A federal judge’s decision not to overturn a jury’s $9 billion verdict against Takeda Pharmaceutical Co. and Eli Lilly for withholding Actos bladder cancer risks from doctors and patients sends a new warning to pharmaceutical companies that co-promote a drug. That they, too, can be held liable for failing to warn of a drug’s potential risks even if they are not responsible for updating the drug’s safety label.

Last month, Judge Doherty upheld a jury verdict awarding $3 billion in punitive damages against Eli Lilly and $6 billion in punitive damages against Takeda for withholding information that the Type 2 diabetes drug Actos could increase the risk of bladder cancer.

Eli Lilly had previously tried to skirt liability in the Actos bladder cancer lawsuit, claiming that it shouldn’t be held liable since its role was limited to sales and marketing functions. But U.S. District Judge Rebecca Doherty disagreed, saying that Eli Lilly was just as guilty as Takeda since the company was fully aware of Actos’ potential bladder cancer risks and its financial interest even after its co-promotion deal with Takeda ended in 2006.

Plaintiffs presented evidence that in 2003 Eli Lilly agreed not to bring up bladder cancer risks with Actos during its phone calls to doctors to promote the drug. Judge Doherty also noted that Eli Lilly worked with Takeda to develop a strategic plan to deal with bladder cancer concerns raised by federal regulators before Actos was approved for marketing.

Judge Doherty’s ruling upheld the jury’s decision to rule against the drugmakers. She will address the size of the verdict at a later date. The $9 billion judgment is considered to be the seventh largest punitive damages award in U.S. history.

Source: Law 360

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