The federal government is asking a federal appeals court to overturn a decision by a Boston federal judge who ruled that Takeda Pharmaceutical was not liable for informing the FDA of adverse event reports on several of its drugs.
The case was originally filed by Takeda safety consultant Helen Ge who said Takeda had misrepresented or altered descriptions of adverse events for the Takeda drugs Actos, Uloric, Kapidex/Dexilant and Prevacid. Mrs. Ge contended that all of the drugs, including Prevacid, used to treat heartburn, would not have been as widely prescribed had adverse events been reported properly to the FDA.
Consequently, she said that the federal healthcare programs including Medicare paid for more prescriptions than might otherwise have been dispensed.
The adverse reactions she said were hidden were life-threatening, according to Mrs. Ge’s complaint and that Takeda did not adequaely change the package insert warnings to reflect this. She says Takeda employees intentionally misrepresented and altered the descriptions of adverse events in reports and intentionally misclassified adverse events as “non-serious”.
Helen Ge filed her claims under the False Claims act which protects the government from effots to fraudulently collect government reimbursements. The law allows a whistleblower to collect up to 30% of what the government collects in the case.
The judge in the case U.S. District Court Judge F. Dennis Saylor ruled that Mrs. Ge failed to provide sufficient details of the fraud and that the adverse events that Takeda failed to report were not material to the decision by federal healthcare programs to pay for the medications. The Department of Justice disagrees, as does the FDA and Uncle Sam is filing an appeal on its own, joining in Ms. Ge’s appeal.
I will watch the appeal closely and report the resultes here. Jeffrey Newman