WEST VIRGINIA RECORD

WAYNE - Fourteen complaints have been filed in Wayne Circuit Court against Takeda Pharmaceuticals USA Inc. after the plaintiffs claim they suffered bladder cancer as a result of taking Actos.

Takeda Pharmaceuticals USA Inc. was formerly known as Takeda Pharmaceuticals North America Inc.

Takeda Pharmaceuticals America Inc.; Takeda Global Research & Development Center Inc.; Takeda California, formerly known as Takeda San Diego Inc.; Takeda Pharmaceuticals International Inc.; Takeda Pharmaceuticals Company Limited; and Eli Lilly and Company were also named as defendants in the suits.

Carolyn Holley, individually and on behalf of the Estate of Mitchell Holley; Richard M. Douglas Sr.; Sidney Farah; Ronald Ramsey and Barbara Ramsey; James Duncan; Henry L. James and Cynthia B. James; James R. Smith and Sharon Smith; William R. Payne; Raymond E. Plank; Donald Carlton Peters; Bonnie Cain, individually and on behalf of the Estate of Robert Cain; John Murphy; Herbert Ragusca; and Harlan Lee Tyler and Virginia Tyler were diagnosed with bladder cancer and/or related injuries after ingestion of Actos, according to 14 complaints filed June 17 in Wayne Circuit Court.

The plaintiffs claim Actos was advertised, analyzed, assembled, compounded, designed, developed, distributed, formulated, inspected, labeled, manufactured, marketed, packed, produced, promoted, processed, researched, sold and tested by the defendants.

Actos received U.S. Food and Drug Administration approval in 1999 to treat Type 2 Diabetes Mellitus and was jointly launched by Takeda North America and Eli Lilly in 1999, according to the suits.

The plaintiffs claim they were prescribed and took Actos as prescribed by their treating physicians and suffered bladder cancer and/or death as a result.

The injuries suffered by the plaintiffs were a direct result of their ingestion of Actos in a manner and dosage recommended by the defendants and prescribed by their physicians, according to the suits.

The plaintiffs claim prior to applying for and obtaining approval for Actos, the defendants knew or should have known that Actos use in humans was associated with and/or would cause the induction of bladder cancer and the defendants possessed pre-clinical scientific studies, including animal evidence, which they knew or should have known was a signal that bladder cancer risk needed to be further tested and studied before placing Actos on the market.

Despite bladder cancer findings in animal model carcinogenicity studies and other pre-clinical evidence, the defendants failed to adequately conduct complete and proper testing of Actos, prior to filing its New Drug Application of Actos, according to the suits.

The plaintiffs claim for more than 10 years, the defendants concealed and failed to completely disclose its knowledge that Actos was associated with or could cause bladder cancer or its knowledge that it had failed to fully study and test regarding that risk.

The defendants knew that Actos had unreasonably dangerous risks and caused serious side effects of which the plaintiffs and their physicians and pharmacists would not be aware, according to the suits, and the defendants "nevertheless advertised, analyzed, assembled, compounded, designed, developed, distributed, formulated, inspected, labeled, manufactured, marketed, packaged, produced, promoted, processed, researched, sold and tested Actos knowing that there were safer methods and products available."

The plaintiffs are seeking compensatory and punitive damages with pre- and post-judgment interest. They are being represented by Paul T. Farrell Jr. and Bert Ketchum of Green, Ketchum, Bailey, Walker, Farrell & Tweel.

The cases have been assigned to Circuit Judge James H. Young Jr.

Wayne Circuit Court case numbers: 13-C-111, 13-C-112, 13-C-113, 13-C-114, 13-C-115, 13-C-116, 13-C-117, 13-C-118, 13-C-119, 13-C-120, 13-C-121, 13-C-122, 13-C-123, 13-C-124