Actos—a medication for type-2 diabetes manufactured and distributed by the Takeda Corp.—was approved by the U.S. Food and Drug Administration in 1999.

Numerous Actos cancer lawsuit actions were later filed against Asia’s largest pharmaceutical company by Blue Cross & Blue Shield of Massachusetts, alleging that the manufacturer knew the drug—when either used long-term or in higher doses—increased the risk for bladder cancer development.

According to these Actos cancer lawsuit allegations, Takeda was aware of the associated risks through animal (rat) testing the decade prior to FDA approval. Purportedly, this information was hidden when the pharmaceutical company sought market access.

Actos, which decreases insulin resistance in patients diagnosed with type-2 diabetes, went on to become a blockbuster medication which contributed nearly 30 percent of Takeda’s revenue as measured in 2010.

Takeda was required to undertake a 10-year post-market clinical trial of the diabetes medication. At the 5-year mark, the FDA had enough data to warrant warning the public that taking it for a year or more or at high doses could radically increase the risk of bladder cancer. The warning went out and the FDA requested a label change reflecting these new concerns in 2011.

Another concurrent study shored up the data on bladder cancer risk with Actos as well, and when the 10-year study completed in 2016, the FDA without equivocation announced that the drug might be linked to a higher probability of developing bladder cancer.

By this time, there were already 9,000 pending Actos cancer lawsuits gathered in federal court in a class action multidistrict litigation (MDL). Blue Cross & Blue Shield opted to join this MDL.

When one of the first cases of Actos cancer lawsuit among this group went to “bellwether” trial phase, a jury slapped a $9 billion punitive damages fine upon Takeda, which was later reviewed and reduced to $38 million.

Takeda and Eli Lilly Co., its U.S. distributor, wanted to avoid further court exposure and came to an agreement to settle most of the leftover cases of Actos cancer lawsuit with a payment of $2.4 billion.

In a separate legal action, Blue Cross & Blue Shield sought to regain the costs of medical bills it paid out for several hundred people who purportedly developed bladder cancer as a direct consequence of taking Actos. This action went into a mediation process, according to a March 2018 report by Law360, that was resolved around the same time.

While a settlement has been reached between the parties, details were not shared publicly, and counsel comment was not provided by either side. A U.S. District Judge in Massachusetts dismissed the case because of the non-disclosed but pending deal.

If you or a loved one took Actos and later developed bladder cancer, you may have a legal claim.