Actos Manufacturer Faces First Trial over Bladder Cancer Link

Actos trial

Takeda Pharmaceutical Co. is facing its first trial over Actos in Los Angeles, with claimants alleging that the popular diabetes drug causes bladder cancer and other complications in some patients.

Takeda is facing more than 3,000 lawsuits over Actos-related bladder cancer and other side effects in patients who took the drug. Judge Kenneth Freeman will oversee cases in California, and additional cases are pending in state court in Illinois.

More than 1,200 federal lawsuits have been consolidated in Louisiana for pretrial proceedings. The first federal trial is planned for November 2014.

Court filings from the lawyers of former Actos patients assert that Takeda de-emphasized or ignored early research suggesting the drug’s link to bladder cancer. The lawyers claim that Takeda deceived U.S. drug regulators about Actos safety risks before it was approved for the U.S. market in 1999.

Top Seller Worldwide

Once the world’s best-selling diabetes medication, Actos has been linked to a 40 percent higher risk for bladder cancer in long-time users, according to a 2011 FDA drug safety communication. One study puts the increased risk at 83 percent. The drug has also been linked to other side effects, including congestive heart failure and liver failure.

According to Bloomberg, Actos sales reached a pinnacle of $4.5 billion in the year that ended in March 2011, accounting for 27 percent of Takeda’s profit in that time period.

But in 2011, the U.S. Food and Drug Administration (FDA) reviewed a Takeda-sponsored study that revealed some long-time Actos users are at an increased risk for bladder cancer and heart problems. A bladder cancer warning was added to the label that year. That same year, drug regulators convinced Takeda to pull Actos from the market in Germany and France.

FDA investigations into the risks of Actos use are ongoing, and officials say results will be available next year.

Former Takeda Employee Backs Claims

In a whistle-blower lawsuit, former Takeda medical reviewer Helen Ge accused the drug manufacturer of withholding reports of Actos-related congestive heart failure from the FDA. Ge stated that from 2007 to January 2010, Takeda failed to classify non-hospitalized or non-fatal cases of congestive heart failure as serious side effects in reports submitted to the FDA’s safety database.

“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.

In November 2012, Massachusetts U.S. District Judge F. Dennis Saylor dismissed Ge’s claim, stating that she should have filed her complaint to the FDA rather than filing a suit under the federal False Claims Act.

Former Actos patients argue that Takeda executives dodged FDA requests for the drugmaker to add bladder cancer warnings to the drug’s safety labels for years. The results of a confidential Takeda-sponsored survey of 12 doctors in 2003 indicated that a bladder cancer warning on the Actos safety label would destroy sales of the company’s best-selling drug.

Responding to these allegations, Takeda lawyers insist the company communicated with the FDA responsibly and that no evidence supporting a causal link between Actos and bladder cancer exists.

Jury selection for the first Actos trial began Tuesday, Feb. 19.