Actos Litigation

Actos lawsuits that have been filed on behalf of patients who developed bladder cancer are moving forward in multidistrict litigation (MDL) in the U.S. District Court for the Western District of Louisiana. Actos (also known as Pioglitazone) is an oral medicine which is used to treat type 2 diabetes by regulating the level of glucose in the blood. Actos is supposed to be used with a proper diet and exercise to control blood sugar levels. Actos is commonly used with other medicines such as insulin, metformin, or sulfonylurea agents. Type 2 diabetic patients cannot naturally produce enough insulin, and what little insulin they do produce is not effective because body cells do not respond to it in a proper manner. Since the body’s natural insulin production and its effectiveness are compromised, the level of glucose in the blood rises. This is where Actos is used. This drug pairs with the insulin in order to help the body use insulin more efficiently and effectively. Actos was the tenth-bestselling drug in the U.S. in 2008, with sales exceeding $2.4 billion.


Some of the most common side effects of the drug when taken on its own, or in combination with other drugs, are: sinusitis, sore throat, upper respiratory tract infection, headache, muscle aches, and hypoglycemia. Other serious side effects include: bladder cancer, macular edema, bone fractures, and hepatic failure. Unfortunately, bladder cancer is one of the most dangerous side effects of Actos. During a two-year carcinogenic clinical study, drug-induced tumors were discovered in the urinary bladders of male and female rats. The first 5 years of a 10-year follow-up study showed an increased risk of bladder cancer in those patients who take Actos for an extended time. According to the Food and Drug Administration (FDA), patients taking Actos for more than one year have a 40 percent increased risk of bladder cancer. A study published by the British Medical Journal in May 2012, puts the increased risk at 83 percent.


Following the FDA’s announcement regarding the increased risks of bladder cancer associated with Actos, more than 2,500 Actos lawsuits involving bladder cancer allegations have been filed in the U.S. District Court for the Western District of Louisiana. The basis of these lawsuits is the failure of Takeda Pharmaceuticals, the manufacturer of Actos, to adequately warn users of the potential side effects associated with the drug. In June 2011, the FDA ordered Takeda Pharmaceuticals to include a warning on the Actos label after the increased risk of bladder cancer was revealed.


The Actos lawsuits allege that the manufacture’s failure to adequately warn consumers of the increased risk of bladder cancer, and other potential medical problems, makes them potentially liable for the resulting injuries and damages. In 2011, 22,512 people reported a side effect when taking Actos. Sales of this drug were suspended by medical regulators in France and Germany as a result of this risk. When the French National Agency of Medicine and Health Product Safety did a study on the drug, they found that people were more likely to develop a severe form of the cancer. They also found a 22 percent increase in bladder cancer compared to other diabetics taking a different drug. As a result, the drug was banned.


The first trial of Jack Cooper vs. Takeda Pharmaceuticals for the Actos bladder cancer lawsuits began in February 2013. Cooper is one of the first out of 3,000 people in the U.S. to claim that the drug caused him to develop a life-threatening bladder cancer. The plaintiff said he took Actos for two years to regulate his blood sugar levels before he was diagnosed with cancer. In the lawsuit he claimed that the Japanese maker of the drug, Takeda Pharmaceuticals, concealed specific risks that should have been printed on the drug’s label. Later, the FDA ordered Takeda Pharmaceuticals to include a warning of an increased risk of bladder cancer due to the use of the drug. The FDA had determined that taking a significant number of doses for more than a year substantially increased a patient’s risk. Most European countries have removed Actos from their market.


The largest concentration of Actos users to develop bladder cancer had been taking the medication between 2-5 years, but the next largest group had only been taking the drug for 1-6 months. No matter how short of a time a person has been taking Actos, he or she might be entitled to compensation if he or she has suffered the following side effects:

• Blood in urine
• Pain during urination
• Frequent urination
• Feeling of a need to urinate without results
• Bladder Cancer
• Heart Attack
• Death


For more information about the MDL litigation, or to see if you have a legal remedy under the law, you should contact our firm at 866.789.1664.

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