A Takeda Manager Asks The Supreme Court To Review A Whistleblower Ruling

Will a recent appeals court ruling restrict the ability of whistleblowers to file lawsuits that allege drugmakers duped federal healthcare programs into paying for medicines? This is the contention made by Noah Nathan, a sales manager at Takeda Pharmaceuticals, who claims the drugmaker defrauded Medicare by falsely marketing higher doses of its Kapidex treatment for gastroesophageal reflux disease, or GERD, than what was approved by the FDA. So far, Nathan has lost two rounds in court, but now hopes the US Supreme Court will review his case. Why? In his view, a decision earlier this year by the US Court of Appeals for the Fourth Circuit requires whistleblowers to meet an impossibly high bar for satisfying a key provision of the False Claims Act. And his lawyers argue that, given division among federal appeals courts, if the Fourth Circuit decision is allowed to stand, the ability of the US government “to recover billions of dollars for fraud is at stake.” At its core, the fight is over the standards used to determine whether a lawsuit alleging violations of the False Claims Act sufficiently provides enough specific information to provide evidence of fraud. Any decision could have enormous implications for the federal government and the pharmaceutical industry. In fiscal year 2012, the US government recovered $3 billion from violations of the False Claims Act, including illegal pricing and marketing by drug and device makers (see this). The issue in this case is interpreta...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs