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Trial begins in Arkansas over antipsychotic drug

By Allen Reed
Associated Press / March 27, 2012
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LITTLE ROCK, Ark.—A lawyer for the state of Arkansas told jurors Tuesday that a subsidiary of pharmaceutical company Johnson & Johnson improperly marketed an antipsychotic drug and lied to doctors for years about the risk of side effects.

Arkansas wants Janssen Pharmaceuticals Inc. fined for each of the 250,000 Risperdal prescriptions issued to the state's Medicaid patients from November 2002 through June 2006, an award that could range from $1.25 billion to $2.5 billion and would go toward the state's Medicaid fund.

Fletch Trammell, a Houston lawyer representing the state, told jurors that Janssen violated Arkansas' Medicaid Fraud False Claims Act by misrepresenting of the drug's side effects of diabetes and hormonal imbalance. The state also claims the company violated the Deceptive Trade Practices Act by lying about the drug's risks in a letter sent to Arkansas doctors.

Janssen attorney James Simpson told jurors the company did not deceive doctors or release inaccurate information.

"The state will not present any evidence that a single person was injured while taking Risperdal," Simpson said. "There will not be any evidence that the state of Arkansas lost a penny in paying for Risperdal."

Arkansas sued in 2007. The case is being heard before Pulaski County Circuit Judge Tim Fox.

Risperdal, introduced in 1994, is a "second-generation" antipsychotic drug and earned the company billions of dollars in sales before generic versions became available years ago. It is used to treat schizophrenia, bipolar disorder and irritability in autism patients. Risperdal and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly dementia patients, seizures, weight gain and diabetes.

At the beginning of opening statements, Trammell spoke bluntly.

"Some companies lie to make money," he said to the jury of six men and six women. "It just happens."

Trammell said the drug caused deaths among elderly users and breast growth and lactation in young boys. He said Arkansas patients were deceived about the risks of taking the medication.

Simpson touted Risperdal as a revolutionary breakthrough for mental illness and that the medicine has helped countless Arkansas residents.

"With all due respect, the state of Arkansas is wrong about Risperdal and the science behind Risperdal," he said. "They're wrong about the facts."

The state claims a November 2003 letter to Arkansas doctors lied about the drug's risks. Without accurate information, Trammell argued, doctors and patients couldn't make informed decisions about the medication.

"It doesn't matter how good your drug is, you have to give patients and you have to give doctors a choice," Trammell said.

Simpson disagreed.

"The claim is that one paragraph, maybe even one sentence, from an almost 9-year-old letter is allegedly a deceptive trade practice," he said. "An almost 9-year-old letter that was true, deceived nobody and didn't influence a single decision here in Arkansas."

The prosecution also alleged the pharmaceutical company lied about its self-sponsored studies of the risks of Risperdal. Trammell said the findings, which state the drug is dangerous, have never been published.

Simpson said the studies had been dismissed and cited they were "full of errors."

The Arkansas suit is 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, but the company did not admit liability or fault. Texas sought damages of about $1 billion.

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