domingo, 31 de octubre de 2010

Research Activities, November 2010: Safety and Quality of Care: Whistleblowers in pharmaceutical fraud cases pursue Federal lawsuits for moral reasons, not money


Safety and Quality of Care
Whistleblowers in pharmaceutical fraud cases pursue Federal lawsuits for moral reasons, not money


Whistleblowers who help the U.S. Department of Justice (DOJ) identify and win health care fraud cases can reap large financial awards. However, a new study finds that money is not a motivator for the individuals who launch these lawsuits. Instead, integrity, altruism, public safety, justice, and self-preservation prompt them to file lawsuits under the Federal False Claims Act.

Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women's Hospital and Harvard Medical School, and his colleagues identified all individuals who had filed lawsuits leading to settlements against pharmaceutical companies under the Federal False Claims Act from 2001 to March 2009. These "qui tam" actions let individuals who have direct knowledge of a fraud initiate a lawsuit on the government's behalf. If the DOJ pursues the claim, the whistle-blower can receive between 15 and 25 percent of the judgment. The researchers found 42 unique whistleblowers, and 26 agreed to participate in semi-structured long-form interviews (62 percent). Among the sample, 5 received awards under $1 million, 13 received between $1 and $5 million, and 7 received more than $5 million (1 chose not to disclose the amount).

None of the respondents cited money as a reason for going forward with a lawsuit. In fact, the most common reason, cited by 11 whistleblowers, was integrity. According to the authors, these individuals described strong personal ethical standards that inspired the whistleblowers to come forward with evidence of wrongdoing. More than 80 percent of the whistleblowers described some form of retribution related to their behaviors. Five reported loss of employment, five reported being blackballed from subsequent jobs in the pharmaceutical industry, and five reported some form of direct intimidation, including possibly being implicated in the wrongdoing. Whistleblowers also felt that their involvement in the qui tam lawsuits led to financial turmoil, personal stress, and health problems, and some whistleblowers reported conflicts with DOJ personnel about the speed of the process or the ability of DOJ investigators to share information about the stage of the investigation.

The authors suggest that the toll these lawsuits take on their filers may limit the effectiveness of the False Claims Act in combating health care fraud, for example, by making prospective whistleblowers reluctant to come forward. Greater recognition by the government of the hardship associated with this process, such as offering whistleblowers temporary financial help or medical benefits, could help promote responsible whistle-blowing. Additionally, because financial awards were not always proportionate to the whistleblowers' contribution in the case (e.g., those who work inside a company were likely to bring the most relevant evidence to light and were also more likely to experience professional or personal stress), the DOJ should develop better approaches to equitable distribution of the whistleblower portion of the settlement. This study was funded in part by the Agency for Healthcare Research and Quality (HS18465).

See "Whistle-blowers' experiences in fraud litigation against pharmaceutical companies," by Dr. Kesselheim, David M. Studdert, LL.B., Sc.D., M.P.H., and Michelle M. Mello, J.D., Ph.D., M.Phil., in the May 13, 2010, New England Journal of Medicine 362(19), pp. 1832-1839.

Research Activities, November 2010: Safety and Quality of Care: Whistleblowers in pharmaceutical fraud cases pursue Federal lawsuits for moral reasons, not money

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