Fla. Couple Sues Boehringer Ingelheim for Pradaxa Bleeding

James Guy Wilhelm and Joan S. Wilhelm of Florida are suing Boehringer Ingelheim for the uncontrollable bleeding James allegedly sustained from taking the blood thinning medication Pradaxa. 

According to his Pradaxa lawsuit, James had been on warfarin but switched to Pradaxa due to its higher efficiency ratings. Due to his non-valvular atrial fibrillation, he was at a high risk for developing stroke, and wanted a stronger prevention medication.

While James discovered Pradaxa to be more powerful than warfarin, he also found it to be more dangerous. Not long after he was prescribed Pradaxa, James allegedly started suffering from uncontrollable internal bleeding. Unfortunately, James discovered that, unlike Warfarin, Pradaxa had no reversal agent to stop the bleeding. As a result, he required emergency medical care.

James survived the ordeal, but was reportedly outraged that he had not been warned of this possible occurrence. According to the Pradaxa lawsuit, there were no warnings or indications about bleeding risks on the drug’s label. Had the plaintiff known about the potential for uncontrollable Pradaxa bleeding, James says he never would have taken the medication.

The Pradaxa lawsuit accuses Boehringer Ingelheim of manufacturing, selling, marketing and distributing a dangerous drug. The charges against the company include negligence, false advertising, concealing information and misrepresenting a product.

Overview of Pradaxa Complications

Pradaxa (dabigatran etexilate) is a powerful anticoagulant that was first approved by the U.S. Food & Drug Administration (FDA) on Oct.19, 2010. Similar to its older competitor warfarin, Pradaxa is used as a blood thinner to prevent stroke and systemic embolism in high risk patients. Pradaxa is one of the fastest-growing drugs in the United States, with sales reaching $1 billion in Boehringer’s 2011 fiscal year.

While Pradaxa is widely considered a success, there have been many concerns about a potential design flaw in the drug itself. While Pradaxa worked well as a blood thinner, it was apparently too good at its job, and started causing major concern for the FDA. It was discovered that in many patients, Pradaxa was causing uncontrollable internal bleeding, which led to some deaths. While Boehringer Ingelheim is working on a remedy for this condition, there is currently no reversal agent for Pradaxa.

In 2011, there were 3,781 Pradaxa injury reports, and 542 reports of death associated with Pradaxa that were submitted to the FDA. These reports caused the agency to start its own investigation into the drug in December 2011. In 2012, a study conducted at the University of Pécs in Hungary concluded that patients taking Pradaxa were three times more likely to suffer internal bleeding incidents than patients who took other blood thinners.

On January 17, 2012 Boehringer updated the warning label to indicate the possibility of Pradaxa internal bleeding, adding that there is no currently available reversal agent. Despite this warning, many people are filing Pradaxa lawsuits, claiming that the manufacturer failed to adequately warn about the bleeding risks associated with the drug. These lawsuits have been grouped into multidistrict litigation (MDL) in Illinois federal court.

The Pradaxa bleeding MDL is In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the U.S. District Court for the Southern District of Illinois.

File a Pradaxa Injury Lawsuit Today

If you believe that you or a loved one have been the victim of a Pradaxa internal bleeding injury, you have legal options. Please visit the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned Pradaxa lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The Pradaxa attorneys working this investigation do not get paid until you do.