An Alabama man who developed inflammatory bowel disease after taking the acne drug Accutane has won $25.1 million in damages from Roche, which makes the medication. The verdict came in an appeal of a lawsuit Roche had already lost and included more than $159,000 in direct compensation for the medical expenses the man incurred while undergoing colon removal and other treatments for his IBD.
A juror who heard Roche’s appeal and ruled for the plaintiff told Business Week that the drug maker had failed to warn users sufficiently about possible severe side effects from taking Accutane. The product, which contains the active ingredient isotretinoin, has also been linked to major depression, suicide, birth defects, miscarriages and strokes. Isotretinoin is also marketed in the United States under the brand names Amnesteem (Genpharm), Claravis (Barr/Teva) and Sotret (Ranbaxy).
Accutane and other isotretinoin products undoubtedly work to cure acne, as the following video indicates. But the medication also has numerous serious potential side effects, which the video shows, too.
Regulators consider Accutane and its identical competitors dangerous enough that U.S. prescribers, pharmacists and patients can only distribute and purchase isotretinoin products if they participate in an access control system called iPLEDGE. However, iPLEDGE was not launched until 2004, which was 22 years after the FDA first approved Accutane, and nearly a decade after the man who won this latest judgment against Roche for injuries suffered from the drug developed IBD. Roche withdrew Accutane from the U.S. market in June 2009.
Drug makers have a duty to warn patients and prescribers fully about the side effects of medications. When companies fail to meet this duty, people injured or killed by the drugs have an undeniable right to compensation for their suffering and medical expenses. The jury that heard Roche’s appeal of the Accutane judgment recognized this and ruled accordingly.
EJL