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Takeda and Lilly hit with $9 billion Actos damages bill

Published on 08/04/14 at 08:51am

A US jury has ordered Japanese firm Takeda Pharmaceutical to pay $6 billion (£3.6 billion) in punitive damages, over claims it was hiding cancer risks associated with its diabetes drug Actos.

US firm Eli Lilly, a co-defendant in the case, has also been ordered to pay $3 billion in punitive damages, bringing the total bill to $9 billion.

The massive award was met with ‘stunned silence’ according to observers in the Louisiana courtroom, the plaintiffs’ lawyer Mark Lanier tells Reuters.

Actos (pioglitazone) works by helping patient with type II diabetes improve their blood glucose levels and is in the same groups of medicines as GSK’s troubled drug Avandia (rosiglitazone).

Avandia was pulled of the European market in 2010 after studies showed that the drug increased the risk of serious cardiovascular events – the FDA however only limited its use and added further safety warnings.

Actos received a ‘Boxed Warning’ from the regulator cautioning that it can cause or worsen heart failure, particularly in certain patient populations – it has also been show to slightly increase the risk of bladder cancer, but regulators were not inclined take it off the market.

Takeda’s shares fell by about 9%, their biggest drop in five years, following the ruling – the drugmaker says it ‘respectfully disagrees with the verdict’.

Earlier this week, the same jury awarded $1.5 million in compensatory damages to plaintiff Terrence Allen.

In his lawsuit, Allen alleged that Takeda was aware of the link between Actos and bladder cancer early in the decade, but chose to withhold the information from consumers and the healthcare industry.

Allen was diagnosed with bladder cancer in January 2011. He was using the Actos drug from 2004 to 2011.

Last May, a US judge had nullified a separate jury verdict for $6.5 million against Takeda after ruling that the plaintiffs had failed to offer any reliable evidence that Actos had caused cancer.

In a statement, Takeda said it intended to “vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal”.

The firm adds: “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.”

Big sales, safety warnings

Takeda started selling Actos in the US in 1999 while Lilly and Takeda co-promoted Actos from 1999 to 2006.

Actos has generated more than $16 billion in global sales since it was first approved in 1999, according to court documents.

But the FDA announced in 2011 that using Actos for more than one year could be associated with an increased risk of bladder cancer after a conducting a safety review into the medicine.

Governments in France and Germany banned Actos after the FDA’s announcement, although the EMA did not pull the drug from the market.

In 2012 the drug lost its US patent protection and is now sold by a number of generic companies.

Ben Adams

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