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.
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