Pradaxa was initially approved by the U.S. Food and Drug Administration (FDA) in the Fall of 2010 and was designed to prevent strokes associated with atrial fibrillation, or a fluttering heart rhythm. The drug is an anticoagulant that inhibits the production of thrombin, an enzyme necessary for the formation of blood clots. The Pradaxa blood thinner drug was subsequently approved for the treatment of deep vein thrombosis (DVT) and pulmonary embolism.
Pradaxa was introduced as an alternative to warfarin and was marketed as being superior since it does not require frequent blood test monitoring in order to determine the dose and does not require patients to closer monitor their diets to avoid complications. With the introduction of Pradaxa, patients were able to forego the blood testing and diet monitoring process altogether.
What’s the Problem?
Both warfarin and Pradaxa are designed to thin the blood, which subsequently increases the risk of internal bleeding. Indeed, blood thinners can be fatal by causing abdominal bleeding, hemorrhaging, and bleeding in the brain. But these blood thinners are particularly useful following certain types of surgery, such as knee or joint replacement, as the chance of developing blood clots is higher, and are also useful for those who live a sedentary lifestyle.
However, one key difference between warfarin and Pradaxa was that in an emergency, a doctor could administer an antidote medication, a simple dose of Vitamin K, in this case, in order to prevent excessive bleeding while using warfarin. Remarkably, Pradaxa was introduced on the market with no known antidote, and there was none available for five years. During those first five years, the only way to remove Pradaxa from the bloodstream and stop the blood-thinning effects was through dialysis, which takes between 2-3 hours and is far too long in the event of a medical emergency involving internal bleeding.
In 2014, the FDA launched a study to compare the bleeding risks associated with Pradaxa and warfarin and found that Pradaxa had a 28% higher rate of gastrointestinal bleeding versus warfarin, although a lower rate of stroke and death. Another study, when compensating for patient risk-factors, found it to have an 85% increased risk of gastrointestinal bleeding.
Studies have also found that elderly patients with impaired kidney function and who weigh less than 130 pounds are at the highest risk for severe bleeding due to Pradaxa.
Approval Process and Legal Challenges
The FDA initially approved Pradaxa based on the results of a clinical trial which was sponsored by Boehringer Ingelheim, and which concluded that dabigatran, the active ingredient of Pradaxa, caused fewer bleeding events than warfarin and was therefore safer to use.
However, thousands of users have found that that isn’t necessarily the case with this pharmaceutical. The rising medical complications, deaths, and other problems lead to thousands of lawsuits being filed against Boehringer Ingelheim, the drug’s manufacturer. The majority of the lawsuits which have been filed argue that the manufacturer was aware or should have been aware of the higher risk of gastrointestinal bleeding and in turn warned consumers and doctors about the elevated risks. Not only that, but they argue that the marketing was in violation of regulatory requirements and that ultimately Boehringer Ingelheim was negligent and committed breach of warranty by manufacturing and promoting a dangerous drug.
The primary grounds for filing a claim was based on a failure to warn patients about the higher associated risks of severe bleeding and that these side effects were “unreasonable and dangerous.” However, these initial concerns lead to other legal accusations.
For example, claims were filed based on the fact that some of those who took Pradaxa had pain and suffering that went beyond what was expected for a drug of its type. The drug meant that even small wounds could take a great amount of time to heal and that even simple cuts or bruises could pose serious medical problems for those taking Pradaxa, sometimes requiring painful procedures or expensive hospital stays.
In October 2015, the antidote to Pradaxa called Praxbind was introduced on the market to stop internal bleeding in the event of an emergency, but that development was obviously too little, too late for those who already suffered severely or lost their lives by taking a drug that was ostensibly meant to help them.
The first wave of lawsuits was consolidated into a single multidistrict litigation (MDL) case. An MDL is used to bring together different lawsuits from a variety of districts across the country, in order to answer the same questions and to make the lawsuit process more efficient.
Boehringer Ingelheim resolved these lawsuits with a $650 million settlement to compensate victims and their families. While approximately 4,000 cases were settled in 2014, not everyone was able to or chose to participate in the MDL case. Furthermore, many cases have continued to be filed for the damages caused by Pradaxa and their manufacturer Boehringer Ingelheim.
What Can be Done?
Anyone who was taken the drug Pradaxa and suffered severe bleeding or related complications may be able to file a personal injury lawsuit. Family members who have lost a loved one due to complications from Pradaxa may also be eligible to file a lawsuit seeking damages.
Punitive damages, designed to hold companies accountable for negligent actions and to force them to change business practices to protect future consumers, may also be on the table.
The amount of damages that can be awarded by a Pradaxa lawsuit differs from case to case, and often comes down to the severity of the negligence in a given case and how much the company knew (or should have known) about the dangers or problems posed by the drug they manufactured.
Drug companies like Boehringer Ingelheim make billions of dollars every year on the drugs they make, and they have spent millions of dollars to protect those earnings and maintain the status quo. This is why you need a team of experienced Pradaxa lawyers who know how to navigate the complicated legal waters, avoid pitfalls, and ultimately achieve at least some form of closure and justice for the suffering that you or your loved one had to endure.
The team at Fears Nachawati understands the frustration and anguish felt by those who have suffered from a drug that was meant to help them, whose consequences or complications were never adequately made clear, and we are fully prepared to help victims recover from this devastating blow.
If you or a loved one has suffered severe bleeding or death as a result of using Pradaxa, then the legal team at Fears Nachawati is here to help you hold the responsible parties accountable. Contact our experienced team today for a free, no obligation legal consultation to discuss the specifics of your Pradaxa case. Please call (866) 705-7584 or visit the offices of Fears Nachawati located throughout the great state of Texas, including in Houston, Dallas, Austin, Fort Worth, and San Antonio.