Lawsuits alleged that Pradaxa, a blood thinner made by Boehringer Ingelheim, caused serious bleeding in patients who took it. The claims were filed in state and federal courts.
In May 2014, the company paid $650 million to settle about 4,000 of those claims. More than 2,500 federal suits had been consolidated before one judge in East St. Louis, Illinois, with about 1,500 more in state courts.
If you take Pradaxa now, talk with your health care professional before you change anything. FDA says patients should not stop taking it without that talk, because stopping can increase the risk of stroke.
- Case or litigation name: Pradaxa (dabigatran etexilate) litigation in U.S. state and federal courts
- Defendants: Boehringer Ingelheim
- Court and docket number, when available: Federal suits consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois (Southern District of Illinois); state suits in Illinois, Connecticut, California and Delaware; no docket number stated
- MDL number, judge, and case count, when an MDL exists: Federal cases consolidated before U.S. District Judge David Herndon, East St. Louis, Illinois; more than 2,500 suits as of May 28, 2014; MDL number not stated
- Filing date: Not stated
- Main allegations: Claims that Pradaxa caused serious adverse events such as major bleeding; the company says the claims lacked merit
- Products or people involved: Pradaxa (dabigatran etexilate) capsules; people who took Pradaxa and reported serious bleeding
Table Of Contents
Latest Pradaxa Lawsuit Updates
March 22, 2023: Ascend Recalls Generic Dabigatran Capsules
On March 22, 2023, Ascend Laboratories announced a voluntary nationwide recall of generic dabigatran etexilate capsules. The 75 mg and 150 mg capsules went to the consumer level. The lots shipped nationwide from June 2022 to October 2022.
The FDA notice says a nitrosamine, N-nitroso-dabigatran, was above the daily limit that FDA calls acceptable. Ascend had received no reports of adverse events [1].
May 7, 2018: Health Canada Reviews Liver Injury
On May 7, 2018, Health Canada issued a safety review of Pradaxa and liver injury. Health Canada’s review found that there may be a link between Pradaxa and liver injury [2].
Health Canada had 27 Canadian reports of severe liver injury. In most reports it assessed, other conditions and medicines could have caused the harm, as its summary review states.
May 28, 2014: Boehringer Ingelheim Announces Settlement
On May 28, 2014, Boehringer Ingelheim said it would settle about 4,000 claims in state and federal Pradaxa cases for $650 million, as reported by Healio [3].
Some claims alleged serious adverse events, such as major bleeding, from taking Pradaxa. The company called it a full settlement of the state and federal cases.
What Is Pradaxa?
According to the FDA label, Pradaxa (dabigatran etexilate) is a direct thrombin inhibitor. It is a prescription blood thinner [4]. Boehringer Ingelheim Pharmaceuticals distributes it in the United States.
Health Canada says Pradaxa is authorized to prevent blood clots after knee or hip surgery. It also treats clots in the legs and lungs. It helps prevent stroke in patients with atrial fibrillation, an abnormal heart rhythm.
Who May Be Affected?
The Pradaxa claims centered on people who took Pradaxa and then had serious adverse events such as major bleeding. Boehringer Ingelheim said it believed the plaintiffs’ claims lacked merit, according to the ABA Journal [5].
Whether any person can still bring a claim depends on individual facts, such as when and where the bleeding happened, so it needs an individual legal review.
Reported Injuries or Damages
Plaintiffs alleged that Pradaxa caused major bleeding. Those claims are allegations. The FDA label states that “PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding” in section 5.2.
AFP wrote that “Pradaxa has been blamed for more than 500 deaths caused by uncontrolled bleeding” [6]. That is a news report. It is not a regulator finding.
On May 13, 2014, FDA described a Medicare study. It included more than 134,000 patients aged 65 or older.
Compared with warfarin, Pradaxa was associated with a lower risk of clot-related strokes, brain bleeding and death among the Medicare patients FDA described.
It was also linked to more major stomach and bowel bleeding. FDA said it still considers Pradaxa to have a favorable benefit to risk profile.
Recall and Regulatory Background
The brand Pradaxa itself is not recalled. The only recall tied to dabigatran is the generic recall by Ascend Laboratories, described in the March 22, 2023 update above.
FDA issued safety communications on November 2, 2012, December 19, 2012 and May 13, 2014. A recall does not prove liability.
Evidence to Preserve
Keep any records that show what you took, when, and what happened afterward. Useful items include:
- Pradaxa prescription and pharmacy fill records, with dates and doses
- Medical records of the bleeding event, including hospital and emergency records
- Lab results
- A list of other medicines taken at the time
- Photographs
- Communications with doctors and the manufacturer
- A written timeline of events
Filing Deadlines
State law sets the time limits for filing a claim. The limit that applies to you depends on your state and on when the injury and its diagnosis happened.
Filing late can end a claim, however strong the facts. If you think Pradaxa harmed you, talk to a lawyer promptly. Bring your prescription and medical records so the review can start with real dates.
Frequently Asked Questions
Is There a Pradaxa Class Action Lawsuit?
Pradaxa claims were filed as individual suits, and no class action is part of the litigation. Judge David Herndon handled the federal suits, and about 1,500 more were filed in state courts.
How Much Was the Pradaxa Settlement?
The Pradaxa settlement was $650 million. It covered suits in federal court and in state courts in Illinois, Connecticut, California and Delaware. The company said the deal let it avoid the distraction and uncertainty of protracted litigation.
Has Pradaxa Been Recalled?
Pradaxa has not been recalled, but patients with affected lots of Ascend’s generic dabigatran were told to keep taking their medication and call their physician. Ascend’s phone number is 877-272-7901.
What Did Earlier FDA Communications Say About Pradaxa Bleeding?
Earlier FDA communications on Pradaxa bleeding came in 2012. In November 2012, FDA said bleeding rates with new use did not appear higher than with warfarin. In December 2012, it required a contraindication for patients with mechanical prosthetic heart valves.
References
- https://drugs.com/fda-alerts/3266-0.html
- https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00196
- https://www.healio.com/news/cardiology/20140528/boehringer-ingelheim-settles-pradaxa-litigation
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214358s009lbl.pdf
- https://www.abajournal.com/news/article/pradaxa_suits_will_be_settled_for_about_650m_drug_maker_says
- https://www.industryweek.com/operations/safety/article/21962920/boehringer-ingelheim-pays-650-million-in-pradaxa-lawsuits