A New Jersey jury has awarded $2.62 million in damages to a patient who needed to have his colon removed after taking the drug Accutane. The case was the first of more than 400 suits pending against Roche Holdings AG, the manufacturer of Accutane acne medication. The verdict, issued on May 29, could be ominous news for Roche, as many legal analysts believe it portends more findings against the company.
Andrew McCarrell, the plaintiff in the case, developed Inflammatory Bowel Disease (IBD) after taking Accutane for four months in 1995. In addition to having his colon removed, McCarrel also had most of his rectum removed and had to wear a colostomy bag for years. He recently had surgery that rid him of the colostomy bag, but the 36-year-old software manager testified that he still suffers from severe, chronic diarrhea.
The jury agreed with McCarrell’s lawyers that the Accutane label did not provide sufficient warning about the drug’s IBD risk. In addition to the $2.62 million, the jury also awarded McCarrel $119,000 to cover medical expenses.
Introduced 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 to 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.
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