Genentech Beats FCA Suit, Thanks to Escobar

On Monday, May 1, 2017, the United States Court of Appeals for the Third Circuit stopped a False Claims Act suit that accused Genentech Inc. of defrauding Medicare by concealing certain side effects of its cancer drug Avastin, stating that the whistleblower did not show that failing to report such safety information was relevant to government reimbursement for medication. Prior to filing his qui tam suit, The relator, Gerasimos Petratos, a prior global head of health care data analytics for Genentech, allegedly recommended implementing a different database that he believed would more accurately reflect the drug’s side effects. There were Genentech employees who agreed with Petratos but declined to follow his recommendations, citing “business risk.” After Petratos brought his concerns to the heads of regulatory affairs and product development, the executives did not follow Petratos’ recommendations, and he received a “scathing email” from his supervisor. In June 2011, Petratos filed his initial complaint, arguing that Genentech based regulatory submissions off databases with inadequate information about Avastin’s risks and omitted electronic medical records that would have given better answers about the drug’s safety. Petratos claimed Genentech concealed information about Avastin’s health risks in its reports to the United States Food and Drug Administration (FDA). Therefore, he alleged, doctors submitted more Medicare reimbursements than they would have i...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs