Actos News

Baum Hedlund Files Five New Actos Bladder Cancer Lawsuits Against Takeda
February 3, 2014

Lafayette, Louisiana, February 3, 2014 -- Seven plaintiffs have filed personal injury lawsuits against seven Takeda pharmaceutical entities and Eli Lilly, claiming to have suffered from serious side effects as a direct result of taking Actos (pioglitazone), a Type 2 diabetes drug manufactured by Takeda. 

Five Plaintiffs in the case claim to have developed bladder cancer as a direct result of taking Actos. (Two additional plaintiffs are spouses.) According to the lawsuit, Takeda was aware of the link between Actos and an increased risk of developing bladder cancer, but the company continued to promote the drug as "a safe and effective treatment for Type 2 diabetes."  

The lawsuits, filed in a bundled complaint (case no. 6:11-md-2299), will join over 2,600 personal injury and wrongful death Actos bladder cancer cases already filed and consolidated in multi-district litigation (MDL No. 6:11-md-2299) before U.S. District Judge Rebecca Doherty in the U.S. District Court for the District of Louisiana.  (The first of the federal Actos trials just began yesterday.)

The Plaintiffs claim that Takeda concealed clinical data linking Actos to bladder cancer, and failed to inform consumers, physicians, and the medical community about the dangers of the drug. According to the lawsuit, Takeda had known about a link between Actos and bladder cancer prior to the drug receiving approval from the U.S. Food and Drug Administration (FDA) in July of 1999.

As a result of this deception, the plaintiffs allege that neither they nor their doctors knew, nor could they have known, about the risk of developing bladder cancer associated with the use of Actos. If Takeda had disclosed the risks, the plaintiffs would not have used the drug, the lawsuit contends.

A number of studies have shown that Actos "is linked to a statistically significant increase in the risk for developing bladder cancer, according to the lawsuit. In 2011, the FDA issued a safety announcement indicating that prolonged use and increased dosages of Actos could increase the risk of developing bladder cancer by at least 40 percent. Actos was the tenth best-selling medication in the United States in 2008. Plaintiffs in this case allege that Takeda accomplished this feat with the knowledge that Actos was placing American citizens at risk for developing bladder cancer.

Punitive Damages

The plaintiffs in these cases are seeking punitive damages to deter other drug manufacturers from engaging in similar conduct in the future. The plaintiffs allege that Takeda knew or should have known that using Actos for longer than 12 months was associated with an increased risk of developing bladder cancer. In spite of knowing about the true relationship between Actos and bladder cancer, Takeda refused to warn patients about the bladder cancer link, refused to pull the drug from the market, and continued to market the drug as safe and effective, the lawsuit claims. Takeda's negligence and recklessness were substantial factors in causing the plaintiffs' pain and suffering, mental anguish and loss of enjoyment of life, the lawsuits contend. Furthermore, the lawsuits allege that Actos' defective design and manufacturing defects, combined with Takeda's misrepresentations of the drug were factors that led to injuries sustained by the plaintiffs in this case.   

Background Information

Takeda North America and Eli Lilly launched Actos in 1999, the same year the FDA approved it for Type 2 diabetes.

Actos is in a class of insulin-sensitizing diabetes agents known as thiazolidinediones (known as "TZDs"). Before receiving FDA approval, a two-year carcinogenicity study was conducted on rats. Male rats receiving the equivalent of a clinical dose of Actos developed drug-induced tumors.

In 2005, the results of the three-year PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study were published. Takeda became aware that there was a "statistically significant demonstrated higher percentage of bladder cancer cases in patients receiving Actos versus comparators," according to the lawsuit. In the published paper containing the data (referred to as the "Dormandy paper"), the information linking Actos to bladder cancer was omitted. Takeda never issued the information (in the form of a Dear Doctor Letter) to the medical community, and only added a clause to the label that 16 bladder cancer cases were reported in the PROactive study. All the while, the company denied bladder cancer causality associated with Actos, the lawsuit claims.

Since receiving FDA approval in 1999, Takeda received on average or more than 180 cancer reports each year (1,813 over ten years), from spontaneous sources, but Takeda never included these cancer reports in the label, and never issued a Dear Doctor Letter in the last ten years to warn the medical community of the risk of developing cancer while taking Actos, according to the lawsuit.

The current Actos label states: "There are too few events of bladder cancer to establish causality."

On September 17, 2010, the FDA issued a Safety Announcement stating it was undertaking a review of the data from an ongoing, ten-year epidemiological study being conducted by Kaiser Permanente to evaluate the association between Actos and bladder cancer.

The planned five-year interim analysis demonstrated that the risk of bladder cancer increases with increasing dose and duration of Actos use, reaching statistical significance after 24 months.

In addition, a three-year liver safety study was performed, and according to the FDA’s September Safety Communication, that study demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators.

In 2011, the American Diabetes Association published a study showing that the odds ratio for pioglitazone was indicative of a "definite risk." In June 2011, the French Medicines Agency announced that it would be pulling Actos from its shelves, pending an ongoing European review of the drug. Germany joined suit the same month, and the FDA issued another Safety Announcement, this one stating that the "use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer."

In spite of the FDA announcement, Takeda refused to recall Actos in the U.S.

About Baum Hedlund

Baum, Hedlund, Aristei & Goldman is a leading prescription drug defect law firm that has been investigating the link between Actos and bladder cancer for many years. The firm has handled well over 4,000 individual cases involving clients that were harmed by dangerous medications. They have litigated personal injury, consumer fraud and wrongful death cases against some of the world's largest pharmaceutical companies, and have recovered over $1.4 billion for their clients in all types of litigation.

Attorney Michael L. Baum is leading the firm’s Actos bladder cancer litigation. Mr. Baum works directly with the Plaintiffs’ Steering Committee overseeing the Actos multi-district litigation cases in the U.S. District Court for the Western District of Louisiana. They have also been appointed to the Actos Plaintiffs' Steering Committee for the California state court cases consolidated in Los Angeles. The firm has filed over 70 Actos lawsuits in both federal and state court (California).