A husband and wife team have filed an Actos bladder cancer lawsuit against drug maker Takeda Pharmaceuticals, alleging that the diabetes drug caused life-threatening bladder cancer.

The Actos lawsuit was jointly filed by Marc Album and his wife. According to their Actos lawsuit, Album took the drug from 2003 to 2013.

In July 2012, it was discovered that Album had developed bladder cancer. The Albums’ lawsuit alleges that the drug caused the cancer, and that the makers of the drug were aware of this risk.

According to the Albums’ Actos lawsuit, Takeda tested the drug for carcinogenicity, the ability to cause cancer, before submitting the drug for U.S. Food and Drug Administration (FDA) approval.

This was performed through animal trials involving rats. In these trials, the Albums’ Actos lawsuit contends, it was found that the drug could cause cancer in mammals.

Additional evidence allegedly mounted when with the PROactive Study. This study was designed to look for signs that Actos could cause heart problems. Instead, researchers found that using Actos was correlated with an increased risk of developing bladder cancer. This study was published in 2005, seven years prior to Marc Album’s bladder cancer diagnosis. Other studies made similar discoveries, including an FDA study that originally set out to evaluate the safety of Actos with respect to liver disease.

Eventually, government regulators across continents responded to the alleged evidence that Actos could cause bladder cancer in 2011. Various European governments, including those of Germany and France, either banned or advised against the use of Actos over Actos bladder cancer concerns. In the United States, the FDA issued warnings to physicians that the drug had been linked to an increased risk of bladder cancer.

The Albums’ lawsuit is not the only one facing Takeda Pharmaceuticals over alleged Actos bladder cancer.

In the United States, so many individual Actos bladder cancer lawsuits have been filed that the legal system has coordinated them into a type of group litigation called multidistrict litigation (MDL) or mass tort.

MDLs are a legal device where a large number of very similar individual lawsuits are coordinated together to avoid duplicating steps of the legal process. MDLs are designed to help streamline legal situations where a large number of plaintiffs have very similar lawsuits, but are unable to coordinate a class action lawsuit.

The Actos Lawsuit is Marc Album, et al. v. Takeda Pharmaceuticals America Inc., et al., Case No. 6:14-cv-02555-RFD-PJH in the U.S. District Court for the Eastern District of Pennsylvania.

The Actos MDL In Re: Actos (Pioglitazone) Products Liability Litigation, MDL No. 2299, in the U.S. District Court for the Western District of Louisiana.