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February

2010

New Jersey Appellate Division Affirms Exclusion of Plaintiffs’ Expert Report, But Accutane Lawsuit May Go Forward

Blogs, Life Sciences

Earlier this week, the New Jersey Appellate Division held that a product liability lawsuit against Hoffman La Roche for the drug Accutane may go forward. Palazzolo v. Hoffman La Roche, Inc., 2010 WL 363834 (N.J. App. Div., Feb. 3, 2010). A copy of the decision may be obtained by clicking here.

Plaintiff’s estate filed a product liability and consumer fraud complaint against Hoffman La Roche, Inc. and Roche Laboratories, alleging that plaintiffs’ decedent’s depression and eventual suicide was caused by Accutane, a prescription acne medication. During the litigation, the plaintiffs’ expert conducted a study commissioned specifically for use in the lawsuit. The study employed positron emission tomography (PET) scanners to compare the brain metabolism between two groups of patients, one of which was receiving Accutane, and a control group receiving antibiotics. The plaintiffs’ expert concluded on the basis of his study that the patients treated with Accutane showed decreased metabolism in the orbital frontal cortex, which is associated with depression. (The expert also published a peer-reviewed article in the American Journal of Psychiatry. Click here to review the article). 

Based on the PET study, the plaintiffs disclosed the expert’s report, which included the expert’s opinion as to general causation (i.e. that that administration of Accutane may causes depression and suicide). The defendants challenged the admissibility of the expert’s report, and after a lengthy hearing, the trial judge held that the plaintiffs’ expert would not be permitted to testify as to general causation, based on the trial judge’s findings that the plaintiffs’ expert’s methodology was flawed.

On appeal, the Appellate Division affirmed the trial court’s decision to bar the plaintiffs’ expert’s testimony which relied on his PET study as evidence that Accutane caused depression, noting that the expert could not document much of the data on which his published results were based, admissions during his testimony that some of his statistical analysis was inaccurate, and the expert’s own admission that he had not followed the methodology his article had established.

Despite these flaws in the plaintiffs’ expert’s methodology, the court held that the trial judge had not addressed other bases for the plaintiffs’ expert’s opinion, such as his review of other, relevant literature, the temporal relationship between the events of depression and suicide reported to the FDA, and other various factors that played a part in his opinion. Accordingly, the Appellate Division remanded the case to the trial court for a determination as to whether the plaintiffs’ expert would be permitted to testify as to whether Accutane caused depression without making reference to his PET study.