The U.S. Supreme Court on Monday declined to hear an appeal from Takeda Pharmaceutical and Eli Lilly, allowing a $7 billion Racketeer Influenced and Corrupt Organizations (RICO) lawsuit to proceed in federal district court.
The lawsuit, filed on behalf of a class of health insurers and benefit plans, alleges that the companies conspired to hide the bladder cancer risks associated with the diabetes drug Actos (pioglitazone). Takeda manufactured the drug; Eli Lilly co-marketed it in the U.S. until 2013.
Plaintiffs claim that internal company documents from 2005 onward showed a statistically significant link between Actos and bladder cancer, but that the companies delayed releasing the data to the FDA and continued aggressive marketing. Actos generated more than $16 billion in U.S. sales before generic competition began in 2015.
RICO claims rare in pharmaceutical litigation
RICO claims — typically associated with organized crime — are unusual in drug injury cases. Plaintiffs allege that the companies' conduct constituted a criminal enterprise because they allegedly committed mail and wire fraud through deceptive marketing and regulatory filings.
Takeda and Eli Lilly argued that the claims were preempted by federal drug regulation and that RICO did not apply. The Court's denial of certiorari means the case will proceed to trial, likely in 2027. If plaintiffs prevail, damages could be trebled under RICO to $21 billion.
For more than a decade, Takeda and Eli Lilly put profits ahead of patient safety. We look forward to proving that in court.
Takeda said in a statement: 'We respectfully disagree with the plaintiffs' allegations and believe the evidence will show that Actos' label was appropriate and updated as scientific understanding evolved.' Eli Lilly declined to comment.
