Pradaxa lawsuits claim the blood thinner's manufacturer failed to warn patients about the drug's high risk of severe bleeding. Early Pradaxa patients were at risk of bleeding to death, as there was no antidote for years. Pradaxa patients have filed 4,000+ lawsuits against Boehringer Ingelheim. Many of these lawsuits were resolved as part of a $650 million settlement.
Why Are People Filing Pradaxa Lawsuits?
In recent years, concern over the blood thinner Pradaxa has led thousands of people to file lawsuits against Boehringer Ingelheim, the drug's manufacturer. The primary claim against the pharmaceutical company is that it failed to warn consumers about the medication's high risk of severe bleeding.
Many lawsuits against Pradaxa refer to the fact that for the first five years Pradaxa was available to the public, no antidote existed to reverse the effects of the drug. Patients who took the anticoagulant could potentially bleed to death from an otherwise minor injury. Bruising and internal bleeding could also cause major health issues for people taking the drug.
"Anticoagulant" is the technical term for a blood thinner. A blood thinner makes it more difficult for blood to clot. Physicians use this type of drug in patients who are at risk of dangerous internal blood clots.
Most people are familiar with clots in the form of external scabs. The body creates a clot in order to prevent excessive bleeding. But when clots develop internally, they can cause big problems, including:
- Deep vein thrombosis or DVT (blood clot in the leg)
- Pulmonary embolism or PE (blood clot in the lungs)
- Heart attack
For people at risk of dangerous internal clots, blood thinners can be life-saving. But it is important for patients to understand how to take these drugs correctly. Patients should also understand ways to modify their lifestyle and medications to avoid blood thinner side effects.
In 2014, Boehringer Ingelheim resolved many outstanding claims with a $650 million Pradaxa lawsuit settlement to compensate victims and their families. Since then, additional Pradaxa bleeding lawsuits have been filed, and additional compensation could be available for those who have been harmed by the drug more recently.
Serious Pradaxa Side Effects
The most common complaints in Pradaxa lawsuits reference dangerous side effects of the blood thinner, the most serious of which is a higher risk of severe bleeding that can lead to death.
Initially approved by the U.S. Food & Drug Administration (FDA) in 2010, Pradaxa (apixaban) was marketed by Boehringer Ingelheim as an alternative to warfarin, the most commonly used blood thinner in the preceding 60 years. Some studies showed that Pradaxa could treat certain conditions (such as atrial fibrillation and stroke) better than warfarin, and a number of other studies have shown that Pradaxa and other newer anticoagulants like Xarelto may cause fewer overall bleeding events than warfarin for some patients.
However, the important difference is that although warfarin could be reversed with a relatively straightforward vitamin K treatment, Pradaxa had no antidote for the first several years it was available. As a result, many patients suffered from severe or prolonged bleeding events while taking Pradaxa, which they may not have had to endure when taking warfarin. Many Pradaxa lawsuits filed cite the lack of an antidote and a risk of severe bleeding as the primary reason for filing a legal claim.
Secondary Effects of Pradaxa
Pradaxa lawsuits also often refer to secondary effects caused by excessive bleeding from taking the drug. For example, some patients who took Pradaxa claim they experienced unnecessary pain and suffering due to the extended amount of time it took for wounds to heal while the anticoagulant was still active. Prolonged bleeding could also lead to other complications, requiring painful procedures and expensive treatments. Also, extended hospital stays could lead to further potential problems, such as a higher risk of infection or mental health issues.
These secondary effects can vary greatly among individuals who experience severe bleeding events after taking Pradaxa, and some people may not experience any of them. However, in each case, plaintiffs argue that they likely would not have suffered any of these secondary side effects, or the secondary effects would have been less severe, had they not taken Pradaxa.
Design, Manufacturing and Marketing Defects
The FDA approved Pradaxa based largely on the results of a clinical trial called Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY), which was sponsored by Boehringer Ingelheim. RE-LY concluded that dabigatran - the active ingredient in Pradaxa - caused fewer bleeding events than warfarin, and was, therefore, safer to use in comparison with the longer-used drug. The drugmaker then promoted its new prescription as an improvement over the more popular anticoagulant. Unlike warfarin, Pradaxa had fewer interactions with foods and other drugs, and it did not require weeks of calibration to determine the right dosage.
In the years following Pradaxa's approval, additional problems were discovered, including an issue with how bleeding events were counted in the original RE-LY trial data. These discoveries led to additional drug label updates to inform medical professionals and consumers about the risks of the drug.
Timeline of Pradaxa Warnings and Label Updates
- 2010: Researchers discover additional bleeding events in RE-LY trial data, resulting in an update to Pradaxa's drug label.
- 2011: The FDA reviews post-market reports of serious bleeding events to determine whether such incidents were occurring more than expected.
- 2013: Boehringer Ingelheim adds a black box warning about risks of prematurely discontinuing the drug and an increased risk of spinal hematomas in some patients.
- 2014: The FDA issues a safety communication stating that the blood thinner caused a higher risk of gastrointestinal bleeding than warfarin (although, it had a similar risk for myocardial infarction and a lower risk for ischemic stroke, intracranial hemorrhage and death).
Many Pradaxa lawsuits claim Boehringer Ingelheim should have known about these high risks sooner and warned consumers and doctors appropriately. In addition, plaintiffs argue that the manufacture and marketing of the drug violated regulatory requirements because they did not provide proper warnings about the blood thinner's risks. Many plaintiffs also argue that Boehringer Ingelheim was negligent and committed a breach of warranty by producing and promoting a dangerous drug.
Pradaxa Lawsuit Update
Boehringer Ingelheim lawsuits began materializing shortly after patients experienced problems with severe bleeding and other side effects. Between 2012 and 2014, thousands of lawsuits were filed in federal courts, with most of them being resolved by a payout in 2014.
In October 2015, the U.S. Food & Drug Administration approved a Pradaxa antidote called Praxbind (idarucizumab). The availability of the new antidote effectively stopped many of the Pradaxa lawsuits, though claims filed after the 2014 lawsuit payout but before Praxbind became available to the public could still have some validity.
Pradaxa Multidistrict Litigation (MDL 2385)
In August 2012, the U.S. Judicial Panel on Multidistrict Litigation transferred 21 Pradaxa Lawsuits to the Southern District of Illinois, creating MDL 2385 in re: Pradaxa (Dabigatran Etexilate) Products Litigation. Centralizing administrative duties under multidistrict litigation allowed plaintiffs to use common pretrial procedures for complaints that relied on the same questions of fact, increasing the efficiency of the overall process. Cases consolidated in the MDL are not Pradaxa class action suits.
Approximately 4,000 Pradaxa cases were settled in 2014 (see below), but not everyone chose to participate in that settlement. Furthermore, additional cases have since been filed by others seeking compensation for the negative side effects of the blood thinner.
Pradaxa MDL 2385 was officially shut down by judicial order on December 11, 2017. However, patients or surviving family members may still be able to file a Pradaxa lawsuit depending on their specific circumstances.
Pradaxa Settlement & Lawsuit News
Within 18 months of consolidating a handful of Pradaxa lawsuits into a single MDL, thousands of additional complaints were filed and moved into the MDL. In 2014, the judges overseeing the cases approved a $650 million Pradaxa settlement agreement between the plaintiffs and Boehringer Ingelheim.
To facilitate the processing of both personal injury and wrongful death claims, the court established a settlement fund from which victims could receive Pradaxa settlement checks. In addition to compensating plaintiffs, a small portion of the fund was designated to cover legal and administrative costs.
Pradaxa Settlement Fund Breakdown
|Payments to Plaintiffs
|Common Benefit Costs
By setting up the settlement fund this way, plaintiffs do not have to pay legal fees upfront when submitting a claim. This allows more eligible people to file a Boehringer Ingelheim Pradaxa lawsuit without having to worry about attorney fees and other costs.
In late 2017, coordinating Judge David Herndon issued an order recommending the closure of MDL 2385, after dismissing the few remaining cases on the docket. The District Court for the Southern District of Illinois had previously disbanded the Plaintiff's Steering Committee and disbursed nearly all of the settlement funds according to the agreement (pending payments to a handful of claimants). Judge Herndon would continue to oversee any final matters of the case, including final distribution of the remaining funds.
May 2020: Appeals Court Sides with Boehringer Ingelheim
The estate of Mary Boone filed one of the earliest lawsuits over Pradaxa. Mary Boone died in 2014 after doctors failed to control a gastrointestinal bleed. Her lawyers claimed the warnings on Pradaxa were not adequate. They blamed the blood thinner for her death.
A Connecticut jury decided in favor of Boehringer Ingelheim in 2018, but Boone's lawyers appealed. In May 2020, the Connecticut State Supreme Court issued a ruling on the appeal. The court upheld the initial decision in favor of Boehringer Ingelheim.
Note: Every case is different. If you think you may have a viable case related to Pradaxa, you should speak with a lawyer. They can help you understand the merits of your individual case.
Pradaxa Lawsuit FAQs
Am I Eligible to File a Pradaxa Lawsuit?
Anyone who has taken the drug and suffered severe bleeding may be able to file a Pradaxa lawsuit. Also, family members of those who have died from complications of Pradaxa, such as gastrointestinal bleeding or brain bleeds, may be able to recover expenses and lost income by filing a wrongful death lawsuit.
What Compensation Can I Receive from a Pradaxa Lawsuit?
The specific Pradaxa lawsuit awards you might receive as part of a payout or verdict depends on your individual situation. Damages claimed in Pradaxa internal bleeding lawsuits include:
- Physical pain and suffering
- Physical impairment
- Physical disfigurement
- Mental anguish (past and future)
- Loss of companionship and consortium
- Wrongful death
Other damages may be available to certain people, such as to recover lost income or medical expenses.
Do I Need a Pradaxa Lawyer?
Drug companies make billions of dollars every year, and they spend millions to protect earnings and maintain the status quo. Legally confronting Pradaxa manufacturers alone could easily result in a verdict favoring the drug company.
How Much Does a Pradaxa Lawsuit Lawyer Cost?
Through a contingency agreement, you will not need to pay anything upfront when pursuing a Pradaxa lawsuit unless you receive compensation from the settlement fund or a trial verdict.