Pharmaceutical giant Eli Lilly & Company ("Lilly") will pay federal and state governments more than $1.4 billion

Pharmaceutical giant Eli Lilly & Company ("Lilly") will pay federal and state governments more than $1.4 billion to remedy a wide-ranging, off-label marketing scheme for its prescription drug, Zyprexa(R). This settlement is the largest qui tam settlement in the history of the False Claims Act. Stephen A. Sheller, a well-known mass tort and class action lawyer from Philadelphia, filed the first Complaint in the case in February 2003, bringing the off-label drug allegations to the government under seal as required by law. Today, after six years, the Department of Justice settled with Lilly the allegations that six former Lilly drug marketing representative whistleblowers brought to Sheller.Lilly will pay more than $1.4 billion for its illegal off-label marketing of the antipsychotic drug, the U.S. Attorney's Office for the Eastern District of Pennsylvania announced. Zyprexa is Lilly's top-selling drug with worldwide sales of nearly $40 billion since its approval in 1996.In today's settlement, Lilly will pay $800 million in civil penalties and plead guilty to criminal charges, paying an additional $600 million fine. The six whistleblowers who brought the Complaint against the drug company will share in approximately 18 percent of the federal and qualifying states' recoveries, Sheller said.Related complaints filed by other law firms in 2005, 2006 and 2007 were ultimately consolidated into Sheller's first-filed Complaint."The reason the settlement and fine are record-breaking is because Eli Lilly perpetrated an outrageous fraud on the American government and taxpayers" said Sheller.
The whistleblowers represented by Sheller, two with 27 or more years' service at Lilly, expressed concern through proper channels about Lilly's improper marketing practices. All six whistleblowers were eventually fired or forced to resign. One sales representative, who also is a pharmacist, contacted the company hotline regarding unethical sales practices but received no response, according to the Complaint.

Zyprexa is approved by the U.S. Food and Drug Administration ("FDA") for very limited conditions - schizophrenia and a specific type of bipolar disorder. Under FDA rules, prescription drug manufacturers and marketers may only promote their products for approved uses.

To boost sales, Eli Lilly marketed Zyprexa for numerous off-label uses including Alzheimer's, depression and dementia according to Sheller's Complaint.
Eli Lilly's off-label sales strategies were very effective. The government's investigation found that a substantial amount of Zyprexa sales were for off-label uses, particularly in children and the elderly