In re Accutane Litig., 191 A.3d 560

Background

This is a mass-tort MCL involving >2,000 plaintiffs alleging Accutane (isotretinoin) causes Crohn's disease; litigation coordinated in Atlantic County after designation in 2005.
Since 2009 multiple large epidemiologic studies and a meta-analysis uniformly found no causal link between Accutane and Crohn's disease; plaintiffs' experts disputed those studies as methodologically flawed.
Plaintiffs offered two experts: Dr. Kornbluth (gastroenterologist) who opined general causation, and Dr. Madigan (statistician) who critiqued epidemiologic study design and performed disproportionality analyses.
Defendants offered epidemiology and clinical experts who maintained the epidemiological evidence is the best, most reliable evidence and that meta-analysis supports no association.
After a pretrial (Kemp) Rule 104 hearing the trial court excluded plaintiffs' experts as using unsound, cherry-picked methodology; the Appellate Division reversed and allowed the testimony.
The New Jersey Supreme Court granted certification to decide (1) whether the trial court properly excluded the testimony, (2) the correct standard of appellate review, and (3) whether Daubert factors should inform New Jersey's Rule 702 analysis.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Admissibility of plaintiffs’ experts on causation	Plaintiffs: experts used accepted scientific methods, considered all evidence, and may challenge epidemiology.	Defendants: experts ignored superior epidemiologic evidence and relied on lower-tier data (case reports, animals); methodology unreliable.	Court: Trial court properly excluded plaintiffs’ experts for using internally inconsistent, cherry-picked methodology in face of uniform epidemiology.
Standard for assessing expert reliability under N.J. law	Plaintiffs: Rubanick/Kemp methodology-based standard suffices; no need to adopt Daubert.	Defendants: Courts should adopt Daubert factors to give concrete guidance and ensure robust gatekeeping.	Court: Incorporates Daubert factors as non-exclusive guidance into New Jersey Rule 702 gatekeeping but stops short of wholesale adoption of federal jurisprudence.
Appellate standard of review for exclusion of expert testimony	Plaintiffs: Appellate Division may give less deference; expert-admissibility review warrants closer scrutiny.	Defendants: Appellate courts must defer to trial court gatekeeping; abuse of discretion standard applies.	Court: Reaffirms abuse of discretion standard for appellate review of civil expert-admissibility rulings; trial court afforded deference.
Proper use of epidemiology vs. lower‑tier evidence in causation	Plaintiffs: Epidemiology is one line of evidence; other lines (case reports, animal studies, biologic mechanism) may support causation and justify critiquing epidemiology.	Defendants: Epidemiologic evidence is higher in the evidence hierarchy; experts cannot disregard consistent epidemiology absent sound methodological reasons.	Court: Trial court correctly required experts to apply methodologies accepted in the scientific community and rejected reliance on lower-tier evidence when uniform epidemiology exists and experts’ methodology was inconsistent.

Key Cases Cited

Frye v. United States, 293 F. 1013 (D.C. Cir. 1923) (historic general-acceptance test for novel scientific evidence)
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) (trial-court gatekeeping; flexible factors for assessing scientific validity)
General Electric Co. v. Joiner, 522 U.S. 136 (1997) (abuse-of-discretion standard for appellate review of admissibility rulings)
Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (Daubert gatekeeping applies to non-scientific expert testimony; flexible factors)
Rubanick v. Witco Chem. Corp., 125 N.J. 421 (1991) (New Jersey moved from Frye to methodology-based reliability in toxic-tort causation)
Landrigan v. Celotex Corp., 127 N.J. 404 (1992) (trial court must assess methodology and whether comparable experts rely on similar data)
Kemp ex rel. Wright v. State, 174 N.J. 412 (2002) (expanded methodology-based review beyond toxic torts and endorsed pretrial Rule 104 hearings)
In re Accutane Litig., 451 N.J. Super. 153 (App. Div. 2017) (appellate panel decision reversing trial court's exclusion of plaintiffs' experts)