Thousands of injured patients have filed Actos bladder cancer lawsuits. The first Actos bladder cancer trial has been eagerly anticipated, as there are approximately 3,000 lawsuits being filed.
The trial began on February 19th in California Superior Court in Los Angeles. On April 26, 2013, after the jury deliberated for more than 8 days, a verdict of $6.5 million against Takeda Pharmaceuticals America Inc. was returned.
The jury found Takeda’s failure to provide adequate warnings to physicians and patients about the dangers of pioglitazone, sold under the brand name Actos. This drug is prescribed for the treatment of Type 2 diabetes. The jury also found that this negligence was a substantial factor in the plaintiff developing bladder cancer. The jury awarded $5 million in damages to Jack Cooper and another $1.5 million for loss of consortium to his wife.
Jack Cooper, a former Pacific Bell telephone cable splicer was diagnosed with terminal bladder cancer in November 2011, after taking Actos for about four years. The judge ordered that Cooper’s case be the first to go to trial after his doctors indicated that he was gravely ill and only had months to live.
Despite the verdict, Takeda Pharmaceuticals continues to deny liability and has filed motions asking the judge to rule in favor of the company as a matter of law and is considering its options, including a possible appeal if the motions are denied.
During the almost two-month trial, the jury heard evidence that Takeda knew of the links between Actos and bladder cancer as early as 2004 but failed to disclose the risk to the FDA for almost seven years. Evidence was presented showing internal emails from Takeda executives that urged colleagues to persuade the U.S. Food and Drug Administration (FDA) not to demand increased warnings regarding bladder cancer on Actos’ label. “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Takeda executive Kiyoshi Kitazawa stated in an email. They chose to downplay the dangers of their drug in order to avoid hurting sales of Actos, their most profitable product.
Takeda sales for Actos in the U.S. peaked in 2011 at $4.5 billion, or approximately 27 percent of Takeda’s revenue, according to data compiled by Bloomberg news. According to court records, Takeda is facing more than 3,000 lawsuits alleging that Actos caused cancer of the bladder.
Other cases are currently pending in California and Illinois and in federal court in Louisiana, where more than 1,200 lawsuits have been consolidated into federal multidistrict litigation. The first federal case is set for trial in January, according to court filings.
In June 2011, the FDA issued a drug safety alert warning that use of Actos for more than one year may be associated with an increased risk of bladder cancer. At the same time, health authorities in France and Germany responded to the evidence of bladder cancer risk by recalling Actos.
In April 2012, Health Canada issued a safety warning on Actos. They found that diabetes patients taking Actos for more than a year had two times higher risk of bladder cancer than diabetes patients not taking the drug.
The FDA ordered a safety review of Actos in September 2010. The agency continuously reviews 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 40 percent higher risk of bladder cancer.
In 2005, Takeda published the results of a study on Actos with the intention of proving the cardiovascular benefits Actos provides. The study found 14 bladder cancers among the patients in the Actos group, compared to 5 bladder cancers in the group that did not take the drug. Takeda denied that the higher rate of cancer was due to Actos.
When Actos was approved in 1999, the FDA instructed Takeda to conduct a post-market study on the safety and effectiveness of Actos. Takeda allegedly delayed the study’s initiation until 2003 and devised the study as a 10-year trial. Due to the structure of the study, the final results will not be available until Takeda’s patent on Actos has expired. The interim results which were published in 2011, did not report an increased risk of bladder cancer.
Many of the Actos complaints allege that prior to the drug’s introduction in 1999, Takeda had results of studies performed on laboratory animals, which showed an increased risk of bladder cancer in animals that were given Actos. The manufacturer allegedly never disclosed the lab results to health regulators.
Even today, the warning label on Actos states, “There are too few events of bladder cancer to establish causality.”
Drug manufacturers have a responsibility to produce safe products to patients, as well as to warn physicians and patients of any dangers or adverse side effects. The lawsuits filed by Actos bladder cancer patients contend that Takeda was negligent and should be held accountable for the harm they caused.
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