In In re Accutane Litigation, No. 079958, 2018 WL 3636867 (Decided Aug. 1, 2018), the Supreme Court of New Jersey provided much-needed clarity regarding the admissibility of scientific evidence under the New Jersey Rules of Evidence. Although the state’s highest court stopped short of declaring New Jersey a “Daubert jurisdiction,” it adopted a majority of the factors laid out by the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Facts of In re Accutane Litigation
The class-action suit involves more than two thousand plaintiffs who allege that they developed Crohn’s disease as a result of taking Accutane. In the years since many earlier Accutane cases were decided, epidemiological studies were published, all of which concluded that Accutane is not causally associated with the development of Crohn’s disease. Accordingly, defendants filed a motion seeking a hearing on the association between Accutane and Crohn’s disease.
At the hearing, both sides produced expert witnesses. Plaintiffs produced Dr. Arthur Asher Kornbluth, a gastroenterologist, and Dr. David Madigan, a statistician. Dr. Kornbluth explained why he found the epidemiological studies unreliable and uninformative regarding causation. He also explained his reliance on other forms of evidence such as case reports, animal studies, causality assessments, and his biological mechanism hypothesis. Dr. Madigan focused on whether the epidemiological studies were appropriately designed to discover an association between Crohn’s disease and Accutane, if such an association did exist. He concluded that, after accounting for the prodrome (or the period between the onset of symptoms and diagnosis), the epidemiological studies do not provide statistically reliable information.
Defendants produced gastroenterologist Dr. Maria Oliva-Hemker, and biostatistician Dr. Steven Goodman. Dr. Oliva-Hemker’s testimony disputed Dr. Kornbluth’s testimony and explained why epidemiological studies are preferred to case reports and animal studies in the hierarchy of evidence. She also explained why Dr. Kornbluth’s reliance on animal studies was flawed, namely because dogs cannot get inflammatory bowel disease. Dr. Goodman’s testimony focused on why the epidemiologic evidence is the best available evidence on the question of Accutane’s causal relation to Crohn’s disease and why a meta-analysis was a proper way of pooling those study results to reach a conclusion that Accutane does not cause Crohn’s disease.
Following the hearing, the trial court excluded plaintiffs’ experts’ testimony. Citing the standard established in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), the court noted that an expert opinion must be based on a “sound, adequately-founded scientific methodology involving data of the type reasonably relied on by experts in the scientific field.” Here, the court concluded that the plaintiffs’ experts’ testimony lacking was a “conclusion-driven” attempt to cherry-pick evidence supportive of their opinion while dismissing better forms of evidence that did not support their opinion.
The Appellate Division reversed, finding that the trial court’s negative reaction to plaintiffs’ experts was not supported by the record. The appeals court further found that, although a trial court’s decision to admit or exclude evidence is subject to an abuse of discretion standard, a reviewing court owes “somewhat less deference” to determinations regarding expert testimony.
NJ Supreme Court’s Decision in In re Accutane Litigation
The Supreme Court of New Jersey reversed. It held that the trial court properly excluded plaintiffs’ experts’ testimony. “In this matter, the trial court did not abuse its discretion in its evidential ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts,” the court concluded.
In reaching its decision, the court decided to adopt the Daubert factors, a non-exhaustive list of factors for courts to consider using when assessing the reliability of scientific expert testimony. “[W]e now reconcile our standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases,” the court wrote. It further explained:
We are persuaded that the factors identified originally in Daubert should be incorporated for use by our courts. The factors dovetail with the overall goals of our evidential standard and would provide a helpful — but not necessary or definitive — guide for our courts to consider when performing their gatekeeper role concerning the admission of expert testimony.
With regard to how courts should evaluate scientific expert testimony, the court also emphasized the gatekeeping role of the trial court, writing:
Our view of proper gatekeeping in a methodology-based approach to reliability for expert scientific testimony requires the proponent to demonstrate that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology. When a proponent 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.
Applying the above principles to the case, the New Jersey Supreme Court found that the trial court had fully fulfilled its “rigorous” gatekeeping role and properly concluded that plaintiffs’ expert testimony should be excluded.