Boehringer Ingelheim announced on May 28, 2014 an agreement to settle litigation involving their prescription blood thinner Pradaxa (dabigatran). The company estimates that the Pradaxa settlement of $650 million will close nearly 4,000 cases involving the drug in the United States. A representative from Boehringer Ingelheim stated the company feels the drug is safe as it carries risk levels within accepted parameters. The FDA is in agreement. However, the company wants to put this legal battle behind them and move forward, rather than engaging in long-term litigation that could take years to resolve.
Pradaxa And Its Uses
Anticoagulants like Pradaxa are blood-thinners. They are used to reduce the chance of stroke and blood clots due to atrial fibrillation that is not caused by a heart valve problem. The issue is in how much a person is actually bleeding due to the drug. One of the primary complaints against Pradaxa is the lack of a counter measure to enable blood clotting in the event the patient is injured or develops internal bleeding.
Warfarin was the go to oral anticoagulant for many years. Medical care providers can give a person on warfarin an injection of Vitamin K to cancel out warfarin’s anticoagulant properties. Pradaxa, Xarelto (Johnson & Johnson), and Eliquis (Bristol-Myer Squibbs) do not have such a safe guard available.
The FDA launched a new study to compare dabigatran and warfarin after long-term speculation in the European and American markets.
Though Pradaxa was found to perform better than warfarin in that study conducted by the FDA of 134,000 Medicare patients, it was also found to have an increased risk of serious gastrointestinal bleeding. This newer review screened an older segment of patients whereas the first screened patients of multiple age groups. The FDA reports it will continue to conduct studies to pinpoint the reason that Pradaxa causes greater GI bleeding than warfarin. The Pradaxa settlement will have no bearing on continued studies to pinpoint the cause.
Pradaxa’s statistics scored better in reduced number of ischemic strokes, deaths, and bleeding in the brain against warfarin in the study group.
Do I Need Legal Counsel?
The Pradaxa settlement opens the door to getting a number of these pending lawsuits rectified. In the event that you or a loved one have experienced harm or death due to uncontrollable bleeding after taking Pradaxa, contact Attorney Group today. We can provide a no obligation consultation at no cost to you. Should you decide to pursue a case, we can connect you with an experienced attorney who can help you through the legal process.