If you were injured by Pradaxa, you are not alone — over 2,000 Pradaxa lawsuits are pending in a federal Multi-District Litigation (MDL). Judge David R. Herndon presides over the litigation in the U.S. District Court for the Southern District of Illinois:
What is Pradaxa?
Pradaxa (dabigatran) is a once-daily, orally-administered medication that is approved to prevent blood clots in patients following hip or knee surgery, and stroke in patients with atrial fibrillation (abnormal heart rhythm). It works by inhibiting thrombin, which is an enzyme that blood platelets need to stick together and form a blood clot. Pradaxa was developed by Boehringer Ingelheim and approved for sale in the United States in 2010.
Pradaxa and Bleeding
Like all blood-thinners, bleeding is one of the most dangerous side effects of Pradaxa. However, unlike other blood-thinners, the outcome for Pradaxa patients who start bleeding may be very different. With warfarin, doctors can easily administer Vitamin K to reverse its blood-thinning effects.
The problem is that Pradaxa lacks an antidote or any effective reversal agent. In an emergency, such as after a traumatic accident or before an unplanned surgery, it is essential that any blood-thinning medications are de-activated so that a patient can form blood clots and stop bleeding. Unfortunately, the only way to de-activate Pradaxa is with dialysis — removing a patient’s blood and mechanically cleaning it with a machine — which can take several hours. By that time, a patient can easily bleed to death.
Risk-Factors for Bleeding on Pradaxa
- Impaired kidney function
- Patient age
- Low body weight
- Elderly patients at risk of head injuries from falling
Pradaxa Bleeding Risk with Head Injuries from Falls
In March 2012, the Journal of Neurosurgery published a case report in which an 83 year-old man on Pradaxa died from uncontrollable bleeding in his brain following a minor fall. Three doctors from the University of Utah cared for the man, who was initially alert and could answer questions. Despite the doctors’ best efforts, they were unable to reverse the blood-thinning effects of Pradaxa, and the man died of a cerebral hemorrhage.
In September 2013, the Journal of Neurosurgery published a study of ground-level falls in 5 patients on Pradaxa and 15 on warfarin. Death occurred in 40% of Pradaxa patients who had a cerebral hemorrhage (bleeding in the brain) after a fall, versus 0% for patients on warfarin. The authors of the study were concerned about the lack of guidelines and protocols for how to reverse the anti-coagulation effects of Pradaxa, which significantly increased the risk of death.
Black Box Warning for Pradaxa and Stroke
The Prescribing Information for Pradaxa includes a “Black Box” warning about the increased risk of stroke and blood clots from missing a dose. Unlike warfarin, which remains effective for up to five days with every dose, Pradaxa is a once-daily pill that must be taken at the same time every day to protect against blood clots. Many patients find it extremely difficult to remember to take a pill every day. Unfortunately, missing doses of Pradaxa can be deadly — it rapidly stops protecting against blood clots after 24 hours.
Pradaxa Side Effects
- Blood clots
- Pulmonary Embolism (PE)
- Deep Vein Thrombosis (DVT)
- Internal bleeding
- Gastrointestinal bleeding
- Cerebral hemorrhage
- Heart attack
- Esophageal ulcers
- Kidney failure
Pradaxa Bleeding Class Action Filed in Canada
June 30, 2015 – A Canadian couple filed a class action lawsuit against Boehringer Ingelheim today in BC Supreme Court. According to the complaint, plaintiff Michael Weddle was prescribed Pradaxa in 2010 for a cardiac arrhythmia, and in November 2012 was hospitalized for a week in intensive care after experiencing “an episode of pericardial bleeding.” Click here to learn more.
Do I have a Pradaxa Class Action Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Pradaxa Class Action Lawsuit Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by joining a Pradaxa class action filing a Pradaxa lawsuit, and our lawyers can help.