Takeda faces a new Actos lawsuit from a consumer alleging that he developed diabetes medication bladder cancer from their drug.

Plaintiff Jason T. says he took Actos from 2008 to 2011 for the treatment of his type-2 diabetes. In October 2016, Jason says he developed diabetes medication bladder cancer which was allegedly caused by his treatment with Actos.

Actos was approved by the FDA for the treatment of type-2 diabetes in 1999. Takeda enlisted the help of Eli Lilly for the marketing of the drug and continued the partnership until 2006. Actos works to treat type-2 diabetes by managing blood sugar levels.

In 2005, the results of the PROactive study were published. The three-year study investigated the mortality and cardiac effects of Actos but discovered that the drug was associated with an increased risk of bladder cancer.

“During the course of monitoring the study, the researchers and Defendants became aware that there was a statistically significant demonstrated higher percentage of bladder cancer cases in patients receiving Actos versus comparators,” Jason’s diabetes medication bladder cancer lawsuit states.

Despite the results of this study, Takeda allegedly chose to not reveal the risks to the public. Jason claims that the company intentionally withheld knowledge of diabetes medication bladder cancer in order to prevent any delaying or rejection of their product registration by the U.S. Food and Drug Administration (FDA).

“Defendants willfully, wantonly and with malice withheld the knowledge of an increased risk of cancer in users of Actos to prevent any chance of its products’ registrations being delayed or rejected by FDA,” the diabetes medication bladder cancer lawsuit claims.

In September 2010, the FDA announced that it was reviewing results from a ten-year diabetes medication bladder cancer study which investigated Actos. The planned five-year interim analysis reportedly showed that the risk of developing bladder cancer increased with the increased dose and duration of Actos treatment.

In July 2011, Takeda recalled Actos in France. However, the company allegedly refused to initiate a recall in the United States, thereby “continuing to subject American citizens to the significant risk of developing bladder cancer while ensuring the users in France and Germany were no longer subject to this risk,” the lawsuit says.

In December 2016, the labeling for Actos was changed to indicate that the drug “may be associated with an increase in the risk of urinary bladder tumors.” However, Jason argues that this label change is not enough. He argues that Takeda should have recalled the drug as soon as they knew about the risk for diabetes medication bladder cancer, or that they should have at least warned consumers.

Instead, Jason claims the company allegedly represented their products as safe and concealed the risks of diabetes medication bladder cancer.

Jason brings claims of strict liability, negligence, breach of express warranty, and breach of implied warranty. The diabetes medication bladder cancer lawsuit seeks punitive damages, court costs, and attorneys’ fees.

The Diabetes Medication Bladder Cancer Lawsuit is Case No. N18C-09-262 JRJ in the Superior Court of the State of Delaware.