A New York man has filed suit against Takeda Pharmaceuticals, Eli Lilly and others, claiming his many years of <“https://www.yourlawyer.com/topics/overview/actos”>Actos use caused him to develop bladder cancer. The lawsuit, dated September 1, 2011, was filed in U.S. District Court, Northern District of New York. Plaintiff Clement Dabiere is being represented by the national law firm of Parker Waichman LLP.
Actos is the best selling type II diabetes drug in the world, but in recent months, it has caused safety concerns because of its possible association with bladder cancer. Last September, the U.S. Food & Drug Administration (FDA) announced it had begun an Actos safety review after preliminary data from a study conducted by Kaiser Permanente demonstrated that the risk of bladder cancer rises with increasing dose and duration of Actos use, reaching statistical significance after 24 months. On June 15, 2011, the FDA issued another safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer.
A separate study commissioned by the French government that also demonstrated an increased risk of bladder cancer associated with Actos caused regulators in France and German to suspend sales of the drug there, just a few days after the FDA’s most recent alert. That study, which drew data from the French National Health Insurance Plan and followed 1.5 million patients for four years (2006-2009), also found a higher risk of bladder cancer among those who took Actos the longest, and at the highest cumulative dose. Takeda officially issued a recall of Actos in France on July 12, 2011.
According to his complaint, Mr. Dabiere began taking Actos as prescribed and directed by his doctor to treat type II diabetes in 2006. In September 2010, he was diagnosed with bladder cancer. Mr. Dabiere alleges that his years of Actos use caused him to suffer severe, permanent and life-threatening personal injuries, pain, suffering, emotional distress, and lifelong fear of premature death. It further alleges that because of his use of Actos, he will require continued lifelong monitoring, treatment and medications.
Mr. Dabiere’s complaint alleges that the Defendants promoted Actos as a safe and effective treatment for type II diabetes, even though they knew or should have known that taking Actos for longer than 12 months increased the risk of bladder cancer. Among other things, the complaint points out that even after the FDA issued its September 2010 Safety Communication, Robert Spanheimer, Vice President of Medical and Scientific Affairs for Takeda, told Reuters that the Kaiser Permanente study has not shown a risk to patient’s of bladder cancer or other cancers from Actos.
Mr. Dabiere’s complaint is just the latest Actos bladder cancer lawsuit to be filed since the FDA issued its most recent alert in June. Earlier this summer, one plaintiffs’ attorney told the Associated Press that his firm already had 100 Actos bladder cancer lawsuits pending, and is receiving up to 40 inquiries per week from potential plaintiffs.