Accutane Inflammatory Bowel Disease Warnings Sufficient: MDL Judge

A federal judge in Florida has granted summary judgment for Roche in an Accutane lawsuit, finding that the drug maker provided adequate warnings under New York law about the risk of inflammatory bowel disease (IBD) from the popular acne medication. 

In an order (PDF) issued on July 24, U.S. District Judge James Moody, Jr. found that the Accutane inflammatory bowel disease warnings on the label in 2004, when the plaintiff in the case used the medication, were legally adequate under New York law that applied to the case.

Judge Moody presides over the federal Accutane MDL (multidistrict litigation), which has been established for all lawsuits filed against Roche in federal district courts throughout the United States by individuals who developed inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, after taking the acne medication. The complaints allege that the manufacturer failed to adequately warn about these side effects of Accutane.

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The order applies to a lawsuit filed by Michelle Colli, who was diagnosed with IBD after using Accutane in 2004. Judge Moody determined that the warnings provided on the drug’s physician label and medication guide provided adequate information about the risk of bowel problems, and found that it was the job of Colli’s physician to make sure she was aware of these risks.

Although the federal Accutane litigation has been centralized before Judge Moody since November 2004, most lawsuits filed by individuals throughout the United States are pending in New Jersey state court, where plaintiffs have been successful in obtaining several multi-million dollar verdicts after juries determined that Roche failed to adequately warn about the risk of inflammatory bowel disease from Accutane.

There are currently more than 7,000 Accutane inflammatory bowel disease lawsuits pending in New Jersey state court, where the cases are centralized for “mass tort treatment” before Judge Carol E. Higbee in the New Jersey Superior Court for Atlantic County.

Accutane, known generically as isotretinoin, has been used by more than 16 million people worldwide since it was first introduced in the early 1980s as a treatment for severe acne.

Earlier this month, a New Jersey state court jury awarded $9 million each to two Accutane plaintiffs who used the medication in the 1990s. The jury found that Roche was responsible for failing to warn those plaintiffs about the risks associated with Accutane, however, the same jury found that the drug maker was not liable for injuries suffered by two other plaintiffs, whose cases were presented during the same trial, since they believed that an adequate warning would not have led to a different result for those plaintiffs.


  • ImranNovember 1, 2012 at 1:40 am

    Forgot to say I also had to get a pregnany test once a month (even tuhogh I was abstinant, and still am), and also had to get blood drawn once a month to check my cholesteral level, because rise in cholesteral was also a possible side effect.I'm glad I took it tuhogh, it was worth it.

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