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The jury in federal court in Louisiana, sent a loud and clear message yesterday, in rendering a bombshell verdict. Takeda Pharmaceutical Co. and Eli Lilly & Co.  were ordered to pay a combined $9 billion in punitive damages. The federal court jury found they hid the cancer risks of their Actos diabetes drug in the first federal U.S. trial.

Takeda, Lilly $9 Billion Punitive Damages

Takeda, based in Osaka, Japan, was ordered to pay $6 billion by the jury yesterday in Lafayette, Louisiana. Indianapolis-based Eli Lilly, Takeda’s partner, was ordered to pay $3 billion. Punitive damages are awarded in these types of cases to punish the companies for their wrongful acts.

The jury earlier awarded $1.5 million in compensatory damages to Allen, who blamed the drug for his cancer. Takeda, Asia’s largest drugmaker, is exposed to more than 2,700 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Louisiana.

Punitive Award to be Appealed

The $9 billion jury award, the seventh-largest in U.S. history according to Bloomberg, is certain to be reduced because the U.S. Supreme Court has said punitive verdicts must be proportional to the awards of compensatory, or actual, damages.

Plaintiff Allegations

Allen sued both Takeda and Eli Lilly over Actos. Allen alleged in the Louisiana case that he developed bladder cancer after taking Actos for more than five years. Lilly served as Takeda’s U.S. partner in selling and marketing the drug over a seven-year period. According to court documents, Takeda agreed to indemnify Lilly for any personal injury liability associated with Actos. As a result, Takeda will probably bear the brunt of the final punitive and compensatory damages amount.

Actos Bladder Cancer Trials

The Louisiana trial is the fourth trial to hear allegations that Takeda marketed Actos knowing it could cause bladder cancer and failed to properly warn doctors and patients about the risks. Takeda and Lilly face hundreds more claims over Actos in state courts including Nevada and Illinois.

Lawyers in an Actos case that began in state court in Las Vegas in February have said they are seeking more than $1 billion in compensatory and punitive damages for two women who blame the drug for their bladder cancers.

FDA Mislead

Allen alleged in his lawsuit that Takeda ignored concerns about the drug’s cancer-causing potential and misled FDA regulators about its risks to protect billions in sales. Takeda didn’t provide a specific warning about Actos’ cancer risks until 2011, seven years after experts said the bladder-cancer link became clear and 12 years after the drug went on the U.S. market.

Court testimony revealed that Takeda officials intentionally destroyed documents about the development, marking and sales of Actos.

Documents Lost or Destroyed

Because Takeda failed to properly protect the Actos documents, the court allowed  jurors to infer that the files may have supported Allen’s claims that the company wrongfully hid the Actos bladder cancer risks.

After deliberating for about four hours, jurors found Takeda and Lilly “failed to adequately warn” about Actos’ 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 and that justified a punitive damage award against both companies.

The consolidated Actos cases in Louisiana are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299. Allen’s case is Allen v. Takeda Pharmaceuticals North America Inc., 12-cv-00064, both in U.S. District Court, Western District of Louisiana (Lafayette).

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