Takeda Held Responsible in First Federal Actos Bellwether Trial
After 34 days of trial, a Lafayette, Louisiana jury returned its verdict against Takeda and Lilly and ordered the PHARMA giants to pay $1.475 million in compensatory damages and $8 billion in punitive damages for injuries including bladder cancer to Terrance Allen, a hardware store manager, who took Actos for his diabetes treatment from 2004 to 2011. (In Re: Actos Products Liability Litigation Case No. 6:11-md-2299.). The jury felt that Takeda concealed the risks of cancer associated with Actos. Lilly, which co-promoted Actos from 1999 to 2006, said in a press release it will be indemnified by Takeda for its losses and expenses around the litigation based on the terms of its agreement with Takeda.
Actos entered the US market in 1999 and its peak sales were in 2008 at well over $3 billion. The patent expired in 2011 and sales declined.
Medical Studies Linking Actos to Bladder Cancer
Plaintiff contended 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.
The Allen lawsuit was the fourth Actos trial litigated to verdict. There have been two prior verdicts for plaintiffs in California and Maryland (though those results were later overturned) and defense verdict in Las Vegas. The Allen case in Louisiana was the first federal bellwether case to be tried. There remain about 3,000 Actos lawsuits pending in the federal MDL in the Western District of Louisiana and a number of cases pending in the coordinated California cases JCCP, where The Brandi Law Firm represents a number of Plaintiffs. (Case No. JCCP 4696 Assigned to Hon. Kenneth Freeman).
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.