As a dangerous drug attorney I’ve written in this space about some of the dangers of the acne drug Accutane. Accutane is available only by tightly controlled prescriptions, in part because it’s a known cause of birth defects. Less well known, however, is the research connecting Accutane to a risk of depression and irritable bowel disease, a collection of conditions that includes ulcerative colitis. In Kendall v. Hoffman-LaRoche Inc., Kamie Kendall alleged that Accutane’s manufacturer, Hoffman, was responsible for failing to warn her of the risk of ulcerative colitis, which she developed at the age of 14 after taking Accutane. The drug maker argued that Kendall’s suit was barred because she waited too long to file it, but the trial court and the New Jersey Supreme Court agreed that Kendall’s suit was timely from the time when she received notice of the connection.
Kendall started taking Accutane when she was 12, in 1997. At that time, doctors had received warnings about a possible connection between Accutane and IBD, but it wasn’t until 2003 that information given to patients began to include a mention of abdominal pain. That information nonetheless focused on the better-known risk of birth defects. The doctor who originally prescribed Accutane did not mention the IBD risk to Kendall because he was not aware of it. She took four nonconsecutive courses of Accutane for three months each, ending in September of 1998. Seven months later, she was hospitalized and diagnosed with ulcerative colitis. Her grandmother also had IBD, so no connection to Accutane was made. After learning of the connection later, Kendall filed a lawsuit in late 2005 alleging Hoffman was liable for failure to warn her of the IBD risk.
Hoffman moved to dismiss the suit as untimely. The trial court denied this, finding a reasonable person would not have been on notice about the connection within the two-year deadline before the suit was filed. The appeals court agreed, taking into account Kendall’s age and other circumstances. Hoffman appealed.
The New Jersey Supreme Court agreed. The test in New Jersey is whether a reasonable person in Kendall’s situation would have had adequate warning before the two-year deadline started to run. It found that she would not. Kendall’s dermatologist did not warn her originally because he was unaware of the connection; the gastroenterologist she saw two years later also was unaware. Indeed, the two doctors agreed in 2000 that Kendall could continue the Accutane, which she did for at least two more courses. No warnings, including the new information distributed to patients in 2003, mentioned IBD or colitis by name, and the 2003 warnings mentioned only that she should stop taking it if she developed certain gastrointestinal symptoms. This was not enough to induce a reasonable person to ignore her doctors, the court found. Thus, it denied dismissal based on the statute of limitations. A dissent argued that Kendall’s statute of limitations should have started running until her eighteenth birthday in 2002, barring the suit.
As a defective drug lawyer, I’m pleased that the majority of the court allowed Kendall’s case to go forward. Consumer information given to patients is necessarily controlled by the manufacturer, and the manufacturer has a financial incentive to gloss over potential risks from the product. Manufacturers are legally required to give the warnings the FDA asks them to — so they give these warnings and nothing else. Technical compliance is certainly better than no compliance, but it’s not the same as an honest list of risks given in clear language. It’s also notable that these events started when Kendall was 12. In my opinion as a pharmaceutical liability attorney, this should diminish her responsibility to go beyond her doctors’ orders, which is hard even for adults.
If you or someone you love suffered an injury or illness because of a medication that you didn’t know had safety risks, you should call Carey, Danis & Lowe. For a free, confidential consultation, send us an email or call 1-877-67-3400.
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