A U.S. unit of Takeda Pharmaceutical Co. failed to give accurate reports to regulators about hundreds of congestive heart failure cases associated with its diabetes drug Actos, a whistle-blower claimed in a lawsuit.
The company failed to classify “non-hospitalized or non-fatal” congestive heart failure cases as serious from late 2007 to January 2010, former Takeda medical reviewer Helen Ge said in the complaint in federal court in Boston. Takeda, like other drugmakers, is required to update the U.S. Food and Drug Administration’s Adverse Event Reporting System.
“These events were not properly identified or reported in the FDA’s safety database,” Ge claimed in the complaint, filed in June 2010 and recently unsealed. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales,” Ge said.
The case against Takeda Pharmaceuticals North America Inc., filed by Ge on the government’s behalf, became public after the U.S. Justice Department declined to join it on Feb. 22. Twenty-four U.S. states also declined to join Ge’s complaint, said one of her attorneys, Michael L. Baum.
Takeda, based in Osaka, Japan, said Feb. 1 that annual profit will fall 48 percent to 130 billion yen ($1.6 billion) in the year ending March 31. Sales of Actos, which generated 27 percent of revenue last fiscal year, declined 19 percent in the previous nine-month period and will slump more when it faces competition from generic copies in August, Takeda said.
“Takeda complies with all laws and regulations regarding the reporting of adverse events,” Hisashi Tokinoya, a company spokesman based in Tokyo, said in an e-mailed response today, declining to comment on specific allegations because the lawsuits are pending.
Takeda dropped 1.6 percent to 3,655 yen at the close in Tokyo trading, while the benchmark Topix Index fell 0.6 percent.
Ge’s complaint claims that on multiple occasions, Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” When she protested, “her contract was summarily terminated,” according to the complaint.
Takeda wanted to make it appear that Actos was safer than GlaxoSmithKline Plc’s Avandia diabetes drug, according to the complaint.
Ge sued under the federal False Claims Act and similar state statutes, and seeks to recover damages on behalf of governments. She would be entitled to between 15 and 30 percent of any recovery.
“Takeda’s fraud has caused tens of thousands of false claims to be made on federal and state health care programs,” causing “hundreds of millions of dollars” in damages, according to the complaint.
In 2007, the FDA ordered Takeda and Glaxo to place its strongest warning on the labeling of their drugs about the risk of congestive heart failure, a condition that occurs when the heart doesn’t adequately pump blood.
Ge claimed that Takeda’s culture is “riddled with systematic fraud and deceit,” and that the company downplayed data suggesting a link between Actos and bladder cancer.
Baum, of Baum, Hedlund, Aristei & Goldman, said he is undeterred by the Justice Department’s decision to not join the lawsuit after investigating. The U.S. declines to join four out of five cases filed under the False Claims Act. Companies settle the vast majority of cases when the U.S. intervenes.
“I believe that the documents we obtain in discovery will induce the government to come back in,” Baum said. “But whether they come back in or not, I believe the documents will show that the company violated the False Claims Act.”
One of Ge’s lawyers is Michael Sullivan of The Ashcroft Group LLC. He is the former U.S. attorney in Boston.
The case is U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of Massachusetts (Boston).