Cooper v. Takeda Pharmaceuticals America, Inc.

Actos was a prescription drug made by Takeda Pharmaceuticals America, Incorporated (Takeda) (defendant) to treat type 2 diabetes. Jack Cooper (plaintiff) had type 2 diabetes, and in 2006, a physician prescribed Actos to Cooper. Cooper took Actos until 2011, when he was diagnosed with bladder cancer. Cooper took over 50,000 milligrams of Actos over a five-year period. Cooper sued Takeda for failing to adequately warn Cooper’s treating physician of the risk of bladder cancer associated with Actos. Dr. Norm Smith testified during trial on the general association between Actos and bladder cancer and the specific causation of Cooper’s bladder cancer. Dr. Smith’s testimony was based on a review of Cooper’s medical records, Smith’s own study of bladder cancer, and Smith’s review of 15 studies linking bladder cancer to Actos. Ultimately, Dr. Smith opined that Actos was the most substantial causative factor of Cooper’s cancer. Takeda did not offer substantial evidence of an alternative causation to Actos. The jury found in favor of Cooper and awarded damages of $5 million to Cooper and $1.5 million to Cooper’s wife, Nancy (plaintiff) for loss of consortium. The court ruled on several outstanding motions after the jury delivered the verdict. The court concluded that Dr. Smith’s diagnosis was speculative and unreliable, so the court struck Dr. Smith’s testimony on medical causation. Takeda moved for judgment notwithstanding the verdict (JNOV) and a new trial. The court found that Dr. Smith’s testimony did not constitute substantial evidence of causation and granted Takeda’s motions for JNOV and a new trial. Nancy Cooper appealed.