In re Accutane Litigation

Supreme Court of New Jersey · 2018 · Evidence

234 N.J. 340 (2018)

Updated August 22, 2026

EvidenceExpert testimonyScientific evidenceMedical causationN.J.R.E. 702N.J.R.E. 703Rule 104 hearingKemp hearing

Facts

Plaintiffs alleged that Accutane can cause Crohn's disease. Since the New Jersey Accutane litigation began, multiple epidemiological studies had been published, all concluding that there was no causal relationship between Accutane and Crohn's disease, but plaintiffs' experts rejected most of those studies as flawed and instead relied on other materials such as case reports, animal studies, post-marketing reports, and a biological mechanism theory. Plaintiffs' causation expert, Dr. Kornbluth, opined that Accutane can cause Crohn's disease, while plaintiffs' statistician, Dr. Madigan, argued that most epidemiological studies were underpowered or biased because they failed to account for a longer Crohn's-disease prodrome. Defendants challenged that methodology as inconsistent with accepted scientific practice and offered experts who testified that epidemiological studies were the best available evidence and that plaintiffs' experts had improperly disregarded them in favor of weaker hypothesis-generating evidence.

Issue

Whether the trial court properly excluded plaintiffs' expert testimony on the ground that the experts' methodology was unreliable under N.J.R.E. 702 and 703. The court also considered what standard of appellate review applies to such civil evidentiary rulings and whether New Jersey should clarify its methodology-based admissibility standard by incorporating the Daubert factors.

Rule

In civil cases involving scientific expert testimony, the trial court must act as a rigorous gatekeeper under N.J.R.E. 702 and 703 by assessing both the expert's methodology and the underlying data to determine whether the expert applies a scientifically recognized methodology as others in the relevant field do. The proponent must show that the expert's reasoning, use of data, and application of methodology are scientifically sound and accepted by comparable experts, not merely that the expert is qualified or reaches a plausible conclusion. New Jersey courts may use the non-exhaustive Daubert factors in civil cases as helpful guidance: testability, peer review/publication, known or potential error rate and standards, and general acceptance. Appellate review of a trial court's admission or exclusion of scientific expert testimony in civil matters is for abuse of discretion.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In a New Jersey civil products-liability case in Newark, Dana Ruiz alleges that a prescription sleep aid caused her autoimmune liver disorder. Her hepatology expert rejects six large observational studies finding no association, relies instead on a handful of case reports and a rat study, and cannot identify any comparable experts who would use that evidentiary mix once those human studies are available.

Should the trial court admit the expert's causation testimony?

Explanation. In civil cases involving scientific expert testimony, the trial court must rigorously assess the expert's methodology and underlying data under N.J.R.E. 702 and 703. The key question is whether the expert applies a scientifically recognized methodology as comparable experts do, not merely whether the expert is qualified or offers a plausible conclusion. Where the expert disregards a substantial body of higher-tier epidemiologic evidence and instead relies on lower-tier hypothesis-generating evidence without showing that similar experts would do so, exclusion is proper. (Derived from In re Accutane Litigation (2018).)