The prescription blood-thinner Pradaxa was considered better than warfarin because it limited strokes. However, in May 2014 the manufacturer settled more than 4,000 lawsuits for $650 million.
Pradaxa tied for first place as the drug most linked to adverse event reports filed with the FDA in 2011, showing that it ranks among the highest risk of all drug treatments, reported QuarterWatch, a non-profit drug monitoring organization. The FDA received reports of 7,387 serious, harmful events in 2012, as well as 1,158 deaths in the U.S. alone. Among the reports of hemorrhage, acute renal (kidney) failure and stroke, Pradaxa surpassed all other drugs.
Approved by the FDA in October 2010 to prevent strokes in patients with atrial fibrillation, Pradaxa was the first blood thinner to compete with the longtime treatment of warfarin (brand names Coumadin and Jantoven). Just over a year later, research began to emerge, linking Pradaxa to serious bleeding risks that were not communicated to patients.
Many believe that manufacturer Boehringer Ingelheim GmbH rushed Pradaxa through clinical trials and the FDA approval process in order to beat two similar drugs to the market, thereby capturing as many consumers as possible. Unfortunately, this ploy worked, and in April, Pradaxa became a “blockbuster” drug, meaning it generated annual sales of $1 billion or more. Negligence on the part of Boehringer means this dangerous drug has reached millions of patients, potentially caused thousands of injuries and hundreds of deaths.
Time Line of Dangerous Pradaxa
- November 2014 – JAMA: Internal Medicine reports that Pradaxa is associated with a 30% greater risk of a bleeding event, a 58% greater risk of major bleeding, and 85% greater risk of gastrointestinal bleeding.
- May 2012: The European Medicines Agency acknowledges fatal bleedings with Pradaxa and encourages clearer guidance for usage.
- January 2012: Pradaxa use is linked to a 33 percent increased risk of heart attack, according to a study published in the Archives of Internal Medicine.
- December 2011: The Food and Drug Administration (FDA) issues a safety announcement regarding the bleeding incidents reported for patients taking Pradaxa. The FDA notes such bleeding risks are serious and have proven deadly.
First Pradaxa Settlement
More than 4,000 people suffered from serious bleeding issues after using the blood thinner, Pradaxa. This includes gastrointestinal, rectal and brain bleeding. Over 540 patients lost their lives because of this fatal side effect. Thousands of others reported serious harm. Boehringer Ingelheim still denies any wrongdoing; however, the company announced in May 2014 that they would pay $650 million to settle before the lawsuit went to jury trial. This amounted to an average of $162,500 per claimant.
Lawsuits claimed that Boehringer Ingelheim did not adequately label Pradaxa, lied in published studies claiming the drug is safer than warfarin, misrepresented the drug, did not require patients to return to the doctor for dosage adjustment, failed to establish a treatment protocol, intentionally concealed the dangers of Pradaxa and did not warn consumers.
Deaths Attributed to Pradaxa Use
Only 10% of serious and fatal events are reported directly to the FDA. The rest are submitted by drug manufacturers or health professionals. In 2012, 1,158 cases of serious bleeding that resulted in the death of Pradaxa users were recorded. Additional deaths are likely to occur as Pradaxa remains available in the U.S. market.
Uncontrollable bleeding risk can turn deadly in a variety of ways, including:
- Cerebral (brain) hemorrhaging
- Unstoppable internal bleeding of ulcers
- Vehicle accidents resulting in injury
- Mistakes during operations
Your Pradaxa Lawsuit Attorney
Michael Brady Lynch, the founder of The Michael Brady Lynch Firm, was a member of the Plaintiff’s Steering Committee in the Pradaxa Multi-District Litigation and instrumental in securing the $650 million settlement for those injured by Pradaxa’s uncontrollable bleeding. Mr. Lynch continues to be a leader in Pradaxa litigation nationwide in representing those who continue to suffer uncontrollable bleeding events from Pradaxa.
Attorney Lynch has said, “The U.S. numbers for Pradaxa bleeding events are truly staggering. It is on the verge of a national health disaster.”
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects to your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed melanoma after taking Viagra, please speak to us to learn more about your rights.
If you have experienced internal bleeding / hemorrhaging, stroke, heart attack or have lost a loved one after Pradaxa use, you may be eligible for compensation to offset your financial, physical and emotional burdens. Contact us today to set up a free consultation during which we will listen to your story and discuss your legal rights and options. If you choose us to represent you, we will work with you on a contingency fee basis; this means you pay nothing until we have secured compensation for you, either through a jury verdict or settlement.