BOSTON - (Mealey's) Two whistle-blowers who went it alone in prosecuting a False Claims Act lawsuit against Pfizer Inc. in a Massachusetts federal court have forced a $14.5 million settlement for the off-label marketing of Detrol, according to announcements by the plaintiffs on Oct. 20 and a federal prosecutor's office on Oct. 21 (United States of America, et al., ex rel. David Wetherhold, et al. v. Pfizer, Inc., No. 1:06-10204, D. Mass.).
According to the announcement by counsel for relators David Wetherhold and Marci Drimer and today's announcement by the U.S. Attorney's Office for the District of Massachusetts, Pfizer will pay the federal government $11,878,846 plus 2.125 percent interest from Dec. 1, 2010, and will pay the state Medicaid programs $2,621,154 plus 2.125 percent interest. Wetherhold and Drimer will be paid their 27 percent statutory recovery fee of $3,282,019 under the False Claims Act out of the federal government's share.
Participating states will enter into separate settlement agreements, according to the settlement agreement.
The settlement covers alleged off-label marketing of Detrol from Jan. 1, 2003, through Dec. 1, 2010.
Detrol is approved by the Food and Drug Administration for the treatment of overactive bladder. Wetherhold and Drimer, both former Pfizer employees, allege that the company marketed the drug for off-label treatment of benign prostatic hyperplasia (BPH, or enlarged prostate gland in males), lower urinary tract symptoms and bladder outlet obstruction.
In 2006, Wetherhold and Drimer filed their lawsuit on behalf of the federal government and 23 states in the U.S. District Court for the District of Massachusetts. Both relators alleged that when they exposed Pfizer's fraudulent marketing of Detrol, they suffered retaliation that led to their forced resignations.
The complaint originally included allegations involving the off-label marketing of Bextra, but the relators withdrew that claim in September 2009.
That same month, the United States declined to intervene. In its statement today, the U.S. Attorney's Office said that although the government declined to intervene, it subsequently participated in settlement efforts.
On Jan. 18, 2011, Judge Douglas P. Woodlock ordered the case dismissed after the parties told him they had settled. The settlement agreement, however, was not signed by the various parties until Oct. 13, 14, 17, 18 and 20.
The settlement has not been docketed with the court but was released by the U.S. Attorney's Office.
[Editor's Note: Full coverage will be in the Nov. 3 issue of Mealey's Emerging Drugs & Devices. In the meantime, the settlement agreement is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844. Document #28-111103-012P. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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