Did you develop bladder cancer after taking Actos?

In June 2011, the United States Food and Drug Administration (FDA) released a safety alert to warn healthcare professionals about the increased risk of patients developing bladder cancer after using Actos for longer than one year. The FDA analyzed interim data from a ten-year evaluation of approximately 200,000 diabetic patients. The data indicated that diabetics who took Actos for more than one year had a 40% greater risk of developing bladder cancer.


Actos is a prescription drug used to lower blood glucose levels in individuals with Type-II diabetes. Actos is the brand name for pioglitazone. It is prescribed as a sole treatment or in conjunction with other insulin-monitoring drugs. Takeda Pharmaceutical Company and Eli Lilly Pharmaceuticals market Actos in the United States.

In 2010, more than 2.3 million patients filled a prescription for Actos or a pioglitazone-containing medication. Actos has become the world’s biggest-selling diabetes medication with annual sales generating $4.8 billion globally.

In June 2011, the United States Food and Drug Administration (FDA) released a safety alert to warn healthcare professionals about the increased risk of developing bladder cancer in patients using Actos for over one year in duration. The FDA analyzed interim data from a ten-year evaluation in a large health plan of the treatment and outcomes in approximately 200,000 diabetic patients. The data indicated that diabetics who took Actos for more than 12 months had a 40% greater risk of developing bladder cancer. The FDA has since required Eli Lilly to add a Black Box Warning regarding the risk of bladder cancer to the drug’s label.

The increased risk of users of Actos developing bladder cancer was also confirmed by the French Agency for Safety of Health Products’ study involving 1.5 million patients with diabetes from 2006 to 2009. As a result of the study, France banned the sale of Actos.

In Germany, physicians have been advised by the Federal Institute of Drugs and Medical Devices to discontinue prescribing Actos until a more comprehensive evaluation of the drug’s risks can be performed.

Bladder cancer is a painful disease. While researchers have not been able to determine a precise cause for bladder cancer, they have determined that individuals who have a history of smoking, chemical exposure or Actos ingestion are at risk for developing bladder cancer. Patients with this disease may experience a variety of symptoms, including urinary frequency, blood in the urine, bone pain, painful urination, urinary urgency, incontinence (urine leakage), abdominal pain, fatigue, or weight loss.

A combination of surgery, radiation and chemotherapy are used to treat bladder cancer depending on its progression stage. If the cancer persists, the tumors can metastasize spreading to other vital organs.

Actos Litigation Update

As of March 2015, over 8,000 Actos lawsuits have been filed against Takeda Pharmaceuticals in various federal and state courts around the U.S.

Approximately 4,100 Actos lawsuits are consolidated in In Re: Actos (Pioglitazone) Products Liability Litigation, MDL No. 2299 before the Honorable Rebecca F. Doherty in the United States District Court for the Western District of Louisiana. The federal Actos MDL was established in December 2011. All Actos cases that are filed in or removed to federal court around the country are transferred to the MDL for coordinated pre-trial discovery.

Additionally, there are approximately 4,600 Actos lawsuits docketed in various state courts. The majority of the state court cases are being litigated in Cook County, Illinois, before the Honorable Deborah M. Dooling. Similar to the MDL, cases that are filed in Cook County are undergoing a coordinated discovery process.

To date, five Actos cases have gone to trial in the U.S.

    • In April 2013, a California jury awarded $6.5 million to Jack Cooper in the first Actos bladder cancer case to go to trial in the country. The jury awarded $5 million in compensatory damages to Mr. Cooper and $1.5 million to his wife, Nancy, for loss of consortium. The jury did not award punitive damages. Following trial, Takeda successfully had the verdict thrown out after the trial judge ruled that the testimony from plaintiff’s case-specific causation expert was “inherently unreliable.” The case is Jack Cooper v. Takeda Pharmaceuticals America Inc., Civil Action No. CGC-12-518535, California Superior Court, Los Angeles County.
    • Five months later in September 2013, a Maryland jury awarded $1.7 million to the family of Diep An, who died from bladder cancer after ingesting Actos. Again, Takeda was able to successfully convince the trial judge to throw out the verdict because the jury also determined that Mr. An’s smoking history contributed to his death. Under Maryland’s harsh contributory negligence law, if a plaintiff’s conduct is found to have contributed to his or her injury, the plaintiff is barred from recovering any damages. The case is An v. Takeda Pharmaceuticals America, Inc., Civil Action No. 24-C12003565, Maryland Circuit Court, Baltimore City.
    • In May 2014, a Las Vegas jury found in favor of Takeda in the country’s third Actos bladder cancer trial. This case involved two plaintiffs, Bertha Triana and Delores Cipriano, who both claimed that their use of Actos caused them to develop bladder cancer. This was a particularly contentious trial. The plaintiff’s lawyers filed motions with the court to sanction Takeda’s lawyers arguing that Takeda’s attorneys violated court orders and treated the trial judge disrespectfully during the proceedings.
    • In April 2014, a federal jury in Louisiana hit Takeda and Eli Lilly & Co. with a $9 billion punitive damages verdict in Terrence Allen, et ux v. Takeda Pharmaceuticals North America, Inc. The Allen case was the first trial to take place in the federal MDL. The jury found that Takeda was responsible for $6 billion of the punitive verdict and Eli Lilly was responsible for $3 billion. The punitive damages verdict is the seventh largest punitive damages award in U.S. history.
    • Finally, in March 2015, a jury in Philadelphia, Pennsylvania returned a $2.3 million verdict in favor of the plaintiff, John Kristufek, who claimed that Actos had caused his bladder cancer. The jury determined that Takeda acted with reckless indifference to the health and safety of Mr. Kristufek. The case is Kristufek v. Takeda Pharmaceuticals America Inc., Civil Action. No. 120702275, Philadelphia County Court of Common Pleas.In April 2015, it was reported that Takeda had agreed to pay more than $2.2 billion to resolve more than 8,000 lawsuits filed in federal and state courts which claim that the drug maker hid the risks of bladder cancer associated with Actos.

Contact Lewis Saul & Associates, P.C. To Discuss Your Rights

If you or a loved one used Actos and suffered bladder cancer, you may be entitled to pursue a claim against the manufacturers for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.