While all diabetes patients may face a slight increase in the risk of bladder cancer, several studies have suggested that long-term Actos users face a greater risk. Osaka, Japan-based Takeda Pharmaceuticals, manufacturer of Actos, is defending against an ever-growing multidistrict litigation, or MDL, from victims of Actos bladder cancer who say Takeda knew of the risk but neglected to publicize it.

One of the latest victims to join the litigation is plaintiff Darold Netser of California. From 2011 to 2012, Netser took Actos as prescribed and directed by his physician to treat his diabetes, according to his Actos complications lawsuit. In September 2012, Netser was diagnosed with bladder cancer. His cancer treatment continued for more than a year, and he still receives follow-up care. Netser alleges his cancer was as a result of his using Actos, so he is seeking damages for pain, suffering, economic losses, and past and future medical expenses.

He claims that the “Defendants failed to warn [him] or his treating physicians and healthcare providers, including his prescribing physicians and healthcare providers, that Actos can cause bladder cancer and heart damage.” Had Netser known of the risks, he would have “chosen safer, alternative medicines which are effective at treating type-2 diabetes without an increased risk of serious, deadly adverse events, including bladder cancer,” according to his Actos lawsuit.

Netser’s Actos lawsuit accuses Takeda and Eli Lilly of manufacturing defect, failure to warn, breach of express warranty, breach of implied warranty of merchantability and fitness, negligence, common law fraud, constructive fraud, and negligent misrepresentation.

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

Overview of Actos’ Hidden Risk

Type-2 diabetes is one of the fastest growing diseases in the United States, with a plethora of potential issues including heart disease and bladder cancer. There are many medications available to treat it, including Actos. However, while all diabetes patients may face a slight increase in risk of bladder cancer, several studies have suggested that long-term Actos users face an increased risk.

Actos was jointly launched in 1999 by Takeda U.S.A. and Eli Lilly, and approved by the U.S. Food and Drug Administration (FDA) in July 1999 to treat type-2 diabetes. Actos is part of a class of insulin-sensitizing diabetes agents known as thiazolidinediones (TZDs).

It has been alleged in the Actos multidistrict litigation that Takeda and Lilly knew, or should have known, about Actos’ connection to heart damage and bladder cancer before applying for and obtaining FDA approval. Numerous studies showed the link between Actos and congestive heart failure, but the drug’s label wasn’t updated until Takeda was forced to do so by the FDA in 2007.

After the heart findings, more studies came online. One such study was PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events). Designed to evaluate cardiovascular events, the results of the three-year study were published in 2005 with findings of a higher percentage of bladder cancer cases in patients receiving Actos versus those taking other medications. But Takeda allegedly withheld this knowledge from the public as well.

It wasn’t until 2010 that the FDA issued a Safety Announcement for Actos, stating it was “undertaking a review of the data from an ongoing, 10-year epidemiological study being conducted by Kaiser Permanente to evaluate the association between Actos and bladder cancer.” The study found that the longer Actos is used, the more pronounced the risk of bladder cancer. Afterward, several European countries issued an Actos recall.

Takeda Pharmaceuticals and U.S. partner Eli Lilly are facing lawsuits from thousands of plaintiffs alleging they suffered from Actos bladder cancer. Earlier this year, a federal jury in Louisiana ordered the two companies to pay more than $9 billion in damages to a former shopkeeper who developed bladder cancer after taking Actos. This is the largest award a pharmaceutical company has been ordered to pay in one case. Takeda is fighting it.