The litigation surrounding the type 2 diabetes drug Actos is moving forward. In an order issued Monday, the federal judge in Louisiana overseeing Actos bladder cancer lawsuits has scheduled the first status conference in the litigation for March 22.
According to her order, U.S. District Judge Rebecca Doherty of the Western District of Louisiana said she would appoint lead attorneys for the Actos bladder cancer multidistrict litigation (MDL 2299) following that hearing. As we reported previously, all federally filed Actos bladder cancer lawsuits were ordered transferred to Judge Doherty by the U.S. Judicial Panel on Multidistrict Litigation in December.
There are roughly 200 lawsuits alleging Actos caused users to develop bladder cancer pending in courts around the U.S. However, as we’ve reported, plaintiffs’ lawyers expect that upwards of 10,000 lawsuits could eventually be filed against Takeda Pharmaceuticals, the drug’s maker. The suits accuse the company of concealing knowledge of the cancer risks and failing to adequately warn consumer and health care providers.
On June 15, 2011, the U.S. Food & Drug Administration (FDA) issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. The June safety communication was a follow-up to one the agency issued in September 2010 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.
That same month, the French and German governments decided to suspend sales of Actos in those countries after a separate study commissioned by French regulators demonstrated an increased risk of bladder cancer associated with Actos in people who took it the longest and at the highest cumulative dose. On July 12, Takeda Pharmaceuticals officially recalled Actos from the market in France.
Actos is the best selling type 2 diabetes drug in the world, and according to the Associated Press, Takeda says the drug accounted for $3.4 billion in sales in 2011. However, U.S. sales of Actos fell by roughly 3 percent last year.