When the man started taking the medication, he was not made aware the drug could increase the risk of developing bladder cancer. This failure to warn is material because Takeda and Lilly appear to have known of the potentially fatal side effect as early as 2005 and did not publish the results of studies indicating the problem.
In June 2011, the U.S. Food and Drug Administration required the increased cancer risk be added to the warnings section of Actos' labeling, and Takeda has recalled the drug in France.
The man stopped using Actos in 2011. His lawsuit states that because of his use of the drug and his subsequent illness, he experienced extreme pain, and incurred medical costs. His wife alleged she lost his companionship and services.
Takeda and Lilly are accused of negligent failure to warn, negligent design defect, breach of implied warranty, negligence, violation of consumer protection laws, breach of express warranty, negligent misrepresentation, and loss of consortium.