Accutane Inflammatory Bowel Disease & Ulcerative Colitis

Roche Ignored Accutane Risks, Actor’s Lawyer Tells Jurors

-Bloomberg

02/23/2011 - Roche Holding AG executives ignored research showing that the company’s Accutane acne drug causes inflammatory bowel disease, a lawyer told a New Jersey jury hearing a Hollywood actor’s claims over the medicine.

To protect profits, Roche researchers turned a blind eye to animal studies that found Accutane could cause bleeding and bowel blockages in users, said Michael Hook, an attorney for James Marshall, who played U.S. Marine Louden Downey in the 1992 hit movie “A Few Good Men.” Jurors in state court in Atlantic City, New Jersey, are hearing claims by Marshall and two other ex-Accutane users that the drug destroyed their intestinal systems.

“These people have been seriously hurt,” Hook told the seven-woman, one-man jury today in opening statements.

About 16 million people have taken Accutane, once Roche’s second-biggest selling drug, since it went on the market in 1982, according to plaintiffs’ lawyers. Basel, Switzerland-based Roche, the world’s biggest maker of cancer drugs, pulled its brand-name version of Accutane off the market in 2009 after juries awarded millions of dollars in damages to former users over bowel-disease claims. Roche has lost all seven cases that have gone to trial.

Marshall, 44, a New Jersey native, is seeking at least $11 million in damages. His portion of the case will feature testimony from Hollywood celebrities such as Martin Sheen, Brian Dennehy and Rob Reiner.

Career Derailed

They will testify that Marshall was headed for stardom before bowel ailments allegedly caused by Accutane forced doctors to remove his colon, Hook said before the start of the trial. The surgery left Marshall in severe pain and unable to work, Hook said in his opening statement.

Roche contends that Accutane doesn’t cause inflammatory bowel disease, according to court filings. Roche’s lawyers will make their opening statements tomorrow, Judge Carol Higbee said late today.

Roche researchers ignored studies, done before Accutane’s approval for the U.S. market, showing that dogs given the drug bled in their gastrointestinal tracts, Hook told jurors today. The company never fully disclosed Accutane’s risk of causing inflammatory bowel disease in its warning label, he said.

Accutane is made by Roche unit Hoffmann-LaRoche Inc. of Nutley, New Jersey, allowing Marshall, Gillian Gaghan and Kelley Andrews to bring their claims in the state. All three are California residents. Andrews, 29, is an account manager while Gaghan, 34, is a nursing assistant. Marshall was born James Greenblatt, according to court filings.

‘Lupus-Like Symptoms’

All three contend the drug left them struggling to deal with their bodily wastes, Hook said before the trial, which is slated to last six weeks. Both Andrews and Marshall battle incontinence while Gaghan has “developed lupus-like symptoms” as a result of taking drugs to deal with her Accutane-linked bowel disease, he said.

Marshall took Accutane over a two-year period, in 1992 and 1993, according to court papers. Andrews, who took Accutane for two years starting in 1997, has endured dozens of hospitalizations and surgeries, including the removal of part of her colon and small intestine, Hook said. Gaghan, who took the drug for five months in 1998, has daily pain from the resulting inflammatory bowel disease, he said.

The case combining the three ex-Accutane users’ claims is the eighth to go to trial since juries began weighing allegations against the drug. Juries in New Jersey and Florida have ordered Roche to pay at least $45 million in damages.

Verdicts Overturned

Appeals courts have thrown out some of the verdicts, including a 2007 award of $7 million to a Florida man who blamed the drug for his inflammatory bowel disease. Last year, an Atlantic City jury ordered Roche to pay $25.1 million to a man who attributed his inflammatory bowel disease to Accutane. That case was a retrial of an earlier verdict overturned by appellate judges.

In August, a New Jersey appellate court also overturned a $10.5 million Accutane verdict against the company on an evidentiary issue.

Roche has won dismissals of Accutane cases filed in federal court and has challenged the state court verdicts by asking judges to throw them out or filing appeals, officials said last year.

The case is Greenblatt v. Hoffmann-La Roche Inc., ATL-l- 1246-06, New Jersey Superior Court, Atlantic County (Atlantic City).