Accutane Med Guide May Have Been Inadequate

- Pharmalot

12/12/2008- Whether a medication guide provided by Roche for its Accutane acne drug adequately warned of inflammatory bowel disease will have to be decided by a jury in litigation brought against the drugmaker by 84 people in a New Jersey state court, Mealey’s Emerging Drugs & Devices reports.

The plaintiffs allege Accutane caused them to develop IBD and Roche sought a summary judgement to dismiss the litigation, arguing that a patient medication guide adopted in January 2001 made warnings about IBD adequate, according to Mealey’s. But Superior Court Judge Carol Higbee agreed with the plaintiffs that the language of the med guide does not mention IBD.

“In fact, the new language refers generally to ‘the liver, pancreas, and bowel,’ ” she wrote. “It is so general it could be found to weaken the information in the label, not strengthen it. There is no direct reference to IBD.” She added the guide also states symptoms “may not get better” after Accutane is stopped. “It is not disputed,” she wrote, “that if you have IBD, you will not get ‘better,’ in the sense you will ever be cured.”

Other language in the medication guide that Accutane “could lead” to serious health problems that “may not” clear up is “ambiguous,” Higbee continued. Noting that four juries have found that Accutane causes IBD (back story), Judge Higbee said, ” ‘could lead’ and ‘may not’ are just not direct enough to render the warning adequate as a matter of law even if they directly discussed IBD which they did not. Again, it may be adequate, but it clearly is a jury question.”

The judge rejected Roche’s argument that the guide and existing package insert form an adequate warning. Higbee already denied summary judgment on the package insert warnings and said the guide is not “sufficiently forceful to render the warning adequate as a matter of law.” And so she decided the question of whether inserts after May 2002 and the January 2001 medication guide are adequate warnings are questions best left to a jury.

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