Terry Allen, a retired hardware store manager is the plaintiff in the case currently in trial against pharmaceutical giant Takeda, the manufacturer of Actos, the diabetes drug that Allen and his experts say caused him to have bladder cancer. (See In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299; Allen’s case is Allen v. Takeda Pharmaceuticals North America Inc., 12-cv-00064, both in U.S. District Court, Western District of Louisiana (Lafayette).
Actos has generated more than $16 billion in sales since its 1999 release, according to court filings with sales peaking in 2011 at $4.5 billion. Takeda contends Allen’s bladder cancer was not caused by his Actos use and that it properly warned of about the drug’s risks. Two earlier trials ended in $8.2 million in verdicts for Plaintiffs but both were overturned by the trial judges.
In an unusual development the trial judge, US District Judge Rebecca Doherty, has allowed Plaintiff to present evidence that Takeda intentionally destroyed files related to its Actos drug. Takeda admitted that it cannot find files compiled by 46 current and former employees involved with the development, marketing and sale of Actos, including those of two directors. In a January 27, 2014 ruling, Judge Doherty stated “The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing,”
Click here to read the full Bloomberg article: Takeda Jury Can Hear Claims Over Destroyed Actos Files
Medical Studies Linking Actos to Bladder Cancer
Plaintiff contends that Takeda failed to warn Allen and other users of Actos of the link between Actos and bladder cancer, and that if Takeda properly advised of the risks associated with Actos, Allen never would have used it.
In September 2010, the FDA ordered a safety review of Actos. The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos. A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year. Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.
A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.
A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.
In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer.
FDA Updates Warnings on Actos
On August 4, 2011, the U.S. Food and Drug Administration (FDA) issued updated warning information concerning Actos and the increased risk of bladder cancer. The warning states that it should not be used in patients with active bladder cancer or in those with a history of the condition. Results of a 10-year study suggest that taking Actos for periods longer than 12 months may increase the relative risk of developing bladder cancer in any given year by as much as 40 percent. A study published in the May 2012 issue of the British Medical Journal puts the increased risk at 83 percent.
If you or a loved one has had a problem with Actos or has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuries. The Brandi Law Firm is a leader in nationwide pharmaceutical litigation for decades and is now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 1-800-481-1615 or email us.
Actos is a registered trademark of Takeda Pharmaceutical Company, Ltd. The use of this trademark is solely for product identification and informational purposes. Takeda Pharmaceutical Company, Ltd. is not affiliated with this website, and Takeda Pharmaceutical Company, Ltd. has no affiliation with the Brandi Law Firm. Nothing on this site has been authorized or approved by Takeda Pharmaceutical Company, Ltd.