Judge Tosses Accutane Mass Tort Against Roche Labs

A multidistrict litigation against the makers of the acne medication Accutane, alleging that it causes inflammatory bowel disease (IBD) was tossed by a Florida federal judge, saying that the warnings included with the medication were adequate.

U.S. District Judge James S. Moody says in his Tuesday summary judgement that “a court may hold a prescription drug warning to be adequate as a matter of law ‘if it directly warns in plain and explicit terms of the specific risk that has caused injury to plaintiff.'”

Judge Moody cites a previous lawsuit against Accutane’s makers, Roche Laboratories Inc. and Hoffman-La Roche Inc.

“Here, defendants argue that Roche’s extensive IBD warnings in place during the time plaintiff used isotretinoin (in 2006-2007) were adequate as a matter of law,” Moody writes in his decision. “The court agrees.”

Plaintiff Karly Greenshields was prescribed Accutane (isotretinoin) in 2007 when she was 18-years-old by her dermatologist, Dr. Emily Jong. She began seeing Dr. Jong for acne treatments in July 2006, when she first inquired about Accutane.

“Her records reflect that Dr. Jong and plaintiff reviewed an isotretinoin pamphlet, discussed side effects, and Dr. Jong answered plaintiff’s questions,” Judge Moody wrote.

“Dr. Jong provided plaintiff with materials for a mandatory patient registry program called iPLEDGE that, at that time, were included within the patient brochures for isotretinoin,” he explained further.

“The materials included two consent forms, which plaintiff signed,” he said, as required by Roche Labs.

Greenshields tried other acne treatments that were not effective before taking Accutane in October 2007, when Dr. Jong reviewed the Accutane side effects with her again. She took Accutane until May 2008.

Under the “Warnings” section of the Physician Package Insert reviewed in 2006 and again in 2007 Roche Labs lists “Inflammatory Bowel Disease” as a side effect associated with the drug.  “Gastrointestinal inflammatory bowel disease” is mentioned again under the “Adverse Reactions” section.

The Medication Guide given to patients in 2007, when Greenshields began taking Accutane, also states that “possible serious side effects” are “stomach area (abdomen) problems,” which includes damage to internal organs including the intestines.

“If your organs are damaged, they may not get better even after you stop taking [isotretinoin],” it stated.

She visited a gastroenterologist in 2012 when she was diagnosed with inflammatory bowel disease.

Judge Moody ruled that the failure to warn claims could not stand because the “warnings were adequate as a matter of law under California law, which is where plaintiff resided and was prescribed isotretinoin.”

As for the negligence and design defect allegations, the Florida federal judge says that “the court agrees that, under California law, where warnings are adequate, as a matter of law, any related claim for manufacturing or design defect are precluded.”

The same goes for the negligence claim, which he says “is similarly premised on the failure to warn.”

Greenshields is represented by R Parker White of Poswall White & Cutler.

Roche Labs is represented by Edward Moss of Shook Hardy & Bacon LLP, and Michael X. Imbroscio of Covington & Burling LLP.

The Accutane Federal MDL is In re: Accutane Products Liability, case number 8:04-md-02523, in the U.S. District Court for the Middle District of Florida.