Here’s an update on the Pradaxa (dabigatran etexilate) bleeding injury lawsuits. This is a drug that has done much to take over the market share of warfarin, a blood thinner with decades of history. The problem with Pradaxa is that it can cause internal bleeding and hemorrhaging. Compared to warfarin, those complications are more difficult to manage. The manufacturer, Boehringer Ingelhim, has confirmed that at least 260 people on Pradaxa have died between October 2010 and November 2011. Candidly, plaintiffs’ lawyers expect these Pradaxa wrongful death cases to be high settlement value cases, and attractive lawsuits to take to a jury.
The first of the Pradaxa lawsuits have been filed. These are not class action lawsuits—right now they are individual lawsuits filed by individual victims and their families. Most lawyers expect that these cases will be grouped together in a Pradaxa class-action like lawsuit, known as multidistrict litigation (MDL). The goal will be to streamline discovery, and perhaps create opportunities for early Pradaxa settlements. Here are the recently-filed lawsuits:
- Lege et al. v. Boehringer Ingelheim Pharmaceuticals Inc., et al.; U.S. District Court for the Western District of Louisiana, Case No. 6:12-cv-00572
- Bivens et al. v. Boehringer Ingelheim Pharmaceuticals Inc., et al.; U.S. District Court for the Eastern District of Tennessee, Northern Division; Case No. 3:12-cv-00103
- Hawkins et al. v. Boehringer Ingelheim Pharmaceuticals Inc., et al.; U.S. District Court for the Eastern District of Kentucky, London Division; Case No. 6:12-cv-45
The FDA’s investigation into Pradaxa is continuing. You might recall that Pradaxa, released to the U.S. market in October 2010, quickly caught the FDA’s eye in early 2011. By December 2011, the FDA had published a very detailed Pradaxa safety announcement, explaining that they are interested in “serious bleeding events.” Between October 2010 and August 2011, approximately 1.1 million prescriptions were filled.
They caution that the following events should be immediately reported to physicians (with reports also to the FDA):
- Unusual bleeding from gums
- Frequent nose bleeds
- Heavier than normal menstrual bleeding
- Severe, uncontrollable bleeding
- Pink or brown urine
- Tar like stool, red or black in color
- Spontaneous bruising, or bruises that increase in size
- Coughing up blood or blood clots
- Vomiting blood
The FDA set up a new warning label (see the medication guide here) in January 2012, which describes many of the complications associated with the drug. In particular, it notes the bleeding danger and lack of a reversal agent. Unlike warfarin, there is no known method to immediately counteract the effects of Pradaxa, should bleeding become uncontrollable. It also warns patients about the drug’s instability—new bottles should not be opened until they are ready to be used, and should be used or disposed of within four months.
Scientists are helping to determine under what conditions Pradaxa should and should not be used:
- Archives of Internal Medicine (January 2012): Dabigatran and Risk of Acute Coronary Events — Further Investigation is Warranted (concluding that there may be a 33% increased risk of heart attack and severe coronary events in Pradaxa patients)
- Journal of Neurosurgery (March 2012): Neurosurgical complications of direct thrombin inhibitors—catastrophic hemorrhage after mild traumatic brain injury in a patient receiving dabigatra (discusses the problem of Pradaxa patients who suffer an injury, including head trauma, which leads to uncontrollable bleeding and even death because of Pradaxa use)
Pradaxa does not have a “safety valve” like Warfarin. When bleeding becomes a problem in warfarin users, doctors can simply administer vitamin K to counter the effects. The closest solution for Pradaxa users is kidney dialysis, which may be able to remove up to 60% of the drug from the body within two to three hours. Unfortunately, that may not be quick enough in emergencies.
If You Need Help with a Potential Padaxa Lawsuit
If you or a loved one has experienced a heart attack or other coronary event or uncontrolled bleeding while taking Pradaxa, contact our lawyers at 1.800.553.8082, or online for a free consultation.