Actos Bladder Cancer Doesn’t Appear to Be Hurting Takeda

Washington, DCCritics of recent Actos bladder cancer jury decisions that have found for the defendant remain curious that Takeda Pharmaceuticals Inc. (Takeda), the Japanese manufacturer of Actos, remains somewhat shielded from responsibility in spite of various demonstrations of adverse courtroom behavior and revelations surrounding a failure to preserve documentation.

What’s more, The Globe and Mail (4/9/14) reminds us in an Associated Press (AP) report of the disclosure produced by a former medical reviewer for Takeda in recent court filings. Helen Ge alleged in a 2012 filing in US District Court that Takeda understated the number of bladder cancer cases potentially associated with Actos and bladder cancer, in disclosures to the US Food and Drug Administration (FDA), the federal regulatory authority keeping watch over the nation’s pharmaceutical drugs and medical devices.

And this month marks the third anniversary of the June 2011 FDA drug safety update that revealed a potential 40 percent increased risk of Actos bladder cancer in patients using Actos for a period of time exceeding 12 months. Actos is a medication indicated to help manage type 2 diabetes, a disease that remains chronic for most patients and requires constant management. An inability to stay on Actos for longer than a year would mean patients would be constantly switching their meds in order to lower the risk.

One recent bellwether Actos lawsuit ended with a decision in favor of the plaintiffs, who were awarded about $1.5 million in compensation. There was also a $9 billion hit for punitive damages, with $6 billion charged to Takeda and $3 billion charged to Eli Lilly and Co., which originally helped market Actos on Takeda’s behalf when Actos was first approved in 1999.

But many an Actos bladder cancer lawsuit has found for the defendant. This, in spite of judicial censure for failure to preserve important evidence in at least two cases. One recent case saw the defendant’s legal team censured for disobeying pre-trial orders. With the aforementioned allegation of misleading the FDA by allegedly understating cases of Actos and bladder cancer, critics are surprised that bladder cancer plaintiffs are not treated with more fairness by juries.

Even Takeda, which has won more Actos bladder cancer lawsuits than it has lost, is not satisfied with paying $6 billion in punitive damages - a bill that could balloon to $9 billion if former marketing partner Eli Lilly and Co. can prove that it is indemnified from liability by way of a pre-existing agreement between the two parties. That would leave Takeda to cover Eli Lilly’s $3 billion share of the punitive damages bill.

No matter. Takeda has signaled it will vigorously challenge the punitive damage hit, as well as Lilly’s claim on indemnification. They could also launch an appeal.

Meanwhile, a plethora of additional Actos bladder cancer lawsuits are lined up in the starting gate, ready for their respective days in court. And that’s just bladder cancer. Other Actos side effects include Actos heart failure and, according to an AP report, Actos liver problems, and a higher risk of broken bones.