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Table Of Contents
- Pradaxa Lawsuit Overview
- Latest Pradaxa Lawsuit Updates
- ISMP Reports and Statistics
- Pradaxa Injuries & Side Effects
- Do You Qualify for a Pradaxa Lawsuit?
- Pradaxa Recall Information
- Statute of Limitations for Pradaxa Lawsuits
- FAQs
- 1. Can I sue the healthcare provider who prescribed Pradaxa if it caused harm?
- 2. What should I do if I still have Pradaxa in my possession?
- 3. Can I seek compensation for psychological trauma resulting from my Pradaxa-related injury?
- 4. What if I’m still taking Pradaxa?
- 5. Can I sue if my loved one died from Pradaxa complications?
- 6. What evidence do I need to make a claim?
- Take Action Now: Time-Sensitive Legal Claims
- Get a Free Pradaxa Lawsuit Evaluation With Our Lawyers
Pradaxa Lawsuit Overview
Pradaxa, a blood thinner manufactured by Boehringer Ingelheim Pharmaceuticals, has been linked to severe bleeding complications and fatalities worldwide. The primary allegations against the manufacturer involve failure to adequately warn patients about the risk of uncontrollable bleeding and the lack of an effective reversal agent. Hundreds of reports of Pradaxa-related side effects were submitted to the FDA within weeks of its release, with many involving gastrointestinal bleeding in elderly patients.
Latest Pradaxa Lawsuit Updates
March 16, 2025
– Morgan & Morgan notes that thousands of Pradaxa users who suffered internal bleeding injuries have received compensation after Boehringer Ingelheim agreed to a $650 million settlement. New cases may still qualify under specific criteria.
March 13, 2025 – According to Drugwatch, lawsuits against Pradaxa’s manufacturer allege that the drug caused preventable deaths due to the absence of an antidote and insufficient warnings about bleeding risks. Despite a $650 million settlement, ongoing cases continue to emerge [1].
ISMP Reports and Statistics
According to the Institute for Safe Medication Practices (ISMP), in its January 2012 QuarterWatch report, the FDA received 540 reports of serious adverse events linked to Pradaxa (dabigatran etexilate) in the last quarter of 2010 (October–December), shortly after its U.S. approval in October 2010 [2]. These reports significantly outnumbered the 202 adverse event reports for warfarin and other blood thinners combined during the same period. The majority of Pradaxa-related reports involved bleeding events, with gastrointestinal bleeding being the most common, particularly among elderly patients. The ISMP noted that Pradaxa was linked to more reports of injury or death than 98.7% of the 800 drugs it monitors, highlighting its safety concerns.
Health Canada, in March 2012, required updated warning labels for Pradaxa to indicate an increased risk of internal bleeding in patients with kidney problems, particularly those with severe renal impairment (creatinine clearance [CrCl] <30 mL/min). Health Canada also contraindicated Pradaxa for patients with rheumatic valvular heart disease (especially mitral valve stenosis) or prosthetic heart valves, as its safety and efficacy have not been studied in these populations. These warnings were based on post-marketing reports of serious bleeding, particularly in elderly patients with kidney issues.
Pradaxa Injuries & Side Effects
Pradaxa has been linked to various side effects, ranging from life-threatening conditions to moderate digestive issues.
High-Risk Side Effects (Severe and Life-Threatening):
- Serious Internal Bleeding: Uncontrolled bleeding inside the body, which can be life-threatening
- Serious Internal Hemorrhaging: Excessive internal blood loss that may require urgent medical attention
- Bleeding Disorders: Conditions where blood does not clot properly, leading to prolonged bleeding
- Rectal Bleeding: Blood in the stool, which may indicate severe gastrointestinal damage
- Brain Bleeds (Cerebral Hemorrhaging): Bleeding in the brain, increasing the risk of stroke or permanent brain damage
- Heart Attack: Blockage in the arteries that supply the heart, potentially leading to heart failure
- Atrial Fibrillation: Irregular heart rhythm that can increase the risk of stroke
- Kidney Failure: Loss of kidney function, which can cause toxins to build up in the body
- Stroke: Blocked blood flow to the brain, potentially leading to paralysis or loss of speech
- Pulmonary Embolism: A blood clot in the lungs, which can make breathing difficult and be fatal
- Deep Vein Thrombosis (DVT): Blood clot in deep veins, usually in the legs, which can break off and travel to the lungs
- Death: In severe cases, complications from Pradaxa-related bleeding can be fatal
Medium-Risk Side Effects (Potentially Serious but Manageable):
- Digestive Tract Ulcers: Open sores in the stomach or intestines, which can cause pain and bleeding
Low-Risk Side Effects (Mild to Moderate Symptoms):
- Indigestion: Discomfort in the stomach after eating, often causing bloating or nausea
- Heartburn: A burning sensation in the chest caused by stomach acid backing up into the esophagus
- Abdominal (Stomach) Pain: General discomfort in the stomach, which may range from mild to sharp pain
- Gastroesophageal Reflux Disease (GERD): A chronic condition where stomach acid frequently flows back into the esophagus, causing irritation
The doctors in this case stated:
In the event of traumatic hemorrhage in patients receiving dabigatran (Pradaxa) … there are currently no effective reversal agents to neutralize the drug.”
Do You Qualify for a Pradaxa Lawsuit?
You may qualify for a Pradaxa lawsuit if:
- You used Pradaxa between 2010 and the present
- You experienced serious side effects including severe internal bleeding, brain hemorrhaging, heart attack, or other serious complications
- The injuries required medical treatment or hospitalization
- You can provide medical documentation linking your injuries to Pradaxa use
Evidence Required for a Pradaxa Lawsuit
Strong evidence for your case typically includes:
- Documentation of prescription timing (pharmacy records, doctor’s instructions)
- Medical records showing bleeding events (hospital records, lab results)
- Evidence of inadequate warning about the risks
- Documentation of financial and emotional impact (medical bills, lost wages)
Damages You Can Recover
By filing a Pradaxa lawsuit, you may be able to recover compensation for:
- Medical expenses related to treatment of bleeding complications
- Lost wages due to inability to work during recovery
- Pain and suffering caused by your injuries
- Punitive damages against the manufacturer
Pradaxa Recall Information
While Pradaxa has not been subjected to a full recall, health regulators in various countries have required updated warning labels. In Canada, new labels were mandated to indicate the increased risk of internal bleeding in patients with kidney problems.
Statute of Limitations for Pradaxa Lawsuits
The time limit for filing a Pradaxa lawsuit varies by state. Generally, you must file within 1-3 years from the date you discovered or reasonably should have discovered your injury was related to Pradaxa use. Consulting with a product liability attorney promptly is essential to ensure your claim is filed within the appropriate time frame.
FAQs
1. Can I sue the healthcare provider who prescribed Pradaxa if it caused harm?
Yes, you can sue the healthcare provider if they were negligent in prescribing Pradaxa or failed to properly monitor its use, leading to your injury. Consulting with an attorney can help determine if this is a viable option.
2. What should I do if I still have Pradaxa in my possession?
Consult with your healthcare provider before discontinuing any medication. Retain the medication and any relevant documentation as evidence, and consult with your attorney for further instructions.
Yes, you can seek compensation for psychological trauma, including anxiety, PTSD, and other mental health issues resulting from your Pradaxa-related injury. Documentation from mental health professionals will support your claim.
4. What if I’m still taking Pradaxa?
If you are still taking Pradaxa, consult your doctor before making any changes. Stopping suddenly can increase the risk of stroke or blood clots. If you have concerns about bleeding risks, discuss alternative medications or monitoring options with your healthcare provider.
5. Can I sue if my loved one died from Pradaxa complications?
Yes, you may sue if your loved one passed away due to Pradaxa complications. Claims often involve proving that the manufacturer failed to warn about risks or that the drug was prescribed without proper safety precautions. A product liability attorney can assess your case.
6. What evidence do I need to make a claim?
Evidence you need to make a claim includes medical records showing Pradaxa use, documentation of bleeding events or complications, hospital bills, proof of prescription history, and any evidence that adequate warnings were not provided.
See the other dangerous drugs lawsuits we’ve covered.
Take Action Now: Time-Sensitive Legal Claims
Time is limited to pursue legal action for Pradaxa-related injuries. Depending on your state, you may have as little as one year from the date of injury to file a claim. Don’t delay in seeking the compensation you deserve.
Schmidt & Clark, LLP services include:
- Free, confidential consultations to evaluate your case
- No upfront costs or fees to begin your claim
- Payment only if we win your case
If you or a loved one has suffered serious complications after taking Pradaxa, contact our experienced legal team today to discuss your options and protect your rights.
Get a Free Pradaxa Lawsuit Evaluation With Our Lawyers
The Products Liability Litigation Group at our law firm is an experienced team of Pradaxa attorneys that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual Pradaxa litigation nationwide and currently accepting new injury and death cases in all 50 states.
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