FDA Concludes Actos May be Linked to Bladder Cancer. The U.S. Food and Drug Administration (FDA) has concluded that pioglitazone, sold under the brand names Actos, Actoplus Met, Actoplus Met XR, Duetact and Oseni, may be associated with an increased risk of bladder cancer. The agency issued a Dec. 12, 2016 Safety Communication following an updated review. The label on Actos and other drugs containing pioglitazone will be updated to include additional information about bladder cancer studies. The current label for these type 2 diabetes drugs already communicate a possible increased risk of bladder cancer.
Parker Waichman LLP has remained actively involved in the Actos bladder cancer litigation. Jerrold S. Parker, founding partner of the firm, has maintained a leadership role throughout the multidistrict litigation (MDL) by serving on the Plaintiff’s Steering Committee. The firm is still accepting Actos bladder cancer cases, and continues to offer free legal consultations to individuals with questions about filing an Actos lawsuit.
The FDA previously issued warnings regarding Actos and bladder cancer in September 2010 and June 2011. These alerts were based on interim results from an ongoing 10-year epidemiological study. The agency announced a label update in August 2011, which advised physicians not to use Actos in patients with active bladder cancer or a prior history of bladder cancer. Patients taking Actos should contact their healthcare professional if they experience possible symptoms of bladder cancer, which include blood in the urine, a red color in the urine, a new or worsening urge to urinate, or painful urination. The FDA ordered Actos makers to revise and continue the 10-year study.
At around the same time, sales of the drug were suspended in France and regulators in Germany advised healthcare professionals not to start Actos in new patients. These actions were based on the results of an epidemiological study in France.
In its most recent alert, regulators said they reviewed additional published studies assessing whether patients taking Actos had a higher risk of bladder cancer. The agency said there were mixed results. The diabetes drug was not linked to an increased risk of bladder in the 10-year epidemiological study. However, another study did find that the drug was linked to bladder cancer. The agency also notes a randomized controlled trial where Actos was associated with bladder cancer during the trial period, but this link was not found after the trial was completed. “Furthermore, findings of these and other reviewed studies conflicted about whether the duration of use and/or total dose over time of pioglitazone influenced the risk of bladder cancer.” FDA said. In 2010, the agency said that Actos exposure was associated with bladder tumors in animal studies.
“Overall, the data suggest that pioglitazone use may be linked to an increased risk of bladder cancer.” FDA said.
Actos Bladder Cancer Lawsuits, Settlements, Verdicts
Parker Waichman notes that thousands of Actos lawsuits were filed alleging bladder cancer, and cases continue to be filed. In 2015, Takeda Pharmaceuticals offered to pay $2.4 billion if 97 percent of eligible claimants agreed to the settlement. According to court documents, an estimated 8,000 Actos bladder cancer cases were pending in state and federal courts at the time. Takeda initially marketed the drug with Eli Lilly. The companies have faced substantial litigation over the drug, including a $9 billion verdict handed down by a Louisiana jury. Even though both parties knew the award would likely be reduced, the large verdict caught the drug makers’ attention. The $9 billion was reduced by 99 percent to $36.8 million. Still, Actos announced its $2.3 billion settlement six months later. The offer was later raised by $100 million if certain conditions were met. The settlement was offered without admitting liability.
As the settlement heads towards completion, new Actos bladder cancer lawsuits continue to be filed. Federal Actos bladder cancer lawsuits are consolidated into an MDL in the U.S. District Court for the Western District of Louisiana before Judge Rebecca F. Doherty. The U.S. Judicial Panel on Multidistrict Litigation (JPML) creates MDLs to consolidate cases that have common questions of fact. In the Actos MDL, plaintiffs commonly allege that the type 2 diabetes drug contributed to bladder cancer and drug makers knew about these risks but failed to warn patients or the medical community. Centralizing similar lawsuits to one court helps make proceedings more efficient by eliminating duplicate discovery.
The first Actos bladder cancer lawsuit went to trial in California in 2013. The jury awarded the plaintiff $6.5 million. The verdict consisted of $5 million to the man who developed bladder cancer, allegedly due to Actos, and $1.5 million to his wife. Several days after the verdict was handed down, however, the verdict was tossed because a trial judge found that the expert’s testimony was speculative. In 2015, however, the $6.5 million verdict was reinstated. This lawsuit headed to trial before others because the plaintiff’s doctor said he only had months to live.
The plaintiff, a former cable splicer for Pacific Bell, took Actos for over five years before being diagnosed with bladder cancer in December 2011. The lawsuit filed on his behalf, like others in the Actos litigation, allege that the manufacturers failed to warn about the risk of bladder cancer in a timely manner. The jury found Takeda liable for strict liability and negligence. Five days after the verdict was issued, Los Angeles Superior Court Judge Kenneth R. Freeman found that the expert witness failed to rule out all other possible causes of bladder cancer, and tossed the verdict. Later, an appeals court ruled that the judge overstepped, reinstating the verdict. The appeals court found that, based on the plaintiff’s medical records, the plaintiff expert did rule out other possible causes for bladder cancer, including radiation exposure and chemotherapy.
“By requiring that the expert rule out all other possible causes…even where there was no substantial evidence that other such causes might be relevant, the court exceeded the proper boundaries of its gatekeeping function in determining the admissibility of the complex scientific testimony,” the appeals court ruled.