
. Doc. No. 1558.
. 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 consent,”).
. 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. Warner-Lambert Co., 424 F.3d 249, 254 (2d Cir.2005)),
.Feit v. Great West Life and Annuity Ins. Co.,
. 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 marks omitted).
. Heller, 167 F.3d at 156.
. Pis.’ Exs. 7& 9 at ¶ 15. Dr. Abdulla also stated that he considered "epidemiological evidence” and "all relevant scientific and medical literature.” Pis.’ Ex. 7 at ¶ 18.
. Smith Decl. Ex. 1 at 14; Fox Deck Ex. 3 at 14.
. Smith Deck Ex. 1 at 11; Fox Deck Ex. 3 at 11.
. Smith Deck Ex. 1 at 15; Fox Deck 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.1.1994), aff'd, No. 94-7199, 1994 WL 16973481 (3d Cir. Dec. 15, 1994).
. DeLuca v. Merrell 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).
. 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, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) (holding that "nothing in either Dau-bert 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.
. 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. Kes-sler, 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 Glastetter, 252 F.3d at 989-90 (noting that case reports do not screen out alternative causes for the adverse event and often lack analysis).
. 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.
. See Meridia Prods. Liab. Litig, v. Abbott Labs., 447 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 thé 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,
. 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 Fed.Appx. 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 Fed.Appx. 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 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).
. Id.
. 916 F.2d 829 (3d Cir.1990).
. Id.
. Id.
. 603 F.Supp. 239 (E.D.N.Y.1985).
. Id. at 247.
. Id. at 248.
. Plaintiffs do not argue that there is any basis for liability against the Wolters Kluwer Defendants in the absence of liability against Pfizer.