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New Jersey Couple Files Actos Bladder Cancer Lawsuit

Takeda Pharmaceuticals and Eli Lilly are facing a new Actos bladder cancer lawsuit brought by a New Jersey couple who argue the defendants manufactured and distributed a dangerous drug. The claim was filed on November 27, 2013 by Alexander Vacula and his wife, Alice. The plaintiffs are suing on counts of strict products liability – failure to warn, fraudulent misrepresentation, breach of warranties, design defect, redhibition and loss of consortium, among other causes of action.

Actos bladder cancer risks concealed, alleges lawsuit

According to the claimants’ Actos cancer lawyer, the defendants knew or should have known that side effects of pioglitazone included carcinogenic tumors, yet the manufacturer failed to caution doctors or their patients about these risks.

Actos is one of Takeda’s top selling medications, and is used by millions of Americans who suffer the effects of Type 2 diabetes. The drug was approved in 1999, but within a few short years, complaints began rolling in of adverse side effects, including cancer of the bladder.

Court documents state that Alexander Vacula took Actos for a period of 18 months, under the supervision of his doctor, and was diagnosed with bladder cancer in December 2011 – the same year the FDA issued a public safety communication on cancer risks with prolonged exposure to the drug.

The FDA warning alerted health care professionals that use of Actos for 12 months or longer put patients at a greater risk for developing bladder cancer. Based on interim data from a 10-year study, the agency determined that risk to be 40 percent higher, but later medical research has estimated Actos cancer risks to be as high as 80 percent.

Plaintiffs like Vacula argue that despite this knowledge, the “defendants refused to warn patients, physicians and the medical community about the risk of bladder cancer.”

The lawsuit further asserts that Takeda and Eli Lilly, through their misrepresentations and omissions, actively concealed from the plaintiffs and their doctors the true risks of long-term Actos use. The New Jersey couple alleges that as a direct and proximate result of Vacula’s Actos ingestion, they have suffered severe mental and physical pain and suffering, as well as economic losses due to medical expenses for the plaintiff’s bladder cancer treatments.

Couple demands punitive damages to punish defendants

In addition to compensatory damages for past and future medical bills, lost wages and lost earning capacity, the Vaculas are also asking the court to consider awarding punitive damages against Takeda, for their alleged “malicious failure to disclose information” and reckless disregard for the safety and wellbeing of the public.

While their Actos bladder cancer lawsuit was filed in New Jersey district court, it will likely join the multidistrict litigation in Louisiana (MDL 2299, US District Court for the Western District of Louisiana) where more than 1,200 cases have been centralized before one judge. The Honorable Rebecca F. Doherty is overseeing the coordinated litigation, which was established to facilitate efficiency, reduce duplicative discovery and potentially encourage settlement negotiations.

As plaintiffs await resolution to their claims, Actos is still sold in the U.S. despite known cancer risks. Germany and France both banned the diabetes drug in 2011, prompting many in the U.S. to question why regulators haven’t recalled the drug here.

Takeda continues to deny any wrongdoing and contends that potential side effects of Actos are outweighed by its benefits.

  1. FDA, Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone),

  2. U.S. District Court, Western District of Louisiana IN RE: Actos (Pioglitazone) Products Liability Litigation,