Monday, January 28, 2013

Information Regarding an Actos Lawsuit

Actos—pioglitazone—is one of the best-selling drugs in the United States, used in the treatment of Type 2 diabetes. Actos gained FDA approval some thirteen years ago, and despite numerous reports of adverse health symptoms linked to Actos, the drug remains on the market. After a significant number of negative side effects reported by those taking Actos, the FDA required Takeda, the manufacturer of Actos to conduct a study to determine whether Actos increased the risk of bladder cancer. The study, which had over 193,000 participants, concluded that among those who were taking the drug in higher dosages or for periods of time longer than a year, had as much as a 40% increase in the incidence of bladder cancer.

Aside from bladder cancer, Actos has been found to have other life-threatening side effects including congestive heart failures, macular edema and bone fractures. Many plaintiffs who have filed a lawsuit against Takeda for harm suffered by Actos allege that Takeda failed to adequately warn physicians or patients about the risks. The majority of the Actos users who developed cancer and subsequently filed suit against Takeda took the drug for a number of years. Bladder cancer symptoms can include blood in the urine, painful urination, urinating small amounts very frequently, frequent urinary tract infections, pain in the kidney area, pelvic mass, bone pain, anemia and weight loss.

Although bladder cancer is treatable, it has an extremely high rate of recurrence and the treatments—including surgery, chemotherapy and radiation—can severely limit the quality of life of the patient. While the FDA issued a public safety warning on June 15, 2011, they nonetheless approved the first generic version of Actos on August 17, 2012. True, the generic version will come with a warning which will state the increased risk of bladder cancer for those who take the drug in high dosages or for periods longer than a year, however many believe the FDA should have recalled the drug altogether in light of the extremely serious side effects. The FDA has required that Takeda also warn on their label of the higher incidence of bladder cancer as well as the potential for the drug to cause or worsen congestive heart failure in some patients. Congestive heart failure can bring symptoms of chest pain, bone fracture, nausea, breathing difficulties, excess fluid, fatigue, swollen abdomen or liver and insomnia. France and Germany recalled Actos in 2011.

Among the lawsuits filed, one of the most recent was filed by Vincent Pellettieri and his wife. This particular lawsuit was filed in the Circuit Court of Cook County, Illinois, and alleges that Mr. Pellettieri developed bladder cancer after taking Actos. The suit alleges Takeda was aware of the risks associated with the drug yet failed to adequately warn patients taking the drug of those risks. Pellettieri used the drug as directed by his physician from 2006 through 2009, then was diagnosed with bladder cancer in 2010 and states he would not have taken the drug had he been aware of the risks and potential side effects. Pelletteri and his wife are seeking medical expenses, lost wages, disability, pain and suffering and loss of consortium damages.

Because of the widespread use of Actos, hundreds of lawsuits are pending in U.S. federal court with others being filed in state courts; it is believed by many legal professionals that the number could climb as high as 10,000 within a relatively short period of time. All federal cases have been transferred to a single court in Louisiana in what is known as Multidistrict Litigation.

Author: Sullo & Sullo Attorneys

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