Eli Lilly's Zyprexa (olanzapine) was approved by the FDA in 1996 for schizophrenia and bipolar disorder. It became Lilly's best-selling drug, generating $4.7 billion in worldwide sales in 2008. But Lilly had known since at least 1998 that the drug caused extreme weight gain — internal documents showed the company considered drug-induced obesity a 'top threat' to sales. A 2013 meta-analysis found Zyprexa had the highest propensity for weight gain out of 15 antipsychotics studied; some patients gained more than 66 pounds in their first year.
Between 1999 and 2003, Lilly aggressively marketed Zyprexa for off-label uses the FDA had never approved — primarily dementia and agitation in elderly nursing home patients. The company created a dedicated long-term care sales force targeting assisted-living facilities, launched a campaign to persuade primary-care physicians to prescribe Zyprexa for symptoms rather than approved indications, and funded CME programs promoting off-label uses. The FDA had issued a black-box warning in 2005 that antipsychotics increased death risk in elderly dementia patients, but Lilly's marketing continued.
Whistleblower lawsuits under the False Claims Act exposed the scheme. In January 2009, Lilly pleaded guilty to a federal misdemeanor charge of misbranding — promoting Zyprexa for uses the FDA had not approved. The company paid $1.415 billion: a $515 million criminal fine (the largest corporate fine in US history), $100 million in asset forfeiture, and up to $800 million in civil settlements. The whistleblowers received $78.9 million. Lilly also agreed to a five-year Corporate Integrity Agreement requiring board oversight, manager certifications, and public disclosure of payments to physicians.
A dedicated long-term care sales force and CME grants pushed off-label use; the $1.415B settlement included a $515M fine, the largest corporate fine in US history.
Lilly promoted Zyprexa for dementia in elderly patients even though the drug was never approved for that use and the FDA had warned that antipsychotics increased the risk of death in that population.
Lilly created a dedicated long-term care sales force, off-label marketing materials, and CME grants to push Zyprexa into nursing homes — a systematic campaign rather than isolated incidents.
Lilly knew Zyprexa caused extreme weight gain (identified as a 'top threat' to sales as early as 1998) but did not adequately disclose this risk in its marketing to doctors and patients.
Lilly's management actively trained sales personnel to disregard the law and promoted off-label uses despite internal warnings, making misconduct corporate policy rather than a few rogue employees.
When a drug company treats a safety warning as a 'top threat' to sales rather than a signal to protect patients, the regulatory bill will eventually dwarf the revenue it was protecting.
FOLLOW THE EVIDENCE