Pfizer’s Warner-Lambert division promoted the drug, Neurontin, for uses it had no scientific evidence to support, and even in cases where the drug was shown to be ineffective, prosecutors said.
For example, the company promoted Neurontin for treating bipolar disease, even though a study showed a placebo worked as well or better than the drug for manic depression.
“Warner-Lambert’s promotional efforts were a highly organized and deliberate attempt to circumvent federal restrictions on marketing,” Associate Attorney General Robert McCallum told a news conference in Washington.
The $240 million criminal portion of Pfizer’s payment is the second largest criminal fine for a health-care fraud case, McCallum said. TAP Pharmaceuticals, a venture of Abbott Laboratories Inc. and Takeda Chemical Industries Ltd. agreed in 2001 to pay $290 million over charges it illegally marketed a prostate cancer drug.
The U.S. Department of Justice and attorneys general of all 50 states agreed to the Neurontin settlement with Pfizer.
The case originated from a lawsuit filed in late 1996 by whistle-blower David Franklin, who had worked for Warner-Lambert before it was acquired by Pfizer in 2000.
Franklin said the company used a variety of schemes to illegally pump up sales of Neurontin — a drug that remains one of Pfizer’s biggest sellers with 2003 sales of $2.7 billion.
According to court documents, a May 1996 voicemail message from a top marketer to “medical liaisons” in the Northeast was like a call to arms: “When we get out there, we want to kick some ass, we want to sell Neurontin on pain.”
Under federal regulations, companies may market and promote drugs only for uses approved by the Food and Drug Administration, although doctors can prescribe drugs to treat other uses. Companies have been increasingly scrutinized by regulators for “off-label” marketing.
Shares of Pfizer fell 56 cents, or 1.6 percent, to $35.15 in afternoon trading on the New York Stock Exchange.