Takeda fined record $6 bn over diabetes drug Actos; Eli Lilly $3 bn

Takeda Pharmaceutical Co Ltd, Japan's largest drug firm, has been fined a record $6 billion in punitive damages by a US court over claims that it concealed cancer risks associated with its best-selling diabetes drug Actos.

US pharmaceutical giant Eli Lilly, which helped Takeda market the drug in the US, and a co-defendant in the case, was fined $3 billion.

The jury at a court in Louisiana also ordered the payment of $1.475 million in compensatory damages in the suit.

The $9-billion fine is the largest, topping the $5-billion fine imposed by a US court on oil giant Exxon Mobil for the Exxon Valdez oil spill in Alaska in 1989.

Takeda, based in Osaka, said it would challenge the ruling, including through post-trial motions and an appeal.

''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,'' said Kenneth Greisman, senior vice president and general counsel for Takeda.

The case was brought by Terrence Allen, who was diagnosed with bladder cancer in 2011, and had used the Actos drug from 2004 and 2011.

Allen alleged that Takeda for years knew that the drug heightened the risk of bladder cancer but continued to sell the drug.

Actos, a diabetes drug, was approved by the US Food and Drug Administration (FDA) in 1999. Its patent expired in August 2012, but not before more than 10 million people globally had taken the drug.

Actos, a competitor to GlaxoSmithKline's blockbuster diabetes drug Avandia, and like its rival was found to have an increased risk of congestive heart failure in a 2007 study, which made the FDA add a black-box warning.

Regulators in the European Union (EU) in 2010 suspended the sale of Avandia, while the US regulator imposed severe restrictions on concerns that the drug increased the risk of heart attacks in diabetic patients. (See: Regulators in EU, US "kill" Glaxo's diabetes drug Avandia)

GSK pulled the drug from both the EU and the US markets, but Actos became more widely prescribed in the US since it was the only drug in the market to help diabetics despite more evidence of increased risk to those who take the drug.

Actos peaked at $4.5 billion in the year ending in March 2011 and generated more than $16 billion of sales since its 1999 launch.