Doctor’s false-claim complaints against Takeda Pharmaceutical tossed
A Massachusetts federal judge has dismissed two whistle-blower lawsuits filed by a former Takeda Pharmaceutical Co. medical reviewer who alleged the company violated the False Claims Act by failing to accurately report adverse events concerning four of its drugs.
Dr. Helen Ge failed to plead her allegations with the particularity required by Federal Rule of Civil Procedure 9(b), U.S. District Judge F. Dennis Saylor IV of the District of Massachusetts said.
According to the judge’s opinion, Ge was a contractor for Takeda from September 2008 to January 2010.
Takeda markets the drugs Actos for diabetes, Uloric for gout, Kapidex/Dexilant for heartburn and Prevacid for acid reflux, according to the opinion.
The suit alleged several life-threatening adverse reactions occurred as a result of the drugs’ interaction with other drugs commonly used by the same patient populations. Takeda knew about the adverse events but failed to report them to the Food and Drug Administration or change the package insert warnings.
Ge filed two qui tam complaints in the U.S. District Court for the District of Massachusetts against Japan-based Takeda and subsidiary Takeda Pharmaceuticals North America Inc.
The qui tam provision of the False Claims Act allows private citizens, or “relators,” to file suit on behalf of the government in cases involving federal funds fraud and to share in any consequent settlement or court award.
Ge filed the first suit in 2010 regarding the drug Actos, and the second action in March 2011 concerning the other three drugs.
The complaints alleged violations of the False Claims Act and the respective qui tam provisions of similar statutes in 24 states.
Takeda moved to dismiss the complaints for failure to state a claim or to satisfy the heightened pleading requirements for alleged fraud.
Judge Saylor granted the motion on both counts.
He said the FCA imposes liability only for the filing of false claims, not for underlying fraudulent activity or the government’s wrongful payment.
Ge’s allegations failed to satisfy the particularity requirements of Rule 9(b) because, while they might demonstrate a “fraud on the FDA,” she failed to allege the specific details of any claims that were rendered false as a result.
Ge identified no specific claimants or government payers — federal or state — the opinion says.
She also failed to make specific allegations to support her inference that the FDA would have withdrawn approval for the four drugs if it had received the adverse-event reports.
As to Takeda’s second argument, Judge Saylor said, a relator must show that the claims at issue misrepresented compliance with a material precondition of Medicaid payment.
He said the essence of Ge’s argument was that Takeda’s compliance with the FDA’s adverse-event reporting requirements was an implied condition of continued FDA approval of the drugs at issue, and that because Takeda intentionally failed to comply with the requirement, all subsequent payment claims for the drugs were false.
According to Ge, each of Takeda’s claims for payment included an “implied representation of compliance,” the judge explained.
Even if there were an implied representation by Takeda, Ge still had to demonstrate that compliance with the reporting requirements was a material precondition of payment, Judge Saylor said.
She failed to do so, according to the judge.
The FDA exercises discretion in its enforcement procedures for violation of adverse-event reporting requirements and allows citizens to petition the agency to bring an action against alleged violators.
Ge’s claims should have been brought to the FDA’s attention rather than being asserted in a False Claims Act suit, the judge said.
United States ex rel. Ge v. Takeda Pharmaceutical Co. et al., Nos. 10-11043 and 11-10343, 2012 WL 5398564 (D. Mass. Nov. 1, 2012).