SYLLABUS
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Kamie S. Kendall v. Hoffman-LaRoche, Inc., et al. (A-73-2010) (066802)
Argued October 24, 2011 -- Decided February 27, 2012
LONG, J., writing for a majority of the Court.
The Court considers whether plaintiff Kamie Kendall’s lawsuit against the developers and marketers of the prescription drug Accutane (collectively, Hoffman-LaRoche), was barred by the two-year statute of limitations.
Accutane is used to treat nodular acne. Its many side effects include dry skin, lips and eyes and a high risk of birth defects if taken while pregnant. This case concerns Accutane’s alleged propensity to cause inflammatory bowel disease (IBD), including ulcerative colitis, which is characterized by frequent and often bloody bowel movements, pain, and other symptoms. The symptoms wax and wane, but the condition is permanent. When the FDA approved Accutane in 1982, it did not require a warning of possible gastrointestinal side effects such as IBD.
Kendall was first prescribed Accutane in January 1997, when she was twelve years old. By that time, the information provided to physicians began to warn of a possible link between Accutane and IBD. The information provided to patients warned to stop taking the drug and consult a doctor if stomach pain, diarrhea and rectal bleeding occurred. In 1998 and 2000, the physician warnings were strengthened with regard to IBD. In 2003, the warnings provided to patients also were strengthened. These included a brochure that focused on the dangers relating to pregnancy, but also warned about “abdomen (stomach area) problems” and damages to the “liver, pancreas, bowels (intestines), and esophagus.” It advised patients to stop taking the drug and call a physician if they developed symptoms that included stomach, chest or bowel pain or diarrhea. Patients also were required to sign a consent form and watch a video about contraception. The 2003 warnings did not mention IBD or ulcerative colitis by name.
When Kendall was first prescribed Accutane, her doctor did not mention the risk of IBD because he was not aware of it. Although the patient brochure Kendall was provided warned to be on the alert for stomach pain, diarrhea and rectal bleeding, she did not experience any gastrointestinal side effects. During three additional courses of Accutane--July to September 1997, February to April 1998, and July to September 1998—Kendall also had no gastrointestinal symptoms. However, in April 1999, at a time when she was not taking Accutane, Kendall was hospitalized for bloody diarrhea and abdominal pain and was diagnosed with ulcerative colitis. Although the doctor did not identify a cause, hospital records indicated that Kendall’s grandmother also had the disease. Thereafter, Kendall took medication for the condition, and the symptoms disappeared and reappeared frequently, as is usual.