Whopping $9 Billion Verdict Hits Takeda, Eli Lilly Over Actos Cancer Claims

A federal jury in Louisiana has ordered Takeda Pharmaceutical Co. Ltd and Eli Lilly & Co. to pay a staggering $9 billion in damages over allegations that the companies’ diabetes medication, Actos, can cause bladder cancer. The verdict comes at the end of the first Actos bellwether trial, selected from the thousands of cases pending in the multidistrict litigation against Takeda.

What makes these cases so tricky is that it’s almost impossible to ever say, for certain, what caused a patient’s bladder cancer.

The judgment, awarded yesterday, is the first such decision at the federal level. Takeda will pay $6 billion in punitive damages to Terrence and Susan Allen, while $3 billion is to be paid by Eli Lilly, the American partner of Asia’s largest drug company. An additional $1.5 million in compensatory damages was awarded to the plaintiffs, the cost of which will be divided between the companies.

The result of this bellwether, which was presided over by U.S. District Judge Rebecca F. Doherty, could prove crucial in patients’ long fight against the companies – companies they claim marketed a dangerous drug and hid the results of a clinical study that linked Actos to bladder cancer. Takeda has always denied its drug poses a risk of cancer, but in June 2011, the FDA warned that using Actos for more than a year could increase patients’ risk of the disease. It also advised doctors not to prescribe Actos to patients with bladder cancer. A harmless medication? It’s becoming increasingly hard to believe.

Despite the FDA’s warnings, and scientific studies that have highlighted the increased risk of bladder cancer in long-term Actos users, Takeda has been surprisingly successful at fighting claims in court. In May 2013, a California judge threw out a $6.5 million verdict after the company argued that the plaintiff’s cancer couldn’t be directly linked to Actos. Takeda is also currently facing accusations that it destroyed key documents, despite the fact that a litigation hold was placed on the company to preserve various printed and electronic files related to Actos’ development and marketing. The lost documents are thought to be potentially helpful for plaintiffs, and Takeda remains under the threat of federal sanctions for its failure to provide the necessary evidence.

What makes these cases so tricky is that it’s almost impossible to ever say, for certain, what caused a patient’s bladder cancer. Plaintiffs’ age, smoking habits and general lifestyle are all potential causes, and Takeda continues to argue that Actos itself can’t be blamed with any certainty. That lack of certainty is what makes courts nervous.

It’s no surprise that Takeda’s lawyers have already vowed to fight this week’s verdict. The company’s stance, as always, is that there is “no evidence to support a finding that Actos caused [Terrence Allen’s] bladder cancer.”

Clearly, the jury felt differently. Terrence Allen sued Takeda in 2011, claiming that the company knew about the possible side effects of Actos, including the risk of bladder cancer, but hid the information because the drug was selling so well. In fact, Allen claimed Takeda knew about the bladder cancer risk in animals and humans before the FDA had even approved Actos for use.

We’ll never know for sure just how honest Takeda is being (though it’s more than tempting to suspect truth can be a tricky thing when you’re dealing with a drug that’s earned more than $16 billion in sales since its launch), and this verdict could still be overturned; however, the number of lawsuits against the company continues to grow. To date, nearly 3,000 Actos patients have filed federal lawsuits against Takeda and Eli Lilly. That’s a lot of lawsuits – and a lot of potential settlement money. You can be sure that the next few trials will be eagerly watched for any clue as to the overall direction of the litigation.