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New York Times
Lilly Said to Be Near $1.4 Billion U.S. Settlement on Drug
By GARDINER HARRIS
January 14, 2009

"Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky."

 Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.

The amount of the settlement is a record sum for so-called corporate whistleblower cases, which are federal lawsuits prompted by tips from company employees or former employees. Details of the agreement were provided by people involved in the negotiations.

Among the charges, Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky.

In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce "nursing time and effort," according to court documents. Like other antipsychotics, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.

The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine's tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa's use in children has soared.

The case is being prosecuted by the United States Attorney's Office for the Eastern District of Pennsylvania. Patricia Hartman, a spokeswoman for the office, declined to comment.
Angela Sekson, a Lilly spokeswoman, said she could not comment on the status of the Zyprexa negotiations. Last fall, the company, anticipating a settlement, had set aside $1.4 billion for that purpose.  

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