$25M Accutane Settlement Reinstated

Santa Clara, CAA $25.16 million award in favor of a man who alleges he developed Crohn’s disease as a result of taking Accutane has been reinstated by the New Jersey Supreme Court. The issue of alleged association between the acne drug and Crohn’s disease has been the subject of a decade long mass torte. Plaintiff Andrew McCarrell’s lawsuit is just one of 3,628 pending Accutane cases.

In a unanimous ruling, New Jersey Supreme Court stated the previously overturned award should stand, even though McCarrell filed his suit after the statute of limitations in his home state of Alabama had expired.

McCarrell was prescribed Accutane in June 1995, when he was 23, according to court documents. In his testimony, McCarrell states that his doctor failed to warn him the acne drug could cause bowel problems. In 1995 he stopped using it but a year later he started experiencing severe stomach pain and diarrhea. Although the pain and diarrhea soon cleared up, it retuned on an intermittent basis. According to court documents, McCarrel was diagnosed with colitis in November 1996, and his symptoms continued to worsen, including bloody diarrhea.

In December 1996, McCarrell had his entire rectum and colon removed and replaced with a surgically constructed "J-pouch." By April 1998, with an inflamed J-pouch and other symptoms that included fever, incontinence and mucus discharge, McCarrell traveled to Utah, where he underwent an ileostomy, in which his small intestine was brought through a hole in his abdominal wall to drain into an ostomy bag, according to the court documents.

However, in 2002 McCarrell had to undergo surgery to reverse the ileostomy and in 2003, a doctor changed McCarrell's diagnosis from ulcerative colitis to Crohn's disease, according to court documents. McCarrell had filed his suit against the Roche, the makers of Accutane, in July 2003.

Accutane was approved by the FDA in 1982 for severe, recalcitrant acne, a serious and debilitating condition that causes cysts, scarring and disfigurement. Since its approval, the drug's label carried a warning that it should not be used by pregnant women or women who might become pregnant. In 2005, the FDA approved safety labeling revisions for Accutane to inform patients of a mandatory risk management program. Roche stopped manufacturing Accutane in 2009, but there was no official recall. Generic versions, known as Isotretinoin, are still available.