Seroquel suit in Arkansas to proceed

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Arkansas Democrat-Gazette (Little Rock)

State drug suit gains court go-ahead McDaniel contends manufacturer’s misinformation proved costly
BY CAROLYNE PARK

The state’s lawsuit against drug manufacturer AstraZeneca will move forward after a judge ruled Thursday against the company’s motion to dismiss the case.

In its complaint filed by Arkansas Attorney General Dustin McDaniel last May, the state claims AstraZeneca gave Arkansas doctors false information that encouraged them to prescribe an antipsychotic drug to children and the elderly for uses beyond its federal approval and thus harmed patients and cost taxpayers millions of dollars.

It’s one of three major drug companies the state is suing with claims they illegally marketed the antipsychotic drugs Zyprexa, Risperdal and Seroquel to be paid for by state Medicaid and employee health-insurance programs.

Pulaski County Circuit Judge Chris Piazza’s ruling Thursday came after a two-hour hearing during which attorneys for AstraZeneca said Seroquel is a “good drug” that’s been successfully used to treat serious mental illnesses for more than a decade.

It was first approved by the U.S. Food and Drug Administration in September 1997 for treatment of such psychotic illnesses as schizophrenia and bipolar disorder.

Arkansas Medicaid continues to cover Seroquel, and a state committee that reviews medications for the program hasn’t recommended restricting prescribing of the drug, argued J. Gordon Cooney Jr., of the law firm Morgan, Lewis & Bockius LLP of Pittsburgh.

Cooney, who’s representing AstraZeneca in at least four other Seroquel cases around the country, said the attorney general’s lawsuit second-guesses the physicians who prescribed Seroquel to patients.

He said the state’s lawsuit fails to give any specific cases in which it claims company representatives gave false information to Arkansas doctors or Medicaid officials. Furthermore, it doesn’t name any patients who suffered harmful side effects from the drug, he said.

“We have no idea what we’re defending, how many claims there are or what the complaints may be,” Cooney said.

The state’s “broad and general allegations of fraud” make the case difficult to argue and would create an “amorphous mess” that would only confuse jurors if it went to trial, he said.

But Fletch Trammell, with Bailey Perrin Bailey LLP of Houston, the private firm hired by the state for the case, argued that the law doesn’t require the state to present specific cases. The complaint against Astra-Zeneca is one of “systemic fraud,” he said.

Trammell said AstraZeneca failed to warn physicians and patients that Seroquel had the potential to cause such conditions as diabetes and stroke even though the company knew of the risks. Knowing the potential harmful side effects would’ve affected how doctors prescribed the medication, and the state has the right to try to recoup its costs, he said.

“Had they not lied to doctors, those doctors wouldn’t have submitted those claims … We allege that every single Seroquel prescription was tainted by fraud,” Trammell said.

In his ruling immediately after attorneys’ arguments, Piazza said the case needed to continue.

“This may be an amorphous mess, but I think it needs to go to the next level,” he said.

Justin Allen, Arkansas’ chief deputy attorney general, said he expects that at least a year will pass before the Seroquel case goes to trial. The state is suing London-based AstraZeneca PLC and four of its related companies in the United States and abroad.

The state’s lawsuits against Titusville, N.J.-based Janssen Pharmaceutica of Johnson & Johnson Inc. and Eli Lilly & Co. of Indianapolis are ongoing.

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