A federal appeals court has overturned a $2 million verdict in an Accutane lawsuit brought on behalf of a California woman who said that the acne medication caused her to suffer severe gastrointestinal damage.
The appeals court reversed a 2011 verdict by a New Jersey jury, which awarded damages to Gillian Gaghan in a lawsuit filed against Roche in 2004 for failing to adequately warn that side effects Accutane were linked to ulcerative colitis, a form if inflammatory bowel disease (IBD).
The court determined that since Gaghan’s doctor indicated that he knew about the IBD risk but felt it was unnecessary to pass that risk on to Gaghan, she could not make a failure to warn case against the company. The appeals court also upheld two defense verdicts from two other Accutane cases that were tried alongside Gaghan’s.
Known generically as isotretinoin, Accutane has been linked to an increased risk of inflammatory bowel disease, which could lead to ulcerative colitis, Crohn’s disease or other damage to internal organs. This has left many former users of the acne medication with severe stomach and gastrointestinal problems that can cause a great deal of pain and can have a devastating impact on their quality of life.
More than 3,000 people have filed a similar Accutane lawsuits against Roche, alleging that they suffered bowel problems as a result of the drug makers’ failure to warn about the potential side effects. Several of the cases have resulted in multi-million dollar damage awards, but Roche continues to defend the cases.
In Gaghan’s case, the New Jersey appeals court applied California law, finding that the case should have been dismissed.
Gaghan testified that had she been adequately informed about the risks of Accutane and IBD, she would hot have taken the drug. In a patient guide there was some warning, but Gaghan believed that the use of the word temporal meant that the side effects would be temporary. However, Accutane IBD can do permanent and lasting damage.
Gaghan suffered severe gastrointestinal damage from the acne medication that left her without nighttime bowel control. She developed ulcerative colitis and lupus-like symptoms. Her doctor testified that he knew about the IBD risk but did not pass that information on to Gaghan, deciding that the benefits far outweighed any risks.
In March, a New Jersey jury awarded $1.5 million in damages in another Accutane bowel disease lawsuit, involving a plaintiff diagnosed with IBD after using the acne medication. That case originally went to trial in 2010, resulting in a $10.5 million award that was overturned on appeal, after Roche challenged the original verdict, arguing that certain evidence was excluded that should have been presented to the jury.
Following the retrial, the jury found once again that Roche failed to adequately warn about the potential side effects of Accutane, which have been linked to the development of ulcerative colitis and Crohn’s disease.
Roche has lost 10 of the 13 cases that have gone before a jury, but has had several overturned or reduced on appeal.