A massive $25.16 million judgment has been awarded by a New Jersey jury to an Alabama man who filed suit against Hoffman-La Roche Inc., the pharmaceutical company that manufactures Accutane. Andrew McCarrell, 38, blamed the drug for his inflammatory bowel disorder, said the Associated Press (AP).
Accutane, which is used to treat severe acneâ€”nodular and/or inflammatoryâ€”that cannot be cleared up by other treatments, including antibiotics, has been the subject of controversy for years. It first garnered attention in the late 1980s for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the U.S.
Accutane has also been associated with inflammatory bowel disease; problems of the liver, kidneys, central nervous system, and pancreas; and cardiovascular, musculoskeletal, and autoimmune systems problems. Most recently, we wrote that Accutane has been associated with severe, and possibly fatal, skin reactions, including erythema multiforme [EM], Stevens-Johnson syndrome [SJS], and toxic epidermal necrolysis [TEN].
McCarrell took Accutane in his 20s and alleges that Hoffmann-La Roche did not appropriately warn of the Accutane side effects; McCarrell ultimately required colon removal, said the AP. Of note, the award was issued during a retrial, noted the AP. In May 2007, an appeals court overturned the original $2.6 million judgment awarded to McCarrell.
This is not the first time that the pharmaceutical giant has lost <"http://www.yourlawyer.com/topics/overview/accutane_ibd">Accutane lawsuits. Prior to this recent award, Roche has been ordered to pay in excess of $33 million to people who claim they were injured by the drug. Roche lost several Accutane lawsuits brought by people who claimed the drug caused them to develop IBD; in November 2008, a New Jersey jury ordered the company to pay $13 million to three such plaintiffs. The previous April, another New Jersey jury awarded $10.5 million to a woman who blamed the drug for her ulcerative colitis. In May 2007, a New Jersey trial resulted in an award of $2.62 million to a patient who needed to have his colon and most of his rectum removed after taking the drug. In October that same year, a Florida jury awarded $7 million in damages to another Accutane user who developed the IBD.
When Roche finally pulled Accutane from the market, it cited the high cost of product liability suits. At the time it was facing 5000 such lawsuits involving the drug.
Approved by the U.S. Food and Drug Administration (FDA) in 1982, it was ultimately pulled from U.S. markets as well as in 11 other countries. The last date for distribution of Accutane in the U.S. was June 25, 2009.
According to a recent Health Canada public health alert, a review of the Roche global safety database found that as of November 22, 2009, 66 cases of severe skin reactions including EM, SJS, and TEN in adults and children have been reported worldwide in association with Accutane. Two of the cases were fatal. While there are confounding factors for the majority of the reports received, a causal association between Accutane and these severe skin reactions cannot be excluded, Health Canada said.