A number of members of the Painters and Allied Trades District Council 82 Health Care Fund (“Painters Fund”) filed an Actos lawsuit, and formed an Actos multidistrict litigation (MDL ) against Takeda Pharmaceuticals.

The Actos patients along with the Painters Fund, which paid for their Actos prescriptions, allege that Takeda consistently misrepresented the bladder cancer risks to consumers, prescribers, third-party payers, and the U.S. Food and Drug Administration (FDA).

Painters Fund is “a health and welfare benefit fund involved in the business of providing health benefits for covered members and their families.” As a fund, it relies on members and their doctors to “make informed decisions about which drugs will be prescribed and, in turn, submitted to Plaintiff Painters Fund for reimbursement.“

Some who have filed Actos bladder cancer lawsuits include plaintiff Annie Snyder, who was prescribed a daily dose of Actos by her physician to treat her type-2 diabetes in October 2009.

Prior to starting the prescription, Snyder says she read and relied upon the Actos label for accurate information about the drug. For over two years, she was taking a risk of acquiring bladder cancer and didn’t know it.

Plaintiff Rickey Rose took Actos from 2007 through 2011, when he quit after learning on television that Actos posed a bladder cancer risk.

Plaintiff John Cardarelli ingested Actos from 2006 until he was made aware of the danger in 2009.

According to the Actos bladder cancer lawsuit, none of the plaintiffs saw the September 2010 FDA alert about Actos. All of them say had they known of the risks, they would never have purchased or ingested the drug. Had this been the case, the third-party payor would have saved thousands of dollars as well.

As the Actos lawsuit states, “if the medical community were aware that Actos could cause bladder cancer, it would not have been the blockbuster drug that they needed Actos to be. So, instead of being honest and forthright, the Defendants engaged in a decade-long scheme to mislead, manipulate, and stonewall the FDA, consumers, prescribers, and third-party payors into believing that Actos did not pose any significant risk for bladder cancer.”

The plaintiffs represented in this MDL are scattered across the country.

The Actos Bladder Cancer Lawsuit is Painters and Allied Trades District Council 82 Health Care Fund, et al. v. Takeda Pharmaceutical Company Limited, et al., MDL No. 6:11-md-2299, in the U.S. District Court for the Western District of Louisiana. The Actos MDL is In Re: Actos Products Liability Litigation, MDL No. 6:11-ms-2299, in the same federal court.

Actos Bladder Cancer History

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

Meant to reduce blood sugar, Actos is only used to treat type-2 diabetes because it “exerts its antihyperglycemic effect only in the presence of endogenous insulin.”

In the 15 years since its release, Actos has generated more than $16 billion in sales. As type-2 diabetes is one of the fastest-growing diseases in the United States, this is not surprising. There are a plethora of medications available to treat this disease, but Actos has a large part of the market share.

It is alleged by many 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. Takeda knew the issues with Pioglitazone. Early on in their research and testing showed safety-toxicology issues raised by animal trials. The companies allegedly knew that if such information got out, it would have hindered its efforts to one day obtain FDA approval for Actos.

Numerous studies showed the link between Actos and bladder cancer, but the warning label wasn’t updated until Takeda was forced to do so by the FDA in 2007.

The FDA enforced the warning label based on a number of adverse event reports and studies. 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.

In 2010, the FDA issued a Safety Announcement for Actos after undertaking a review of the data from an ongoing, ten-year epidemiological study by Kaiser that evaluated the association between Actos and bladder cancer. The study showed that the longer Actos is used, the more pronounced the risk of bladder cancer. Several European countries issued an Actos recall because of this in 2011.