A US court has ordered Takeda and Lilly to pay a massive $9bn in punitive damages after concluding that the companies covered up cancer risks associated with diabetes blockbuster Actos.
After listening to more than a month of legal sparring, the jury in the Louisiana court case awarded damages of $6bn against Takeda and $3bn again Lilly, along with compensatory damages to plaintiff Terrance Allen of nearly $1.5m.
Allen was diagnosed with bladder cancer in January 2011 and had been using Actos (pioglitazone) to help control his diabetes between 2004 and 2011. His case was the first of a number of federal lawsuits claiming injury from Actos to go to trial.
In the lawsuit, Allen’s counsel alleged that he developed bladder cancer after taking Actos for more than five years, arguing that the companies downplayed concerns about the drug’s link with cancer – despite being aware of it since the early 2000s – misled regulators about the risks and acted with “wanton disregard” of patient safety.
One of the points that seems to have swayed the jury was evidence presented suggesting Takeda employees lost or destroyed files relating to Actos, which at its height was bringing in $5bn a year in sales, according to a report in The Legal Examiner journal.
Takeda’s general counsel Kenneth Greisman said in a statement that the company “respectfully disagrees” with the jury’s verdict.
“We intend to vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal,” he averred, adding: “we believe the evidence did not support a finding that Actos caused [Allen’s] bladder cancer.”
In 2012, the European Commission (EC) concluded that Actos should still be prescribed in Europe following a safety review, but said its labelling should be updated to reflect a small increase in the potential risk of bladder cancer.
France and Germany both suspended use of the drug in 2011 until the conclusion of the review, while an FDA review in the same year concluded that use of the drug “for more than one year may be associated with an increased risk of bladder cancer”.
All told, a little under 3,000 Actos suits have been consolidated and are pending in the Louisiana court. Three previous civil Actos trials ended in Takeda and Lilly’s favour.