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Pradaxa (dabigatran) is a blood-thinning drug used to reduce the risk of ischemic stroke and blood clots in people with atrial fibrillation. The responsible drug company is Boehringer Ingelheim Pharmaceuticals.
Since Pradaxa was approved by the FDA in October 2010, this popular anticoagulant medication has been associated with the following side effects:
- brain bleeds / hemorrhages
- intracranial hemorrhages
- hemorrhagic strokes
- Serious bleeding
- gastrointestinal (GI) bleeds
- rectal bleeding
- Irreversible life-threatening bleeding events
- Deaths as a result of excessive bleeding
Here are some of the possible Pradaxa-related bleeding events that have been reported to us:
Pradaxa – Gastrointestinal (GI) Bleed – 74 yr old man
Pradaxa – Gastrointestinal (GI) Bleed; Massive Bleeding – Death – 24 yr old man
Pradaxa – Intracranial Hemorrhage – Death – 86 yr old man
Pradaxa – Serious Bleeding – 62 yr old woman
Pradaxa – Serious Bleeding within the Pericardium (sack that surrounds heart) and Abdomen – 89 yr old woman
Pradaxa – Serious Bleeding within the Pericardium (sack that surrounds heart) – 75 yr old man
Pradaxa – Serious Bleeding Event – 85 yr old woman – almost fatal occurence; in hospital for 2 weeks, followed by 7 weeks in nursing facility
If you experienced serious side effects from the use of Pradaxa, or a person died due to an adverse reaction while taking Pradaxa, you may have a claim for legal compensation. Such claims involving a serious injury or death caused by the use of Pradaxa are made by filing a lawsuit in court. All states have statutes of limitations that determine the deadlines by which to file lawsuits involving Pradaxa side effects.
We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
As can be seen from the following set of drug safety alerts, Pradaxa has caused significant concern among doctors and patients since soon after it first became available for use in the US.
In early December 2011 the FDA announced it would evaluate reports of bleeding in patients taking Pradaxa that have been submitted to the agency’s Adverse Events Reporting System (AERS) database to determine whether serious side effects are occurring at a higher rate than should be expected.
From the ISMP QuarterWatch 2011 Quarter 1 edition, which was published January 12, 2012, we get this summary of those adverse event reports to the FDA as regards the “substantial bleeding risks” associated with Pradaxa. In particular, gastrointestinal hemorrhages and hemorrhagic strokes were identified as some of these serious side effects in those elderly patients using Pradaxa.
The next Pradaxa safety “update” came from the ISMP QuarterWatch 2011 Quarter 2 edition, which was released April 5, 2012:
[Pradaxa], a new anticoagulant intended to reduce the risk of stroke, was a suspect drug in 856 reported cases, more than any other regularly monitored drug, but showed a decrease from 931 reports in the previous quarter. The new quarterly total included 117 reported patient deaths. With 511 reported cases of hemorrhage, and a median patient age of 80 years, these new bleeding reports reinforce our concern that vulnerable older patients may be receiving an overdose of this one-size-fits-all drug.
Due to these serious side effects, beginning in 2012 a growing number of personal injury and wrongful death Pradaxa lawsuits were filed against Boehringer Ingelheim Pharmaceuticals, Inc.
In August 2012 this federal court Pradaxa MDL, or case consolidation, was created: IN RE: PRADAXA (DABIGATRAN ETEXILATE) PRODUCTS LIABILITY LITIGATION, MDL No. 2385.
In May 2014, following several years of legal proceedings in the Pradaxa MDL, the defendant Boehringer Ingelheim agreed to settle most if not all of the approximately 4,000 filed Pradaxa lawsuits. This so-called “global-settlement” deal was reached just as the first federal court Pradaxa cases were set to go to trial in September 2014.
In May 2015 U.S. District Judge Herndon issued an Order which disbanded and ended the federal court Pradaxa MDL litigation he had presided over since August 2012. His reason for doing so: There were no active federal court Pradaxa lawsuits pending other than those which were part of the 2014 global settlement by Boehringer.
But at about the same time as Judge Herndon’s Order, there began to be a number of new Pradaxa lawsuits being filed in various state courts around the country. And this was the start of what has been referred to as a “round two” or the “second wave” of Pradaxa drug injury litigation.
The only difference, essentially, is that this round two or second wave of Pradaxa litigation is being pursued at the state court level.
The bottom line is this: If you experienced serious side effects from the use of Pradaxa, or a person died due to an adverse reaction while taking Pradaxa, you may still have a claim for legal compensation.
- The Pradaxa Gastrointestinal (GI) Bleeding Debate Continues: Is There An Increased Risk Or A Risk Reduction With Pradaxa Use?
- Pradaxa Adverse Drug Events (ADEs) Result In Death More Often Than Other Anticoagulants / Blood Thinners ADE Reports
- Pradaxa Safety Debate Continues During November 2012 With Many Different Conclusions And Positions
- Pradaxa Hemorrhage Cases May Occur In Oldest Patients Due To Age-Related Decline In Renal Function
- Pradaxa: FDA Investigating Possible Higher Than Expected Incident Rate Of Serious Bleeding Side Effects
All content by attorney Tom Lamb