Jon Campisi Jul. 20, 2012, 7:32am

A western Pennsylvania man has filed a pharmaceutical mass tort claim against the makers of the diabetes drug Actos, alleging the product’s use led to him developing bladder cancer.

John Kristufek, who resides in Harrisville, Pa., is suing Philadelphia-based Takeda Pharmaceuticals and various company subsidiaries over allegations that the defendants concealed, and continue to conceal, their knowledge of Actos’ “unreasonably dangerous risks from Plaintiff, his physicians, other consumers and the medical community,” the suit says.

Specifically, the lawsuit claims, the defendants failed to disclose the risk of bladder cancer associated with the use of the drug, which is designed to treat Type 2 diabetes.

The complaint, which was filed July 17 at Philadelphia’s Common Pleas Court by Virginia attorney Tayjes Shah, of The Miller Firm, also names as defendants Colleen Carver, Mary Brooks and Lynn Gagne.

All three western Pennsylvania women were employed as senior sales representatives for Takeda.

The complaint states that while sales reps don’t deliver the drugs or information to pharmacies and doctors’ offices, they do “aggressively and proactively formulate strategies to induce physicians to prescribe their drugs so that they can receive bonuses, commissions and other prizes from Takeda.”

The lawsuit claims that the women urged Kristufek’s physicians to promote the use of Actos over “other safer more effective Diabetes medications.”

“Consumers, including Plaintiff, who have used Actos for treatment of type II diabetes, have several alternative safer products available to treat the conditions and have not been adequately warned about the significant risks and lack of benefits associated with Actos therapy,” the lawsuit states.

Kristufek, the suit states, was not made aware of the dangers of Actos until the risks of bladder cancer development were exposed in a June 15, 2011, safety announcement by the Food and Drug Administration.

“As a direct result of being prescribed Actos, Plaintiff has been permanently and severely injured, having suffered serious consequences from Actos use,” the complaint states. “Plaintiff requires and will in the future require ongoing medical care and treatment.”

The suit states that Kristufek was diagnosed with bladder cancer in August 2009, after having ingested Actos for about four years.

Kristufek would have never taken Actos if he had been made aware of the risks associated with the drug, the lawsuit states.

As a result of his injuries, Kristufek has suffered severe mental and physical pain, economic losses due to medical expenses and emotional distress.

The mass tort claim contains counts of negligence, negligent misrepresentation, breach of express and implied warranties, strict products liability, negligence per se and deceptive trade practices violations.

Kristufek seeks compensatory damages in excess of $50,000, treble damages, damages for pain and suffering, pre-and-post-judgment interest, attorney’s fees, and expert witness fees.

A jury trial has been demanded.


The case ID number is 120702275.

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