ATLANTIC CITY, NJ - A state court jury has determined Roche Holding AG, manufacturer of the popular acne medication Accutane, must pay $18 million in damages to two former users who developed inflammatory bowel disease because of the drug.
The trial, which concluded last Friday after nearly two-months of testimony, involved the combined claims of four individual plaintiffs treated with Accutane who also developed inflammatory bowel disease, or IBD. The two prevailing plaintiffs, Kathleen Rossitto and Riley Wilkinson, received $9 million each, however the jury found in favor of Roche in the two other cases and awarded no damages, according to a Courtroom View Network video webcast of the verdicts being read in court.
In all four cases, attorneys for the plaintiffs argued Roche knew of the risks associated with Accutane but failed to properly warn doctors and patients. During closing arguments, David Buchanan of Seeger Weiss repeatedly told the jury Roche purposely ignored studies suggesting Accutane caused bowel problems. "Roche had internally concluded Accutane has been causally associated with inflammatory bowel disease," he said. "They want to focus on what is outside of Roche's walls and not inside their internal conclusions."
Buchanan referenced expert witness testimony from Dr. David Sachar, a former adviser to the Food and Drug Administration, stating Roche had access to studies suggesting out of 100 patients with IBD who also take Accutane, 80% of those IBD cases were caused by the Accutane itself. "There's a reason why Roche does not want to talk about the numbers from the study," said Buchanan, who also noted Roche's attorneys declined to cross-examine Dr. Sachar on those claims, instead relying on testimony from their own expert witness.
Representing Roche, Orlando Richmond of Butler Snow argued strongly to the jury against the connection alleged between Accutane and IBD, citing that similar bowel conditions have been known to the medical community since the 19th century. "The vast majority of these (IBD) cases are idiopathic, meaning the cause is unknown," said Richmond. "It's always been the case. It was the case during the 90's, and it's the case now."
Richmond also referred to one of Roche's expert witnesses, a pediatrician who testified individuals from the same young adult age range are the most likely to both take Accutane and to independently develop IBD, which would explain the apparent overlap in some cases without also suggesting Accutane caused the disease. The jury seemed to accept this argument for two of the four plaintiffs by determining Accutane did not cause their health problems.
Accutane was first manufactured in 1982, and Roche claims to have treated over 13 million acne patients since then. In 2009 Roche stopped manufacturing Accutane after patents on the drug expired, but the generic version known as isotretinoin is still widely produced and prescribed for acne treatment throughout the United States.
Nine of the 13 Accutane lawsuits to reach a jury to date resulted in verdicts against Roche, though a number have been reversed on appeal. The first case went to trial in New Jersey in 2007, and since then Judge Carol Higbee has had responsibility for thousands of similar Accutane lawsuits consolidated at the state court level in Atlantic City with federal claims consolidated in Florida before United States District Judge James Moody.
All of the New Jersey Accutane trials have been video recorded in full and archived by Courtroom View Network. New Jersey, along with many other states, allows for video coverage of civil trials, though news media cameras are generally not permitted in federal court.
The lead case caption is Kathleen Rossitto v. Hoffmann-La Roche Inc., ATL-l-7481-10-MT, New Jersey Superior Court, Atlantic County (Atlantic City).
David Buchanan explains to the jury what Roche knew internally about the risks associated with Accutane.
