After four years of taking the drug Actos (pioglitazone hydrochloride) to treat type-2 diabetes, Missouri resident Charles H. received a grim diagnosis in 2012: bladder cancer.

Charles has filed an Actos bladder cancer lawsuit against drug manufacturer Takeda Pharmaceuticals, alleging that the company knew or should have known that the medication carried a significant risk of causing bladder cancer in humans.

“Before seeking FDA approval, Defendants were aware of scientific studies, including animal studies, indicating this risk,” his Actos bladder cancer lawsuit, filed Jan. 21, 2o15, reads.

“After receiving FDA approval, Defendants learned of human clinical trials in the early 2000s that further indicated this risk. Nevertheless, at all pertinent times, Defendants failed to adequately conduct complete and proper testing of Actos and pioglitazone hydrochloride with regard to its carcinogenicity.”

Had Charles been adequately warned of the dangers associated with the use of Actos and pioglitazone hydrochloride, including the risk of developing bladder cancer, he would not have taken the product, he alleges.

Charles is one of thousands of people to file Actos lawsuits against Takeda Pharmaceuticals Co. and Eli Lilly after developing bladder cancer. Studies have found the risk of bladder cancer is increased by 40 percent in people who take the drug for more than one year.

A federal jury in 2014 awarded $9 billion in damages to an Actos user who was diagnosed with bladder cancer after using the drug. The plaintiff in the Actos bladder cancer lawsuit argued that the manufacturer knew of the increased risk of bladder cancer but concealed the information from the public. A judge later reduced the award, saying it was excessive.

U.S. District Judge Rebecca Doherty instead ordered Takeda to pay $27.6 million and Eli Lilly to pay $9.2 million.

The basis of the thousands of Actos bladder cancer lawsuits contain similar allegations — that Takeda and Eli Lilly failed to warn consumers and health care providers that taking Actos for longer than 12 months may increase the risk of bladder cancer, that they willfully concealed safety concerns, and that they provided misleading information data to the public.

Takeda and Eli Lilly were aware of Actos’ dangers, but sold it anyway, the bladder cancer lawsuits allege.

Some 430,000 new cases of bladder cancer were diagnosed in 2012. Europe and North America have the highest incidence of bladder cancer patients and those with diabetes are at an increased risk of the bladder cancer.

Understanding Bladder Cancer

Bladder cancer is the ninth most common cancer in the world.

Bladder cancer begins most often in the cells that line the inside of the bladder. Older adults are most likely to get bladder cancer, though it can strike at any age.

“The great majority of bladder cancers are diagnosed at an early stage — when bladder cancer is highly treatable,” according to the Mayo Clinic.

“However, even early-stage bladder cancer is likely to recur. For this reason, bladder cancer survivors often undergo follow-up tests to look for bladder cancer recurrence for years after treatment.”

Bladder cancer symptoms include blood in the urine, (urine may appear dark yellow, bright red or dark brown), frequent urination, painful urination, back pain or pelvic pain.

In 2011, the FDA issued a statement that a label change had been ordered, informing the public that using pioglitazone-containing medicines such as Actos for more than one year may be associated with an increased risk of bladder cancer. The updated drug labels also warned that patients with active bladder cancer or a prior history of bladder cancer not use the drug or use it with caution.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual Actos lawsuit or Actos class action lawsuit is best for you. [In general, Actos bladder cancer lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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