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Price Tag Grows for Off-label Marketing
As Cephalon Inc. concluded the painful check-writing phase in early January of its off-
label-marketing lawsuit involving three drugs and all 50 US states and the District of
Columbia, Eli Lilly & Co. entered the swallow-hard phase of its own such case by
pleading guilty to a criminal charge and agreeing to payments. Both cases achieved, at
their respective times, the distinction of largest settlement: Cephalon for achieving the
largest biotech medical fraud case in the United States; Eli Lilly for largest amount paid
by a single defendant in the history of the U.S. Justice Department. Both actions are the
whistleblower suits. And both also involve a heightened level of
regulation in the form of corporate integrity agreements between the offender and the
Cephalon’s settlement for the illegal marketing of Provigil, Gabitril and Actiq amounted
to more than $440 million, and the company also pleaded guilty to a misdemeanor. The
settlement reimburses the federal government and states for Medicaid payments made to
Cephalon due to off-label marketing. For Lilly, $1.42 billion covers the criminal
settlement for activities as well as federal and state settlements over the marketing of its
blockbuster antipsychotic drug Zyprexa from 1999 to 2001.
Qui tam lawsuits have shown a gradual rising trend in the healthcare industry for the past
20 years, according to government statistics reported by the nonprofit Taxpayers Against
Fraud Education Fund.