Praxair, the manufacturer of Pradaxa, has reached a $37 million settlement with plaintiffs. Class action lawyers say that there is an unlimited number of claims to be filed against Praxair and will continue to pursue them in court.
The “pradaxa lawsuit update 2020” is a lawsuit filed by the manufacturer of Pradaxa. The plaintiff alleges that the drug maker knew about the risks associated with its product but failed to disclose them.
There was no treatment to stop excessive bleeding caused by Pradaxa until 2015. Thousands of adverse occurrences and hundreds of deaths happened as a consequence of this.
Pradaxa (dabigatran) is an anticoagulant (blood thinner) made by Boehringer Ingelheim, a German pharmaceutical firm. It was licensed for usage in Europe and Canada before getting FDA clearance in the United States in October 2010 for the prevention of strokes in individuals with atrial fibrillation (a-fib).
Prior to the approval of Pradaxa (and subsequently, Xarelto), warfarin enjoyed a 60-year monopoly on the blood thinner market. Pradaxa, unlike warfarin, does not need frequent blood tests. Pradaxa has been prescribed to about 725,000 people in the United States by 2012.
Unfortunately, there was no means to cure a serious bleeding incident caused by Pradaxa until 2015. (Vitamin K may be able to prevent warfarin-related events.) Thousands of adverse events and hundreds of deaths ensued as a consequence of this, most of which were caused by excessive bleeding.
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Thousands of lawsuits resulted from these injuries and deaths. Approximately 4,000 claims made by Pradaxa patients were merged into a multidistrict action in August 2012. (MDL).
Pradaxa has been related to over 1,000 fatalities by February 2014. In May of that year, Boehringer Ingelheim settled all of its 4,000 cases for $650 million. (The business had paid the US government $95 million eighteen months before, in October 2012, to resolve a whistleblower complaint over its off-label marketing of multiple medications.)
The British Medical Journal (BMJ) issued a paper in July 2014 stating that Boehringer Ingelheim concealed critical data showing that monitoring Pradaxa patients’ plasma levels might enhance the drug’s safety.
Finally, in October 2015, the FDA authorized Praxbind (idarucizumab), an antibody that has been demonstrated to swiftly reverse Pradaxa’s anticoagulation effects, potentially saving a patient’s life in the case of a significant bleeding episode.
Pradaxa’s permitted uses were increased by the FDA in November 2015 to include the prevention of venous thromboembolism (VTE) in patients who had recently had knee or hip replacement surgery.
Anticoagulants and How They Work
Anticoagulants are used to prevent blood clots from obstructing blood flow to essential organs, which may be deadly.
Blood clotting is generally a healing process, but it may sometimes occur when blood clots develop improperly inside blood vessels, break free, and move through the circulation. A thromboembolism occurs when they get trapped in a blood artery and obstruct the flow of blood to the lungs, heart, or brain.
Some individuals, such as those recuperating from an accident or surgery, and those with certain health problems, are at a higher risk of blood clot development and may be administered a medicine like Pradaxa to help prevent thromboembolism.
Blood-thinning drugs do not thin the blood or dissolve clots that have already formed. They do not cause clots to develop in the first place; rather, they prevent them from forming in the first place. They may help prevent clots from growing in size.
Pradaxa’s Approved Uses
Pradaxa was initially licensed in the United States as a blood thinner for a-fib patients who are at a higher risk of stroke. Pradaxa was also authorized by the FDA late last year to lower the risk of venous thromboembolism (VTE) in individuals who underwent knee or hip replacement surgery.
The most frequent kind of heart arrhythmia is atrial fibrillation. The atria (the heart’s upper chambers) contract swiftly and erratically as a result of abnormal electrical impulses. Because blood does not flow as efficiently into the lower chambers as it should, it pools in the atria. Because A-fib raises the risk of stroke, patients are prescribed blood thinners such Pradaxa.
A blood clot in a deep vein is known as VTE (often in the leg). It is more frequent in elderly individuals and after surgery, and it is responsible for hundreds of thousands of fatalities each year.
Of course, every blood thinner has the risk of causing uncontrolled bleeding. Unfortunately, before 2015, there was no antidote to halt these bleeding occurrences in Pradaxa patients.
Hold Pharmaceutical Companies Accountable
Risks of Bleeding and Adverse Events
In 2011, Pradaxa had more bleeding, stroke, and acute renal failure adverse events than any other medicine.
Pradaxa is one of the most dangerous medications to be administered in recent memory. Pradaxa was connected to 542 fatalities in 2011, the year after the FDA authorized it. The Institute for Safe Medication Practices states:
The anticoagulants dabigatran (PRADAXA) and warfarin (COUMADIN) were the most often recognized suspect medications in direct complaints to the FDA, indicating that suppressing clotting is among the most dangerous pharmacological treatments.
With 817 direct notifications to the FDA, Pradaxa was the most questionable medicine that year. In 2011, it was the major cause of 3,781 severe adverse events, including 2,367 instances of bleeding, 644 cases of stroke, and 644 cases of acute renal failure (291). According to the Institute’s QuarterWatch report,
Anticoagulant medications used in a susceptible elderly population are causing thousands of major injuries and fatalities, according to the 2011 yearly findings, and they must be among the most dangerous of all outpatient pharmacological regimens. Additional measures to ensure the safe use of these medications, particularly dabigatran, should be a top priority.
Two independent studies published the following year—one in the Journal of the American College of Cardiology and the other by the Cleveland Clinic—found that Pradaxa increases the risk of heart attack when compared to warfarin.
While the FDA and Boehringer Ingelheim often contested that Pradaxa was linked to an equal or lower risk of bleeding events than warfarin, neither could refute the essential distinction that warfarin hemorrhage had an antidote (vitamin K). There was no such antidote for Pradaxa until 2015. This is why the medicine was so harmful to so many people, particularly the elderly (who are more prone to hemorrhaging).
“The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be a catastrophe than with Coumadin [warfarin],” Dr. Richard H. Schmidt, a surgeon at the University of Utah who witnessed a Pradaxa-related fatality firsthand (an 83-year-old patient), told The New York Times.
Pradaxa caused so many problems that hundreds of people filed lawsuits against the company.
Boehringer Ingelheim Reaches a $650 Million Settlement
Pradaxa sufferers began filing wrongful death and personal damage claims against the company as early as 2010. Approximately 4,000 claims made by Pradaxa patients were merged into a multidistrict action in August 2012. (MDL).
Pradaxa has been related to over 1,000 fatalities by February 2014. Boehringer Ingelheim agreed to pay $650 million to resolve all of its 4,000 claims in May, under pressure from plaintiffs, health experts, and the media.
However, it wasn’t until October 2015 that the FDA authorized Praxbind (idarucizumab), an antibody that has been demonstrated to reverse Pradaxa’s anticoagulant effects, potentially saving a patient’s life after a catastrophic bleeding episode.
That implies that Pradaxa patients did not get any compensation from Boehringer Ingelheim for over a year and a half (from May 2014 to October 2015), and they still had no antidote for hemorrhages.
Eligibility for a Lawsuit
You may be eligible for damages if you were not a part of the 2014 Pradaxa settlement and were taking the medicine when Praxbind was released last autumn. The following expenses may be covered by these monetary awards:
• Medical costs • Lost pay and other financial losses • Funeral expenditures (in the case of the death of a loved one)
After over a thousand deaths linked to Pradaxa, it’s incredible that neither Boehringer Ingelheim nor the FDA ever removed the drug off the market. The antidote for Pradaxa was many years late, and hundreds of individuals died as a consequence.
Contact us for a free, no-obligation case evaluation if you or a loved one had a serious bleeding incident or died after using Pradaxa. Don’t delay; some situations are time-sensitive, and you may be eligible for compensation if you act quickly.
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The “pradaxa class action lawsuit” is a drug that has been the subject of lawsuits. There are many different law firms that specialize in cases related to Pradaxa.
Frequently Asked Questions
Is PRADAXA the best blood thinner?
Who manufactures PRADAXA?
A: PRADAXA is a generic drug that was created by the pharmaceutical company Sanofi.
Will PRADAXA be taken off the market?
A: In November of 2018, the FDA announced that it would be ending a highly controversial drug trial. This meant the drug can no longer be studied or sold on US markets because it has not been proven safe enough for use in humans.
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