Accutane or isotretinoin is a drug prescribed for treating acne. It was approved by FDA in 1982. In late 80s, the manufacturers of Accutane faced strong public criticism as the drug was linked with birth defects caused in patients taking the drug during pregnancy. Later, Accutane also faced charges for causing psychiatric problems and inflammatory bowel disease. This lead to a number of lawsuits filed against La Roche Pharmaceuticals, the manufacturing company of Accutane.
In recent years, a sharp increase has been witnessed in the number of lawsuits filed against La Roche Pharmaceuticals related to inflammatory bowel disease. Although few such cases have gone to trial, the trend has been a disturbing news for Roche, which has already realized the potential damages these lawsuits can cause to the company. Roche was compelled to recall Accutane from the market in 2009, but the number of lawsuits have been increasing since the results and diagnosis take time to reveal the factors responsible.
Roche is facing around 400 lawsuits alleging that Accutane caused severe inflammatory bowel diseases. The U.S. Food and Drug Administration agency has been warning patients, over internet, of possible risks with the Accutane use. FDA has advised patients to take Accutane only after consulting the doctor.
An Accutane lawsuit against Roche went for trial in Florida. Adam Mason, the plaintiff of this lawsuit, blamed Roche for not providing sufficient warning against inflammatory bowel diseases. Mason used this drug for nine years and as a result suffered from Crohn’s Disease. Mason was diagnosed with this disorder in the year 2000. The patient has also suffered from fatigue, diarrhea, and depression. This made him unable to work full time. He asked for medical expenses, compensation for loss of work, pain and suffering.
An expert on gastroenterology, Dr. David Sachar, testified for the plaintiff that Roche seems not to have done any clinical studies regarding inflammatory bowel diseases caused by Accutane. He said that Accutane was the cause of the plaintiff’s condition. Roche also called their expert on gastroenterology, Dr. Richard Blumberg, who argued that Mason’s illness was not caused due to Accutane. Roche’s attorney also argued that the client had a warning printed on Accutane’s label regarding inflammatory bowel diseases, and that the warning was sufficient to put consumers on notice of the risk of these side effects.
The jury came to conclusion that the warning provided by Roche was not sufficient, as it did not indicate the severity of the problem. The jury awarded Mason with $5,146,500 for future pain and suffering, $766,500 for prior pain and suffering and $387,561 for future medical expenses. He was also awarded with $617,599 for the lost earning capacity, and $110,134 for lost earnings. Roche spokeswoman Shelley Rosenstock has said in a statement that the company was disappointed and would appeal the verdict.
Powers Taylor LLP had no involvement with the Mason lawsuit.
Since its approval in 1982, Accutane has been used by around 13 million people. Basel, Switzerland-based Roche had lost patent protection on the drug in 2002. Accutane is manufactured by the Roche unit of Hoffmann-LaRoche Inc. of Nutley, New Jersey. Accutane has been used for acne treatment since its introduction to the market, but it has been associated with many psychiatric problems, inflammatory bowel disease, and birth defects if taken by pregnant women. Under significant pressure from the FDA and consumers’ groups, Roche finally removed this drug from the market in the year 2009.
