New Orleans, LATakeda Pharmaceuticals may have won another Actos lawsuit, but an insurance company has now filed its own Actos bladder cancer lawsuit, alleging Takeda, maker of Actos, failed to properly warn patients about the risk of developing Actos side effects.
The lawsuit (case number 6:14-cv-01159) was filed by Blue Cross in the District Court, Western District of Louisiana and seeks damages for injuries caused by the use of Actos in Blue Cross patients.
“As a result of the defective nature of ACTOS, persons who were prescribed and ingested ACTOS for more than twelve (12) months, including Plaintiffs’ insured, have suffered and may continue to suffer from bladder cancer,” the court documents state (capitals in original).
The lawsuit alleges that defendants “concealed and continue to conceal their knowledge that ACTOS can cause bladder cancer from Plaintiffs’ insured, other consumers, and the medical community.” Furthermore, the lawsuit alleges that Takeda has still not provided adequate warnings about the risk of using Actos for more than 12 months. This, Blue Cross alleges, has resulted in and will continue to result in its insured patients suffering from various injuries.
The lawsuit notes that a two-year study of Actos on rats showed drug-induced tumors in the male rats. It further alleges that a three-year study in humans, called PROactive (Prospective Pioglitazaone Clinical Trial in Macrovascular Events), showed a higher percentage of bladder cancer in patients who received Actos compared with similar drugs, but that this information was not included in a publicized account of the trial.
The US Food and Drug Administration (FDA) announced an ongoing review of Actos to examine the potential link between the drug and bladder cancer. In 2011, the FDA warned that “use of the diabetes medication ACTOS (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” Court documents note that the FDA calculated that Actos therapy for longer than 12 months was linked to 27.5 extra cases of bladder cancer per 100,000 person-years compared with people who never used the medication.
Meanwhile, the French Medicines Agency has reportedly suspended use of Actos until a review of the drug is complete.
Blue Cross alleges Takeda knew or should have known about the risk associated with Actos but promoted the drug as safe and effective. The insurer further claims that there are safer products available on the market for patients, but because of Takeda’s alleged actions, patients and doctors could not have known about the risks.
“The information Defendants disseminated to physicians concerning ACTOS drug products was, in fact, inaccurate, misleading, and otherwise inadequate,” the plaintiffs claim.
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