Accutane Lawsuit
Initially utilized in chemotherapy treatments, researchers noted the ability of Accutane (isotretinoin) to treat acne, a skin condition characterized by whiteheads, blackheads and red pimples. Accutane is a strong form of medication used to treat acne, typically after other options to treat the skin condition have been unsuccessful.
Legal Assistance
Legal assistance is available to those who used Accutane. If you were prescribed Accutane and experienced severe side effects following use of the medication, you may wish to file a lawsuit to cover the cost of medical expenses and compensate for the pain and suffering caused by the adverse effects of the drug. If you would like additional information or have questions about Accutane lawsuits, please call 1-800-439-8180.
A current Black Box warning on Accutane cautions consumers about its potential to harm unborn children. Additional serious side effects associated with Accutane use include depression, ulcerative colitis, and liver disease. Roche Pharmaceuticals, the manufacturer of Accutane, has been named in thousands of lawsuits filed by patients who experienced severe side effects or whose loved ones experienced adverse reactions following Accutane use.
Inflammatory Bowel Disease
In 2006 the American Journal of Gastroenterology published a study that noted a link between the use of isotretinoin (Accutane) and the development of inflammatory bowel disease (IBD), a gastrointestinal disorder that refers to two chronic conditions known as ulcerative colitis and Crohn's disease.
Though ulcerative colitis and Crohn's disease are similar, the conditions affect different parts of the digestive tract. Patients with ulcerative colitis experience swelling and the formation of ulcers on the surface of the lining of the top layer of the large intestine while patients with Crohn’s disease experience thickening of the intestinal wall, most frequently in the last part of the small intestine and the first part of the large intestine.
The development of IBD following treatment with Accutane has prompted the filing of numerous lawsuits against Roche Pharmaceuticals. A woman diagnosed with ulcerative colitis received a $10.5 million award for pain and suffering in a lawsuit filed against the company, and was awarded $78,500 for medical expenses after her attorneys proved the company knew of a potential risk of IBD from Accutane, and failed to report it to the Food and Drug Administration (FDA).
Accutane Lawsuits in 2009/2010
Approximately 5,000 personal injury lawsuits have been filed against Roche Pharmaceuticals, alleging that Accutane caused the onset of bowel problems. Additional lawsuits have been filed against Roche Pharmaceuticals for adverse reactions to Accutane including suicide, psychiatric side effects, and various gastrointestinal disorders.
Accutane Lawsuit 2009: In June of 2009, Roche Pharmaceuticals pulled Accutane from the U.S. market. While the company cited growing competition from generics as a key reason for the pull, Accutane sales had declined dramatically as Roche suffered harsh criticism and a string of lawsuits filed by plaintiffs who claimed the company did not provide proper warning about the dangers of the medication.
Accutane Lawsuit 2010: In February of 2010, Roche was ordered to pay more than $25 million to a man who developed inflammatory bowel disease years after taking Accutane. The verdict was issued after an earlier decision forcing the company to pay the man $2.5 million was thrown out in a state appeals court.
Suicide Risk
The risk of suicide due to Accutane use has been denied by Roche Pharmaceuticals, though numerous lawsuits have been filed following an Accutane patient’s suicide. In 1997, the FDA addressed concerns with Roche Pharmaceuticals about reports of psychiatric disorders surfacing in Accutane patients. Roche did not inform the U.S. FDA that the French equivalent of the FDA instructed the company to include a “suicide attempt” warning on the label of the medication in early 1997. In May 2000, a warning of adverse psychiatric side effects was included on the Accutane label.
- http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107086.htm
- http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm
- http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.DrugDetails
- http://online.wsj.com/article/SB120890352155036159.html?mod=dist_smartbrief
- http://www.house.gov/stupak/accutane_chronology.shtml
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