WASHINGTON (Legal Newsline) - U.S. Attorney General Eric Holder announced a settlement Friday with Pfizer Inc. worth $14.5 million to resolve False Claims Act allegations related to marketing of the drug Detrol.
The settlement resolves the last of a group of 10 qui tam, or whistleblower, suits that were filed in the District of Massachusetts and two additional districts starting in 2003. The other nine suits were settled or dismissed in 2009 as part of the government's global resolution with Pfizer, under which the company agreed to pay $2.3 billion to resolve criminal charges and civil claims regarding multiple drugs.
The current agreement addresses allegations the Pfizer illegally marketed Detrol, a drug for the treatment of overactive bladder, for use in male patients that suffered from benign prostatic hypertrophy and several allied conditions, notably bladder outlet obstruction and lower urinary tract symptoms - all uses for which the Food and Drug Administration had not approved the drug as effective and safe.
As part of the settlement, the $14.5 million recovery will be divided between the United States and participating state Medicaid programs. Under the qui tam provisions of the False Claims Act, the whistleblowers will receive a $3,282,019 share of the federal recovery.
"Whistleblowers play an important role in protecting taxpayer funds from fraud and abuse," Tony West, the assistant attorney general of the Justice Department's Civil Division, said. "Settlements like this one help maintain the integrity of FDA's drug approval process and support important federal and state health care programs."
The United State declined to intervene in the case, which was litigated independently by the relators. The United States subsequently closely participated in efforts to resolve the case.
The settlement is a part of the government's emphasis on combating health care fraud and another stop for the Health Care Prevention and Enforcement Action Team initiative, which was announced by Holder and Kathleen Sebelius, the secretary of the Department of Health and Human Services, in May 2009. The partnership between the two departments has focused on efforts to reduce and prevent Medicare and Medicaid financial fraud. One of its most powerful tools is the False Claims Act, which the Justice Department has used to recover more than $6.3 billion in cases involving fraud against federal health care programs since January 2009. The department's total recoveries in False Claims Act cases since January 2009 exceed $8.1 billion.