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In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation

United States District Court, E.D. Pennsylvania

January 7, 2015



CYNTHIA M. RUFE, District Judge.


Zoloft (sertraline hydrochloride) is a prescription antidepressant, commonly used to treat depression, anxiety, and other mental health conditions.[1] Plaintiffs in this multi-district litigation ("MDL") allege that Zoloft, when taken during pregnancy, causes birth defects in the children born to exposed mothers. The Plaintiffs' Steering Committee ("PSC") offered the testimony of four expert witnesses on the issue of general causation.[2] After extensive proceedings pursuant to Daubert v. Merrill Dow Pharmaceuticals, Inc., [3] the Court determined that because Dr. Anick Berard failed to base her opinion upon scientifically valid methodology and reasoning, the opinion had to be excluded from consideration by ajury.[4] By separate opinion, the Court excluded the opinions of the PSC's three other witnesses, Drs. Thomas Sadler, Robert Cabrera, and Michael Levin, in part, ruling 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 in which altered concentrations of serotonin in a developing embryo could cause birth defects.[5]

The PSC now seeks to introduce expert testimony by Nicholas Jewell, Ph.D., a professor at the University of California, Berkeley in the Division of Biostatistics, School of Public Health, and in the Department of Statistics. The PSC represents that based "on the existing studies that were in evidence at the past Daubert hearing [and]... the results of several scientific studies that were not available at the time Dr. Berard authored her report... Dr. Jewell will opine that in utero exposure to Zoloft can cause congenital heart defects."[6] Defendants (collectively, "Pfizer") oppose the motion.


The PSC presents two bases for the Court to permit the introduction of Dr. Jewell's testimony. First, the PSC seeks to amend the relevant scheduling orders for good cause pursuant to Federal Rule of Civil Procedure Rule 16(b)(4).[7] Alternatively, the PSC argues that to deny the opportunity to present Dr. Jewell would constitute exclusion of the testimony as a discovery sanction under Rule 37(b)(2)(B)[8] because the PSC failed to identify Dr. Jewell in the time frame set by the Court and that such a sanction is unwarranted. Under these Rules, the Court has "considerable" discretion in determining whether to allow the new expert and is guided by five factors: 1) prejudice or surprise to the opposing party; 2) the ability of the opposing party to cure the prejudice; 3) the disruption of the orderly and efficient trial of the case; 4) bad faith or willfulness; and 5) the importance of the evidence.[9]


A district court is not required to "provide a plaintiff with an open-ended and never-ending opportunity to meet a Daubert challenge until [the] plaintiff gets it right.'"[10] At the same time, the district courts have an "independent responsibility for the proper management of complex litigation, " and plaintiffs "need[] an opportunity to be heard" on critical issues of admissibility of expert testimony.[11] Here, the Court is confident that the PSC has had a full opportunity to be heard. The Court, however, also must be confident that all of the implications for the MDL as a whole have been addressed. As the Court of Appeals has held:

[A] sprawling multidistrict matter such as this presents a special situation, in which the district judge must be given wide latitude with regard to case management in order to effectively achieve the goals set forth by the legislation that created the Judicial Panel on Multidistrict Litigation. See 28 U.S.C. ยง 1407(a) (permitting transfers of actions "for the convenience of parties and witnesses and [for] just and efficient conduct of such actions"). At the same time, efficiency must not be achieved at the expense of preventing meritorious claims from going forward.[12]

In assessing the relevant factors in this context, the Court finds that although there is some prejudice to Pfizer, in that it will be put to the additional expense required to litigate the admissibility of Dr. Jewell's proposed testimony, this prejudice is not of a character sufficient to warrant denial of the motion. Had the PSC presented Dr. Jewell earlier, as Pfizer contends the PSC should have done, Pfizer would be in the same position with regard to the question of the admissibility of Dr. Jewell's testimony. Although the PSC and Dr. Jewell have had the benefit of the Court's prior Daubert rulings in the formulation of the new expert report, that does not create prejudice to Pfizer. Either Dr. Jewell's expert report and testimony will pass muster under Rule 702 or they will not. In addition, there is every possibility that Dr. Jewell will be presented as an expert witness in Zoloft cases currently pending in state courts, or in cases that may be filed in the future and therefore Pfizer likely must address his expert testimony at some point. Although additional Daubert proceedings will of necessity extend the trial schedule, the MDL has moved expeditiously through the diligence and cooperation of all counsel and any delay can be addressed through the use of appropriate orders to avoid unfairness to any parties.

The Court weighs heavily the indisputable fact that the evidence is of critical importance to Plaintiffs, as "[t]he decision to admit or exclude scientific evidence and testimony... strongly affects the ability of a party to prevail."[13] The Court fully appreciates Pfizer's argument that the PSC had every opportunity to select its expert witnesses and now seeks a "Daubert do-over" after an unfavorable outcome. Had this issue arisen outside of the MDL context, this argument may have carried the day.[14] The Court in no way suggests seeking to present an additional expert only after an unfavorable Daubert ruling is an appropriate litigation strategy. The Court recognizes that "[s]ince Daubert, ... parties relying on expert evidence have had notice of the exacting standards of reliability such evidence must meet. It is implausible to suggest, post-Daubert, that parties will initially present less than their best expert evidence in the expectation of a second chance should their first try fail."[15] However, the Court has no reason to conclude that the PSC has acted in bad faith or that its present predicament is the result of deliberate strategy instead of a miscalculation as to the persuasiveness of Dr. Berard's testimony.[16] The Court also notes that the initial Daubert hearing was not futile, as the testimony ofDrs. Cabrera, Sadler, and Levin has been limited, and as it appears that Dr. Jewell's proposed expert testimony encompasses a significantly more limited range of birth defects than did Dr. Berard's. This MDL Court must consider the broader ramifications of barring an attempt to present Dr. Jewell, and has concluded that the interests ofjustice do not support such a step. The Court will grant the PSC's motion to permit the opportunity to offer for vetting the testimony of Dr. Jewell.[17] The PSC's motion will be granted.[18]

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