Pradaxa (dabigatran) has been prescribed to millions of patients to help prevent strokes in patients with atrial fibrillation, deep vein thrombosis, pulmonary embolism and hip replacement surgery. After roughly two years on the market, Pradaxa earned manufacturer Boehringer Ingelheim more than $1 billion in sales revenue. Pradaxa was the first of a new category of anticoagulants which did not require blood testing for administration. Prior to Pradaxa, a blood thinner called Coumadin (warfarin) had been used for nearly 60 years but it was thought to be inconvenient for patients and professionals to monitor.
In 2011 alone, the FDA received reports of 3,781 adverse events and 542 deaths associated with Pradaxa use. The Institute for Safe Medication Practices reported that Pradaxa was linked to more injury and death reports than any of the 800 drugs that it regularly monitors. Since Pradaxa is a blood thinner, a majority of the adverse reports and deaths were due to excessive bleeding.
Many patients suffered rectal, brain, and gastrointestinal bleeding and unfortunately, there was no antidote to reverse the fatal bleeding that Pradaxa can cause. An antidote to Pradaxa was not approved until 2015, with the introduction of Praxbind. Though bleeding caused by Pradaxa can now be treated in some cases, many patients were harmed, and some may still be at risk.
Pradaxa Lawsuit Claims
Thousands of Pradaxa lawsuits were filed on the basis that Boehringer Ingelheim used deceptive marketing practices to promote the drug. Boehringer marketed the drug as a safer and more effective alternative to warfarin. However, evidence suggests that Pradaxa has equal or higher risks of internal bleeding. Additionally, Pradaxa was misrepresented as a “one-size-fits-all” treatment. Checkups, laboratory testing and dosage adjustments were not required in the instructions.
Many claim that Boehringer was negligent by not establishing protocols for treating bleeding episodes. The company recommended dialysis treatment to help remove the drug from the bloodstream. However, medical professionals assert that dialysis treatment is unrealistic, unavailable or difficult to tolerate by patients who may be experiencing a severe bleeding episode.
It is alleged that the company failed to adequately warn the public of the risks of using Pradaxa. By doing so, Boehringer is held accountable for willfully endangering the public by continuing to market and sell a defective drug. Many believe that Pradaxa was released onto the market prematurely, since there is no option for reversing the potentially deadly effects.
Boehringer Ingelheim had originally claimed that an antidote would not be needed and that serious events would be rare. In 2015 however, the company received expedited approval for Praxbind, a Pradaxa-specific antidote.
Pradaxa Lawsuit Status
Many Pradaxa lawsuit claims that were filed in federal court were consolidated into a multidistrict litigation (MDL). 4,000 of these cases were settled in 2014, for $650 million and the company was required to pay $95 million to settle a case over improper marketing.
Since the 2014 settlements were announced, the company has not disclosed additional settlements, but many patients were not covered in the claim. Patients who experienced side effects before the antidote became available in 2015 may have been at risk and bleeding episodes may still occur. In 2017, a federal court judge recommended shutdown of all remaining federal lawsuits but no final action has been taken and Pradaxa lawsuits may remain in state and local courts.
If you or a loved one was harmed after using Pradaxa, you may be eligible for compensation for:
- Medical costs
- Pain and suffering
- Lost wages
- Future medical expenses
- Wrongful death
Each case is unique and you should have your Pradaxa lawsuit case reviewed by legal experts.