IN RE: ACCUTANE LITIGATION (MCL NO. 271, ATLANTIC COUNTY AND STATEWIDE) (CONSOLIDATED)
165 A.3d 832
| N.J. Super. Ct. App. Div. | 2017Background
- This appeal arises from 2,076 consolidated Accutane (isotretinoin) products-liability suits claiming the drug caused Crohn’s disease; the trial court barred plaintiffs’ experts (a gastroenterologist and a statistician) after a Kemp hearing and dismissed the cases with prejudice.
- Plaintiffs’ experts (Dr. Kornbluth and Dr. Madigan) relied on multiple evidence types: epidemiological studies, animal studies, case reports, MedWatch/ADE reports, company causality assessments, and biological plausibility (Bradford Hill factors).
- Defendants relied primarily on several observational epidemiological studies and meta-analyses that, with few exceptions, did not show a statistically significant increased risk of Crohn’s disease from Accutane.
- The trial court excluded plaintiffs’ experts for allegedly using unsound methodology, cherry-picking small/abstract studies, overvaluing non-epidemiologic evidence, and substituting litigation-driven hypotheses for accepted science.
- The Appellate Division reversed, holding the trial court overstepped its gatekeeping role under New Jersey’s relaxed standard for toxic-tort causation evidence (Rubanick/Landrigan/Kemp), and that plaintiffs’ experts used methodologies and source-types reasonably relied on by comparable experts.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility standard for expert causation testimony | Apply the relaxed Rubanick/Kemp standard allowing non-fully‑accepted theories if methodology and sources are reliable | Experts must defer to higher‑tier epidemiological evidence; exclusion appropriate when methodology departs from mainstream | Court applied relaxed standard; trial court should focus on methodology and whether comparable experts rely on same data rather than second‑guess conclusions — admissibility favored plaintiffs |
| Reliance on non‑epidemiologic evidence (animal studies, case reports, ADE reports, company assessments) | Such evidence is appropriate when epidemiological studies are inconclusive or flawed; can support causation and biological plausibility | These lines of evidence are inferior and cannot trump population studies; reliance on them is methodology‑poor and advocacy‑driven | Appellate court: these evidence types are within acceptable scientific methodology and may be considered; weight for jury and cross‑examination |
| Treatment of epidemiological studies and meta‑analysis | Plaintiffs: many studies are underpowered, have prodrome/design flaws, or are biased toward the null; meta‑analysis may compound biased studies | Defendants: epidemiological studies and pooled analyses show no association; experts who ignore them are unreliable | Court: experts properly critiqued study design (power, prodrome, confounding); rejecting or de‑emphasizing such studies can be methodologically justified; admissibility appropriate |
| Trial judge’s gatekeeping role (did judge usurp jury/expert functions?) | Kemp hearing should test methodology, not reweigh evidence or credibility; judge erred by substituting own scientific interpretations and labeling experts "hired guns" | Judge permissibly excluded testimony that he found to be methodologically unsound and selectively reasoned | Reversed: judge went beyond gatekeeping (improperly weighed credibility and conclusions); admissibility decision abused discretion; experts may testify at trial |
Key Cases Cited
- Rubanick v. Witco Chem. Corp., 125 N.J. 421 (1991) (articulates relaxed admissibility standard permitting non‑generally accepted causation theories if methodology and sources are accepted by comparable experts)
- Landrigan v. Celotex Corp., 127 N.J. 404 (1992) (addresses reliability of epidemiological evidence and expert reliance in toxic‑tort cases)
- Kemp ex rel. Wright v. State, 174 N.J. 412 (2002) (applies Rubanick standard to gatekeeping hearings in toxic‑tort context)
- Hisenaj v. Kuehner, 194 N.J. 6 (2008) (explains admissibility requirements under N.J.R.E. 702 and scope of Rule 104 hearings)
- DeLuca v. Merrell Dow Pharm., 911 F.2d 941 (3d Cir. 1990) (federal precedent rejecting strict Frye in favor of methodology focus; persuasive on review of expert methods)
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (federal standard emphasizing methodology and gatekeeping; discussed as comparative framework)