In In re: Accutane litigation (A-4952-16T1) – an appeal decided only 10 days after oral argument – the New Jersey Appeal Division applied the landmark New Jersey Supreme Court ruling In re Accutane Litigation, 234 NJ 340 (2018) (Accutane 2018), arising from the same multi-account dispute, to affirm the exclusion of two of the complainants’ experts and the dismissal of more than 3,000 cases.
the Accutane multi-country litigation involves thousands of cases in which plaintiffs claim the prescription acne drug caused inflammatory bowel disease (IBD). The litigation was divided into two parts, based on the alleged IBD injury subtype: the cases in which the plaintiffs claim that Accutane caused Crohn’s disease (CD) and the cases in which the plaintiffs claim that ‘it caused ulcerative colitis (UC).
Recap: The decision of the Supreme Court of the NJ in Accutane (2018)
On the CD side of the litigation, in 2015, the trial court allowed a request to exclude the experts of two plaintiffs, a gastroenterologist and a statistician, from testifying that Accutane caused Crohn’s disease. The Appeal Division quashed.
In 2018, the Supreme Court of New Jersey quashed the appeal division and upheld the exclusion of experts by the court of first instance. In its landmark decision, the Supreme Court reconciled the New Jersey framework for analyzing the reliability of expert testimony set out in NJRE 702 and 703 with the federal standard set out in Daubert v. Merrell Dow Pharm., Inc. In particular, the Court incorporated Daubertfactors “to be used by our courts” to assess the reliability of expert testimony, but did not declare New Jersey a “Daubert jurisdiction. âThe Court incorporated these factors because theyâ align with the general objectives of the âNew Jerseyâ standard of proof and would provide useful – but not necessary or definitive – guidance that our courts should consider when considering they are fulfilling their role of gatekeeper regarding the admission of expert testimony. “
The app of the NJ Appeal Division Accutane (2018)
In 2017, while the appeal of the trial court’s order excluding evidence on CD causation was pending, the trial court proceeded to a Kemp hearing regarding the UC side of the litigation and allowed a motion to prohibit two other experts of the plaintiffs, a gastroenterologist (the âCU-gastroenterologistâ) and an epidemiologist (the âUC-epidemiologistâ), from testifying that Accutane caused UC. The court of first instance held that the methodologies of the experts were unfounded, in part because they “ignored the fundamental principles of the scientific method, in particular the hierarchy of medical evidence”, for example: “[deviating] of accepted scientific methodology for elevating case reports and animal studies above epidemiological studies. This decision resulted in the rejection of 3,231 requests.
Initially, the UC plaintiffs’ appeal was put on hold pending the decision of the NJ Supreme Court on the CD side of the litigation. Subsequently, the Appeal Division requested further information on whether the new Daubert factors applied and whether a referral was necessary. All parties have agreed to the Daubert factors applied, even if Accutane (2018) was decided after the decision of the trial judge in this case.
Apply Accutane (2018), confirmed the Appeal Division, finding that the trial judge had not abused his discretion in excluding the applicants’ EC expert testimony. The court ruled that although these UC experts appeared qualified, their opinions incorporated the “same methodological flaws identified by the Court” in Accutane 2018, “Including disregarding eight of the nine epidemiological studies in favor of animal studies and case reports.”
Resting on Accutane (2018) and the “Reference Manual on Scientific Evidence,” the Appeal Division highlighted the accepted hierarchy of scientific evidence, with meta-analyzes “at the top, followed by single randomized trials, systematic reviews of studies of observation, single observational studies, physiological studies, and unsystematic clinical observations âbelow. The court noted that the plaintiffs’ UC experts relied exclusively on inferior forms of evidence, such as animal studies and individual case reports, to arrive at their views on causation, and did not ignored an almost uniform body of epidemiological evidence that found no association between Accutane and UC. UC experts also rejected published studies that examined thousands of subjects as “undernourished,” but relied on single case reports and studies in small animals. The Appeal Division ruled that this amounted to a failure “to apply the methodology followed by other experts in the field”.
Although epidemiological studies are “slightly more favorable to an association between Accutane” and UC than they had been to an association between Accutane and CD, the Appeal Division considered that there was insufficient scientific evidence “of a difference between these subtypes of” IBD “to justify excluding expert testimony in causation on CD while allowing similar expert testimony on causation with respect to” UC “. The court concluded that âthe trial judge did not abuse his discretion by prohibiting the expert testimony in question. Instead, it embarked on the same type of review that the Supreme Court approved in its earlier ruling.
While this decision by the Appeal Division is groundbreaking, it is expected to end the Accutane IBD litigation after more than a decade. This well-reasoned opinion, which emphasizes the reliability of the expert’s methodology, can serve as convincing support to parties seeking to exclude unfounded scientific expert testimony.
Â© 2021 Faegre Drinker Biddle & Reath LLP. All rights reserved.Review of national legislation, volume X, number 35