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Actos Manufacturer Agrees to Landmark $2.37 Billion Settlement

This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.

In a huge win for justice and consumer rights, Takeda Pharmaceutical has agreed to pay $2.4 billion to settle thousands of lawsuits from patients and their family members who said that the company’s diabetes drug Actos caused bladder cancer.

Takeda, a Japanese company, said the settlement would resolve most of the product-liability lawsuits related to Actos. It said it would take a $2.7 billion charge against earnings to cover the settlement and costs for defending the remaining cases.

About 9,000 bladder cancer claims are pending against Takeda involving Actos. Lawyers representing the plaintiffs had said Takeda concealed the cancer risk of the big-selling medication.

In one case last year, a jury in Louisiana ordered Takeda and Eli Lilly to pay a combined $9 billion in punitive damages after deciding that Takeda had hidden the cancer risks. The judge later reduced the award to $36.8 million. Lilly had once been a co-marketer of the drug.

AS expected, Takeda did not admit liability, saying it had settled to “reduce the uncertainties of complex litigation.” It said that the claims in the lawsuit were without merit and that the benefits of Actos outweighed any risks.

The settlement will become effective if 95 percent of the plaintiffs agree to it, in which case Takeda would pay $2.37 billion. If that figure rises to 97 percent of plaintiffs, Takeda will pay $2.4 billion.

The amount given to individual plaintiffs will depend on their particular circumstances, like the cumulative dosage of the drug used, the extent of the injury and their smoking history.

According to a filing in the Louisiana case, sales of Actos in the United States have exceeded $24 billion since it went on sale in 1999, with more than 100 million prescriptions written. The drug now faces generic competition.

The settlement is one of the largest product-liability settlements in the pharmaceutical industry.

Wyeth, later acquired by Pfizer, set aside more than $20 billion to cover the costs of lawsuits related to drugs used in the fen-phen diet pill combination.

Merck agreed to pay $4.85 billion in 2007 to settle 27,000 lawsuits related to its pain reliever Vioxx, which was taken off the market in 2004 after a study found it increased the risk of heart attacks.

Many of the cases were in Illinois because Takeda’s American operations are based there. The Michael Brady Lynch Firm has over 30 cases in suit in Illinois state court.

The case with the initial $9 billion verdict was the only one tried so far in a federal court. There have been eight trials in various state courts with mixed verdicts, according to a spokeswoman for Takeda.

In three of the cases, the juries returned verdicts in favor of Takeda. In the other five, the juries found in favor of the plaintiffs, but in two of those cases the judge subsequently ruled in favor of the company.

The Food and Drug Administration added a warning about the risk of bladder cancer to the label for Actos in 2011. It said that use for two years or more led to a 40 percent increased risk of bladder cancer.

Actos, known generically as pioglitazone, is in the same class of drugs for Type 2 diabetes as GlaxoSmithKline’s Avandia. Sales of Actos increased after concerns arose starting in 2007 that Avandia might increase the risk of heart attacks.

About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Xarelto bleeding injuries, Mirena IUD, Actos Bladder Cancer, Testosterone heart attack and stroke injuries and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.