Tuesday, April 10, 2012

Jury rules against J&J subsidiary in Arkansas | Seattle Times Newspaper

via seattletimes.nwsource.com


A Johnson & Johnson subsidiary downplayed and hid risks associated with the antipsychotic drug Risperdal, a jury determined Tuesday in Arkansas' billion-dollar lawsuit against Janssen Pharmaceuticals Inc.

Arkansas Attorney General Dustin McDaniel's office is seeking fines of at least $1.2 billion for the 250,000 Risperdal prescriptions the state's Medicaid program paid for over 3 1/2 years. The penalty will be decided in a separate hearing before Circuit Judge Tim Fox, who presided over the trial.

The 12-person jury returned its verdict about three hours after it started deliberating. Jurors had heard 10 days of testimony. They weren't told about the financial stakes, beyond that Janssen could have seen a $200 million swing in its revenues if it issued alarming warnings that the drug could cause weight gain, diabetes and other health effects.

Attorney Fletch Trammell, a Houston lawyer hired by McDaniel's office to handle the suit, told jurors in closing arguments Tuesday that Janssen lied to doctors, saying the drug didn't cause weight gain, diabetes and other adverse health effects, particularly in older patients.

"The law is broken once they tell a lie," Trammell said.

He explained that Janssen was ordered by the U.S. Food and Drug Administration to issue a letter to doctors correcting an earlier letter saying the drug didn't increase the risk of developing diabetes.

Janssen attorney James Simpson argued that neither McDaniel's office nor the state Medicaid office issued any warning to doctors that Risperdal carried greater risks than believed. He also noted that even after the lawsuit was filed, the state continued to pay for Risperdal prescriptions.

"That doesn't make any sense," Simpson said. "They never restricted a single ... Risperdal prescription."

Simpson also questioned why the state didn't have any testimony from doctors complaining about how the company disclosed the drug's side effects.

Trammell said any action the state did or did not take regarding Risperdal wasn't a concern for the jury. He said it is up to drug companies to notify doctors of any problems with a medication and that companies are obligated to act before the FDA gets involved.

"You have to ring the bell. You have to tell the public," Trammell said.

He cited instances in which patients gained 60 or 100 pounds, leading to diabetes.

Trammell said the rural nature of Arkansas makes it more important for drug companies to keep doctors informed. People outside of cities often rely on primary care doctors rather than specialists, he said, and non-specialists in mental health were prescribing the drug without knowing the full range of side effects.

Arkansas' lawsuit was one of dozens of state and federal cases accusing Janssen of fraud connected with Risperdal. In January, Janssen settled with Texas for $158 million in a similar suit. Texas sought damages of about $1 billion.

Simpson and co-counsel Laura Smith played up their Arkansas ties, with Simpson saying he gets chills when the University of Arkansas cheerleaders run on the field. Smith told the panel that she has lived in Arkansas for all of her 60 years.

Simpson pointed out that McDaniel's office relied on an out-of-state law firm to handle the case, a move McDaniel has previously defended by saying it was appropriate to seek help from outside specialists.

Jurors had a set of 10 questions to decide - five regarding Janssen and five nearly identical ones regarding its Johnson & Johnson parent company. The jury ruled in favor of the state on all 10 questions. Only nine votes were needed to reach a decision on any question.

Posted via email from Jack's posterous

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