Actos Lawsuit Alleges Takeda Withheld Knowledge of Bladder Cancer Risks

New Orleans, LAAs Actos lawsuits work their way through the litigation process and into multidistrict litigation, more Actos side effect lawsuits are being filed, alleging patients were not properly warned about the link between Actos and bladder cancer.

A look at court documents in a lawsuit involved in the Actos lawsuit and multidistrict litigation gives an idea of what plaintiffs are claiming against Takeda Pharmaceuticals. In July 2012, Robert Raymond filed a lawsuit against Takeda (MDL No: 6:11-md-2299, in the US District Court, Western District of Louisiana). The lawsuit was filed by Raymond who was the administrator of the estate of Joseph Raymond Sr., who died after using Actos.

The wrongful death lawsuit alleges that Joseph Raymond was prescribed Actos from 2002 to 2010, and died of bladder cancer linked to his use of Actos.

“Defendants concealed and continue to conceal their knowledge of Actos’ unreasonably dangerous risks from Joseph Raymond, his physicians(s), other consumers, and the medical community,” court documents state. “Specifically, Defendants failed to adequately inform consumers and the prescribing medical community about the risk of bladder cancer associated with more than twelve months of Actos ingestion.”

The lawsuit further claims that researchers involved in the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events; published in Lancet 2005) found a statistically significant higher percentage of bladder cancer cases in patients who were given Actos when compared with other drugs used to treat diabetes but did not publish those findings.

“Defendants willfully, wantonly and will [sic] malice withheld the knowledge of increased risk of cancer in users of Actos to prevent any chances of its products’ registrations being delayed or rejected by the FDA,” the lawsuit alleges.

Actos is used to treat Type 2 diabetes and was approved by the US Food and Drug Administration (FDA) in 1999. In June 2011, the FDA issued a safety announcement warning that the use of Actos for more than one year may be associated with an increased risk of bladder cancer. The agency also requested that the warning label be updated to reflect that risk.

In April 2012, BMJ (British Medical Journal) published a study that found that the use of pioglitazone, the generic form of Actos, was linked to an increased risk of bladder cancer. Specifically, they found that the highest risk was found in patients who used Actos for more than two years or who had the highest cumulative dose of the medication.