Healthy Skepticism Library item: 14422

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Berenson A.
33 States to Get $62 Million in Zyprexa Case Settlement
The New York Times 2008 Oct 6
http://www.nytimes.com/2008/10/07/business/07zyprexa.html

Full text:

Eli Lilly has agreed to pay $62 million to 33 states to settle claims that it improperly marketed Zyprexa, its top-selling drug, to patients who did not have schizophrenia or bipolar disorder, its only approved uses.

The settlement, to be announced Tuesday, ends an 18-month investigation led by the offices of the attorneys general of Illinois and Oregon, which contended that Lilly had violated consumer protection laws by urging doctors to prescribe Zyprexa to patients who did not need it.

It is the largest settlement paid by a drug company in a state consumer protection case, topping the $58 million that Merck paid to settle similar allegations about Vioxx, lawyers for the states said.

The agreement may also be a sign that a much larger deal is near in a separate but related civil and criminal investigation led by federal prosecutors in Philadelphia. In that case, Lilly is expected to pay more than $1 billion in fines and restitution to states and the federal government and may also plead guilty to a misdemeanor criminal charge related to off-label marketing of Zyprexa.

“We know they’re working hard to get that settlement done,” said James D. Kole, the chief of the consumer fraud bureau for the Illinois office.

The states’ investigation and the Philadelphia case center on Lilly’s marketing of Zyprexa, a potent brain tranquilizer that calms the hallucinations associated with schizophrenia and bipolar mania. Internal Lilly documents and e-mail messages appear to show that the company marketed it for patients with dementia and milder forms of bipolar disorder, a violation of federal law.

Zyprexa can cause severe weight gain and an increase in blood sugar in many patients and is more likely to cause diabetes than most other medicines for schizophrenia and bipolar disorder, according to the American Diabetes Association.

Once the Food and Drug Administration approves a drug for sale, doctors can prescribe it for whatever disease they see fit because the F.D.A. does not regulate the practice of medicine. But pharmaceutical companies can market and advertise their medicines only for the uses specified on the drug’s label.

“The company’s deceptive marketing practices were illegal and highly dangerous,” Lisa Madigan, the attorney general of Illinois, said in a statement.

A spokesman and a lawyer for Lilly did not return a call and an e-mail message for comment.

David Hart, senior assistant attorney general for Oregon, said, “We’re trying to send a message to the pharmaceutical industry that consumer fraud is something we’re going to investigate and prosecute.”