A California woman has filed a lawsuit against Takeda Pharmaceuticals USA Inc. alleging she developed bladder cancer after taking the type-2 diabetes drug Actos. Plaintiff Evelia Valladares was prescribed and took Actos from about May 2009 to February 2013.

The Actos lawsuit alleges that Takeda “failed to warn plaintiff or her treating physicians and healthcare providers, including her prescribing physicians, that Actos can cause bladder and heart damage.”

Had Valledares or her treating physicians been warned, she would have chosen a safer, alternative medicine which are effective at treating type-2 diabetes. Even the product warnings, according to the Actos lawsuit, were vague, incomplete or inadequate, “to alert prescribing physicians as well as plaintiff,” of the risks associated with the drug.

The Actos lawsuit claims that Takeda “should have known that Actos use in humans was associated with and/or would cause bladder cancer, and defendants knew or should have known that the bladder cancer risk needed to be further studied before placing Actos on the market.”

The Actos lawsuit further alleges that Takeda concealed and failed to completely disclose for more than 10 years their knowledge of the side effects of Actos and that they had failed in adequately studying and testing the drug for the risks.

In 2011, several drug regulatory agencies around the world took action regarding Actos:

• On June 9, 2011, the European Medicines Agency announced that it had been informed by the French Medicines Agency that it had suspended the use of Actos in light of findings regarding the increased risk of bladder cancer.
• On June 10, 2011, Germany’s Federal Institute for Drugs and Medical Devices followed suit and suspended the use of Actos.
• On June 15, 2011, the U.S. Food and Drug Administration announced that the use of Actos for more than one year may be associated with an increased risk of bladder cancer.
• On June 17, 2011, Health Canada said that they will undertake a review of the drug’s status.

Despite suspensions and reviews of the use of Actos in other countries, the Actos lawsuit alleged that Takeda refused to issue a recall of its drug in the U.S.

Valladares could have filed her Actos bladder cancer lawsuit in California, but opted to file it as part of the Actos multidistrict litigation, MDL No. 2299. The MDL, however, does not waive her right to trial in her own state.

This Actos bladder cancer lawsuit is Evelia Valladares v. Takeda Pharmaceuticals USA Inc., Case No. 6:14-CV-00785-RFD-PJH, in the U.S. District Court for the Western District of Louisiana.