Lilly Considers $1 Billion Fine to Settle Case (illegally promoted off-label use of Zyprexa)

Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company’s marketing of the antipsychotic drug Zyprexa that could result in Lilly’s paying more than $1 billion to federal and state governments.

If a deal is reached, the fine would be the largest ever paid by a drug company for breaking the federal laws that govern how drug makers can promote their medicines.

Several people involved in the investigation confirmed the settlement discussions, which began last year and took on new urgency this month. The people insisted on anonymity because they have not been authorized to talk about the negotiations.

Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Eli Lilly show that from 2000 to 2003 the company encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously had a diagnosis of depression.

Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines for any uses not formally approved by the Food and Drug Administration...

The documents were under federal court seal when The Times published the articles, and Judge Jack B. Weinstein of United States District Court in Brooklyn rebuked The Times for publishing them.

The settlement negotiations in Philadelphia began several months ago, according to the people involved in the investigation.

Last fall, the two sides were close to a deal in which Lilly would have paid less than $1 billion to settle the case, which at the time consisted only of a civil complaint.

Then Justice Department lawyers in Washington pressed for a grand jury investigation to examine whether Lilly should...

Can you tell me more? My father-in-law was prescribed Zyprexa in 2005 while diagnosed with vascular dementia. He took a huge dive in function and died of aspiration pneumonia within 2 months.

I hope you read the Times story. I can't tell much more. It can cause weight gain and type II diabetes. It was a very old female who had a diagnosis of dementia. She had episodes of agitation at a nursing home where I was the doc for the floor. The nursing staff insisted on a consult from from a shrink who recommended one of the atypical antipsychotics. Not long after that she was unresponsive. When she got to the hospital her blood chemistry was a mess. I don't recall blood glucose. She died not long after she was started on the atypical. This happened somewhere in 2001 - 2002.

This really stinks. My father-in-law was referred to a geriatric psych unit for his paranoid delusions. He was having a lot of difficulty in his assisted living home because of his fears, aggression, and agitation. We had hoped to calm him so he could live out his time in a bit more comfort. We were never told of higher CVA risks (he already had vascular dementia and a history of quad by-pass) or a risk of pancreatitis. He had just survived pancreatitis and a gall bladder removal 3 months prior. It sounds like the doctors should have known he was a poor candidate for Zyprexa.

When Pop entered the geri-psych unit, he was ambulatory and could sign himself in. Within 24 hours he had suffered a fall from his wheelchair and was in the ER with a head injury. He was heavily medicated, drooling and barely responsive for 3-4 weeks while they attempted to adjust his meds for an improved result. He returned to the assited living unit and went right into the full nursing care unit for the remainder of his life. He never walked again, and had to be spoon fed. My husband always regretted putting his Dad into the psych unit, given what happened. We did the best we could with the information that we had, but in retrospect, it seems we were given poor medical advice. We're usually quick to do our own research and challenge medical advice if we have serious questions. At the time, a lot was happening all at once with his medical and personal situation, and we trusted his doctors to advise us. It seems we shouldn't have been so trusting.

In Pop's last week or two, we were cutting back on the Zyprexa in hopes of restoring a little mental acuity, and he was doing better, and interacting more with us and with his aide. I wonder whether he would have been with us longer if he'd not had the Zyprexa. His aspiration pneumonia would certainly have been less likely had he been less sedated. It's really very sad. It's difficult to know how best to help a loved one whose brain is so afflicted.

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