Takeda's Actos — a diabetes drug that cost $2.37 billion in settlements

Actos (pioglitazone) was a type 2 diabetes drug developed by Takeda Pharmaceutical Company, a Japanese pharmaceutical company founded in 1781. The drug was patented in 1985 and came into medical use in 1999. It became a major product for Takeda, generating billions in revenue as one of the most prescribed diabetes medications in the world.

In June 2011, France withdrew pioglitazone from the market after an epidemiological study by the French National Health Insurance showed a significantly increased risk of bladder cancer with long-term use. Germany's Federal Institute for Drugs and Medical Devices advised doctors not to prescribe it pending further investigation. The US FDA announced that use for more than one year may be associated with an increased risk of bladder cancer and updated the label with a warning.

Takeda faced lawsuits from thousands of patients who developed bladder cancer after taking Actos. In 2014, a federal court jury awarded a plaintiff $9 billion in punitive damages, which was later reduced to $26 million by a judge who deemed the original amount excessive. The award was the largest in US pharmaceutical history at the time.

In April 2015, Takeda agreed to pay $2.37 billion to settle claims from approximately 9,000 people. The average claimant received $267,000, with the exact amount depending on dosage, injury extent, and smoking history. The settlement was one of the largest pharmaceutical product liability settlements in history. The drug remained available in the US with a label warning and as a generic, but the damage to Takeda's reputation and finances was significant.