A Florida jury has awarded $7 million in damages to a patient who needed to have his colon removed after taking the acne drug Accutane. After deliberating for two days, the jury found that the drug’s maker, Roche Holdings AG, failed to warn Adam Mason, 31, that Accutane could cause inflammatory bowel disease (IBD). The verdict was the second awarded to a patient who developed the serious condition after taking Accutane, and Roche still faces 400 other lawsuits filed by people who suffered serious side effects related to the use of Accutane.
Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. In addition to IBD, the drug has been associated with myriad other serious side effects. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to 266 cases of suicide in the United States. Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems.
A 2004 USA Today article reported that in the mid-1990s, contrary to advice from its own doctors, Roche executives chose not to issue stronger warnings about Accutane’s depression risks. According to the article, Roche decided against the warnings after its marketing department expressed concern that doing so would hurt sales. At the time, Accutane was one of Roche’s top-selling medications, bringing in more than $1.2 million every year.
In 1997, in the face of mounting evidence, the FDA finally required Roche to include a suicide warning on the Accutane package insert. Then in 2006, the FDA began the iPledge registry program. This program requires patients to sign a document informing them of the drug’s risks. Patients must also agree not to share their medication with anyone else, and to make follow up visits with their doctors. The program has special requirements for women of childbearing age, including the requirement that they submit to regular pregnancy tests at their doctor’s office. The prescribing physician is then required to enter the results of the tests into the iPledge database. Women also must sign a pledge that they would use birth control while taking Accutane. Despite these precautions, many consumer advocacy organizations have called for Accutane to be removed from the market, contending that its risks far outweigh its benefits.
In May, a New Jersey jury ordered Roche to pay another IBD victim $2.62 million for his injuries. That patient had developed IBD after having taken Accutane for 4 months in 1995. In addition to having his colon removed, that plaintiff also had most of his rectum removed and had to wear a colostomy bag for years. In addition to the $2.62 million, the jury also awarded the patient $119,000 to cover medical expenses.
Roche insists that the link between Accutane and IBD is still unproven, despite the fact that Accutane’s label includes a warning about IBD risk. Roche said it plans to appeal the New Jersey Accutane verdict, and it is expected that the company will appeal the Florida verdict as well.
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