Pradaxa Trials: Fines Against Manufacturer Upheld in Court
Pradaxa, approved in 2010 by the U.S. Food and Drug Administration to treat blood clots and strokes in those with atrial fibrillation, has helped countless patients living with the condition. However, the medication has recently raised concerns that use of the drug may increase a patient’s risk of suffering from internal bleeding and death. As a result, plaintiffs across the country are filing claims currently pending in Pradaxa trials in an effort to seek compensation for their injuries. If you have questions about Pradaxa lawsuits, or if you have been injured after taking Pradaxa, contact the American Injury Attorney Group today for your free consultation.
Fines Upheld in Pradaxa Trials
Court documents indicate that a federal appeals court has overturned some of the most recent sanctions pending in the Pradaxa trials, finding that the presiding judge does not have the authority to order Boehringer Ingelheim employees from Germany to the U.S. However, sanctions that have been put in place that require the drug maker to pay $1 million for discovery violations were upheld.
U.S. District Judge David R. Herndon placed several sanctions on the drug maker in December 2013, including $500 per case pending in the multidistrict litigation, after learning that Boehringer Ingelheim failed to preserve numerous files relevant to the Pradaxa trials pertaining to bleeding complications and also withheld information during the discovery process. The drug maker subsequently challenged these sanctions.
Judge Herndon ruled in December 2013 that the sanctions were appropriate due to bad faith actions during the litigation process. He claimed that the drug maker’s excuse for losing data pertaining to the medication and employees working on the drug included absurd claims such as an erased hard drive by an operating system update and that the company did not understand the Pradaxa litigation was coming until August 2013. This announcement comes as both parties are preparing for the first Pradaxa trials in the MDL, which are currently scheduled to begin in August 2014.
Pradaxa, a blood thinner, was the first of a new group of anticoagulants that the drug maker promoted as a superior alternative to warfarin for stroke prevention. However, shortly after Pradaxa was introduced, patients who had experienced uncontrolled bleeding events submitted a record number of adverse event reports to the FDA.
Warfarin has been the most popular anticoagulant for decades. Although Pradaxa does not require as much monitoring as its predecessor, concerns have arisen over the lack of a reversal agent to stop the severe blood thinning effects of the drug. Unlike warfarin, which can be quickly reversed with plasma and a dose of vitamin K, there is no such antidote for Pradaxa.
The Institute for Safe Medication Practices has also released a warning pertaining to Pradaxa use. The organization asserts that those taking the medication may be five times more likely to die from complications from internal bleeding than those who chose other drugs. Additionally, a 55 percent increase of suffering from internal bleeding was noted in a recent clinical trial that analyzed Pradaxa and other blood thinners and their possible effects on the body.
Do You Believe You Have a Claim?
If you have been injured, have suffered from internal bleeding or other complication while taking Pradaxa or if you have questions about the pending Pradaxa trials, contact the American Injury Attorney Group today. We will provide you with a free, no-obligation consultation, help you determine if you are eligible to pursue a claim against Boehringer Ingelheim to recover damages for your condition, and connect you with an affiliated attorney who will help you throughout the legal process. You may also be entitled to file a wrongful death lawsuit on behalf of a loved one who passed away due to complications caused by Pradaxa.