On August 1, 2018, the New Jersey Supreme Court clarified the state's standard for scientific evidence by incorporating the four core factors from Daubert. That ruling, In re Accutane Litigation, No. 079958, 2018 WL 3636867 (N.J. Aug. 1, 2018), unanimously overturned the decision of the Appellate Division, which itself had reversed the trial court's exclusion of plaintiffs' expert testimony. The immediate result is the death knell for the New Jersey Accutane litigation. But long term, this decision could be a game-changer and portend a sea change in product liability litigation in New Jersey.
Before Accutane, New Jersey courts followed a "relaxed" standard, which was originally adopted in 1991 for toxic tort cases only and then extended to all civil cases in 2002 in the Kemp decision: "[A] theory of causation that had not yet reached general acceptance in the scientific community 'may be found to be sufficiently reliable if it is based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.'"1
Since 1993, when the US Supreme Court decided Daubert, 39 states and the District of Columbia followed the federal courts and embraced the Daubert standard. But the New Jersey Supreme Court declined to do so and barely touched this subject, despite the significant amount of product liability litigation in the state. Accutane marked the first time the high court had addressed the Kemp standard in over a decade, the first such ruling in a toxic tort case in over 25 years, and the first ruling ever in a prescription drug case. Even on those few occasions where the Supreme Court did rule on the issue, prior to Accutane, it never found an expert's testimony to be inadmissible under the Kemp standard.
With infrequent pronouncements from the high court, references to a "relaxed" standard, and a dearth of rulings excluding expert testimony, the lower courts frequently were reluctant to exclude testimony, even when opinions were clearly against the grain and premised on little hard data. For example, in one case where the expert was excluded for impermissibly reaching conclusion based on epidemiological studies that did not support his opinion, the Appellate Court reversed the trial court for "improperly conduct[ing] its own independent review of the epidemiological studies."2 Similarly, the Appellate Division in Accutane effectively faulted the trial judge for considering whether other experts in the scientific field "would use the underlying facts and data as did plaintiffs' experts."3
In the Accutane litigation itself, a series of published epidemiological studies consistently found no statistically significant association between Accutane and IBD. Litigation regarding Accutane and IBD elsewhere in the country, including a federal MDL, had long since disappeared, with the MDL judge excluding key general causation testimony of one of plaintiffs' experts back in 2007. But the New Jersey Accutane litigation flourished. The past decade and a half saw a consolidated litigation, with roughly 7000 cases filed, at least half a dozen trials, and numerous appeals, including two previous trips to the New Jersey Supreme Court that resulted in landmark decisions on statutes of limitations and choice of law in products liability cases. Finally, Judge Nelson Johnson in 2016 granted the company's motions to exclude plaintiffs' expert testimony on general causation, but the Appellate Division reversed every page of it.
The Supreme Court granted certification and reversed the Appellate Division, providing once and for all clear rules and direction to the lower courts. The Court explained that the scientific community as a whole acknowledges a hierarchy of medical evidence, with epidemiological studies being the strongest and case reports being the weakest.4 In Accutane, however, plaintiffs' experts "employed a methodology whereby they disregarded eight of nine epidemiological studies," which found no statistically significant association between Accutane and IBD, and instead "relied on case reports and animal studies to support their opinion."5 Moreover, the Court found, "plaintiffs' experts deviated from core scientific principles and strayed from their own claimed methodology in order to reach their conclusions."6
Although the Court stopped short of declaring New Jersey a "Daubert jurisdiction," it made clear that the trial court, in its vigorous role as gatekeeper, must "assess both the methodology used by the expert to arrive at an opinion and the underlying data used in the formation of the opinion.7 When the expert "does not demonstrate the soundness of a methodology, both in terms of its approach to reasoning and to its use of data, from the perspective of others within the relevant scientific community, the gatekeeper should exclude the proposed expert testimony on the basis that it is unreliable."8 At bottom, the role of the trial court is "to determine whether the scientific community would accept the methodology employed by plaintiffs' experts and would use the underlying facts and data as did plaintiffs' experts."9
New Jersey's adoption of the Daubert factors—coupled with the Court's emphasis on the rigorous nature of the trial court's gatekeeping function and the hierarchy of scientific evidence—will have significant implications for product liability cases, which frequently rise or fall on the science. Under the US Supreme Court's recent personal jurisdiction decisions in Daimler AG v. Bauman, 571 U.S. 117 (2014), and Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), a product liability plaintiff effectively can sue only in his or her home state (where an out-of-state defendant can remove the case to federal court) or in the defendant's home state. For New Jersey's many life sciences companies, the Accutane decision should make the prospect of litigating on their home turf even more acceptable.
© Arnold & Porter Kaye Scholer LLP 2018 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
footnoes
1 Kemp ex rel. Wright v. State, 174 N.J. 412, 425 (2002).
2 Lewis v. Airco, Inc., No. A-3509-08T3, 2011 WL 2731880, at *23 (N.J. Super. Ct. App. Div. July 15, 2011).
3 In re Accutane Litig., 2018 WL 3636867, at *33.
4 Id. at *9.
5 Id. at *29.
6 Id. at *31.
7 Id. at *31.
8 Id. at *33.
9 Id.
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