Posts Tagged ‘Kruszewski’

Lawsuit alleges Pfizer used bogus research to get approval for its blockbuster antipsychotic drug Geodon

Monday, October 5th, 2009

Lee Howard
TheDay.com
October 4, 2009

A lawsuit filed against Pfizer Inc. two years ago and just unsealed last month calls into question the safety of the company’s popular antipsychotic drug Geodon as well as the reputation of some of the researchers who worked on its clinical trials.

The lawsuit, filed by Dr. Stefan Kruszewski of Harrisburg, Pa., alleges that three of the researchers who helped conduct Geodon clinical trials – Dr. Richard Borison, Dr. Bruce Diamond and Dr. Louis Fabre – have been sanctioned by regulatory authorities. Borison and Diamond were debarred by the U.S. Food and Drug Administration and received prison time, according to the suit, and Fabre earned sanctions in Texas for research misconduct.

”Pfizer’s reliance on clinical researchers with a known history of professional misconduct” – which news reports indicate go back at least as far as a 1997 indictment of Borison and Diamond and included the FDA’s 2005 shutdown of Fabre’s clinical-testing facility – “demonstrates the lengths to which the company is willing to go to facilitate its ‘positive’ clinical trials’ reporting,” according to the suit.

Read entire article: http://www.theday.com/re.aspx?re=a47a14f8-cbcb-4e3b-b91c-2bebce6d6232

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Pfizer pays $300 million to resolve allegations of off-label marketing of its antipsychotic drug Geodon

Wednesday, September 2nd, 2009

PRNewswire
September 2, 2009

PHILADELPHIA — Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S. history.

Brian Kenney and Tavy Deming of Kenney Egan McCafferty & Young represented the Geodon whistleblowers and served as co-counsel to the Zyvox whistleblower.

As part of the record settlement, Pfizer agreed to pay $300 million to resolve allegations that it engaged in off-label marketing of its blockbuster atypical antipsychotic Geodon, which generated over $1 billion dollars in sales in 2008. The allegations were first made in a qui tam lawsuit filed by Kenney and Deming on behalf of Harrisburg psychiatrist, Dr. Stefan Kruszewski. Pfizer also agreed to pay $100 million to resolve allegations that it improperly marketed its antibiotic Zyvox. That case was filed by Ronald Rainero, a former Pfizer sales manager from New Jersey.

Read entire article: http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/09-02-2009/0005087128&EDATE

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