Accutane’s Warning Labels Enough, Judge Rules

Roche adequately warned of the risks of ingesting acne drug Accutane after April 10, 2002, a New Jersey judge ruled last week, resolving lawsuits filed by people in the state who used the product since that date.

The manufacturer’s labeling and warning literature issued to physicians accurately disclosed the potential risk of inflammatory bowel disease, says Superior Court of New Jersey Judge Nelson Johnson in his summary judgment.

Last week’s ruling is limited to cases involving New Jersey plaintiffs who took Accutane since the most recent warnings were issued. The court intends to determine the effect on cases in other states which could involve up to 800 plaintiffs who are being given a chance to convince the court that some other states’ law with more lenient standards could be applicable.

Counsel from both sides will submit legal briefs regarding which jurisdictions permit decisions on label adequacy based on law, and which ones have a heavier burden of proof than New Jersey. A hearing is set for May 11 to finalize a list of all lawsuits impacted by the ruling.

Roche has for many years provided strong warnings of the potential relationship between Accutane and IBD, although the emerging science has largely ruled out any connection, spokeswoman Tara Iannuccillo said.

The ruling should act as a teaching moment for patients and doctors that labeling is important, that all drugs have risks and that those risks need to be carefully explained to patients, says Peter Pitts, president of the Center for Medicine in the Public Interest.

“This ruling reinforces the need for significant tort reform. These ultimately come down to the category of being frivolous lawsuits. Obviously, people took the drug and had negative effects, but that is completely predictable and it’s part of the proposition of taking any drug,” he said.

The plaintiffs did not respond to a request for comment by press time. — Jonathon Shacat