An attorney with a prominent personal injury law firm says an Actos whistleblower lawsuit filed earlier this year could strengthen legal claims alleging the type 2 diabetes medication caused some users to develop bladder cancer and heart failure.
“What the lawsuit does is essentially says that these things were happening in their clinical testing, within their knowledge, to patients and they weren’t reporting those adverse events properly,” Daniel Burke, senior litigation counsel at Parker Waichman LLP, a national law firm which is representing people who claim they were harmed by Actos, recently told Lawyers.com. “It essentially alleges that the Actos drug was more dangerous than some of the other drugs that were in the same class. Although Actos was being advertised as safer than other drugs, there was evidence it may have been as or more dangerous.”
The Actos whistleblower lawsuit was filed in 2011 by Helen Ge, a former medical reviewer for Takeda Pharmaceuticals, and unsealed in federal court in Massachusetts this past February. The complaint was brought under the federal False Claims Act, which allows private citizens to file suit on behalf of the federal government in cases of alleged fraud. According to Lawyers.com, Ge’s lawsuit was filed on behalf of the federal government and 23 states to recover payments made to Takeda based on the company’s allegedly fraudulent claims.
Ge alleges that Takeda repeatedly directed its medical reviewers to downplay cases of Actos bladder cancer, heart failure, and other side effects when reporting to the U.S. Food & drug Administration (FDA).
This past June, the FDA issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. Bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries last summer. Takeda officially recalled Actos from the French market in July.
Since the FDA issued its warning, scores of people throughout the U.S. have filed bladder lawsuits against Takeda. As we’ve reported previously, all federally filed Actos bladder cancer lawsuits were ordered transferred to U.S. District Court, Western District of Louisiana, by the U.S. Judicial Panel on Multidistrict Litigation in December. Plaintiffs in the Actos multidistrict litigation accuse Takeda Pharmaceuticals and other defendants of concealing knowledge of Actos’ bladder cancer risks and failing to adequately warn consumer and health care providers about its association with bladder cancer.
Parker Waichman LLP attorney Burke says Ge’s revelations could give Actos injury claims a boost.
“They weren’t reporting things. Unsealing the whistleblower complaint certainly brought that to light,” he told Lawyers.com.
His advice to Actos users who are now suffering from either bladder cancer or heart failure:
“Go over when you took the drug, how long you took the drug, when you were diagnosed,” Burke explains. “Folks who developed congestive heart failure, or had heart attacks or strokes are folks we’d like to talk to as potential plaintiffs.”