On September 26, 2013, a jury in Baltimore, Maryland, found that Takeda Pharmaceutical Co. did not properly warn Diep An, an ex-U.S. Army translator, and his doctor about the risks of its Actos diabetes drug and ordered the company to pay more than $1.7 million in damages. Jurors also found that An, a thirty year smoker was contributorily negligent, and under Maryland Law, the Judge immediately threw out the verdict. The case is An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, State of Maryland.
For Actos users and for Takeda, this means two juries have found Actos to be defective, have inadequate warnings, and be the contributing factor to its user’s cancers. However, for reasons unrelated to the conduct of Takeda, but solely due to legal issues, two trial judges overturned the verdicts allowing Takeda to temporarily dodge the Juries inevitable findings of fault.
In An, the case was overturned due to the vagaries of Maryland law as it relates to contributory negligence of the user, where if a Plaintiff is even one percent at fault , the Plaintiff cannot recover. This issue was most recently upheld by the Maryland Court of Appeal in a 5-2 vote on July 9, 2013. Only Maryland, Virginia, Alabama, North Carolina and the District of Columbia still have the law while 46 states use a comparative negligence system that reduces the damages an injured person can receive in proportion to his or her degree of fault.
On April 26, 2013, a Los Angeles jury heard similar evidence and found against Takeda and assessed damages at $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles), but Judge Kenneth Freeman granted a post trial motion to overturn the verdict. First, Judge Freeman granted Takeda’s motion to exclude the opinions of Plaintiff’s causation expert Dr. Norm Smith that Actos was a substantial factor in specifically causing Mr. Cooper’s bladder cancer. With no opinion to support that finding remaining in the case, the Court then granted Takeda’s motion for non-suit, throwing out the verdict.
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. Takeda officials previously said that the study FDA officials reviewed are continuing and final results are expected in 2014. 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.
We continue to believe that Actos is a likely cause and substantial factor in the bladder cancer patients we represent and that ultimately Takeda will be held responsible. If you or a loved one has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuries. Thomas J. Brandi and The Brandi Law Firm are leaders in nationwide pharmaceutical litigation for decades and are 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 or go to our website for further information about Actos.