A North Carolina widower says that his wife was taking a type-2 diabetes medication from Takeda Pharmaceuticals that led to the disease which would cause her death, according to a recently filed Actos bladder cancer lawsuit.

The Actos lawsuit alleges that Sylvia Stephens began taking Actos in December 2005 and continued to do so for just over six years. She was reportedly diagnosed with bladder cancer side effects and died on May 8, 2013. The drug maker should have known of the increased likelihood of this carcinogenic affect, according to her husband’s Actos lawsuit attorney.

In fact, the plaintiffs allege that “additional bladder cancer evidence from human clinical trials also became known to defendants in the early 2000’s.” Medical trials using animal subjects also raised questions during the pre-approval process for the type-2 diabetes drug. As more and more data started to filter out, agencies from other countries with similar duties as the U.S. Food and Drug Administration took action.

The European Medicine Agency suspended usage of the drug because of Actos bladder cancer side effects on June 9, 2011, and its Indian counterpart did the same soon after. In the United States, the FDA warned that using the medication “for more than one year may be associated with the increased risk of bladder cancer,” although there are no other restrictions on its usage here.

Cyrus Jones Stephens and his Actos lawsuit attorney allege that had Takeda and business partner Eli Lilly adequately tested the product and accounted for its potential adverse effects, patients like Sylvia Stephens might still be alive today.

The Actos bladder cancer lawsuit is Cyrus Jones Stephens, et al. v. Takeda Pharmaceuticals USA Inc., Case No. 14-cv-807. It was filed directly into In re: Actos Products Liability Litigation, MDL No. 2299, in the U.S. District Court for the Western District of Louisiana.