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Pharmaceutical Sales Rep Plays Whistleblower for Second Time, Resulting in $520 Million Off-Label Promotion Settlement

AstraZeneca recently settled federal investigations regarding its marketing practices of Seroquel for $520 million.  Although Seroquel had only been approved by the FDA to treat schizophrenia and acute bipolar I disorder, whistleblower James Wetta accused the company of embarking on a national sales program to promote Seroquel for off-label use by the elderly, children and prisoners.  According to the complaint, AstraZeneca disseminated false information to child and adolescent psychiatrists, primary care physicians, and elderly patients suffering from age related dementia.  Among the off-label marketing tactics alleged by Wetta was sponsorship of “continuing medical education” seminars, which doctors must enroll in to keep their medical license. AstraZeneca sponsored taped broadcasts that highlighted the effectiveness of Seroquel for off-label uses and were offered to doctors for continuing medical education credits.

The suit against AstraZeneca was not James Wetta’s first turn as a whistleblower.  In 2002 Wetta filed suit against Eli Lilly which alleged off-label promotion of the drug Zyprexa.  The case against Eli Lilly was settled in January 2009 for a total of $1.4 billion: $515 million in criminal fines and approximately $800 million in a civil settlement with the federal government and several states.  As one of four qui tam whistleblowers under the False Claims Act, Wetta shared in over $78 million set aside from the federal portion of the civil settlement ($438 million).

The AstraZeneca case was originally filed by whistleblower Wetta in August 2003, who was a sales employee of the company after he left Eli Lilly.  According to the Department of Justice, Wetta will receive more than $45 million from the federal portion of the settlement ($301.9 million), and he also stands to receive a lesser amount from the settlement portion reserved for several states and the District of Columbia.

AstraZeneca’s litigation over Seroquel is not over, however.  When Eli Lilly settled with the government for $1.4 billion over its promotion of Zyprexa, it had already spent an additional $1.2 billion in connection with over 32,000 Zyprexa claims.  As reported by Pharmalot, AstraZeneca still faces an estimated 26,000 products liability suits over Seroquel.