Two couples from Nebraska and Utah have filed Actos lawsuits against Takeda Pharmaceuticals, alleging that the type-2 diabetes medication caused them to develop bladder cancer.

Type-2 diabetes is a metabolic disorder where the body loses the ability to control the amount of sugar in the blood. In uncontrolled diabetes, sugar may build up to toxic levels, causing tissues throughout the body to die. Actos works by helping the body recognize and respond to the hormones it usually uses to control diabetes. However, several studies have linked Actos to an increased risk of bladder cancer.

In 2011, the American Diabetes Association published a paper called “Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting.” This paper gathered data from 2004 through 2009 from the FDA’s postmarket surveillance system (AERS). The study concluded that patients taking Actos experienced an increased risk of developing bladder cancer.

The Actos lawsuit points out that in 2011, a series of regulatory actions responded to Actos bladder cancer concerns. For example, government regulators in France and Germany banned or suspended Actos during this time. In France, the drug was eventually recalled over bladder cancer concerns. The U.S. Food and Drug Administration also announced that the drug would receive a warning label during the same timeframe.

This specific bladder cancer lawsuit was filed by plaintiffs David and Sheila Rieger and Mitch and Reiko Taguchi. The Actos lawsuit alleges that the makers of Actos were aware or should have been aware from studies, government regulators, and recalls of the serious risks alleged associated with Actos. It further alleges that not only were the makers of Actos aware of these risks, but that they actively concealed these risks from the general public and endangered lives.

According to the Actos lawsuit, the type-2 diabetes patients would not have used Actos had they been aware of the serious risks allegedly linked to the drug.

This Actos lawsuit may join others in a type of group lawsuit called multidistrict ligation (MDL) or mass torts. MDLs are a type of group lawsuit, sort of like a class action lawsuit. In both class action lawsuits and MDLs, a group of plaintiffs allege that they have suffered similar harm at the hands of the same defendant. This can streamline the legal process by combining dozens, hundreds, or even thousands of similar individual cases into a single legal action. The main difference is that class action lawsuits start out as a group lawsuit, while MDLs start out as individual lawsuits which are later combined into a single coordinated MDL.

The Actos lawsuit is David Rieger, et al. v. Takeda Pharmaceuticals America Inc., et al., Case No. 6:13-cv-02736,  in the U.S. District Court for the Western District of Louisiana.