The U.S. Court of Appeals for the Third Circuit recently halted a False Claims Act lawsuit filed against Genentech Inc. In the suit, the plaintiff claimed the company defrauded Medicare by hiding some side effects of its cancer drug Avastin. The court stated the whistleblower did not show that a failure to report the safety information related to the drug was relevant to government medication reimbursement.
Before filing the qui tam claim, Gerasimos Petratos, who served as global head of healthcare data analytics for the company, had allegedly recommended using a different database that he believed would better outline the side effects associated with the drug. While there were Genentech employees who agreed with the recommendation, the company ultimately declined to follow it, believing the risk to the business was too great.
Petratos raised his concerns with the heads of product development and regulatory affairs, but those executives also did not follow his recommendations. He claims he then received a “scathing email” from his supervisor. He filed his first complaint in June 2011, claiming that Genentech based its regulatory submissions on databases that did not provide adequate information on the risks of Avastin and routinely left out electronic medical records that would have provided more complete information about the drug’s safety.
Decision by the Third Circuit
Judge Thomas Hardiman of the Third Circuit stated in his opinion that Petratos did not prove the materiality element needed for a False Claims Act case to proceed. There was a lack of proof that the company tended to influence or had the ability to influence the receipt or payment of money. The judge also wrote that there were no allegations showing the Centers for Medicare and Medicaid Services would not have eventually reimbursed the claims had the deficiencies been resolved.
To learn more about the process of filing a False Claims Act lawsuit, consult a knowledgeable Dallas attorney at Whistleblower Law for Managers today
