Diabetic patients who developed bladder cancer as a result of taking Actos received compensation following a $2.5 billion Actos settlement.

The settlement was reached in 2015, four years after the FDA required drug maker Takeda Pharmaceuticals to add a “black box” warning to the product label about the elevated bladder cancer risk lined to the diabetes drug. Type-2 diabetics who developed bladder cancer after taking Actos were eligible to receive a payout from the Actos settlement.

About Actos

Actos (pioglitazone) is one of a class of prescription medications known as thiazolidinediones (TZDs), or “glitazones.” The first of these drugs, ciglitzone, was first developed by Takeda in the 1980s. Actos was given FDA approval for the treatment of type-2 diabetes in 1999. Medications of the glitazone class operate on the DNA levels, waking up cellular receptors in order to increase insulin sensitivity. Other prescription drugs in this class include Avandia (rosiglitazone) and Duvie (lobeglitazone), which is sold only in South Korea.

Actos Side Effects

Long before there was any talk of an Actos settlement, problems with the medication became apparent. In February of 2007, Takeda’s rival, GlaxoSmithKline, acknowledged a study that found diabetic women who took Avandia were predisposed to bone fractures of the extremities than those who took metformin. This essentially required Takeda to make a similar acknowledgement about Actos.

Other side effects noted among Actos patients include fluid retention (leading to potential heart failure), anemia, weight gain and elevated risk of respiratory illness, muscular pain and weakness (myalgia), and dental problems. In rare cases, Actos can interfere with bile function, although this condition usually clears up when the patient is taken off  the drug.

Actos Bladder Cancer

In 2011, a study conducted by the French government’s public health service found that long-term Actos patients ran a significantly higher risk of developing bladder cancer. This led to the government-run health care systems in France and Germany to discontinue use of the drug until further research had been done. Shortly afterward, the FDA began requiring Takeda to add a black box warning to Actos labels, advising patients and physicians of the bladder cancer risk.

The Actos Settlement

Plaintiffs in subsequent lawsuits against Takeda and U.S. marketing partner Eli Lilly alleged that the drug maker had been aware of the bladder cancer risk long before the findings of any studies had been made public. By 2015, over 5,000 Actos bladder cancer lawsuits had been joined into multi-district litigation (MDL) before a U.S. District Court in Louisiana. An additional 4,500 complaints had been filed in state courts around the country.

All nine of the initial “bellwether” trials ended in jury verdicts in favor of the plaintiffs, with awards totaling $22 million. Judges overturned two of the verdicts, though one of those was reinstated by an appellate court. Seeing the trend, defendants Takeda and Eli Lilly entered into the $2.5 billion Actos settlement–one of the largest such settlements in U.S. legal history.

In entering into its Actos settlement, neither Takeda nor Eli Lilly have admitted to any wrongdoing. They have also continued to stand by their claims of Actos’ safety and efficacy.