Supreme Court Asks Solicitor General About Whistleblower Cases

The US Supreme Court has asked the US Solicitor General to comment on a case that calls into question whether whistleblowers may be restricted from filing lawsuits alleging drugmakers duped federal healthcare programs into paying for medicines (see page 6). And what may be at stake is the ability of the federal government to recover billions of dollars from healthcare fraud. The case involves a Takeda Pharmaceutical sales manager named Noah Nathan, 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. And Nathan is arguing over the standards used to determine whether a lawsuit alleging violations of the False Claims Act sufficiently provides enough specific information to prove evidence of fraud. Nathan maintains the US Court of Appeals for the Fourth Circuit issued a decision earlier this year that requires whistleblowers to meet an impossibly high bar for satisfying a key provision of the False Claims Act. As we wrote previously, 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). At the moment, there is a split among the appeals courts, but to what extent the Fourth Circuit ruling could be more broadly applied is som...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs