Olanzapine - Controversy, Lawsuits and Settlements

Controversy, Lawsuits and Settlements

"Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers", most of which had been disclosed as the result of lawsuits by individuals who had taken the drug, though other documents had been stolen. Eli Lilly filed a protection order to stop the dissemination of some of them about Zyprexa which also the judge believed to be confidential and "not generally appropriate for public consumption". Temporary injunctions required those who had received the documents to return them and to remove from websites. Judge Jack B. Weinstein issued a permanent judgement against further dissemination of the documents and requiring their return by a number of parties named by Lilly. These health risks include an increased risk for diabetes through Zyprexa's links to obesity and its tendency to raise blood sugar. Zyprexa was Lilly’s top-selling drug, with sales of $4.2 billion in 2011.

The documents, given to The New York Times by Jim Gottstein, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes. The Times of London also reported that as early as October 1998, Lilly considered the risk of drug-induced obesity to be a "top threat" to Zyprexa sales. On October 9, 2000, senior Lilly research physician Robert Baker noted that an academic advisory board he belonged to was "quite impressed by the magnitude of weight gain on olanzapine and implications for glucose."

Lilly told its sales representatives to play down in conversations with doctors their own published data, which has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug. Another study showed 16% of Zyprexa patients gained at least 30 kg (66 pounds) in one year, and some patients have reported gaining 100 pounds or more. Between 1995 to 2004, Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes. In 2002, British and Japanese regulatory agencies warned that Zyprexa may be linked to diabetes, but even after the FDA issued a similar warning in 2003, Lilly did not publicly disclose their own findings.

In 2006, Lilly paid $700 million to settle 8,000 lawsuits from people who said they had developed diabetes or other diseases after taking Zyprexa. On January 4, 2007, Eli Lilly agreed to pay up to $500 million to settle 18,000 similar lawsuits, or - including earlier settlements - at least $1.2 billion to 28,500 people. At least 1,200 suits were still pending. About 20 million people worldwide have taken Zyprexa since its introduction in 1996. On January 8, 2007, Judge Jack B. Weinstein refused the Electronic Frontier Foundation's motion to stay his order. Subsequently, in May 2007, the Zyprexa price in Germany was increased by 18 percent .

On January 15, 2009 Eli Lilly pled guilty to a misdemeanor charge of illegally marketing Zyprexa for off-label use, and agreed to pay $1.4 billion. Although Lilly had evidence that it is not effective for dementia, Zyprexa was marketed for elderly Alzheimer's patients. The drug carries an FDA warning that it increases the risk of death in older patients with dementia-related psychosis.

In Canada, a class action lawsuit was settled in Ontario, Quebec and British Columbia.