Blowing the whistle on drugmakers is becoming a habit for a salesman and a psychiatrist splitting a $45 million

The repeat whistle-blowers

By David Voreacos and Margaret Cronin Fisk



Bloomberg News

http://www.philly.com/inquirer/business/20100516_The_repeat_whistle-blowers.html#axzz0o6N3qbOR

Blowing the whistle on drugmakers is becoming a habit for a salesman and a psychiatrist splitting a $45 million award after AstraZeneca P.L.C. settled claims of illegally marketing a schizophrenia drug.

California resident James Wetta, a former company sales representative, sued in 2004, claiming AstraZeneca, the British drugmaker with U.S. headquarters near Wilmington, marketed Seroquel to children, prisoners, and the elderly for uses not approved by regulators.



Stefan Kruszewski, a Pennsylvania psychiatrist, sued two years later, saying the company misrepresented Seroquel's risks and benefits.



The U.S. Justice Department joined their cases and settled April 27 with the company for $520 million under the False Claims Act. The men received payments after years of waiting. Each previously won awards in such litigation, an event that attorney Erika A. Kelton said is growing more common.



"Repeat whistle-blowers exist in the pharma industry because off-label marketing is so prevalent," said Kelton, of Phillips & Cohen L.L.P., a Washington law firm that successfully represented about 70 such clients over 15 years. "Sales reps do jump from company to company, so they may be exposed to a number of similarly illegal practices."



The False Claims Act lets private citizens sue on behalf of the government and share in any recovery. Whistle-blowers were paid $2.39 billion from 1987 to 2009, or 16 percent of the $15.19 billion collected in lawsuits where the U.S. government joined the case, according to the Justice Department.



Kruszewski said he reluctantly sued, to push companies to change how they describe the benefits and risks of drugs.



"I don't believe the science should be misrepresented, that effectiveness should be embellished, or that adverse effects should be minimized or obfuscated by drug companies," said Kruszewski, 59, who has a private practice in Harrisburg. He also has advised lawyers that sue drugmakers.



Kruszewski earlier sued Pfizer Inc. over claims about Geodon, an antipsychotic. He said he would get $14.5 million from a settlement last year in which Pfizer agreed to pay $2.3 billion to resolve claims over drugs that included Geodon.



Wetta marketed the antipsychotic Zyprexa at Eli Lilly & Co. before joining AstraZeneca. He sued Indianapolis-based Lilly in 2003 over sales practices and was one of nine whistle-blowers to split about $100 million when the company paid $1.42 billion last year to settle state and federal claims. Wetta joined AstraZeneca before the Lilly case was made public.



The work of whistle-blowers is "tremendously important to the development of the cases" in disclosing practices that lead to false claims and providing direct evidence to investigators, said Brian C. Elmer, a lawyer at Crowell & Moring L.L.P., of Washington, who defends companies.



Whistle-blowers collect as much as 30 percent of recoveries, and over two decades three-fourths were in health-care suits.



John T. Boese, a lawyer who has defended companies in such cases for 20 years, said whistle-blowers were overpaid.



"Every dime we give a whistle-blower is money that's supposed to go to the government and doesn't," said Boese, of Fried, Frank, Harris, Shriver & Jacobson L.L.P., of Washington. "They'd do the same thing for far less money, so they're unjustly enriched."



Kruszewski declined to discuss the effect of the awards on his life. Wetta declined to comment through his attorney.



Tony Jewell, a U.S. spokesman for AstraZeneca, declined to comment on Wetta and Kruszewski. The company denied allegations of illegal marketing and settled the case to avoid "the delay, uncertainty, and expense of protracted litigation," Glenn Engelmann, U.S. general counsel, said in a statement.



Chris Loder, a spokesman for New York-based Pfizer, the world's biggest drugmaker, declined to comment on Kruszewski. He said the company did not admit wrongdoing in marketing Geodon.



Kruszewski filed his first whistle-blower case in 2005 against a residential treatment facility and its owner. The defendants settled last year for $150,000, with Kruszewski getting $22,500.



The other whistle-blower cases followed.



Kruszewski, retained by AstraZeneca to discuss Seroquel with other doctors for up to $1,500 per appearance, found he was required to use a prepackaged slide show that contained "false and misleading information" about the drug's efficacy, he said in his complaint.



He accused the company of promoting the drug for unapproved uses and misleading the FDA, doctors, and the public about the drug's safety and its superiority to other medicines.



The Pfizer suit grew out of his experience as a practicing psychiatrist. He said company salespeople encouraged him to write off-label Geodon prescriptions for his patients. He was awarded $14.5 million of Pfizer's settlement last fall.



Kruszewski said his whistle-blowing had made him unpopular with many colleagues.



"Many professionals, including psychiatrists, don't even want to hear about issues pertaining to scientific misconduct or that a drug is being misrepresented by the company or in clinical trials," he said. "I get terrible feedback from doctors who are actively promoting psychopharmaceuticals."



He said that despite the millions of dollars he had made, his legal work as a whistle-blower has been painful.



"It would have been far nicer and better for me if all of this had never happened," he said. "I don't find it fun being a whistle-blower. People have no clue - except other whistle-blowers - how difficult this has been."







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