Jury Hits Pioglitazone Makers With $9 Billion in Damages

Mark Crane

April 09, 2014

Drugmakers Takeda Pharmaceutical Co. and Eli Lilly and Co. promised to appeal an award of $9 billion in punitive damages — one of the largest in US history — after a federal jury found they had concealed the cancer risks for their type 2 diabetes drug pioglitazone (Actos).

In addition, the jury ordered the payment of $1.475 million in compensatory damages.

Pioglitazone is associated with an increased risk for bladder cancer among persons with type 2 diabetes, according to a 2012 study in BMJ, as reported by Medscape Medical News. The US Food and Drug Administration in 2011 updated the pioglitazone label to warn against starting the drug in patients with active bladder cancer and to use caution if starting it in patients with a prior history of bladder cancer, also reported by Medscape Medical News.

The jury in Lafayette, Louisiana, earlier awarded $1.5 million in compensatory damages to former pioglitazone user Terrence Allen, who blamed the drug for his bladder cancer. His attorney Mark Lanier said Takeda officials intentionally destroyed documents about the drug.

US District Judge Rebecca Doherty agreed and penalized the company, telling jurors they could infer that the files may have supported Allen's claims that the company wrongfully concealed the medication's health risks. "The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing," Doherty wrote in a January ruling.

The jury found that Takeda and Lilly "failed to adequately warn" about the drug's bladder-cancer risks and that the drug caused Allen's disease. Jurors also found Takeda and Lilly executives "acted with wanton and reckless disregard" for patients' safety in their handling of the drug.

Takeda, Asia's largest pharmaceutical company, was ordered to pay $6 billion. Takeda's partner, Eli Lilly, was ordered to pay $3 billion, although Takeda has agreed to indemnify Lilly for any legal liability tied to the drug. Lilly served as Takeda's US partner in marketing the drug over a 7-year period starting in 1999.

The $9 billion jury award is likely to be reduced, regardless of any legal appeal, because of US Supreme Court decisions that punitive damages must be proportional to awards for compensatory damages.

"Takeda respectfully disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal," Kenneth D. Greisman, senior vice president and general counsel of Takeda Pharmaceuticals USA, Inc, said in a statement. "We have empathy for the Allens, but we believe the evidence did not support a finding that Actos caused his bladder cancer. We also believe we demonstrated that Takeda acted responsibly with regard to Actos. Patient safety is a critical priority for Takeda. We are confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes."

Eli Lilly and Co. also promised to challenge the verdict. "While we have empathy for the plaintiff, we believe the evidence did not support his claims," Mike Harrington, senior vice president and general counsel, said in a statement. "Lilly disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means."

Takeda won 3 previous trials about pioglitazone. The drug, once the world's best-selling diabetes medicine, has generated more than $16 billion in sales since its 1999 release, according to court filings.

Following the BMJ study, Dominique Hillaire-Buys, MD, PhD, and Jean-Luc Faillie, MD, from the Department of Medical Pharmacology and Toxicology at Centre Hospitalier Régional Universitaire de Montpellier, France, suggested in an accompanying editorial that the risks of pioglitazone seem to outweigh the benefits.

"Taking into account…current findings and given the consistency of these results, the relative strength of the association, the dose-response effect, the known pharmacodynamic characteristics of pioglitazone, and evidence of a significant association in a meta-analysis of randomised trials, it can confidently be assumed that pioglitazone increases the risk of bladder cancer," Drs. Hillaire-Buys and Faillie write. "It also seems that this association could have been predicted earlier. Worldwide, exposure to pioglitazone is estimated to be more than 20 million patient years. Considering that the benefit of pioglitazone in reducing cardiovascular events is questionable, prescribers who are ultimately responsible for therapeutic choices can legitimately question whether the benefit-risk ratio of pioglitazone is still acceptable for their patients with diabetes."

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