Pradaxa Bleeding Lawsuit

Our law firm is no longer reviewing potential Pradaxa lawsuits.

There have already been $650 million in settlements in this case. The average settlement payout was over $160,000.

Overview of Pradaxa

Pradaxa (dabigatran etexilate) is a blood thinner, a product used to prevent the formation of blood clots in people with atrial fibrillation (irregular heartbeat). This is important for the prevention of strokes and heart attacks. Dabigatran etexilate was intended to replace Warfarin (Coumadin), and drug makers were hopeful it would require less monitoring.

Part of the allure of Pradaxa is that, unlike warfarin, it requires no dietary restrictions and no blood tests. This is undoubtedly a huge deal to patients who can better fit their clotting medication with their lives. However, cost analysis suggests that the drug, though more convenient, may have a higher total medical cost than warfarin, a cheaper drug that has been on the market since the 1950s.

The primary concern that everyone drilled down on in the Pradaxa lawsuits is the increased risk of bleeding. Severe bleeding events, such as gastrointestinal bleeding or brain hemorrhages, can occur, especially if the medication is not taken as prescribed or if there are drug interactions with other medications the patient may be taking. There also may be a risk of myocardial infarction with Pradaxa.

The dosage of Pradaxa can vary depending on the specific medical condition it is intended to treat and individual patient factors. Patients must adhere closely to their healthcare provider’s medication dosage and usage instructions.

You may need less blood monitoring, but regular check-ups with a healthcare provider are still necessary while taking Pradaxa. These appointments monitor the medication’s effectiveness, assess for any potential side effects, and identify any complications that may arise during treatment.

Patients also need to inform their doctor r about all other medications, vitamins, and supplements they are taking. This is because Pradaxa can interact with certain drugs, potentially affecting its effectiveness or increasing the risk of side effects.

Who Makes Pradaxa?

Pradaxa, released to the market in October 2010, is manufactured by the German company Boehringer Ingelheim.

What Is the Injury in Pradaxa Lawsuits?

In early 2011, the FDA received over 500 reports of Pradaxa bleeding injuries—within months of the drug’s release. Users of Pradaxa may suffer from internal bleeding, hemorrhaging, or other problems. By December 2011, the FDA announced a Pradaxa safety review, the first step toward determining whether a Pradaxa recall is necessary.

The National Institutes of Health reported 932 serious events between January 2011 and March 2011:

• 120 deaths
• 25 permanent disabilities because of the drug
• 543 hospitalizations
• 505 incidents of hemorrhage or internal bleeding

Warfarin, which Pradaxa was intended to replace, may also cause internal bleeding. However, those problems can be countered by administering vitamin K (because warfarin interferes with vitamin K, which is essential to creating blood clots). Pradaxa patients have no similarly simple solution for excessive internal bleeding.

Additionally, researchers are investigating whether the drug is effective. The FDA is concerned that the drug may have too little effect, which may cause deep vein thrombosis and pulmonary embolism.

What Did Pradaxa’s Manufacturer Do Wrong?

Over 500 Pradaxa-related deaths may have occurred in the first year of use. Experts are concerned that the initial clinical trials were faulty, which may have allowed this defective drug to be rushed to the market. Boehringer Ingelheim conducted a study called the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study and gave that information to the FDA to prove that it was ripe for release to the market.

Warfarin and its generic version, Coumadin, are manufactured by Bristol-Myers Squibb. That company sold over 2.6 million prescriptions in 2006 and had little competition. That’s a substantial financial incentive for other companies, like Boehringer Ingelheim, to get a piece of the action. From when Pradaxa was approved to August 2011, Boehringer Ingelheim sold over 1.1 million prescriptions.

Here are the critical points in the Pradaxa lawsuits:

1. Failure to Warn: Many of the lawsuits alleged that the manufacturer of Pradaxa, Boehringer Ingelheim, failed to provide adequate warnings and information to both healthcare providers and patients about the risks associated with the medication. Specifically, they claimed that the company did not sufficiently warn about the risk of severe bleeding events, which could be challenging to reverse.
2. Serious Bleeding Events: A central allegation in these lawsuits was that Pradaxa was linked to severe bleeding, including gastrointestinal and brain hemorrhages. Some of these bleeding incidents resulted in hospitalization and, in some cases, fatalities.
3. Inadequate Monitoring and Antidote: Plaintiffs argued that Pradaxa lacked an effective antidote to reverse its anticoagulant effects in severe bleeding, unlike older blood thinners like warfarin, which has reversal agents available. They alleged that this absence of an antidote put patients at higher risk.
4. Lack of Proper Instructions: Some lawsuits contended that the manufacturer failed to provide adequate instructions on managing patients during a bleeding event while taking Pradaxa. This was seen as a contributing factor to the severity of the bleeding incidents.
5. Medical Negligence: In cases where healthcare providers prescribed Pradaxa without proper assessment or monitoring, plaintiffs also alleged medical negligence, asserting that healthcare professionals did not adequately evaluate patient risks or provide appropriate follow-up care.

What Is the Status of the Pradaxa Lawsuits?

In 2014, Boehringer Ingelheim announced its agreement to pay $650 million to settle a substantial portion of the approximately 4,000 lawsuits concerning its blood-thinning medication, Pradaxa. So, as far as mass torts go, the Pradaxa lawsuit payouts were very good.

These lawsuits, filed by patients and their families in both state and federal courts, alleged, as we have been saying, that Boehringer Ingelheim neglected to adequately inform them about the severe and fatal bleeding risks associated with the drug, which is prescribed to prevent blood clots.

In 2023, there are few, if any, lawyers handling Pradaxa lawsuits.

The Difference Between 2014 and 2023

The reversing agent for Pradaxa, known as idarucizumab and marketed under the brand name Praxbind, was approved by the U.S. Food and Drug Administration (FDA) in October 2015.  It came too late for many. But now, it is a critical addition to the medical arsenal for managing patients who experience severe bleeding or require emergency surgery while taking Pradaxa.

The approval of idarucizumab addressed a critical need, as one of the concerns with Pradaxa and other newer anticoagulant medications was the lack of a specific antidote to rapidly reverse their effects in emergencies. Idarucizumab provides healthcare providers with a means to quickly counteract the anticoagulant effects of Pradaxa when necessary.

Since its approval, idarucizumab has played a crucial role in enhancing the safety profile of Pradaxa by providing a reliable reversal option for medical professionals. Patients taking Pradaxa are encouraged to discuss idarucizumab with their healthcare provider to ensure they are aware of this reversal agent’s availability in emergencies.

Do I Have a Potential Pradaxa Malpractice Claim?

We are unaware of any lawyers handling Pradaxa lawsuits in 2023. There are Pradaxa malpractice lawsuits related to the prescription and administration of Pradaxa. These lawsuits typically fall into several categories:

1. Failure to Warn: Some lawsuits allege that healthcare providers did not adequately inform patients about the risks associated with Pradaxa, including the risk of serious bleeding events. It is the doctor’s job to pass along appropriate warnings.
2. Inadequate Monitoring: This is where mistakes most often get made.  In cases where patients experience bleeding events while taking Pradaxa, malpractice lawsuits allege that healthcare providers did not properly monitor their condition or adjust their medication as necessary. As we talked about above, adequate monitoring is crucial for patients taking anticoagulants like Pradaxa.
3. Inappropriate Prescribing: In certain cases, patients claim that Pradaxa was prescribed to them when it was not the appropriate medication based on their medical history or conditions, potentially leading to injury or death.
4. Bleeding Events: Malpractice lawsuits can also focus on severe bleeding events that we saw in the product liability cases, such as gastrointestinal bleeding or brain hemorrhages, that patients experience while taking Pradaxa. More Information on the Problems with Pradaxa

• $1.25 Million Pradaxa Verdict Overturned on Appeal in 2021
• A nationwide cohort study in 2023 on the long-term comparative effectiveness and safety of dabigatran, rivaroxaban, apixaban, and edoxaban in patients with atrial fibrillation.”
• Institute for Safe Medication Practices (Pradaxa has more adverse reports than 98.7% of all other monitored drugs)
• Bloomberg Report: Pradaxa users have a significantly higher risk of heart attacks compared with Warfarin users
• Pradaxa Medication Guide