Takeda Pharmaceuticals America, Inc. and Eli Lilly & Company are facing a proposed class action in which the plaintiff alleges the companies attempted to cover up that their type II diabetes treatment, Actos, presented a risk of bladder cancer.
Takeda Pharmaceuticals America, Inc. and Eli Lilly & Company are facing a proposed class action in which the plaintiff alleges the companies attempted to cover up that their type II diabetes treatment, Actos, presented a risk of bladder cancer. According to the complaint, the defendants engaged in “a decade-long scheme” to mislead consumers and the U.S. Food and Drug Administration (FDA) regarding the potentially harmful effects of Actos in order to increase sales.
The lawsuit claims Takeda originally partnered with non-party Upjohn Company during the 1980s to develop Actos, its brand-name pioglitazone diabetes drug, but Upjohn supposedly ended the partnership due to “concern regarding pioglitazone’s margin of safety,” leaving Takeda to continue development independently.
In 1999, the company reportedly convinced the FDA to approve Actos despite concerns stemming from various rat and mice studies that found an association between bladder cancer and long-term use of the drug. Around the same time, the lawsuit continues, Takeda partnered with Eli Lilly to market and distribute the drug, standing behind its argument that Actos would not have the same effect on humans as it did on rats. The case argues that Lilly chose to adopt this “story” despite knowing it didn’t add up and was fabricated to mislead the public.
The complaint then details allegations regarding the defendants’ successful attempts during the next decade to cover up evidence and warnings that Actos presented health risks, some of which, the case says, included lying about the nature of the drug to separate it from known cancer-causing chemicals. Not until 2011 did the FDA finally issue a warning “linking long term [sic] use of Actos to bladder cancer,” the case claims, thereby requiring the defendants to finally change the labeling of their product to include a cancer warning.
After the FDA issued its safety alert and the defendants were required to relabel Actos to include a bladder cancer warning, sales of the drug reportedly dropped by 80 percent. The suit argues that because of the companies’ supposed deception, they “were able to sell millions of prescriptions for Actos that would have never been issued had the truth been known.”