Patients who took Accutane (isotretinoin) and suffered one or more of the severe and lasting side effects from the drug are suing Roche Pharmaceuticals. They claim the manufacturer did not adequately warn consumers and doctors of the serious risks they faced. These patients are seeking compensation for medical expenses, lost wages, and pain and suffering.
So far, lawsuits have focused on the correlations between Accutane and birth defects, depression and suicide, ulcerative colitis and Crohn’s disease.
Accutane is used to treat severe acne when other treatments have failed. Initially developed as a chemotherapy drug, researchers noted the ability of the medication to treat acne. While successful in its dermatological applications, Accutane comes with high risks of complications, including birth defects and serious gastrointestinal side effects.
As such, the name-brand drug was recalled from the United States and many other countries, and generic versions require strict monitoring of patients during treatment. In addition, there are restrictions on how and when the generic drug can be prescribed.
More than 16 million people worldwide have been prescribed Accutane since it was introduced to the market 30 years ago. More than 7,000 personal injury lawsuits have been filed, and hundreds are still pending. Many of the cases have been consolidated on the federal level in a multidistrict litigation (MDL) in Florida and in mass torts at the state level in Philadelphia and New Jersey.
Thousands of patients have suffered and have filed lawsuits against Roche Pharmaceuticals, the manufacturer of name-brand Accutane. So far, the company has paid out more than $53 million to resolve the cases.
Roche has reportedly paid out more than $53 million to Accutane patients so far. This total comes from several large judgments:
- In 2008, a jury awarded a woman with inflammatory bowel disease $10.5 million in compensatory damages and $78,500 for medical expenses. She began taking Accutane at age 12 and was diagnosed with ulcerative colitis at age 14, but the judge said there was not enough evidence for punitive damages.
- In February 2010, the manufacturer was forced to pay more than $25 million — the largest Accutane award to date — to Andrew McCarrell, who developed inflammatory bowel disease years after he had taken Accutane. As a result, he had five surgeries and was forced to have his colon removed. The Honorable Carol E. Higbee, the judge who ruled in the case, said that McCarrell’s “testimony and that of his wife and doctors presented a picture of probably the worst case of pain, suffering and loss of quality of life I ever heard described in my eighteen years on the bench.”
- In June 2012, a New Jersey court ordered Roche to pay $18 million in compensatory damages to two Accutane patients who had developed ulcerative colitis. The cases of two other Accutane users were also tried at the same time, but they were dismissed.
Problems with Accutane
Accutane was introduced in 1982, but it wasn’t until more than a decade later that health care professionals became concerned about the drug’s serious side effects.
Because isotretinoin is a known teratogen — which means it interferes with fetal development if taken during pregnancy — women have been discouraged from the start from becoming pregnant while using the medicine. In fact, prescribers were supposed to regularly test patients for pregnancy, but fewer than half did — until stronger restrictions were put in place by the U.S. Food and Drug Administration (FDA) in 2005. Taking isotretinoin a short time before conception or during pregnancy has been linked to ear malformations, facial abnormalities, cleft palate and neural tube defects.
Many scientists believe that an association exists between Accutane and ulcerative colitis and Crohn’s disease, both of which are forms of inflammatory bowel disease (IBD). The link has not been definitively proven, but a significant number of cases were reported to Roche and published in internal company documents in 1994. Furthermore, the FDA received its own reports of IBD associated with Accutane use between 1997 and 2002.
Despite numerous reports that the medication can cause depression, psychosis and suicidal thoughts or actions, Roche has repeatedly denied that patients using Accutane have an increased risk for suicide. In 1997, the FDA discovered that Roche had failed to notify the agency that French health authorities had already required Roche to include “suicide attempt” warnings on Accutane labels. In 1998, Accutane warning labels in the United States were finally updated to include a possible risk of adverse psychiatric effects. By 2005, there had been 190 suicides linked to Accutane use.
In addition to the most severe side effects, Accutane has been linked to other changes in the body, including:
- Cessation of bone growth in children
- Excessive bone growth
- Decreased night vision
- Dry eyes
- Dry skin
Recall of Accutane
In June 2009, Roche removed Accutane from the U.S. market, citing sluggish sales due to growing competition from generics. The manufacturer’s patents expired in 2002, and many companies began selling the cheaper, generic versions of the medicine. Generic equivalents include Amnesteen, Claravis and Sotret.
Roche continues to sell isotretinoin under the name Roaccutane in other countries.