By DUFF WILSON
NY Times
Published: September 21, 2010
The Justice Department on Tuesday joined a whistle-blower lawsuitagainst Pfizer and its subsidiary Wyeth Pharmaceuticals that accuses Wyeth of illegal off-label marketing of Rapamune, a drug used to prevent rejection of kidney transplants.
Reuben A. Guttman, lawyer for two former Wyeth employees, predicted that the government action could result in recovery of hundreds of millions of dollars in inappropriate billings to public health programs. Nineteen states, including New York, and the District of Columbia also joined the filing.
“It’s always good to have the government on your side,” Mr. Guttman said.
Ray Kerins, a Pfizer spokesman, said the company had previously disclosed that it was cooperating with a government review of Wyeth’s promotional practices involving Rapamune. Pfizer also disclosed in February that there was a criminal investigation into the marketing.
In a statement, the company said the whistle-blower suit was filed in 2005, four years before Pfizer bought Wyeth for $68 billion. Pfizer could be in violation of a corporate integrity agreement it signed a year ago in a separate case if it was involved in further illegal sales.
In that case, Pfizer paid $2.3 billion, including a $1.3 billion criminal fine, the largest in United States history, to settle investigations into illegal marketing of the painkillers Bextraand Lyrica, the schizophrenia drug Geodon and the antibiotic Zyvox.
Patrick Burns, a spokesman for Taxpayers Against Fraud, a Washington nonprofit group that works with many whistle-blowers under the federal False Claims Act, said the government nearly always wins when it joins such a legal action.
“It’s going to be a big case,” Mr. Burns said. “The wild card is, it’s Pfizer. The government’s not happy with Pfizer. These are repeat offenders.”
Charles S. Miller, a spokesman for the Justice Department, declined to comment, saying the brief government filing spoke for itself. Such cases are typically shrouded in confidentiality.
The filing continued a crackdown on drug industry fraud. Over the last three years, the government has also settled false claims suits against Bristol-Myers Squibb for $515 million, AstraZeneca for $520 million, Eli Lilly for $1.4 billion, and last week, a unit ofForest Laboratories for $313 million.
Rapamune had sales of $376 million in 2008. The law allows the government to collect up to three times any amount it was defrauded and pay whistle-blowers 15 to 25 percent of the total. Mr. Guttman said most of those sales were for uses not approved by the Food and Drug Administration.
While doctors can use an approved drug for anything they see fit, companies are prohibited from marketing drugs for uses not approved by the F.D.A.
In the whistle-blower suit, filed in United States District Court in Philadelphia, the former employees, Marlene Sandler and Scott Paris, said they were encouraged to promote the drug for heart, lung, liver and pancreas transplants, even though the F.D.A. had only approved it, in 1999, for kidney transplants.
The suit also contends that Wyeth singled out two hospitals with largely black clients for off-label promotions. They were the SUNY Downstate Medical Center in New York and theAlbert Einstein Medical Center in Philadelphia. Black patients have higher risk oftransplant rejection. The Pfizer statement on Tuesday said that Wyeth was allowed to market Rapamune for that population.
The Justice Department during the Bush administration declined to join in the Rapamune case. Mr. Guttman praised the Obama administration for aggressive action.
Mr. Burns said the civil division of the Justice Department, which handles the cases, has been nonpolitical and commonly joins an action, after first declining, once new information emerges. He also said the health care reform overhaul strengthened the False Claims Act and increased money for enforcement.
http://www.nytimes.com/2010/09/22/business/22drug.html?_r=1&scp=1&sq=U.s.%20Joins%20Pfizer&st=Search
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