A new Actos lawsuit has been filed, alleging the diabetes drug can cause life-threatening complications.

Plaintiff Clyde Hardesty claims he was diagnosed with bladder cancer after using Actos. His Actos lawsuit alleges that the drug caused his cancer, and that the drug’s makers were aware — or reasonably should have been aware — of the alleged cancer risks associated with the drug. His Actos lawsuit is very similar to other cases across the country, which are being coordinated in multidistrict litigation (MDL).

To support this allegation, Hardesty’s Actos lawsuit cites a 2010 Drug Safety Announcement from the U.S Food and Drug Administration. The statement stated that the FDA was reviewing information from a 10-year epidemiological study. The FDA statement added that preliminary data suggested a link between Actos and bladder cancer. Further, the tentative link between Actos and bladder cancer appeared dose dependent. Higher doses over longer periods of time seem to increase the risk.

In 2011, several countries’ regulatory agencies banned Actos over the alleged risk of bladder cancer. Both France and Germany banned the drug that year. The same year, the FDA added a black box warning to Actos. Black box warnings are the most serious warnings the FDA can mandate for drug labeling.

An MDL has been formed to coordinate the Actos lawsuits. MDLs are a type of group lawsuit, similar to class action lawsuits. In both MDLs and class action lawsuits, a group of people allege that they have suffered from similar harm at the hands of the same defendants. Both MDLs and class action lawsuits are designed to help streamline the legal process by combining dozens, hundreds, or even thousands, of potential individual lawsuits into a single coordinated legal action. The main difference between MDLs and class action lawsuits is that class action lawsuits start out as group lawsuits, while MDLs start out as individual lawsuits that are later coordinated into a combined legal action.

The individual Actos lawsuit is formally titled Clyde Hardesty v. Takeda Pharmaceuticals America Inc., et al., filed within the MDL In re: Actos (Pioglitazone) Products Liability Litigation, MDL No. 2299, in the U.S. District Court for the Western District of Louisiana.