Criminal Prosecution of Warner-Lambert Company

In 2004, Warner-Lambert Company, paid $430 million in fines and settled its False Claims Act liability for illegal marketing conduct and fraudulent promotion of the drug Neurontin for uses that were not approved by the FDA. Neurontin was approved by the FDA in December 1993 solely for adjunctive or supplemental anti-seizure use by epilepsy patients. Under the provisions of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq., a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses - any use not specified in an application and approved by FDA. However, Warner-Lambert's strategic marketing plans, as well as other evidence, showed that the company aggressively marketed Neurontin to treat a wide array of ailments for which the drug was not approved. The company promoted Neurontin for the treatment of various pain  disorders, Amyotrophic Lateral Sclerosis (ALS, a degenerative nerve disease commonly referred to as Lou Gehrig's Disease), attention deficit disorder, migraine, drug and alcohol withdrawal seizures, and restless leg syndrome.

Warner-Lambert promoted Neurontin for unapproved uses even when scientific studies did not demonstrate effectiveness. For example, the company promoted Neurontin as effective for use as the sole drug (monotherapy) for epileptic seizures, even after the FDA specifically had not approved monotherapy use. Similarly, Warner-Lambert falsely promoted Neurontin as effective for treating bipolar disease, even when a scientific study demonstrated that a placebo worked as well or better than the drug. As a consequence of the unlawful promotion scheme, patients who received Neurontin for unapproved and unproven uses had no assurance that their doctors were exercising their independent and fully-informed medical judgment, or whether the doctor was instead influenced by misleading statements made by, or inducements provided by, Warner-Lambert.

Warner-Lambert pleaded guilty to felony violations of the Federal Food, Drug, and Cosmetic Act, and paid a criminal fine of $240 million, the second largest criminal fine ever imposed in a health care fraud prosecution. The company also settled its Federal civil FCA liabilities by paying the United States $83.6 million, plus interest, for losses to the Federal portion of the Medicaid program, and resolved its civil liabilities to the fifty states and the District of Columbia by paying $68.4 million, plus interest, for losses to the state Medicaid programs. In addition, Warner Lambert paid $38 million to fund a remediation program, to be administered by state consumer protection offices, to address harm caused to consumers. Finally, Pfizer Inc, agreed to comply with the terms of a corporate compliance program, designed to ensure that the changes Pfizer, Inc. made after acquiring Warner-Lambert in 2000 are effective, and that the company will detect and correct any future off-label marketing conduct on a timely basis. In addition, Warner-Lambert agreed to a state court injunction barring the improper conduct that was the subject of the state's Consumer Protection Division's investigation.

Source: HHS Health Care Fraud and Abuse Control Program, Annual Report for FY 2004

This article was posted on July 15, 2012.

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