The Bottom Line: Pradaxa Is Still Associated With Serious Bleeding Events, Including Patient Deaths, And New Pradaxa Drug Injury Cases Are Still Being Filed
Pradaxa (dabigatran) is a relatively new blood thinner, or anticoagulant, medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF). It was approved for use by the US Food and Drug Administration (FDA) in October 2010. Boehringer Ingelheim Pharmaceuticals, Inc. markets this prescription anticoagulant drug.
Pradaxa is part of a class of novel oral anti-coagulants (NOACs), which includes Xarelto (rivaroxaban), Eliquis (apixaban), and Savaysa (edoxaban). These NOACs are alternatives for patients who had been or would have been treated with Coumadin or warfarin in the past.
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:
[Pradaxa] accounted for 505 reported cases of severe bleeding resulting in death, disability, hospitalization or other serious outcome in the first quarter—more than any other drug we regularly monitor. The hemorrhage cases were occurring in the oldest patients with a median age of 80, and 25% of patients experiencing hemorrhage were 84 years or older, raising the question of whether the oldest patients are getting too high a dose.
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 the United States Judicial Panel on Multidistrict Litigation (JPML) issued an Order which consolidated all federal court Pradaxa drug injury lawsuits into the following case: IN RE: PRADAXA (DABIGATRAN ETEXILATE) PRODUCTS LIABILITY LITIGATION, MDL No. 2385. This federal court Pradaxa MDL, or case consolidation, was placed in the United States District Court for the Southern District of Illinois, with Chief Judge David R. Herndon presiding over the Pradaxa MDL litigation.
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Returning to the drug safety realm for a moment, in December 2013 the FDA posted for public comment on a proposed protocol of a new study intended to be a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of Pradaxa as opposed to Coumadin or warfarin.
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 a statement issued by Boehringer at that time, the drug company said that it stood behind the safety and efficacy of Pradaxa and it continued to believe that the thousands of Pradaxa lawsuits lacked merit, but that settling those drug injury cases allowed the company to move on with its business interests.
Reportedly, Pradaxa had been prescribed to an estimated 850,000 patients in the United States as of May 2014, and is still widely used in the US, today.
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.
These more recent Pradaxa lawsuits claim that Boehringer Ingelheim has continued to provide inadequate warnings about the risk of bleeding from Pradaxa side effects. Put otherwise -- despite the drug company's effort to buy its peace by means of the earlier large Pradaxa MDL settlement back in 2014 -- Boehringer is still, to this point in time, being sued for its alleged failure to warn about the full and real extent of the substantial bleeding risks associated with Pradaxa.
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. Such claims involving a serious injury or death caused by the use of Pradaxa are made by filing a lawsuit in court. It is important to know that all states have certain filing deadlines, or statutes of limitations, by which to file lawsuits involving Pradaxa side effects.
Of course, we will continue to monitor the legal, medical, and regulatory aspects of this Pradaxa situation, and report significant developments here.
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