Lilly executives have for years insisted that the company's Zyprexa marketing efforts were legal and appropriate. When asked whether she could repeat those assurances, Ms. Sekson said, "It would be inappropriate for me to comment further right now."

It could not be confirmed on Wednesday whether the company will acknowledge wrongdoing as part of the settlement. Without a settlement, Lilly risks being barred from participating in the federal Medicaid and Medicare programs — a huge part of its business — even though such bans almost unheard of for big drug makers because their products are considered so essential.

In the United States, most of Zyprexa's sales are paid for by government programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug can cost as much as $25 for a daily pill.
The settlement may have little impact on how doctors actually use Zyprexa, because physicians are free to prescribe drugs as they see fit. But it is because drug makers are barred from promoting drugs for uses not specifically approved by the Food and Drug Administration that Lilly has been charged.

Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.

Just about every major drug company in recent years has pleaded guilty or is under investigation for urging doctors to use medicines beyond their approved uses. The Zyprexa case and others were brought by former drug company employees using a Civil War-era whistleblower law to claim that the companies defrauded government health programs. The former employees usually share in the recovery.

The Zyprexa settlement is the largest such recovery in history, surpassing the $900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed to pay $875 million to resolve criminal and civil charges related to pricing and marketing of its cancer drug, Lupron.
But while the fines in such cases involving drug makers have been substantial, they generally recover only a fraction of the costs associated with unapproved drug uses.

Zyprexa, for instance, has generated more than $39 billion in sales since its approval in 1996, making it one of the biggest-selling drugs in the world. As much as half of Zyprexa's use is estimated to be for unapproved or "off label" use, the $1.4 billion fine — punishment for years of illegal marketing efforts — represent less than one year of off-label sales of the drug.

And despite mounting concern about Zyprexa's risks and the negative publicity surrounding the legal case, sales were $3.5 billion for the first nine of 2008, 2 percent higher than in the first nine months of 2007.