Accutane (isotrenenoine) was developed by Roche Holding over twenty years ago, and was considered the most effective treatment for severe acne ever discovered. It was widely prescribed by dermatologists for intractable cases of nodular acne and was hailed as a "miracle" cure, since it usually cleared up even the worst cases with the first course of treatment. Patients not only found their acne disappearing, they reported that it seemed to be permanently cured. The new drug, originally developed as a possible cure for skin cancer, was hailed as the ultimate answer to severe acne. Unfortunately, it was not only the best drug; it also turned out to be among the worst.

Accutane has been linked to birth defects, depression or suicide, and inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.  Ulcerative colitis is characterized by swelling and the development of ulcers on the lining of the large intestine.  Crohn’s disease symptoms include a thickening of the intestinal wall, typically in the small intestine, but can affect the entire digestive tract.  Symptoms of IBD may appear to be similar to those of the stomach flu, include abdominal cramping or pain, vomiting, diarrhea, weight loss, and intestinal or rectal bleeding.  Medications, ranging from antibiotics and anti-inflammatories to immunosuppressants, may be prescribed to relieve inflammation or infection of the ulcers.  In severe cases, surgery may be necessary. 

Few compounds produced as many severe side effects as Accutane. The most widely publicized of these was the virtual certainty of premature birth, miscarriage or birth defects when used during pregnancy. This proven side effect led to an entire set of rules and regulations concerning Accutane dispensing and treatment. Patients, doctors and pharmacies were required to abide by stringent guidelines, including signing the iPLEDGE in which users of the drug promise either to remain totally celibate or use two approved methods of contraception, to take regularly scheduled pregnancy tests and to follow other rules concerning prescriptions.

As time went on, more and more side effects of the drug were reported. These included brain damage which sometimes led to loss of sight or hearing, seizures, depression, other psychiatric disorders and even suicide. High cholesterol numbers were also frequently noted, as were bone and muscle problems. As these effects came to light, Roche Holding attempted to keep them from being publicized, but the FDA soon ordered more strongly worded warnings to be enclosed with prescriptions. These included proscriptions against breast-feeding, donating blood, taking Vitamin A and some herbal supplements, exposure to sunlight and at least a dozen others.

There's a high incidence of Inflammatory Bowel Disease (IBD) reported by users. After a report presented at the American College of Gastroenterology in 2009 showed that patients who had taken the drug were one and a half times more likely to develop IBD, Roche Holding pulled the plug on the drug. Needless to say, Accutane denied this action was taken in response to the high number of lawsuits it lost, but instead announced it was no longer profitable to manufacture Accutane because of the many generic substitutes now available in the market.

Currently, the Accutane Manufacturer Roche faces nearly 1,000 lawsuits due to the side effects associated with taking the drug.  Roche is facing liability for its failure to adequately warn users of potential Accutane side effects.  To date, Accutane users have been awarded verdicts totaling $56 million. 

A 38-year old New Jersey man, Andrew McCarrell, was awarded $25 million plus medical expenses after taking Accutane and developing inflammatory bowel disease.  McCarrell was originally awarded $2.62 million in a jury verdict, which was appealed by Roche and sent back for a retrial.  Following the retrial, the jury awarded the $25 million verdict to McCarrell who underwent multiple surgeries and ultimately had his colon removed as a result of taking Accutane during his 20’s. 
A Florida jury awarded Adam Mason, 31, a $7 million verdict after suffering from inflammatory bowel disease and undergoing surgery to have his colon removed.

A New Jersey jury also awarded a 24-year old Utah woman, Kamie Kendall, a $10.5 million verdict for her pain and suffering associated with the side affects of taking Accutane.  Kendall also had her colon removed as a result of taking Accutane when she was 12.  The jury awarded her $10.5 million plus past medical expenses over $78,000. 

A New Jersey case which consolidated three lawsuits returned a jury verdict of $12.9 million plus past medical expenses for the three Florida residents.  The plaintiffs, Jordan Speisman, Lance Sager, and Kelly Mace, all suffered from inflammatory bowel disease after taking Accutane.  The jury found Roche liable for failing to adequately warn Accutane users of the dangerous and debilitating side effects.