Accutane Case

Radio Law Talk Segment

Accutane Case

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The Accutane litigation was argued in the Superior Court of New Jersey, Appellate Division on July 8th, 2017. This case is a multicounty Litigation (MCL) case consisting of 2076 products liability cases. The Plaintiffs’ contend that they have developed Crohn’s disease as a result of taking Accutane. Accutane is a prescription acne medication manufactured by defendants, Hoffman La-Roche Inc. and Roche Laboratories Inc.


FACTS (brief, 6 sentences):

After a Kemp hearing at the trial level, the court granted Defendants’ omnibus motion to bar plaintiffs’ expert witnesses, Dr. David Madigan and Dr. Arthur Asher Kornbluth, from testifying that the epidemiology studies on which the defense relied were flawed and unreliable, and that Accutane can cause Crohn’s disease. The trial court then issued an order dismissing 2076 MCL claims with prejudice. The Plaintiffs’ appeal.


ISSUES (both sides):

Plaintiffs – On appeal, the issue is whether the trial court misapplied its discretion in finding that the Plaintiff’s expert witnesses’ methodologies and studies were scientifically unreliable and inadmissible.


LAW (with references, no need for blue book citations):

“Expert testimony should not be excluded merely because it fails to account for some condition or fact that the opposing party considers relevant.” State v. Dreher, 302 N.J. Super. 408 , 464 , 695 A.2d 672 (App. Div. 1997)


N.J.R.E. 104 hearings “are intended to determine admissibility, not credibility.”

“[R]egardless of a trial judge’s view of the weight a party’s evidence deserves, the judge should trust the jury to evaluate witness credibility and decide what weight to give each side’s evidence.” State v. Stubblefield


DETAILED FACTS (tell the story):

On appeal, the court agrees with the Plaintiffs’ that the trial court took too narrow of a view when determining whether the experts were using accepted scientific methodologies to analyze the evidence, and improperly determined the weight and credibility of the experts’ testimony. Furthermore, although the experts had plausible explanations, the Judge condemned the experts for relying on relevant scientific evidence other than epidemiological studies. In reaching the Appellate Courts conclusion, the court notes that the testimony should not be barred because their analysis emphasized different evidence and produced different conclusions than those reached by the defense experts. The fact that plaintiffs’ experts found certain evidence to be critically important did not constitute improper “cherry picking,” because they provided plausible scientific explanations for their choices. The judge’s disapproval of plaintiffs’ experts’ reliance on “lines of evidence” seems misplaced, because the defense used the same terminology and considered the same evidence. Dr. Oliva-Hemker (defense expert) agreed that she and Dr. Kornbluth looked at the same lines of evidence, although they reached different conclusions from the evidence. Therefore, the case was remanded to the trial court and the Plaintiffs’ are entitled to present the expert testimony.


OTHER FACTS (interesting facts, related facts, trivia, etc.):

“Epidemiological studies identify agents that are associated with an increased risk of a disease in groups of individuals, but “is not equivalent to causation.””


“All of the Accutane epidemiological studies to date are less rigorous observational studies, which are considered to be the next best available evidence.”


“Kornbluth reviewed six observational epidemiological studies (Bernstein, Crockett, Alhusayen, Etminan, Racine, and Sivaraman), only one of which (Sivaraman) found a statistically significant positive association between Accutane and Crohn’s disease, one found a statistically significant negative association (Racine) and no study concluded that Accutane use presents an increased risk for developing Crohn’s disease.”




MEDIA (less than a 2 minutes funny sound bite. You can include a couple of options. We realize that for some topics there is not much):


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