FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

New Jersey Supreme Court Tosses Hundreds of Accutane Complaints

Oct. 12, 2018
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New Jersey’s Supreme Court threw out more than 500 claims alleging Roche failed to adequately warn patients that its acne drug Accutane “caused” ulcerative colitis rather than “was associated with it.”

The 532 plaintiffs claimed that the drug caused them to develop the inflammatory bowel disease, and that under laws in the 44 other states where most of the plaintiffs lived, the drug’s labeling provided inadequate warning of the risks.

But the New Jersey court disagreed, ruling that consolidating the suits in the Garden State — which has stronger protections for drugmakers who use FDA-approved labeling — was proper because that’s where the drugmaker was headquartered at the time. The unanimous decision overturned an appeals court ruling reviving the lawsuits after they were dismissed by a trial court.

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