Drug Linked To Increased Risk Of Bladder Cancer

The manufacturers of the diabetes drug Actos, Takeda Pharmaceuticals USA inc. and Takeda Pharmaceutical Co. Limited have proposed one of the largest settlement agreements in US drug litigation history.

According to documents filed in the Western District of Louisiana Court on 28 April 2015, the companies are proposing a $2.4 billion settlement agreement to American patients pursuing multi-district litigation against both companies.

The settlement offer will apply to nearly 9,000 claims being pursued against the companies by patients who have developed bladder cancer since taking the drug, and who allege that Actos is associated with a significantly increased risk of bladder cancer compared with other equivalent diabetes medication.

The settlement will take effect on agreement by 95% of the Claimants. If it is accepted, the offer will equate to a settlement per patient of around $300,000.

Expert Opinion

"Takeda’s offer for settlement follows a steady build up of the US litigation over the past few years. <br/> <br/>"Court cases began to be lodged in America following warnings from the American Food and Drugs Administration (FDA) and a number of other national regulators, including the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) in 2011. <br/> <br/>"The warnings followed large scale scientific studies which identified a significantly increased risk of bladder cancer associated with the drug, which some studies have shown to be as much as double that of its equivalents. <br/> <br/>"Takeda have denied liability from the outset, and continue to do so, in spite of their offer for settlement. Yet, the companies have lost five of eight of the ‘bellwether’ trials brought against them, including the April 2014 case of Allen v Takeda Pharmaceuticals Inc., in which an award of $9 billion, was made against the companies - the largest made against a pharmaceutical company in the history of American litigation. <br/> <br/>"The settlement has particular relevance to UK patients, not only because Actos continues to be prescribed here but also because one of the central scientific studies identifying the link between Actos and bladder cancer was founded on an analysis of the UK general practice research database. <br/> <br/>"UK patients who continue to be prescribed Actos and are worried about the risks of bladder should discuss their concerns with their medical practitioner. Irwin Mitchell can provide initial advice on the possibility of taking legal action in relation to concerns of injury or illness linked to the use of Actos." Matthew Newbould - Associate