Accutane Settlements

Accutane is a prescription medication mainly prescribed for the treatment of severe forms of acne. The Food and Drug Administration gave its approval for the drug in 1982. In the United States, the maker of the drug is Hoffman-LaRoche. The company is a part the LaRoche Group, which has numerous affiliates in 150 countries. Bringing in annual sales of approximately 1.2 billion dollars, Accutane was one of the biggest sellers for the manufacturer.

About Accutane

Accutane is a synthetic form of Vitamin A and is also marketed under the names of Claravis, Decutan, Istane, Sotret, Ratane, Raccutane, Amnesteem. Isotretinoin is the generic name of the medication.

It has been a very controversial drug because of its numerous side effects.

Accutane Side Effects

The first attention given to the drug's side effects occurred in the 1980s, when it was discovered that the drug caused birth defects that were severe in nature.

Some of the other various side effects that have been linked to the drug are problems with the kidneys, pancreas, liver and the central nervous system. Other health issues may include problems with the cardiovascular system, the auto-immune system, and musculoskeletal problems.

In addition, Accutane has been linked to Inflammatory Bowel Disease. IBD makes reference to two different types of diseases that are chronic and are related to inflammation of the in the intestines. Crohn's Disease has a variety of symptoms because it can cause problems in any part of the gastrointestinal tract. The usual symptoms are pain in the abdomen, vomiting, weight loss, or diarrhea. There is no cure, but some medications can control symptoms or stall relapses.

Ulcerative Colitis occurs when the intestine's inner lining is inflamed and ulcers develop. It is severe in the rectal area when it causes diarrhea. If the colon lining is damaged, mucus and blood could possibly appear in the stool.

FDA Warnings

Because of the numerous side effects of Accutane, the FDA required all packaging and marketing for the drug to include black box warnings. There was also the iPLEDGE requirement that pregnant women had to meet according to the FDA's guidelines. Women had to be aware of the possibility of miscarriages and birth defects. Physicians were required to warn women to quit the drug immediately if they found they were pregnant.

Accutane Lawsuits

Because of all the side effects, thousands of lawsuits have been brought against Roche and physicians who have prescribed the drug to patients. While only a few cases have been settled thus far, Roche has been held responsible for more than $45 million in cumulative settlements for victims of severe side effects.

Accutane Settlements

A 24-year old hairdresser from Utah, Kamie Kendall, was awarded compensatory damages of $10.5 million dollars and another $78,500 dollars for medical expenses. Kendall originally started taking Accutane at 12 years of age. When she was 14, she was diagnosed with Ulcerative Colitis. Her colon had to be removed in 2006, and it resulted in her suffering ongoing gastrointestinal problems. She was the third plaintiff that had successfully sued Roche in a case pertaining to IBD.

In a case in Florida, Adam Mason was awarded $7 million dollars from a jury after it was ruled that Roche did not adequately warn patients of the risks involved in taking the Accutane. Mason was diagnosed with Crohn's disease after taking the drug for a period of nine years. Mason suffers from depression, diarrhea, and fatigue. At the time of the court proceedings, it had been 5 years since he was able to work a full-time job.

Manufacturer Response

Roche representatives have stated that the verdicts will be appealed and it has not been proven that there is a link between IBD and Accutane. They also stated that, for over 20 years, the labeling for the drug has contained an IBD warning.