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E-mail allegedly promoting off-label uses could hurt Lilly settlement talks

Pharma Compliance Alert, March 19, 2008

An e-mail in which Lilly's incoming CEO allegedly encouraged off label promotions was not admitted into evidence in the Alaska trial where it was presented, but the impact of the notice could adversely affect Lilly's settlement talks with the federal government.

Lilly, which is defending itself against a lawsuit in Alaksa, is also currently in talks with the federal government to settle civil and criminal allegations relating to the promotion of Zyprexa. The settlement could reach as high as $1-$2 billion. Lilly also faces lawsuits from nine other states.

The 2003 e-mail from John C. Lechleiter, Ph.D., currently Lilly's president and chief operating officer, surfaced last week in an Anchorage courtroom, where Lilly is defending itself in a lawsuit brought by the state. The state alleges Lilly did not to warn customers of the risks of Zyprexa. The judge dismissed the state's off-label allegations before the trial began, so the e-mail was not admitted.

The e-mail "appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators," according to a New York Times article.

Lilly disputes the Times' characterization, saying in a statement the e-mail "was nothing more than a call to action to ensure Lilly's development organization placed a high priority on conducting clinical trials to address these important medical questions."

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