Accutane Labeling and Litigation Angst


. By Jane Mundy

Thousands of Accutane claimants in the consolidated state litigation are likely waiting anxiously to hear New Jersey Judge Nelson Johnson’s decision regarding the link to Accutane and Crohn’s disease. The outcome of the hearing was supposed to be announced by February 20, 2015.

Roche, the Accutane manufacturer, told Judge Johnson that plantiffs’ experts ignored several recent studies disputing an association with Accutane and Crohn's disease (an inflammatory bowel disorder, or IBD), calling their testimony “a war against science.” Roche argued that plaintiffs’ gastroenterology expert Arthur Kornbluth relied on flawed methodology and ignored nine epidemiological studies from the past five years that did not find a link between Accutane and the inflammatory bowel condition.

Currently, about 6,700 Accutane lawsuits claim the acne medication causes bowel disorders.

Last September in the federal Accutane multidistrict litigation (MDL), a Florida judge ruled that there was no research to show causation, although he did acknowledge an association between Accutane and irritation of the linings of the intestine. Plaintiffs claimed that Accutane’s labeling was inadequate but Judge James Moody ruled that the warning label - from 2000 to 2007 - was adequate because Roche listed in the drug’s medication guide and patient’s guides that irritable bowel disorders are a "possible consequence" of taking Accutane

It is expected in this current litigation that Judge Johnson will determine whether Accutane’s warnings after 2002 were adequate. Oral arguments regarding the warnings are scheduled to take place in mid-March.

The consolidated litigation is In re: Accutane Litigation, case number 271, in the Superior Court of New Jersey in Atlantic County.


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