Eli Lilly & Co. has indicated that its former marketing partner, Takeda Pharmaceutical Co., may not pay Lilly’s share of a recent United States jury verdict that ordered Takeda and Lilly to pay $9 billion in punitive damages in a product-liability lawsuit brought over the diabetes drug, Actos.
The award was made in the first multidistrict litigation (MDL) bladder cancer bellwether involving Actos and is also one of the largest jury awards in history. Takeda Pharmaceutical Co. was ordered to pay $6 billion, and Eli Lilly & Co. was ordered to pay $3 billion in punitive damages, respectively, in consolidated Actos cases in Louisiana.
The man involved, from New York State, and his wife, brought the lawsuit over allegations that his use of Actos caused him to develop bladder cancer, according to The Wall Street Journal. The jury also award $1.48 million in compensatory damages. Takeda was ordered to pay 75 percent and Lilly, the remaining 25 percent.
Just following the verdict, Lilly indicated that, as part of its marketing agreement with Takeda, Takeda is to indemnify Lilly against losses and expenses involving Actos litigation. Meanwhile, Takeda advised Lilly that it reserved the right to challenge any obligations to defend and indemnify Lilly in the matter, according to Lilly, the Journal wrote.
According to the Journal, a Takeda spokeswoman confirmed the move; she cited “contractual agreements.” Derica Rice, Lilly Chief Financial Officer, told the Journal that, we fully expect and believe they are obligated to indemnify us.” Lilly co-marketed the Type 2 diabetes drug with Takeda from 1999 to 2006.
More than 3,000 lawsuits have been brought over Actos, and the U.S. Food and Drug Administration (FDA) issued a warning about the risks of taking Actos. In fact, on June 15, 2011, the agency indicated that taking the Actos for more than one year might significantly increase one’s risk of developing bladder cancer. The FDA also noted that the safety label for Actos had been updated to address this risk.
Research has revealed the link between taking Actos and increased risks for developing bladder cancer. According to a British Medical Journal report on May 31, 2012, Actos users were twice as likely to develop bladder cancer after two years. On July 3, 2012, the Canadian Medical Association Journal reported that Actos patients were 22 percent likelier to develop bladder cancer.
Lawsuit allegations include that Takeda researchers ignored or minimized the Actos’ ties to cancer prior to its sale in the United States in 1999. Lawsuits also argue that Takeda misled U.S. regulators about these risks.
Takeda pulled Actos from the French market at that country’s regulator’s request; the German government also removed Actos from its reimbursed list of drugs, Bloomberg News, previously reported.
Some of the symptoms of bladder cancer include blood in the urine, frequent urination, and pain when urinating.