Jury finds Accutane’s lack of adequate warning caused patient’s inflammatory bowel disease

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Recent Cases: Drugs

June/July 2011, Volume 30, No. 3

Jury finds Accutane’s lack of adequate warning caused patient’s inflammatory bowel disease 

Gaghan v. Hoffmann-La Roche Inc., N.J., Atlantic Co. Super., No. ATL-L-3361-04-MT, Apr. 8, 2011.

Gillian Gaghan began taking Accutane in 1998, at age 21. Within several months, she began suffering gastrointestinal pain and was diagnosed with inflammatory bowel disease (IBD). Gaghan now suffers from ongoing abdominal pain and cramping and permanent diarrhea. Her past medical expenses totaled about $125,600.

Gaghan sued Hoffmann-LaRoche, Incorporated, the manufacturer of Accutane, alleging that the drug’s labeling failed to adequately warn her physician about the IBD risk. The plaintiff offered evidence that the label contained only a brief warning in plain type stating that Accutane has been temporally associated with IBD. She contended that the manufacturer was aware of a direct cause-and-effect relationship between Accutane and IBD but failed to make this clear in the labeling. Internal company records showed the company had concluded on several occasions that Accutane was the probable cause of IBD in certain patients.

The plaintiff also alleged that the warning was inadequate because it cited a temporal association between IBD and Accutane, while the side effects and damage caused by the drug could extend long after users stopped taking it.

The jury found that Accutane was a substantial factor in Gaghan’s development of IBD, that the defendant failed to adequately warn her physician of the risk, and that this failure to warn was a substantial contributing factor in Gaghan’s taking the drug.

The jury awarded just under $2.13 million. The addition of prejudgment interest may bring the award to more than $3 million.

Counsel anticipates posttrial motions and a possible appeal.

Plaintiff’s Counsel

Michael D. Hook,

Stephen F. Bolton,

Mary Jane Bass, and

William F. Cash III, all of Pensacola, Fla.

David R. Buchanan, New York, N.Y.


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