PRESS RELEASE FOR IMMEDIATE RELEASE

Contact: 
Susan Bair Purcell, Deputy Attorney General
Medicaid Fraud Control Unit (302) 577-8833

Olha Rybakoff, Deputy Attorney General
Director, Consumer Protection Unit (302) 218-0001



Date: May 13, 2004

ATTORNEY GENERAL BRADY ANNOUNCES NATIONAL SETTLEMENT WITH WARNER-LAMBERT

Settlement Resolves Improper Off-Label Drug Marketing of Neurontin©

(Wilmington, DE): Attorney General Jane Brady today announced that Delaware has reached a 
settlement with Warner-Lambert Company, LLC (Warner-Lambert) which includes as a division Parke-Davis 
and Pfizer, Inc. Pfizer, Inc. subsequently acquired Warner-Lambert and is now the world’s largest 
pharmaceutical company. The settlement resolves allegations of deceptive “off-label” marketing of 
the drug Neurontin© for purposes other than an approved use. Delaware joins Attorneys General and 
Consumer Protection officials nationwide in this historic settlement. This case marks the first time 
that representatives of state Attorneys General Consumer Protection Units and the National 
Association of Medicaid Fraud Control Units (NAMFCU) jointly negotiated a case. Delaware Deputy 
Attorney General Susan Bair Purcell of the Attorney General’s Medicaid Fraud Control Unit, was a 
member of the NAMFCU negotiating team.



The agreement-in-principal reached by NAMFCU provides that Warner-Lambert will pay damages and 
penalties to the various states’ Medicaid programs. Warner-Lambert has also entered into an 
Assurance of Voluntary Compliance with the states’ Consumer Protection Units. The state settlements 
were reached in conjunction with federal criminal and civil settlements negotiated by the United 
States Attorney’s Office in which Warner-Lambert pled guilty in the U.S. District Court in Boston for 
violating the Food, Drug and Cosmetics Act and entered into a Corporate Integrity Agreement with the 
Department of Health and Human Services, Office of Inspector General requiring strict scrutiny of its 
future marketing and sales practices. 



Attorney General Brady stated, “This settlement reinforces that consumers should not be mislead about 
the proven capabilities of the medicines they take. I am pleased that my office was well represented 
on the negotiating team by Deputy Attorney General Susan Bair Purcell in this important, global 
settlement.”



The federal and state settlements are a result of a 1996 False Claims Act qui tam action filed in 
Boston by a former Warner-Lambert employee who alleged that the company engaged in a massive off-
label marketing scheme to promote the epilepsy drug, Neurontin©. Qui tam, commonly referred to as 
the whistle blower provision of the Act, allows a private citizen to file a lawsuit in the name of 
the U.S. Government charging fraud by government contractors or those who receive or use government 
funds, and share in any money recovered. At the time, Neurontin© was FDA approved only as an 
adjunctive treatment of epilepsy. 



Although it may be appropriate for physicians to prescribe drugs for off-label uses, it is illegal 
for pharmaceutical manufacturers to promote the off-label use of their drugs. Warner-Lambert 
subsidized the production and dissemination of anecdotal reports promoting Neurontin© for off-label 
uses including to treat pain management, bipolar disorder, back pain and migranes. In addition, 
Warner-Lambert made payments to physicians for “research” that the government contended was, in 
effect, a kickback for off-label prescribing and provided expensive perks to physicians who attended 
and/or spoke at the continuing medical education classes where Neurontin© was promoted for off-label 
uses. This off-label marketing campaign, aimed at tainting the information provided to physicians 
and ultimately consumers, resulted in inappropriate, unnecessary and/or ineffective prescriptions for 
Neurontin© which were paid for by the Medicaid program. Approximately 90% of Neurontin© usage is for 
off-label purposes. 



As part of the consumer protection settlement, Warner-Lambert has entered into an Assurance of 
Voluntary Compliance (AVC) which prohibits the company from, among other things, making false, 
misleading or deceptive claims about Neurontin© and from promoting off-label uses in violation of the 
federal Food, Drug and Cosmetic Act. The company is also prohibited from misrepresenting the nature 
of scientific evidence related to Neurontin© and is prohibited from disseminating written materials 
about the drug that have not appeared in peer reviewed scientific journals. The AVC also requires 
disclosures by Warner-Lambert about funding of research and educational events related to Neurontin©. 






In total, Warner-Lambert will pay $430 million dollars under these settlements as follows: 



· $152 million dollars in damages and penalties to the various states’ Medicaid programs. As 
part of that settlement, the State of Delaware will recover $234,629.65 in Medicaid restitution and 
penalties

· $38 million dollars to settle the violations of consumer protection laws. Of that amount, 
$10 million dollars will be distributed to the participating Attorneys General’s offices to be

used for attorney’s fees and costs of investigation. Delaware will receive $25,000 for its 
Consumer Protection Fund. 

· $240 million dollar fine as part of the federal settlement for violating the Food, Drug and 
Cosmetics Act





This is the first of what may be many off-label marketing cases being investigated by the 
government to be resolved and sends a strong message to the pharmaceutical industry that off-label 
marketing of pharmaceuticals is not only unacceptable but criminal and will be prosecuted 
aggressively by the government. 

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