The type-2 diabetes drug Actos allegedly caused an Ohio man to develop bladder cancer, a common Actos side effect that manufacturer Takeda Pharmaceutical Co. and drug marketer Eli Lilly & Co. have supposedly known about for years, according to a lawsuit filed by plaintiffs Robert and Doris Y.

This Actos bladder cancer lawsuit is the latest filing in the larger Actos multidistrict litigation (MDL) known as In re: Actos (Pioglitazone) Products Liability Litigation, formed in 2012 and centralized in Louisiana federal court. Hundreds of additional Actos class action and individual Actos bladder cancer lawsuits are being filed nationwide and may be added to this MDL like the case of Robert and Doris.

The plaintiffs, like many other victims of Actos side effects, have claimed to suffer severe bladder cancer symptoms, incluing blood in the urine (making it appear dark yellow, bright red or dark brown), frequent urination, painful urination, back pain, and/or pelvic pain.

“Despite its knowledge of this dangerous side effect that can result from Actos use, Defendants [Takeda and Lilly] refused to warn patients, physicians and the medical community about the risk of bladder cancer,” the Actos lawsuit alleges.

Plaintiffs Robert and Doris are not the only people to allegedly suffer damages from use of the Takeda type-2 diabetes drug treatment. As previously stated, numerous bladder cancer lawsuits have been consolidated into the nationwide Actos MDL, demonstrating the seriousness and widespread effects of Actos complications.

History of Actos Complications and Bladder Cancer Lawsuits

The U.S. Food and Drug Administration (FDA) approved Actos in July 1999 for the treatment of type-2 diabetes. Before receiving FDA approval, a two-year carcinogenicity study was conducted on male and female rats. The results showed that the male rats receiving Actos manifested cancerous tumors, according to the Actos lawsuit.

A subsequent 2005 clinical trial looking at cardiovascular events linked to Actos showed “a statistically significant demonstrated higher percentage of bladder cancer cases in patients receiving Actos versus competitors.” Despite these and other Actos side effects studies, the Actos warning label had not changed its warning and risk content since the original label in 1999. The drug label’s wording has consistently stated that “drug induced tumors were not observed in any organ except for the urinary bladder” and that “there are too few events of bladder cancer to establish causality.”

Like other consumers reporting dangerous side effects after taking Actos, Robert and Doris alleged, “Takeda never issued a Dear Doctor Letter to the medical community regarding the risk of bladder cancer and only added a clause to the label that 16 bladder cancers were reported from the PROactive study, while denying the causality associated with the administration of Actos,” according to the Actos bladder cancer lawsuit.

The Actos lawsuit further alleges that following FDA approval of Actos for marketing in the United States, Takeda received an average of more than 180 cancer reports each year (1,813 over 10 years) from spontaneous sources.

In September 2010, the FDA issued a Safety Announcement stating it would review the data from an ongoing, 10-year epidemiological study conducted by Kaiser Permanente to evaluate the association between Actos and bladder cancer. The resulting five-year interim analysis indicated the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months.

In 2011, Actos manufacturer Takeda issued a recall of the drug in France but refused to do so in the United States. This decision to leave American consumers in the dark about Actos bladder cancer risks did not come without legal consequences for Takeda and Lilly. In April 2014,  Actos manufacturer and marketer Takeda Pharmaceutical Co. and Eli Lilly & Co. were ordered to pay a combined $9 billion in punitive damages after a federal jury found they hid the cancer risks of Actos in the first U.S. trial regarding Actos side effects.

With the ongoing Actos MDL, it is possible that Takeda and Lilly will pay more in actual, compensatory, and punitive damages to plaintiffs like Robert and Doris.

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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