Pradaxa has been under attack by doctors groups and patient advocates since 3,781 adverse effects and 542 deaths associated with the drug were reported to the Food and Drug Administration (FDA) last year. These numbers dwarfed those of all other monitored drugs, and Pradaxa was the number one drug in terms of deaths reported to the FDA in 2011. As a result, the FDA announced in December 2011 that it was conducting a safety review of the drug. Prescribed to patients who suffered medical problems such as stroke and irregular heartbeat, the blood-thinner potentially causes severe internal bleeding. Despite this fact, millions of people are taking the drug twice daily.
Between the Pradaxa’s initial release in October 2010 and February 2012, sales topped $1 billion. It was introduced to replace a similar, older drug: Warfarin, the brand name of which is Coumadin. This was the leading blood thinner on the market, but patients required weekly exams and dietary restrictions. The intention was for Pradaxa to require fewer check ups and no dietary issues. People were optimistic that it would be a simpler drug replacing Warfarin, but Pradaxa’s nasty side effects continue haunting patients even after discontinuing use. A Cleveland Clinic study (January 2012) found that Pradaxa may increase heart attack risk and can cause irreversible bleeding complications.
Legal experts expect this could be one of the largest mass torts in United States history. The number of claims could top 1,000 by next year, even with questionable claims thrown out. Last month, a judicial panel was established in the Southern District of Illinois to hear the Pradaxa cases emerging in the federal court system, to avoid dozens of courts hearing claims on the matter. The consolidated case is called In Re: Pradaxa Products Liability Litigation. Judge David Herndon, overseeing the case, issued an order in July denying attempts by Pradaxa’s manufacturer to dismiss the bleeding lawsuits. Judge Herndon ruled that although the manufacturer warned of internal bleeding, it did not properly address the risk of uncontrolled bleeding and its irreversible effects. Moving forward, there will be a massive amount of evidence documents, and the judges will likely select “bellwether” cases representative of all individual injuries. As many of the victims of Pradaxa are elderly, time is of the essence to allow them to see justice for the harms suffered.
If you or a loved one is the victim of a faulty drug like Pradaxa, our experienced personal injury lawyers at Sammons & Carpenter, P.C., can assist you in determining if you have a valid claim and how to proceed with your legal options. Call us today at 404-814-8949 or or contact our Atlanta product liability lawyers online.
See Our Related Blog Posts: