May 25, 2006 at 17:01:18

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Neurontin Deal - Slap On The Hand To Pfizer

By Evelyn Pringle (about the author)     Page 4 of 12 page(s)

opednews.com     Permalink

Two of the cases began as lawsuits filed under the FCA by whistleblowers and the third began as a case under the Texas Medicaid Fraud Prevention Act.

The defendant in one case was the nation's largest drug maker, Pfizer, with annual sales of $30 billion. The conduct at issue concerned a Pfizer subsidiary, the Parke-Davis Division of Warner-Lambert, acquired by Pfizer in 2000.

Drug maker Schering-Plough was the defendant in the other 2 cases.

Government recoveries from Pfizer totaled $430 million, and the two Schering settlements were $345 million and $27 million.

This is the second FCA whistleblower settlement entered into by Pfizer, and the second largest drug maker settlement ever when measured by the combined civil recovery of $430 million and the criminal fine of $240 million.

The Pfizer case broke new legal ground by recovering losses to Medicaid resulting from the illegal off-label promotion of a drug for uses other than those approved as safe and effective.

At the time of the settlement in May 2004, Pfizer's drug, Neurontin, ranked 9th among all drugs sold in the US, with annual sales of $2.7 billion, according to IMS Health, “Leading 20 Products by U.S. Sales, Moving Annual Total, June 2004,” www.imshealth.com.

The whistleblower, David Franklin, a former medical liaison for Parke-Davis, who filed the FCA lawsuit, received a $24.6 million settlement, when Warner-Lambert agreed to plead guilty to two felonies to settle charges that it fraudulently promoted Neurontin for a wide variety of unapproved uses.

Among the tactics the DOJ found the company using to achieve its goal of increasing off-label use of Neurontin were the following:

(1) Encouraging sales reps to provide one-on-one sales pitches, or "details," to physicians about off-label uses of Neurontin;

(2) Utilizing medical liaisons, who represented themselves, often falsely, as neutral scientific experts on Neurontin, to promote off-label uses, working in tandem with the sales reps to directly sell Neurontin to physicians for off-label uses;

(3) Paying doctors to allow a sales reps to see patients with the doctor and to participate in discussing the treatment plan;

(4) Paying physicians, through both direct payments, and trips, hotel rooms, dinners and other benefits, to attend meetings termed “consultant” or “advisory” meetings or “speaker bureau trainings” in which doctors received listened to presentations about off-label uses;

(5) Implementing frequent teleconferences in which doctors were paid to speak about Neurontin on off-label topics to other doctors; and

(6) Sponsoring independent "medical education" events on off-label uses where there was actually extensive input from the company on topics, speakers, content, and participants.

"Neurontin was marketed for four broad categories of unapproved use: pain, psychiatric
use, monotherapy and dosage," the DOJ stated. In fact, the company promoted the drug for so many unapproved uses, the DOJ said, "some employees referred to the list of these uses as the “snake oil” list."

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