Drugmaker Roche Wins Reversal in Accutane Duty to Warn Case

By and | August 5, 2014

Roche Holding AG won reversal of a $2.1 million verdict by a New Jersey jury in favor of a California woman who blamed the company’s Accutane acne drug for her inflammatory bowel disease.

A judge erred in the 2011 trial because she wrongly ruled that the question of whether Accutane caused IBD was “tied to” the decision by the plaintiff to take the drug, not to her doctor’s decision to prescribe it, an appellate panel ruled today. Plaintiff Gillian Gaghan said Roche failed to warn her of the risks.

“A prescription drug manufacturer fulfills its duty to warn if it provides adequate warnings to the prescribing physician, and it has no duty to ensure that the warning reaches the patient,” according to the 54-page opinion.

Roche, based in Basel, Switzerland, at one point faced almost 8,000 suits blaming Accutane for IBD. Gaghan’s case was tried with those of two other patients who lost before the jury, including actor James Marshall. The appeals panel upheld those decisions, Roche’s first trial wins after five losses starting in 2007. Roche has won other reversals in Accutane cases.

“From the beginning of this litigation, Roche has pressed the common-sense principle that a plaintiff can’t prevail if his or her doctor understood the risk from our warnings and would still prescribe Accutane,” Tara Iannuccillo, a U.S.-based spokeswoman for Roche, said in an e-mailed statement.

Accutane Sales

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. Roche 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.

The appellate panel also ruled that Superior Court Judge Carol Higbee, who oversaw the case, erred on the question of when Gaghan should have filed her lawsuit. She sued in October 2004 after the two-year statute of limitations had lapsed, according to the panel.

Higbee is now serving on the same appellate court. She didn’t participate in this latest ruling.

Marshall, who played U.S. Marine Louden Downey in the 1992 hit movie “A Few Good Men,” didn’t prove Accutane was a “substantial factor” in the development of his disease, according to the jury’s finding. Marshall sought at least $11 million in damages.

Pre-Accutane Symptoms

The appellate panel ruled “there was ample evidence from which the jury could conclude that Marshall’s IBD symptoms predated his first use of Accutane, and therefore, the use of Accutane was not a substantial factor in his developing IBD.”

Neither Mike Hook nor David Buchanan, Gaghan’s lawyers, immediately replied to calls or e-mails seeking comment on the appellate court’s ruling.

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

Topics Drugs

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