Pradaxa (dabigatran) is an oral anticoagulant that works by inhibiting an enzyme involved in clotting. Pradaxa can reduce the risk of certain clotting injuries, including stroke, but also drastically increases the risk of dangerous and potentially uncontrollable bleeding. Because of this trade-off, Pradaxa is only approved for use in certain patients who are at a higher than average risk of developing dangerous or fatal blood clots.
A growing number of injured patients have filed personal injury lawsuits against the manufacturers, citing the dangers of Pradaxa and alleging that the medication was produced, marketed, and sold without regard for patient safety. Product liability lawyers also assert that the company failed to provide the public with adequate warning about the dangers of the blood thinning drug. The Sanders Firm is currently leading the charge against Boehringer Ingelheim, the maker of Pradaxa, on behalf of consumers nationwide who were injured as a result of using the drug.
Pradaxa side effects
Like other drugs that inhibit clotting, Pradaxa puts patients at an increased risk of serious, uncontrolled bleeding. However, while anticoagulants like warfarin can be reversed by doctors to control bleeding in an emergency, there is currently no known way to reverse the effects of Pradaxa. In many cases, doctors have been unable to save patients who have developed uncontrollable bleeding after being administered Pradaxa.
Numerous Pradaxa lawsuits have also alleged that bleeding caused by the drug has resulted in anemia, heart attack, stroke, and death. Pradaxa is also known to cause moderate to severe gastrointestinal distress and is associated with potentially fatal GI bleeding.
Serious Pradaxa side effects include:
- Easy or unexplained bruising
- Heavy menstrual bleeding
- Blood in vomit (looks like coffee grounds)
- Blood in urine (pink or brown)
- Coughing or spitting up blood
- Moderate to severe joint pain or inflammation
- Swelling of the extremities
- Headaches, dizziness or generalized weakness
- Stomach upset or pain
- Indigestion and/or heartburn
- Vomiting and diarrhea
- Kidney or liver failure
- Heart attack
Pradaxa FDA warnings
Since approving the drug in October 2010, the FDA has received over 18,000 reports of adverse events connected with Pradaxa, including over 600 deaths. In January 2012, the prescription information label was updated extensively to include warnings about uncontrolled bleeding, drug interactions, use in patients with kidney problems, and about an increased risk of blood clots and stroke in patients who discontinue Pradaxa.
In April 2013, the warning about blood clots and stroke was upgraded to an FDA black box warning, to indicate the seriousness and severity of the risk.
Currently, the FDA warns that:
- Discontinuing Pradaxa increases patients’ risk of blood clots and stroke
- Pradaxa increases the risk of bleeding and can cause serious, and sometimes fatal, bleeding
- Patients with prosthetic heart valves have an increased risk of clots and bleeding when taking Pradaxa
- Pradaxa should not be used with certain foods or medications
Pradaxa lawsuit allegations
Over 1000 lawsuits have been filed in state and federal courts against Boehringer Ingelheim, makers of Pradaxa, accusing the company of wrongdoing in its design, production, and marketing of Pradaxa. Plaintiffs say the company has downplayed the risks of Pradaxa in order to promote sales, and that the drug is unreasonably dangerous when compared to other therapies on the market. Pradaxa lawsuits also claim that the company did not adequately test the product before releasing it.
Common allegations in a Pradaxa lawsuit include:
- Strict Product Liability
- Breach of Express Warranty
- Breach of Implied Warranty
- Failure to Warn
- Fraudulent Concealment
Compensation in a Pradaxa lawsuit
Plaintiffs who file a Pradaxa lawsuit seek compensation for the injuries and ailments caused by the drug, including the cost of hospital bills, short and long-term medical care, and lost income. Many plaintiffs also ask for punitive damages in order to deter the company from wrongdoing in the future, as well as court and legal fees and any other damages the court deems necessary and proper. Families, and particularly spouses who have lost a loved one because of Pradaxa have also filed wrongful death lawsuits demanding compensation for their own pain and suffering, mental anguish, and loss of consortium.
Pradaxa multidistrict litigation
All federal Pradaxa-related lawsuits currently pending have been consolidated in the U.S. District Court for the Southern District of Illinois in multidistrict litigation (MDL). MDL allows lawsuits making similar allegations of fact to be grouped together for the purposes of pretrial proceedings, including document sharing, witness selection, and settlement negotiations. The Pradaxa MDL currently includes over 1100 plaintiffs from districts across the country and is being presided over by the Honorable Judge David R. Herndon.
Four early trials have been scheduled to serve as bellwether trials, which are chosen to encourage early settlement of claims by demonstrating how each side’s arguments and positions are likely to fare before a jury. The first Pradaxa bellwether case is scheduled for August 2014.
Talk to a Pradaxa lawyer
If you or a loved one has been injured by Pradaxa,or other dangerous drugs, one of our experienced product liability lawyers can help pursue the compensation that the drug manufacturer is rightfully liable for.
The personal injury lawyers at The Sanders Firm have the experience and resources required to fully prosecute a product liability lawsuit in state or federal court and zealously advocate for patients who have been injured because of dangerous medications or unscrupulous marketing practices. Our phone lines are open 24/7, so call The Sanders Firm at 1-800-FAIR-PLAY (1-800-324-7752) for a free consultation and evaluation of your case.