The jury is out, and the manufacturers of Actos, the once-popular type 2 diabetes medication, are now ordered to pay $9 billion (yes, with a 'b') to a man who developed bladder cancer from the medication. The award is the seventh-largest in U.S. history, and there thousands more Actos cases still to be heard. Actos attorneys at Pintas & Mullins take a closer look at Actos' first U.S. trial and what it could mean for other Actos plaintiffs.
The defendants in this case, Eli Lilly and Takeda Pharmaceuticals, are accused of many things in this Actos litigation, ranging from designing a defective drug to intentionally covering up its true side effects. The jury decided on such a large amount in part because of the seriousness of the drugs' side effects, and in part due to the poor conduct of Lilly and Takeda during the trial.
The plaintiff in this case, Terrence Allen, like too many others, developed bladder cancer from taking Actos, which was prescribed to help him manage his type 2 diabetes. The drug was introduced in 1999 and quickly became one of the hottest medications on the market; sales peaked in 2011, at $4.5 billion.
Allen and other Actos plaintiffs argue that the drugmakers knew the medication could cause cancer and chose not to adequately warn doctors and patients in efforts to boost drug sales. Pharmaceutical executives are accused on intentionally downplaying the risk of bladder cancer and misled the FDA about its true safety.
The link between Actos and bladder cancer was scientifically proven in 2004, but the manufacturers refused to acknowledge the association until 2011, when it finally placed warning labels on the drug at the request of federal regulators.
Allen was prescribed the drug in 2006 - meaning after the medical and pharmaceutical community knew of the link between Actos and bladder cancer, but before Lilly and Takeda decided to properly warn patients on the drug. He developed bladder cancer five years after he started taking the drug.
Evidence and Documents Destroyed
One of the most egregious aspects of this case, apart from the seriousness of the injury itself, was how Takeda and Lilly handled its events. Going back to 2004, when the bladder cancer risk was associated, Takeda executives sent internal emails stating that Actos was vital to the company's financial survival and to drag out placing a cancer risk on warning labels as long as possible.
These emails were produced in court because both Takeda and Lilly were under court orders to preserve all documents regarding Actos as evidence. Despite this order, Takeda failed to preserve much of its internal Actos documents - whether this was done intentionally or not is a point of debate, but after lawsuits started being filed the company destroyed the files of over 45 former and current employees, including top executives and sales representatives, so you be the judge.
Regardless, the evidence about how much Takeda knew and when was largely lost, so the judge penalized Takeda by telling jurors that the files may have strengthened and supported Allen's arguments about the company's wrongful information withholding.
Many believe that this document destruction bolstered the jury's award decision, to punish a drug company acting with such malice and disregard for not only patient safety but legal proceedings as well. This was the first bellwether trial in the Actos multi-district litigation (MDL), which consolidates thousands of Actos cases before a single judge in Louisiana.