Actos News

Baum Hedlund Clients File Actos Bladder Cancer Lawsuits
in State and Federal Courts
September 5, 2014 | Los Angeles, California

Several people suffering from bladder cancer have filed personal injury lawsuits in California state court and federal court in Louisiana against entities of Takeda Pharmaceutical Company USA and Eli Lilly, alleging that their bladder cancer was caused by ingesting Actos (pioglitazone), a Type 2 diabetes drug manufactured by Takeda.

Five of the lawsuits (case no. 6:14-cv-02653) were filed on September 5, 2014 in the multi-district litigation (MDL No. 6:11-md-2299) before Judge Rebecca Doherty in U.S. District Court for the Western District of Louisiana. Dick Hopkins of Gig Harbor, Washington and Donald McQuinn, Sr., of Westfield, North Carolina, are two of the five plaintiffs to file suit after taking Actos and being diagnosed with bladder cancer. These cases join 4,000 other Actos lawsuits now before Judge Doherty.

The California lawsuit (case no. BC-556661) was filed on September 4, 2014 and joins hundreds of other Actos bladder cancer cases already filed in the Judicial Council Coordinated Proceedings (JCCP 4696 - In re Actos Product Liability Cases coordinated proceeding) in Los Angeles Superior Court before Judge Kenneth R. Freeman. The case was filed by Ron Stansell of West Covina, California, who was also diagnosed with bladder cancer after taking Actos.

These plaintiffs claim that they developed bladder cancer as a direct result of taking Actos. They further claim that Takeda promoted Actos as safe and effective even though the company knew or should have known about the drug's dangerous side effects.

The lawsuits allege that Takeda was aware of the association between Actos and serious side effects like bladder cancer and congestive heart failure dating back to the 1990's. Takeda, the plaintiffs claim, concealed vital clinical data that linked Actos to bladder cancer and failed to warn the medical community about the dangers associated with the drug. As a result of these and other failures by Takeda, the plaintiffs allege that they did not know, nor could they have known about the dangers associated with Actos. The lawsuits further claim that if the plaintiffs or their doctors had been aware of the dangers, the drug would not have been used or prescribed.

Plaintiffs in these cases allege that negligence, deceit, concealment, defective design and failure to warn on the part of Takeda caused them to suffer from severe and permanent injuries, as well as physical pain and emotional anguish.

Punitive Damages

Plaintiffs further seek punitive damages for Takeda and Lilly’s negligence, in an effort to deter Takeda and other drug companies from engaging in similar conduct. Takeda could have warned patients about the dangers associated with Actos but chose not to. Likewise, the company could have pulled Actos from the shelves but chose to put profit over people.

The Facts About Actos

• Takeda and Eli Lilly released Actos (pioglitazone) in 1999 and received FDA approval the same year.
• Actos is in a class of drugs called thiazolidinediones (referred to simply as TZD's).
• Actos has generated billions in annual revenue for Takeda.

Pre FDA Approval - Takeda performed a preclinical carcinogenicity trial on Actos (pioglitazone) before the drug hit the U.S. market in 1999. The two-year study revealed that male rats were observed to develop drug-induced bladder cancer tumors after they had received a human equivalent dose of Actos.

PROactive Study, 2005 - During the course of the three-year PROactive study, researchers and Takeda became increasingly aware of an increased risk of bladder cancer in patients taking Actos compared to similar drugs. The data clearly showed a link between Actos and bladder cancer, but the link was not included when the study was published.

FDA Actos Safety Announcement, 2010 - On September 17, 2010, the FDA issued a Safety Announcement stating that they would review data from an ongoing 10-year epidemiological study conducted by Kaiser Permanente exploring the link between Actos and bladder cancer. The agency’s review of the study indicated that taking higher doses of Actos increased the risk of developing bladder cancer, and statistical significance was observed when Actos was taken for over 24 months.

American Diabetes Association Study, 2011 - The American Diabetes Association looked at adverse events reports concerning Actos made to the FDA between 2004 and 2009. According to the AERS (Adverse Events Reporting System) analysis, Actos was linked to an increased risk of bladder cancer. "This issue needs constant epidemiologic surveillance and urgent definition by more specific studies,” the study said.

FDA Safety Update Warning, 2011 - Actos "may be associated with an increased risk of bladder cancer.” The safety update was based on further analysis of the Kaiser Permanente study, which indicated that patients taking Actos for over a year experienced a 40 percent increased risk of developing bladder cancer. The FDA also mandated that new information regarding the bladder cancer link be displayed on the 'Warnings and Precautions'section of the label on pioglitazone-containing drugs.

Actos Recalled in France, 2011 - Takeda issued a press release stating that Actos would be recalled in France, in accordance with the French Medicines Agency. The recall was issued one month after France suspended the use of pioglitazone-containing drugs.

FDA Approves New Actos Label, 2011 - In accordance with the FDA, the new label indicates that taking Actos for more than 12 months carries an increased risk for developing bladder cancer.

About Baum Hedlund Aristei & Goldman

The Actos attorneys at Baum, Hedlund, Aristei & Goldman have successfully represented victims in thousands of personal injury and wrongful death cases against some of the biggest drug companies in the world. They have filed over 75 lawsuits for Actos-induced bladder cancer.