On September 21, 2010, the United States moved to intervene in a qui tam action filed by two former Wyeth sales employees. The relators’ complaint, originally filed on December 16, 2005, and most recently amended on May 24, 2010, alleges that Wyeth engaged in improper off-label marketing and promotion of the immunosuppressant drug Rapamune (generic name sirolimus). In 1999, the FDA approved Rapamune to prevent organ rejection in patients aged 13 years or older receiving kidney transplants. Wyeth reported $374 million in Rapamune sales in 2008. Pfizer acquired Wyeth in 2009. A copy of the relators’ second amended complaint filed in United States et al. ex rel. v. Sandler et al., Civil Action No. 05-6609 (E.D.Pa.), can be found here.
The relators allege that Wyeth placed transplant patients at risk and caused false claims to be submitted to the Medicare and Medicaid programs by:
- “systematically engaging in illegal off-label marketing of Rapamune";
- “furthering the unlawful off-label marketing of Rapamune through the transformation of ostensibly independent and unbiased educational and scientific programs, including physician continuing medical education (‘CME’) programs, into promotional vehicles for Rapamune"; and
- “unlawfully promoting Rapamune in violation of the Anti-Kickback Statute, 42 U.S.C. § 1320-a-7b(b), as amended by the Patient Protection and Affordable Care Act (PPACA), Public Law No. 111-148, Sec. 6402(g), and the Stark Law, 42 U.S.C. § 1395nn, and 42 C.F.R. § 411.350 et seq. by providing cash and other incentives to induce doctors to promote and prescribe Rapamune, including for off-label uses.”
The relators assert claims for treble damages, penalties, disgorgement, and attorneys’ fees pursuant to §§ 3729(a)(1)(A) and (B) of the federal False Claims Act and the state False Claims Acts of Arkansas, California, Delaware, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Nevada, New Hampshire, New Mexico, Tennessee, Texas, Utah, Virginia, New York, Georgia, Michigan, and the District of Columbia.
For further commentary on the action, see: