New Jersey Supreme Court adopts use of Daubert factors, dismisses Accutane cases
August 23, 2018 - Kate Halloran
The New Jersey Supreme Court has reconciled its standard for evaluating scientific expert testimony with the federal gatekeeping standard set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc. (509 U.S. 579 (1993)), directing its courts to consider the Daubert factors but stopping short of adopting them as a bright-line standard. The court excluded the plaintiffs’ expert testimony in the coordinated mass tort litigation involving the prescription acne drug Accutane, which the plaintiffs alleged caused their Crohn’s disease, and ultimately dismissed more than 2,000 cases against defendants Hoffman-La Roche Inc. and Roche Laboratories Inc. (In re Accutane Litig., 2018 WL 3636867 (N.J. Aug. 1, 2018).)
The court had adopted a methodology-based approach to assessing the reliability of scientific testimony before the Daubert ruling. Although New Jersey’s approach is similar, its courts never adopted Daubert or incorporated Daubert factors into their analysis. The court initially developed its standard as it moved away from the “general acceptance” standard in Frye v. United States to widen the parameters for scientific testimony in toxic tort cases. It later expanded its reliability standard to include “all novel medical causation circumstances” and required that a pretrial evidentiary hearing be conducted to assess a scientific expert’s testimony.
Thousands of Accutane cases have gone through New Jersey courts over the last decade as part of the coordinated mass tort litigation. Plaintiffs allege that the acne medication causes gastrointestinal disease, and the cases at issue here involved plaintiffs who claimed that Accutane caused Crohn’s disease. Since litigation began, epidemiological studies have determined that a link between Accutane and inflammatory bowel disease may exist but that there is no causal link between the drug and Crohn’s disease specifically.
The trial court initiated a pretrial evidentiary hearing on this issue, and the plaintiffs presented two experts who disputed this lack of causation. One expert testified that he did not believe the epidemiological studies were reliable, partly because they did not offer separate data on Crohn’s disease. He also asserted that the studies were flawed because they did not factor in the time between the emergence of symptoms and a formal diagnosis—meaning that they may have missed patients with longer time periods between the two. The second plaintiff expert testified that the epidemiological studies were flawed as they pertained to Crohn’s disease and that their conclusions were not statistically reliable. Both experts supported one study but ultimately disagreed with its conclusions.
After the hearing, the trial court excluded the plaintiff experts’ testimony on the basis that they could not dismiss the epidemiological studies’ findings since other experts in the field used that methodology to form their opinions. A state appellate court reversed, concluding that the plaintiff experts had reviewed the studies in line with the accepted methodology and had exposed design flaws that led to unreliable results as their reasoning for not finding the studies reliable and interpreting them differently. The defendants appealed to the state supreme court, asking it to clarify the standards by which New Jersey evaluated expert testimony.
Following the U.S. Supreme Court’s ruling in Daubert and subsequent cases, the New Jersey court reviewed its existing standard and expanded it beyond toxic tort cases. It explained that a trial court must ensure that plaintiffs can defend their scientific evidence and that a pretrial hearing would allow courts to “assess whether the expert’s opinion is based on scientifically sound reasoning or unsubstantiated personal beliefs couched in scientific terminology.” The court also pointed out that it was not adopting the three-factor Daubert test that had been added to Federal Rule of Evidence 702.
The gatekeeping role for assessing admissibility of scientific testimony is complicated, the court noted, and “the trial court is the spigot that allows novel expert testimony in areas of evolving medical causation science” as long as that testimony complies with scientific norms and standards. To clarify how courts should review and evaluate scientific testimony as a gatekeeper, the court adopted the Daubert factors, including whether the scientific theory has been or can be tested, whether it has been subject to peer review, known or potential error rates, and whether it is generally accepted in the scientific community. The court emphasized that methodology, not outcome, is the relevant consideration for assessing scientific testimony. The New Jersey approach for a methodology-based reliability test and whether that methodology can reasonably be applied to the facts of a case mirrors Daubert. The court cautioned, however, that it did not “embrace the full body of Daubert case law as applied by state and federal courts.” While the Daubert factors can be helpful, they are not a standard to follow and should be applied on a case-by-case basis.
The court ultimately reversed the appellate court and excluded the plaintiff experts’ testimony because the use of epidemiological studies is the standard methodology and relying instead on other types of evidence, such as animal studies, was not sound methodology in the field.