N.J. Court Revives Accutane Suicide Suit, Reversing Exclusion of Expert Opinion

-The National Law Journal

02/05/2010 - A New Jersey suit alleging Accutane caused a 19-year-old's suicide is back on track, thanks to an appeals court ruling that gives the plaintiffs another shot at admitting expert testimony that the acne drug causes depression.

The state's Appellate Division on Wednesday found that a flawed study, which led the trial court to dismiss the case, made up only a small part of the basis for Dr. J. Douglas Bremner's opinion. The panel remanded the case, Palazzolo v. Hoffman La Roche, Inc., A-3789, for the trial court "to consider whether Bremner should be allowed to testify on causation, without reference to the study."

Since the anti-acne drug was introduced in 1982, it has been the subject of myriad suits alleging it caused birth defects, psychiatric problems and bowel disease. It was withdrawn from the U.S. market in 2009, though generic versions are still available.

Hundreds of Accutane cases were consolidated on a mass tort docket in Atlantic County, N.J., in 2005, but five were left in Essex County, which claimed psychiatric injury.

One of them was a product liability and consumer fraud suit by Virginia Palazzolo over the 1997 suicide of her son, Christopher Tremain, shortly after he started taking Accutane. She alleges the label should have carried a suicide warning, which the Food and Drug Administration did not require until the year after the death.

Bremner, a professor of psychiatry at Emory University and director of the Emory Clinical Neuroscience Research Unit, led the team that conducted a causation study, funded by Accutane plaintiffs and lawyers and published in a peer-reviewed article in the American Journal of Psychiatry in 2005.

Using positron emission tomography scans, Bremner found metabolic changes in the brains of acne patients treated with Accutane that were not present in those given antibiotics instead. The area affected was the frontal lobe which is associated with depression.

Based in part on the PET study, Bremner concluded in his expert report that Accutane can cause depression and suicide.

The defense challenged the report's admissibility, leading Judge Francine Schott to hold a Rule 104 hearing at which the study's defects came to light: missing data, inaccurate data and Bremner's failure to follow the methodology he claimed he used.

Schott, based on her view that the PET study was the linchpin of Bremner's opinion, ruled he could not testify and granted summary judgment dismissing the case.

Appellate Division Judges Ariel Rodriguez, Susan Reisner and Amy Piro Chambers disagreed in a per curiam, unpublished opinion, finding that though the PET study was not reliable and should be excluded, it was not central to Bremner's opinion.

The PET study pertained to only one of the six factors used in the expert report, Accutane's "mechanism of action," or its impact on the brain, and was only one piece of evidence among many used to analyze that factor, they wrote.

The panel noted that at the hearing, Bremner "gave a very long and specific explanation detailing all of the other scientific evidence that supported his conclusion" and testified that he already believed Accutane caused depression and suicide before he did the PET study.

When Schott excluded Bremner's testimony, she "only addressed the PET study and did not address any of the other bases for Bremner's opinion that Accutane causes depression," said the panel.

The lawyer for the plaintiff, says that Bremner's opinion is likely to be admitted on remand and should be cause for concern to Roche and the generic manufacturers.

The plaintiffs attorney says he had other psychiatric injury cases involving Accutane that settled on confidential terms but the Palazzolo case is the strongest because it is the earliest, when the label was "completely devoid of warning content."

He also states that the PET study was commissioned because one was needed and Roche would not do it. His client contributed a small amount, which he declined to specify.

Colleen Hennessey, of Peabody & Arnold in Boston, who represents Hoffman LaRoche and Roche Laboratories, referred a request for comment to Christopher Vancheri, the director of public affairs for Roche.

Vancheri released a statement saying the Nutley, N.J.-based company was pleased that the PET study remains barred and is confident of success on remand.

The statement said that Roche prevailed in the only psychiatric-harm Accutane case to be tried, in a federal court in Oklahoma in 2002, and that the decision was affirmed by the 10th U.S. Circuit Court of Appeals in 2003. It also referred to a 2002 dismissal of a similar case by a federal court in Texas based on the causation expert's lack of a reliable scientific basis and also explained that "business reasons" rather than "safety or efficacy" motivated the decision to discontinue Accutane sales in the U.S.

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