A class-action lawsuit from thousands of third-party payers alleges that the companies broke racketeering laws to market their diabetes drug Actos, while not disclosing its bladder cancer risk.
Pictured: Judicial gavel and scales of justice/Courtesy iStock
A California Federal Judge has certified a class-action case against Eli Lilly and Takeda, accusing the pharmaceutical companies of racketeering after they allegedly marketed their diabetes drug Actos (pioglitazone) without disclosing its risk of bladder cancer, according to a report by Bloomberg.
In his May 24 opinion, which was unsealed Monday, District Judge John Holcomb granted the certification of a National Third-Party Payer (TPP) Class consisting of thousands of TPPs that reimbursed patients for Actos between July 1, 1999 and September 17, 2010. Holcomb appointed Painters and Allied Trades District Council 82 Health Care Fund to represent this class.
However, the district judge refused to certify a California Consumer Class, citing lack of convincing evidence. This class was supposed to represent all consumers in the state who paid or otherwise incurred costs related to Actos.
Holcomb also directed both parties—the TPP plaintiffs as well as Lilly and Takeda—to settle on a case schedule by June 16.
BioSpace reached out to Takeda and Lilly for comment on the class-action lawsuit, but the companies were not immediately available.
Actos was approved by the FDA in July 1999 to improve glycemic control in adults with Type 2 diabetes. The drug’s label bears a boxed warning for congestive heart failure. Actos also comes with a risk of edema, hepatic side effects, hypoglycemia and bladder cancer.
The FDA announced in September 2010 that it was conducting a review of an epidemiological study to assess whether Actos was associated with a heightened likelihood of bladder cancer. When this review ended in June 2011, the regulator found that prolonged use of Actos, lasting for more than a year, could aggravate the risk of this malignancy.
“The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone,” the FDA wrote at the time.
Actos’ label was amended accordingly following these findings.
In their lawsuit, the plaintiffs allege that Lilly and Takeda knew of this risk and instead misled the FDA “by generating false studies, manipulating study results, and controlling the messaging about Actos to conceal aspects about the drug’s mechanism that could have raised concerns,” Holcomb wrote in his opinion.
Several patients and payers filed lawsuits against the companies, which culminated in a $9 billion jury ruling in 2014 against Lilly and Takeda, though this payout was eventually drastically reduced. Takeda settled the lawsuits in April 2015 for around $2.4 billion.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
