The Department of Justice has rounded up billions of dollars from drugmakers in one whistleblower case after another. But some recent court decisions suggest that whistleblowers could face a higher bar for getting their cases heard. Now, as Pharmalot reports, the U.S. Supreme Court is asking the Solicitor General for its opinion on the subject.
The individual case in question pits whistleblower Noah Nathan against Takeda Pharmaceutical. Nathan, a Takeda sales manager, claims that the company pushed higher doses of its Kapidex stomach drug than the FDA had approved. A federal district court tossed out Nathan's claims, however, saying that his evidence wasn't specific enough, and the Fourth Circuit agreed.
Whistleblowers have to put forth details that "allege with particularity that specific false claims were presented to the government for payment," the court ruled (as quoted by Pharmalot). But the court also acknowledged that obtaining that sort of detail on individual health claims or prescription invoices can be stymied by privacy laws.
Nathan has asked the Supreme Court to hear the case, because the Fourth Circuit's opinion--shared by three other circuit courts--contradicts the views of four others, which share a broader view of sufficient evidence. And now that the court is back in session, it has asked for some input from the administration.
Given the Justice Department's dogged pursuit of drugmakers under the False Claims Act, we'd bet that prosecutors would prefer to deal with the lower standards. But we'll have to wait and see what the Solicitor General says--and what the Supreme Court does after that.
- read the Pharmalot piece
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