Before the U.S. Food and Drug Administration approved Pradaxa in 2010, the only blood thinner available to help patients who are at risk for a clot was Warfarin. Within two years, the sales of this drug hit $1.5 billion and only continued to grow. However, patients soon learned that the risks associated with the drug may outweigh the benefits.
Why Is Pradaxa So Popular?
Both patients and doctors were thrilled when they learned that a patient’s diet, weight, sex, exercise habits, and age wouldn’t impact the dose administered, patients are simply prescribed either the 75mg or 150mg dose. This isn’t the case with Warfarin, which means that patients need to have blood tests performed regularly, sometimes as frequently as once a week, to make sure they aren’t getting too much or too little of the drug. This, of course, is both painful and a great disruption to everyday life. So when offered an alternative, it was no great surprise that most opted to make a switch which seemed to make their lives easier.
Conditions The Drug Treats
There are a number of medical conditions that can increase the risk of a patient forming a blood clot. Pradaxa is commonly used to treat:
Atrial Fibrillation (AFib)
When a patient is diagnosed with atrial fibrillation, it means that they have an irregular heartbeat. When blood isn’t moved correctly, the slight pooling can create a blood clot that could travel to the brain, lungs, or any other part of the body. There are nearly 3 million Americans that are currently living with AFib today in the U.S.
Venous Thromboembolism (VTE)
A venous thromboembolism is simply another term for a blood clot in a vein. It can be caused by:
- Deep Vein Thrombosis
- Pulmonary Embolism
- Surgical Complications
- Autoimmune Disorders
Given the millions of Americans whose lives are endangered by potential blood clots, the new blood thinner seemed like an excellent solution. However, two years after the drugs release on the U.S. market, Pradaxa had already been blamed for more than 500 deaths and injuries to thousands of others.
Dangerous Side Effects
Every drug comes with potential side effects, but the reason that the Food & Drug Administration does extensive research on every single drug available is that sometimes, drug side effects can cause serious damage or be deadly. In fact, the administration rejects more drugs every year than it approves.
Pradaxa has side effects that are mild, serious, and deadly. Commonly reported side effects are:
- Stomach Pains
- Headaches / Migraines
- Joint Swelling
- Random Bruising
- Heart Attack
- Excessive Bleeding
When a review of the bleeding issues involving Pradaxa was performed by the FDA, the administration reported that the risk was no higher than in patients who were on Warfarin. The reported failed, however, to take into account that doctors could reduce the effects of Warfarin but could not with Pradaxa.
From 2010 when Pradaxa was first released, to 2015 when the FDA fast-tracked the approval of Praxbind, there was no antidote available for the blood thinner. While this might not seem like a big deal, it is.
Whenever someone is on a blood thinner, if they fall or are involved in an accident that causes them to bleed, there is a risk that they may not be able to stop the bleeding. When a patient is on Warfarin, doctors can immediately administer Vitamin K, which allows the blood to clot. Until recently, if a patient on Pradaxa began to bleed, doctors had no choice but to perform a blood transfusion and hope that the blood clotted in time.
It is these serious side effects which led more than 4,000 plaintiffs to file defective drug and wrongful death lawsuits against the drug’s manufacturers, Boehringer Ingelheim.
The Ongoing Litigation
In the thousands of claims filed, plaintiffs are alleging that:
- The manufacturer used deceptive marketing tactics to advertise the drug, saying that it was a safer alternative to previous blood thinners.
- That the manufacturer failed to adequately inform both the medical community and the public of the risks associated with taking the drug.
- No procedure was created to treat or save the lives of those who begin to excessively bleed.
- That the manufacturer purposefully decided to hide the fact that the blood thinner was dangerous.
Through legal action, these men and women are hoping to regain compensation for their medical expenses, lost wages, emotional turmoil, funeral & burial expenses, and more.
Due to the large number of claims, the U.S. Judicial Panel on Multidistrict Litigation determined that forming an MDL would be appropriate to expedite the process and save everyone time and money. These cases were expected to go to trial, but in May of 2014, Boehringer Ingelheim announced that it would pay $650 million to settle each of the lawsuits that had already been filed.
Does This Mean I Can’t File A Lawsuit?
It is still possible to file a lawsuit if you believe that you or a loved one were harmed by the blood thinner Pradaxa. To learn more, contact our defective drug lawyers today.