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New Hampshire Couple Files Federal Actos Lawsuit

William and May Youngclaus of New Hampshire are the plaintiffs in a federal lawsuit claiming Mr. Youngclaus’ bladder cancer was an Actos side effect. The case is part of the multidistrict litigation in the Western District of Louisiana against the makers of Actos, Takeda Pharmaceuticals and Eli Lilly & Co.

Mr. Youngclaus was diagnosed with bladder cancer in 2009.  He took Actos to treat his type two diabetes starting in 2003 and the plaintiff claims Actos caused his bladder cancer. The plaintiff alleges the two companies jointly manufactured and marketed the drug, which was launched with Food and Drug Administration (FDA) approval in 1999. The complaint, filed December 10, alleges the drug is intended to treat type two diabetes and those using it for a year or more risk developing bladder cancer.

Allegations defendants concealed harmful Actos side effects

The Actos lawsuit alleges the defendants have concealed, and continue to conceal, their knowledge that Actos causes bladder cancer, which resulted in harm to Mr. Younglaus. He claims he wouldn’t have used Actos if he’d known of the cancer risks of taking it. The complaint states there are safer alternative treatments for type two diabetes.

According to the complaint, prior to Actos’ approval by the FDA, a study involving rats showed drug induced bladder cancer tumors. It also alleges a 2005 Prospective Pioglitazone Clinical Trial in Macro Vascular Events study showed a higher percentage of patients using Actos, compared to other diabetes drugs, developed bladder cancer.

In September 2010 the FDA announced it was reviewing data for a ten year study evaluating the association between Actos and bladder cancer. According to the complaint, the planned five year analysis showed the risk of bladder cancer increases with the dose and duration of the drug, reaching statistical significance after two years. The complaint claims that Takeda subsequently denied the study showed a risk of bladder cancer to Actos users.

Actos lawsuit alleges defendants knew of drug’s dangers

The French and German governments suspended the sale of Actos in June 2011, pending further review of a French study showing a statistically significant increase in bladder cancer risk by those using Actos for more than a year. The complaint states the FDA issued an Actos safety warning in June 2011 stating use of the drug for more than a year was associated with an increased risk of bladder cancer. According to the complaint, Takeda recalled the drug in France in 2011. Plaintiffs claim that despite this knowledge, defendants marketed Actos as safe and effective and refused to warn patients and physicians about the increased cancer risk associated with Actos use.

Actos generated $4.8 billion in sales in 2011, accounting for 27% of Takeda’s sales, according to the complaint, which also states the drug was the tenth best selling medication in the U.S. in 2008.

Plaintiffs claims Mr. Youngclaus was exposed to a risk of bladder cancer due to defendants’ acts, omissions and misrepresentations.  Mr. Youngclaus claims that due to his Actos use, his damages include past severe mental and physical pain and suffering and future permanent injuries, emotional distress and economic losses due to increased medical and living expenses.

This Actos lawsuit also accuses the defendants of negligence, breaching express and implied warranties, engaging in fraudulent and negligent misrepresentation, fraudulent concealment, fraud and deceit. May Youngclaus, William’s wife, also filed a claim of loss of consortium. The complaint doesn’t set forth an amount of damages and seeks a jury trial.

  1. Yahoo Health, Actos Side Effects,

  2. Bloomberg News Service, Takeda Failed to Properly Warn About Actos, Jury Rules,