The Japanese drugmaker Takeda has been ordered to pay $6bn (£3.6bn) in punitive damages – the largest fine ever imposed on a pharmaceutical company – for hiding cancer risks associated with a bestselling diabetes medicine.
The punishment met with "stunned silence" when it was announced in a packed federal courtroom in the US, according to the plaintiffs' lawyer.
Takeda's US partner, Eli Lilly, which marketed and sold the Actos diabetes drug in the US between 1999 and 2006, was fined $3bn. Both companies said they would contest the ruling through all available legal means.
"I hope Takeda executives in Japan heard what this jury had to say loudly and clearly," said Mark Lanier, who represents a former Actos user Terrence Allen and other victims. The federal jury in Lafayette, Louisiana, also awarded $1.5m in compensatory damages to Allen, who blamed the diabetes II drug for his bladder cancer.
Thousands of patients have sued both companies since the US health watchdog, the Food and Drug Administration, warned in 2011 that using Actos for more than a year could increase the risk of bladder cancer by 40%. The cancer risk had to be added to the drug's warning label. Germany and France suspended the medicine the same year.
The combined $9bn in punitive damages awarded by the US federal jury against Takeda and Eli Lilly is likely to be reduced as the legal process continues. The US supreme court says that punitive verdicts must be proportional to the awards of compensatory, or actual, damages that underlie them.
Lanier admitted that the damages award against Takeda and Eli Lilly might not be sustained on appeal. "Nobody has gone out and bought a new home," he told Reuters. "This is a conservative judge and a conservative court."
At one point Actos was Takeda's top-selling medicine, but sales have plunged due to competition from generic drugs and fears over its link with bladder cancer.
The verdict comes just days after Christophe Weber quit his job as head of vaccines at GlaxoSmithKline to become Takeda's chief operating officer. He is also due to take on the role of company president from late June when the incumbent and chief executive Yasuchika Hasegawa becomes chairman and chief executive.
Kenneth Greisman, a Takeda lawyer, said: "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." Eli Lilly issued a similar statement.
The federal jury only took an hour and 10 minutes to deliver its verdict finding liability on all 14 questions, and another 45 minutes to come out with the multibillion dollar punitive damages, Lanier said. It was the first federal case to be tried.
Last year, state juries in California and Maryland ordered Takeda to pay a total of $8.2m in damages to former Actos users, but judges in both states threw out the verdicts.
Thanks for this Graham. This is why I read this blog, it beats News at Ten. Having just put a comment on Eddie's forthcoming Dieticians Week, your post here was also worth a thank you. What an eclectic mix it is, but good.
Hi Nicky, we have always been wary of the dangers of many of the diabetes drugs on the market, big pharma's drug trials have been under a lot of scrutiny lately which may produce even more fines in the longer term.
Thanks for your comments.
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