Company confident in drug safety but says court cases are too risky
The patients bringing the lawsuits claim that the drug caused serious, and even fatal, bleeding. However, the US Food and Drugs Administration has backed up Boehringer’s view on Pradaxa’s risk-benefit profile compared to Warfarin, the established standard treatment. A study of 134,000 US patients found that, although Pradaxa is associated with an increased risk of major gastrointestinal bleeding, it presents no greater risk of heart attacks, and is more effective at preventing clot-related strokes, bleeding in the brain and death.
Boehringer lawyer Andreas Neumann said in a statement that the company expects most of the plaintiffs to accept the settlement. He stated that the company was confident it should win the suits based on its evidence, but explained that ‘we have to consider that juries composed of lay people have to decide about very difficult scientific matters. This does not allow reliable predictions for the outcome of a huge number of individual trials. This settlement allows our company to avoid the distraction and uncertainty of protracted litigation.’