The FDA approved of the anticoagulant drug Pradaxa in October 2010. Boehringer-Ingelheim’s product was pitched to patients with non-valvular atrial fibrillation who were at increased risk of stroke and embolism. Pradaxa was the first anticoagulant to hit the U.S. market in 50 years. The response was enthusiastic, with 275,000 prescriptions written between October 2010 and March 2011.
During that time, the FDA received 932 reports of serious adverse events, including 120 deaths and 500 reports of life-threatening bleeding, according to HarrisMartin. Since then, this number has skyrocketed. More information on the side effects of Pradaxa and resulting legal action can be found at pradaxalawsuit-info.co.
The latest court documents show that the number of Pradaxa complaints has increased from 1,133 on July 10th to 1,470 on September 11th, which represents an increase of nearly 30 percent in just two months.
Overview of the Pradaxa MDL
In August 2012, the Judicial Panel on Multidistrict Litigation ordered transfer and consolidation of all past and future federal Pradaxa lawsuits into MDL No. 2385, according to HarrisMartin. Judge David R. Herndon of the U.S. District Court for the Southern District of Illinois will preside over at least 21 personal injury and wrongful death lawsuits consolidated from courts in New York, Ohio, Florida, Illinois, Georgia, Connecticut and elsewhere. Seventy lawsuits originally filed in the U.S. District Court for the Southern District of Illinois will join the MDL, according to the official transfer order. Judge Herndon is no stranger to MDL cases, as he also presides over the Yaz/Yasmin product liability litigation. Of course, the formation of a Pradaxa MDL is just the first step in a very long process.
Pradaxa Lawsuit Mediator Assigned, with Possible Trials to follow in 2014 and 2015
On July 15th, Judge Herndon appointed a mediator to meet with parties at least once a month to discuss the possibility of settling the Pradaxa bleeding cases outside of court. If an agreement cannot be reached, a small group of lawsuits will be prepared for early trial dates, known as “bellwether” trials, which will expose the strengths and weaknesses of the cases. The judge has ordered at least four trials between August 2014 and February 2015 if there is no settlement offer. From there, hundreds of individual cases may be remanded back to U.S. District Courts for individual jury trials.
Boehringer-Ingelheim Prepares to Fight Claims that Pradaxa Causes Dangerous Side Effects
Meanwhile, it appears Defendant Boehringer-Ingelheim is digging into the trenches and preparing to fight these allegations. They recently sponsored a study published in the medical journal Circulation, which found that patients generally fare very well following the major bleeding events associated with Pradaxa.
Despite the lack of antidote, patients required less plasma during transfusions and shorter hospital stays than patients on warfarin, another anticoagulant drug. Overall, the company said Pradaxa bleeding events appeared to be “not worse” than warfarin bleeding events. Given the latest word from the Boehringer-Ingelheim camp, any substantial settlement offer from the drug giant is not imminent. In the meantime, individuals who believe they were injured by the medication are encouraged to contact a lawyer to see if they are eligible to file a Pradaxa lawsuit.