Drug Collections

Actos Litigation Documents


Actos Products Liability Litigation - MDL No. 6:11-md-2299

Terrence and Susan Allen v Takeda Pharmaceuticals International

Actos (pioglitazone), manufactured by Takeda Pharmaceuticals USA, is prescribed for control of blood sugar in Type 2 Diabetes. In 2014, Terrence and Susan Allen brought a lawsuit against Takeda Pharmaceuticals alleging Actos caused Mr. Allens' bladder cancer. The selected documents and court transcripts from this litigation show Takeda misled the FDA and the healthcare community regarding the efficacy and safety of Actos and hid the harmful side-effects that surfaced in their clinical trials. Upjohn (the US partner for Takeda) had backed out of the partnership after clinical trials of Actos posed safety and efficacy questions. Takeda subsequently sought out and found a physician willing to file with the FDA and get the drug to market in the US (1996). Takeda then approached Lilly with a co-promotion agreement and the drug went to market, touted as a safer alternative to a similar drug, Avandia.

Nine Actos cases have gone to trial since 2013 alleging various health issues. Juries ruled against Takeda in five cases, though two of those five were later thrown out. In July 2015 a California appeals court reinstated the first $6.5 million plaintiffs verdict against Takeda, after a lower court had granted the company’s request for a new trial