Latest Update: A $650 million settlement fund has been created to compensate those who have suffered from severe Pradaxa side effects. If you experienced severe bleeding after taking Pradaxa, you may be eligible for a settlement. Get your questions answered by a lawyer for free!
Pradaxa Lawsuit Updates
The blood thinner Pradaxa was sold without an approved antidote for at least five years, leading to severe bleeding incidents and over 1,000 deaths. As a result, Boehringer Ingelheim – the manufacturer of Pradaxa – has faced thousands of lawsuits from patients, who filed personal injury and product liability claims against the pharmaceutical company.
A new study by the Journal of the American Medical Association in October showed an increased risk of severe bleeding from Pradaxa when taken with amiodarone, Rifadin (rifampin), Diflucan (fluconazole), or Dilantin (phenytoin). This study emphasizes the importance of understanding how drugs can interact with each other. Always speak to your doctor and pharmacist about other medications you are taking before starting a new prescription.
Have You Taken Pradaxa?Learn What Legal Rights You Have
Can I still file a Pradaxa lawsuit?
Although thousands of Pradaxa lawsuits were resolved as part of a settlement announced in 2014, individuals who have been negatively affected by the drug since then are still able to file a claim based on their pain and suffering and additional medical expenses incurred because of the drug’s adverse effects.
Contact a Pradaxa lawyer
You don’t need a lawyer to file a lawsuit, however, pharmaceutical companies have made billions of dollars from drug sales to fight your case. Hiring a legal team that understands these trials will give you the best chance of receiving compensation for your injuries. We did the research for you, and partnered with a law group that puts consumers first.
If you or a loved one has suffered bleeding injuries from Pradaxa, we can connect you with our legal parter.
How much does a Pradaxa lawsuit cost?
Our legal partner do not require any money unless you receive compensation through a verdict or settlement. The attorneys we work with have agreed to take their fees as a percentage of the award, rather than taking payment upfront. And if you don’t happen to win your case, you are not required to pay anything.
In May 2014, Boehringer Ingelheim announced that it had reached a comprehensive settlement of all the Pradaxa lawsuits then filed against the company in the United States. According to the company’s press release, the $650 million settlement would resolve approximately 4,000 outstanding claims against the pharmaceutical manufacturer.
Pradaxa qualified settlement fund
As part of the master settlement agreement, a Qualified Settlement Fund was created. Plaintiffs who accepted the terms of the Pradaxa settlement would receive an award from this fund to compensate them for their medical expenses, pain and suffering, and related costs.
A small portion of the settlement fund (6% total) was also set aside to pay fees for lawyers and administrative expenses related to the lawsuits.
Pradaxa Settlement Fund Breakdown
|Payments to Plaintiffs||Attorney Fees||Common Benefit Costs|
Common Pradaxa Lawsuit Claims
Lawsuits filed by those who took Pradaxa (or their surviving family members) have made a number of legal claims against the Boehringer US.
Pradaxa is a defective drug
22,000 severe bleeding injuriesFDA Medwatch Data
One of the most common claims is that because the anticoagulant did not have a reliable antidote for the first five years it was on the market, Pradaxa was an “unreasonably dangerous” drug. Despite the limitations of the drug and the lack of an antidote, Boehringer continued to market the drug without informing the public about alternative medications that were safer or equally effective alternatives they could choose.
The effect of Pradaxa being a defective drug, complainants argue, is that it could cause injuries that should have been foreseeable, had the company properly informed consumers of the drug’s potential harmful effects. Plaintiffs further allege that the benefits of the drug were outweighed by the risks of using it.
Failure to inform of risks
Coinciding with the dangerous nature of Pradaxa as a blood thinner with no antidote, plaintiffs have also argued that Boehringer had a duty to inform patients about the potential dangers of the drug. The pharmaceutical company had relevant information from clinical trials and other data that it could have used to better inform patients (or their physicians) before taking the drug, but instead the company chose to withhold that information.
Part of the failure to inform includes the company’s duty to inform the public about the dangers of Pradaxa. In most cases this is accomplished through the use of a warning on the drug label, but Boehringer US did not include such warnings about the relative risks of their medication. Xarelto lawsuit cases are being filed for similar reasons; complaints of inadequate warnings and no available antidote.
Connect with a lawyer for answers to your Pradaxa questions.
Serious Pradaxa side effects
Another common lawsuit claim is that Pradaxa side effects have led to higher health care costs and more treatments than patients otherwise may have needed. This additional care led to expenses that should never have been incurred in the first place, not to mention pain and suffering caused by the defective drug.
Some of the additional expenses that could be caused by severe bleeding include extended stays in the hospital, additional prescriptions to treat the effects of the drug, and any other long-term issues that may arise from use. Pradaxa isn’t the only blood thinner with these issues, Xarelto side effects are nearly identical.
Boehringer liability and negligence
Many lawsuits against Boehringer include a claim that the pharmaceutical company owed the general public – and the claimants specifically – a certain level of care when developing, studying, and manufacturing Pradaxa. By designing a drug that can cause serious harm and even death in patients who take it, the argument goes, Boehringer US neglected that duty.
Another way that Boehringer US neglected its duty according to Pradaxa lawsuits is by failing to include proper or accurate warnings on the drug’s label, notifying doctors and patients of the potential harms of the drug. Similar claims of negligence over “misbranding” and failure to comply with labeling regulations have also been a part of plaintiffs’ complaints.
Multidistrict Litigation – MDL 2385
The earliest Pradaxa lawsuits were filed separately in various states throughout the U.S. However, in August 2012, the U.S. Judicial Panel on Multidistrict Litigation decided to transfer 21 separate legal actions to the Southern District of Illinois, thereby centralizing administrative duties and making the process more efficient.
According to court records, more than 2,600 cases were transferred to MDL 2385 during the period in which the MDL was most active. The vast majority of these cases were resolved as part of the $650 million settlement described above.
Pradaxa Safety Studies
Concerns have been raised about the trustworthiness of Pradaxa safety studies. The clinical trial RE-LY provided misleading evidence about the drug’s safety and effectiveness. Critics accused the trial of being too general, and appeared to exclude older patients with additional medical conditions who would have been more likely to have been prescribed Pradaxa. The drug safety group, Therapeutics Initiative, also found that RE-LY was not a double-blind study as it should have been. Because administrators knew which patients were being prescribed the drug, the results could have been tainted by bias and false reporting.
Misleading study results impact patient safety
With study results skewed to present the drug as being safer than it was, the FDA moved quickly to approve it for use, an action which ultimately impacted patient safety. Because Pradaxa had no antidote for its blood thinning effects for at least five years, the medication contributed to severe bleeding incidents and over 1,000 deaths. If the study results were more transparent, the FDA may have taken more time to evaluate the drug.