Thousands of people who took the acne drug Accutane sued Roche Pharmaceuticals, the drug's maker, after suffering from side effects such as Crohn's disease.
Patients who took Accutane (isotretinoin) and suffered one or more of the severe and lasting side effects 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 discontinued, 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 reportedly has paid out millions of dollars to resolve the cases.
Roche has been ordered to pay more than $53 million to Accutane patients so far, but is appealing many of the verdicts. 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.
What Conditions Prompted Lawsuits?
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.
Among the more severe reported side effects were Crohn’s disease, miscarriages and birth defects, and suicidal thoughts.
Crohn’s disease (also called regional enteritis) is a form of IBD that can arise at any point along the gastrointestinal tract. The disease affects the lower layers of the intestinal lining and can show up as lesions between areas of healthy tissue. Crohn’s often affects either the small intestine or the colon, or both.
Miscarriage and Birth Defects
Numerous reports have surfaced about pregnant women who have taken or handled Accutane who have given birth to a child with severe birth defects. The U.S. Food and Drug Administration (FDA) advises women of childbearing age who were taking Accutane not to get pregnant. The agency’s iPLEDGE brochure warns women that the drug can cause “birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.”
Depression and Suicide
The FDA called for an additional warning on Accutane in 1998, advising users that the drug could lead to depression and suicidal tendencies. The FDA also examined the link between Accutane and increased incidence of depression or thoughts of suicide. Between Accutane’s debut in 1982 and 2000, the FDA received reports of 431 cases of depression, suicidal ideation, suicide attempts or suicide in patients treated with Accutane; twenty-four committed suicide while taking the drug, and another 13 ended their lives after quitting the drug. Patients who are experiencing any of these side effects should consult an experienced attorney who understands how to win an Accutane lawsuit.
|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||Scarring|
|Dry eyes||Dry skin|
In June 2009, Roche stopped manufacturing Accutane, 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.