One drug that has attracted the attention of plaintiffs’ lawyers in massive numbers is Pradaxa. There are not a lot of cases – you can call it a mini mass tort. But they are very strong cases that I think are going to have a lot of value. (2019 Update: Most of the 2,500 claims against Boehringer-Ingelheim settled for $650 million.)
Pradaxa is an anticoagulant or blood thinner used to prevent strokes in patients with atrial fibrillation and others at risk for developing potentially life-threatening clots. Plaintiffs’ lawyers, then prescription drug safety advocates, and now everyone else under the sun, have realized that Pradaxa may substantially increase the risk of contracting viral infections.
This concern comes after years of warnings that the drug increases the risk of internal bleeding. In fact, some studies show that patients suffering internal bleeding from Pradaxa are five times – five times – more likely to die than those bleeding from other anticoagulants like warfarin. But… unlike warfarin, there is no reversal agent to stop the bleeding.
The University of North Carolina led a study that shows that Pradaxa may increase the risk and severity of certain viral infections such as the flu and myocarditis. Myocarditis is a viral infection of the heart that can cause sudden death, particularly in children and young adults. Pradaxa blocks thrombin activity, a key component of the human blood clotting system.
Thankfully, Pradaxa is a new drug that has been on the market since 2010. The alarm began to sound immediately. In 2011 the FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa. These included 2,367 reports of hemorrhage and 542 patient deaths.
Before 2015, the big difference between Pradaxa and Coumadin was that no antidote exists for Pradaxa. If there is excessive anticoagulation or excessive clinical bleeding from an injury, Coumadin’s anticoagulant effects can be rapidly reversed with readily available fresh frozen plasma in any hospital setting. With Pradaxa, the only way to reverse the anticoagulation is to initiate dialysis. This is hard to do quickly, it is sometimes not available everywhere, and dialysis has increased risk in comparison to fresh frozen plasma.
There are already about 200 lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa. Most of this litigation involves Boehringer’s failure to adequately warn about the serious bleeding problems. Lawsuits are pending across the country. There is also a multidistrict litigation (MDL) federal court action. An MDL is a class action lawsuit for discovery purposes. The trials would go back to individual federal courts around the country. There is no way to know, of course, but I would expect that most of these case will reach a settlement long before going to trial. The first MDL Pradaxa lawsuit is scheduled to go to trial in August 2014. I doubt that case will go to trial because I think Boehringer Ingelheim will realize that a settlement is much preferable to a verdict.