January 15, 2009 — 11:17am ET |

By Tracy Staton

The long rumored settlement between Eli
Lilly and the Department of Justice is a done deal. The drugmaker will
pay $1.4 billion to take care of claims that it promoted its
antipsychotic med Zyprexa
overzealously. As part of the arrangement, Lilly will plead guilty to
one misdemeanor violation of the Food, Drug and Cosmetic Act.

Lilly had been accused of persuading doctors to prescribe Zyprexa to
children and the elderly, despite the fact that the drug wasn’t
FDA-approved for those patient groups–and the knowledge that it was
particularly risky for them to take. As you know, Zyprexa has been
shown to cause excessive weight gain and to boost the risk of death in
elderly patients with dementia.

The company’s marketing worked, at least in kids: Over the past 10 years, the New York Times reports, Zyprexa use in children has skyrocketed.

According to the NYT, the
$1.4 billion settlement deal is a record among whistleblower cases.
Some $615 million of it is earmarked to settle the criminal charges.
Lilly’s misdemeanor guilty plea states that the company promoted
Zyprexa in elderly patients as a dementia treatment even though it’s
not approved for that use. “We deeply regret the past actions covered
by the misdemeanor plea,” CEO John Lechleiter (photo)
said in a statement today. “At Lilly we take seriously our
responsibilities to abide by all the laws governing our business
practices.”

The deal has been in the works for months, and even the amount has been clear since last fall, when Lilly set aside $1.4 billion for an eventual settlement of the case.

– read Lilly’s press release
– see the NYT story

Related Articles:
Zyprexa – Top 10 Drug Warnings and Recalls
Court won’t limit Canadian Zyprexa claims
Lilly: $1.4B ding in profits for Zyprexa charge
States settle Zyprexa claims for $62M
Did Lilly chief support off-label promos?