Pfizer pays $491 Million to Resolve Allegations of Off-Label Marketing of Rapamune
The United States District Court for the Western District of Oklahoma on July 30, 2013, unsealed a whistleblower lawsuit against Wyeth Pharmaceuticals Inc filed in 2007 by the national whistleblower firm Vogel, Slade & Goldstein, LLP, on behalf of Mark Campbell, a former Wyeth sales representative, that alleged that Wyeth for over a decade illegally marketed the transplant drug Rapamune for uses that had not been approved by the U.S. Food & Drug Administration, including potentially dangerous uses subject to a “black box” warning – the most serious type of warning required by the FDA. On July 29, 2013, the United States had intervened in Mr. Campbell’s lawsuit for the purpose of settlement. On July 30th, Pfizer Inc, the world’s largest pharmaceutical company, and the owner of Wyeth Pharmaceuticals Inc., finalized its agreement to pay $491 million to resolve these civil allegations and resulting criminal liability.
Under the settlement, Pfizer in August 2013 paid $257 million of the $491 million to resolve two civil lawsuits – – one filed by Mr. Campbell and one filed by two other whistleblowers – – that alleged that Wyeth’s illegal marketing led to false claims against Medicare and other government health care programs and consequently violated the federal False Claims Act and analogous, state false claims laws.
The whistleblowers in the second case are Marlene Sandler and Scott Paris. They jointly filed a qui tam lawsuit against Wyeth in Pennsylvania in 2005 that alleged aspects of the unlawful off-label marketing subsequently alleged by Mr. Campbell. After the Government declined to intervene in their action, Sandler and Paris commenced to litigate it on their own. After Mr. Campbell filed his case in Oklahoma, the Department of Justice intervened in the Sandler/Paris action, transferred it to the Oklahoma court where Mr. Campbell’s qui tam was pending, stayed the action and consolidated the two cases. This settlement resolves claims in both of the cases.
Mr. Campbell and the two other former Wyeth employees who filed a whistleblower lawsuit have cooperated with each other in support of the Government’s investigation and agreed early on to align their interests and share in the relator share awards. The False Claims Act and the analogous state laws under which the whistleblowers filed suit provide that eligible whistleblowers shall receive between 15 and 25% of the government’s recovery in intervened cases. The federal and state governments are paying awards to Mr. Campbell and the other two whistleblowers pursuant to these provisions.
Mr. Campbell worked for Wyeth for 20 years, up until 2009. He covered sales territories that included Oklahoma and Texas. After resigning from Wyeth at age 48, Mr. Campbell, who has Masters’ degrees in Religious Education and Marriage & Family Counseling, served as Executive Director for Ministries of Jesus, a nonprofit healthcare ministry in Oklahoma. Mr. Campbell said:
I am so thankful to be a citizen of a country with a “citizen attorney general” statute like the False Claims Act that authorizes private individuals to hold corporations accountable when they endanger the public and steal from the U.S. Treasury. I believe this settlement represents at least a small step towards insuring that pharmaceuticals are promoted in a manner which does not compromise patient safety.
The U.S. Attorney for the Western District of Oklahoma led the investigation into Mr. Campbell’s allegations. Commenting on the Government’s investigation, Shelley R. Slade, lead counsel for whistleblower Mark Campbell, stated:
Off-label marketing endangers patients and erodes the public’s confidence in the medical community. We applaud the diligent and thorough investigation by the U.S. Attorney for the Western District of Oklahoma. He has sent a strong message to drug manufacturers throughout our nation.
The FDA has approved Rapamune for use in combination with corticosteroids and cyclosporine following kidney transplantation. Mr. Campbell’s lawsuit alleged that Wyeth marketed the drug for unapproved uses, including use after liver, lung, heart, pancreas and islet transplants, in combination with drug therapies besides corticosteroids and cyclosporine, and following “conversion” from another immunosuppressant. As stated in Mr. Campbell’s complaint, these unapproved uses are potentially dangerous. The FDA in 2002 required Wyeth to place a “black box warning” on the Rapamune product label advising of the risks inherent in using Rapamune after liver transplants, including the risk of death. The FDA in 2003 required a similar type of warning with regard to the use of Rapamune after lung transplants. According to Mr. Campbell’s complaint, a Wyeth marketing employee internally acknowledged that as much as 90% of the company’s Rapamune sales were for so-called “off-label” uses.
Mr. Campbell’s suit was filed under the qui tam provisions of the federal False Claims Act and the false claims laws of multiple states in the U.S. District Court for the Western District of Oklahoma. The investigation into Mr. Campbell’s allegations was overseen by Sanford C. Coats, U.S. Attorney for the Western District of Oklahoma, along with Assistant U.S. Attorneys Vicki Behenna and Lee Schmidt and former Assistant U.S. Attorney Dan Lennington. They worked in conjunction with Brian McCabe, a Washington, D.C.-based Trial Attorney for the U.S. Department of Justice. The FBI, the Office of Inspector General of the U.S. Department of Health & Human Services, and the Medicaid Fraud Control Units of the states all participated in the investigation.