On August 1, the Supreme Court of New Jersey issued a seminal ruling elucidating the state’s standard for admission of expert testimony in civil litigation. In a unanimous decision, the Court adopted the Daubert factors for assessing the reliability of expert testimony, and reaffirmed the trial court’s duty to engage in “rigorous gatekeeping” prior to admitting expert scientific evidence.
In re Accutane Litigation, No. A-25-17, 2018 N.J. LEXIS 988 (N.J. Aug. 1, 2018), the latest iteration of the decade-old Accutane litigation, involves allegations that the prescription cystic acne medication causes Crohn’s disease, a form of irritable bowel disease (IBD). Despite numerous epidemiological studies finding no association between Accutane and IBD, plaintiff’s expert gastroenterologist relied on post-marketing case reports, animal studies, and his theory of biological plausibility to opine that Accutane can cause Crohn’s disease. Id. at *34-41. Granting defendants’ motion to exclude such testimony, the trial court determined that the expert’s opinions “did not pass muster.” Id. at *23-24. Specifically, the trial court concluded “there is no epidemiological evidence to justify a reasonable inference that there is a causal link between [Accutane] and Crohn’s disease,” and “plaintiffs’ experts’ examination of the evidence was a ‘conclusion-driven’ attempt to cherry-pick evidence supportive of their opinion while dismissing other, better forms of evidence that did not support their opinion.” Id. at *59 (internal citations omitted).
The Appellate Division reversed, concluding that plaintiffs’ “experts relied on methodologies and data of the type reasonably relied upon by comparable experts” and “evaluated all of the evidence in accordance with established scientific standards and methodology . . . .” Id. at *59-60 (internal citations omitted). According to the Appellate Division, “defendants’ experts merely interpret[ed] the epidemiological studies differently, and . . . a difference of opinion between the experts did not mean that plaintiffs’ experts failed to rely upon a sound methodology.” In re Accutane Litig., 2018 N.J. LEXIS 988 at *60 (internal citations omitted). Stating that “a reviewing court owes somewhat less deference to a trial court’s determination[s] regarding expert testimony,” the Appellate Court “conclude[d] that the [trial] court mistakenly applied its discretion in excluding scientific testimony.” Id. at *61 (internal citations omitted).
The Supreme Court of New Jersey explicitly rejected the Appellate Division’s heightened standard of review and reaffirmed “that the abuse of discretion standard applies in the appellate review of a trial court’s determination to admit or deny scientific expert testimony on the basis of unreliability in civil matters.” Id. at *90. Finding that the trial court did not abuse its discretion in excluding the testimony of plaintiffs’ experts, the Court expounded on New Jersey’s standard for the admission of expert testimony:
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.
Id. at *102-103. The Court made clear that, to satisfy its gatekeeping role, the trial court 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.” Id. at *98. Further, trial courts are now instructed to consider Daubert’s non-exhaustive list of factors when assessing the reliability of expert testimony:
- Whether the scientific theory can be, or at any time has been, tested;
- Whether the scientific theory has been subjected to peer review and publication, noting that publication is one form of peer review but is not a “sine qua non”;
- Whether there is any known or potential rate of error and whether there exists any standards for maintaining or controlling the technique’s operation; and
- Whether there does exist a general acceptance in the scientific community about the scientific theory.
In re Accutane Litig., 2018 N.J. LEXIS 988 at *100-101. Applying this standard, the Court determined that “the trial court did the type of rigorous gatekeeping that is necessary when faced with a novel theory of causation, particularly one, as here, that flies in the face of consistent findings of no causal association as determined by higher levels of scientific proof.” Id. at *103-104.
While the Court stressed that it was “stop[ping] short of declaring [New Jersey] a ‘Daubert jurisdiction’” and “hesitate[d] to embrace the full body of Daubert case law as applied by state and federal courts,” it made clear that trial courts are to consider the Daubert factors when performing their role as gatekeepers of expert testimony. Id. at *101. It also is worth noting that the Court relied heavily on the Federal Judicial Center’s Reference on Scientific Evidence (3d ed. 2011), which should prove helpful to counsel defending products cases in New Jersey state courts. See, e.g., id. at *27 (acknowledging that “‘an association identified in an epidemiological study may or may not be causal,’ and causation must be assessed in consideration with the ‘strengths and weaknesses of the study’s design and implementation, as well as a judgment about how the study findings fit with other scientific knowledge’”) (quoting Reference Manual at 552-53), *28 (recognizing that randomized trials are “‘considered the gold standard for determining the relationship of an agent to a health outcome or adverse side effect’”) (quoting Reference Manual at 555), *32 (“‘[W]hen there is a substantial body of epidemiological evidence that addresses the causal issue, animal toxicology has much less probative value.’”) (quoting Reference Manual at 564 n.48), *96-97 (recognizing that the Bradford Hill “guidelines are invoked only after an association between an agent and a particular disease has been determined to be present; their pointed purpose is to determine whether a detected association reflects true causality, it is not to create an association that has not already been detected through appropriate studies”).