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Eli Lilly Pays $1.4 Billion to Settle Allegations of Off-Label Marketing Practices Involving Zyprexa

By placing “profits above public safety,” pharmaceutical giant, Eli Lilly and Company found itself facing allegations of defrauding Medicare, Medicaid, and other government-funded health care programs. K&M attorneys, Brian Kenney and Tavy Deming, represented the whistleblower — a former sales representative for Lilly’s Long Term Care (LTC) division.

The Complaints allege that Lilly established its LTC sales force for one purpose: to promote its anti-psychotic drug, Zyprexa, for non-approved use in sedating elderly nursing home residents with symptoms of agitation, anxiety, insomnia. Lilly staffed the LTC sales force with 180 “specialty” representatives, chosen for their aptitude for selling. According to the filed complaints, the off-label Zyprexa revenues generated per LTC sales rep far exceeded any other Zyprexa sales division.

According to the K&M attorneys, Lilly had no legitimate purpose in creating a sales force to call upon nursing homes and other elder care facilities, because Zyprexa is not approved for use in the elderly. What’s more, the typical residents of these homes were not schizophrenic or bipolar. Because of the lack of any FDA-approved use in the LTC demographic, sales representatives were instructed to focus on Zyprexa’s ability to “restore calm” in elderly patients.

One of Zyprexa’s primary side effects is somnolence or drowsiness, so it was often used to sedate patients. “It’s particularly disturbing that such a potent drug, with so many serious adverse side effects, was so blatantly abused in a vulnerable patient population whose health is already at risk,” stated Kenney.

Deming adds, “Our clients questioned their superiors about the legality of Lilly’s Zyprexa marketing practices, but they were instructed that as long as they adhered to Lilly’s LTC marketing message, the LTC marketing tactics were not illegal.”

The court believed differently. The settlement resulted in Eli Lilly and Company pleading guilty to criminal conduct and paying more than $1.4 billion in criminal and civil fines, penalties and damages.

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