The New Jersey Supreme Court has agreed to review two state appellate decisions relating to the coordinated litigation involving Accutane, Hoffmann-La Roche’s anti-acne medication, with far-reaching implications for products liability litigation in New Jersey. The Appellate Division decisions address issues related to adequacy of the drug’s label as well as the admissibility of expert testimony on the dispositive issue of causation.

The first Appellate Division decision held that by stating that the drug had been “associated” with inflammatory bowel disease (IBD), the Accutane label did not adequately warn users of its potential gastrointestinal side effects. See In re: Accutane Litigation, 2017 WL 3138003 (App. Div. July 25, 2017). This reversed the trial court’s dismissal of 18 cases involving plaintiffs who ingested Accutane in New Jersey, finding that the labels were adequate under the New Jersey Product Liability Act (PLA), N.J.S.A. 2A:58C-4.  The PLA creates a presumption that a manufacturer’s warning regarding a drug is adequate if that warning has been approved by the Food and Drug Administration. The Appellate Division held that the word “associated” failed to inform consumers that the drug caused IBD. In its petition to the Supreme Court, Roche argued that the Appellate Division disregarded the PLA’s purpose to reduce the burden of product liability litigation on manufacturers of FDA-approved products by deferring to FDA’s product labeling expertise.

The second Appellate Division decision reinstated 2,076 dismissed cases from individuals who allegedly developed Crohn’s disease as a result of taking Accutane. See In re: Accutane Litigation, 451 N.J. Super. 153 (App. Div. 2017). The Appellate Division found that the trial court improperly barred testimony from plaintiffs’ experts and thus erred in granting summary judgment in favor of Roche.  The appellate court reasoned that when deciding whether expert testimony is admissible, the trial court must determine whether qualified experts relied on methods and data of the same kind that a comparable expert would reasonably rely upon (citing Rubanick v. Witco, 125 N.J. 421 (1991)).

New Jersey generally applies the Frye standard to admissibility of expert testimony (Kemp ex rel. Wright, 174 N.J. 412 (2002)), which is considered to be a more relaxed standard than the federal standard set forth in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). Ultimately, this approach has led to forum shopping by out-of-state plaintiffs who seek to capitalize upon this less rigorous standard and has resulted in inconsistent rulings within the New Jersey courts.

In its petition of that decision, Roche argued that the Supreme Court needed to clarify the appropriate degree of judicial scrutiny used when assessing expert testimony. This appeal gives the New Jersey Supreme Court the opportunity to clarify or expand the gatekeeper role of the trial court, particularly when faced with junk science.

Given the 21 amicus filed by some of New Jersey’s largest employers and product manufacturers in support of Roche’s appeal to the New Jersey Supreme Court, it is clear the industry understands the impact of this potential decision. This new standard could have a substantial impact on future product liability litigation in New Jersey. If the Supreme Court allows modern scientific principles rather than unreliable methods to govern expert testimony, the high court could reinstate the trial court’s ruling and dismiss more than 2,000 cases for lack of causation evidence.

The Orders are reported at In re: Accutane Litigation, No. C-388 September Term 2017 079958 (NJ Sup Ct Dec. 5, 2017) and In re: Accutane Litigation, No. C-390 September Term 2017 079933 (NJ Sup Ct Dec. 5, 2017), respectively.