Pradaxa Lawsuits Quick Facts
To treat and reduce the risk of blood clots and their complications in adults with irregular heartbeats and other clotting risk factors
How Many Lawsuits
Major Side Effects
Severe bleeding, bruising
Federal: Southern District of Illinois
Pradaxa lawsuits claim the blood thinner manufacturer failed to warn patients about the drug’s higher risk of severe bleeding. Early Pradaxa patients could even bleed to death, as there was no antidote for years. Pradaxa patients have filed 2,600+ lawsuits against Boehringer-Ingelheim, many of which were included in a $650 million settlement.
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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 higher risk of severe bleeding.
Part of the problem is 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 drug could literally bleed to death from an otherwise minor injury, and the FDA has since reviewed thousands of deaths attributed to it. Bruising and internal bleeding could also cause major health issues.
In 2014, Boehringer Ingelheim resolved many of the outstanding claims against the drugmaker with a $650 million settlement to compensate victims and their families. However, additional Pradaxa lawsuits have been filed since then, and additional money could become 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 was marketed by Boehringer Ingelheim as an alternative to warfarin, the most commonly used blood thinner in the preceding 60 years. Despite the pharmaceutical company’s claims that the drug was safer, studies showed that Pradaxa had a higher rate of gastrointestinal bleeds along with a similar rate of major bleeds as warfarin.
The important difference between the anticoagulant drugs is that for its first five years on the market, Pradaxa did not have an antidote that could reverse its adverse effects. Patients who took warfarin could be given vitamin K to help blood clot normally; patients who took Pradaxa, however, had no way to stop bleeding, and even a minor cut or bruise could turn into a major health concern.
Lawsuit complaints against the drugmaker often cite the risk of Pradaxa’s “unreasonable and dangerous” side effects as a primary concern. Out of this initial cause, however, arise other legal accusations.
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Pain and Suffering
One result of excessive bleeding is that patients who took Pradaxa experienced pain and suffering above and beyond what was expected for a drug of its type. The most immediate example is physical pain from the extended amount of time it took wounds to heal while the medication was still active in the patient’s body. Prolonged bleeding could cause additional problems, requiring painful procedures and expensive hospital stays.
Many Pradaxa lawsuits also cite mental and physical issues beyond the immediate bleeding and its effects. Additional damages for which plaintiffs often seek compensation cover both past and future harms of the drug, including mental, physical and social injuries.
Pradaxa Lawsuit Pain and Suffering Claims
- Physical pain and suffering
- Physical impairment
- Physical disfigurement
- Mental anguish (past and future)
- Loss of companionship and consortium
- Wrongful death
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.
Furthermore, the drugmaker promoted its new prescription as an improvement over the more popular anticoagulant because it had fewer interactions with foods and other drugs, and unlike warfarin, Pradaxa did not require weeks of calibration to determine the right dosage. Unfortunately, these claims turned out to be inaccurate for several reasons:
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 individuals who file a Pradaxa lawsuit have claimed the drug’s maker should have known about the higher risk of gastrointestinal bleeding – and warned consumers and doctors appropriately. In addition, plaintiffs argue that the manufacture and marketing of the drug were in violation of regulatory requirements because they did not properly warn about the dangerous risks of the blood thinner. Many plaintiffs also argue that Boehringer Ingelheim was negligent and committed a breach of warranty in producing and promoting a dangerous drug.
Punitive Damages to Hold Boehringer Ingelheim Accountable
A Pradaxa attorney will also seek punitive damages for you. This type of compensation is designed to hold companies accountable for past actions and change business practices to protect other consumers from experiencing the same or similar problems.
The amount of money that can be awarded for punitive damages differs from state to state. In some cases, juries can punish drug companies with penalties worth hundreds of millions of dollars, while in others they may decline to award any punitive damages. The decision often comes down to the severity of the negligence and how much the company knew (or should have known) about the defects and problems of the drugs they make.
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 lawsuit.
Pradaxa Lawsuit Types
The first Pradaxa lawsuits were filed shortly after the drug was released and it became clear that patients were suffering from fatal gastrointestinal bleeding and other adverse events. Dozens of cases were launched in different states and various federal district courts.
In general, two types of lawsuits were filed:
- Personal Injury Lawsuits – These lawsuits are filed by individuals who took Pradaxa and experienced severe bleeding, or their representatives.
- Wrongful Death Lawsuits – These claims are filed by loved ones who have passed away due to a bleeding complication related to Pradaxa.
In August 2012, the U.S. Judicial Panel on Multidistrict Litigation transferred 21 legal actions covering both of these lawsuit types to the Southern District of Illinois, creating MDL 2385 in re: Pradaxa (Dabigatran Etexilate) Products Litigation. By centralizing administrative duties, the court made the lawsuit process more efficient, allowing plaintiffs to use common procedures for the same or similar complaints.
While approximately 4,000 Pradaxa cases were settled in 2014, not everyone chose to participate. Furthermore, additional cases have since been filed by others seeking compensation for the negative side effects of the blood thinner.
Do I Need a Pradaxa Lawyer?
Lawsuits can be extremely complicated, and getting an experienced Pradaxa lawyer who knows how to navigate the system will help you avoid potential pitfalls. Drug companies make billions of dollars every year, and they spend millions to protect earnings and maintain the status quo.
If you decide to pursue a Pradaxa lawsuit, you will not need to pay anything unless you receive compensation from the settlement fund or a trial verdict. Pradaxa attorneys accept their legal fees as a percentage of money awarded to the plaintiff.
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Pradaxa Settlements and Case History
The earliest Pradaxa lawsuits were filed when it became clear that the pharma-sponsored RE-LY trial had provided misleading evidence about the drug’s safety and efficacy. Since then, thousands of lawsuits have been filed – approximately 4,000 of which were settled in 2014.
Original Pradaxa MDL and Settlement (2012 – 2014)
Within 18 months of consolidating a handful of Pradaxa lawsuits into a single multidistrict litigation (MDL) case, thousands of additional complaints were filed and moved into the MDL. In 2014, the judges overseeing the cases approved a $650 million settlement between the defendants and plaintiffs.
To facilitate the processing of both personal injury and wrongful death claims, the court established a settlement fund from which victims could be paid. 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||Legal Fees||Common Benefit Costs|
By setting up the settlement fund this way, plaintiffs do not have to pay legal fees up front when submitting a claim. This allows more eligible people to file a Pradaxa lawsuit without having to worry about attorney fees and other costs.
In late 2017, coordinating Judge David Herndon issued an order recommending the shutdown 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.
Praxbind (Pradaxa Antidote) and Future Lawsuits
In October 2015, the U.S. Food & Drug Administration approved a Pradaxa antidote called Praxbind (idarucizumab). As a result, Pradaxa is the only modern blood thinner that has an FDA-approved antidote. Other anticoagulants developed in recent years, such as Xarelto and Eliquis, do not yet have approved antidotes. The lack of an antidote has resulted in about 20,000 Xarelto lawsuits over uncontrollable internal bleeding.
Praxbind appears to successfully reverse the effects of dabigatran. However, no long-term, large-scale studies have yet shown that the blood thinner antidote is without possible risks of its own, so consumers shouldn’t assume one blood thinner is safer when comparing Pradaxa vs Xarelto. Many are worried that it may not be as effective as initial studies indicate, which could lead to further injuries and deaths.
Even though an antidote now exists, patients still have a reasonable expectation of safety when taking Pradaxa. If you suffered a severe bleeding event, connect with a Pradaxa lawyer to understand your legal rights.
Get your legal questions answered during a free consultation with a blood thinner attorney.