Pradaxa® Injury Lawsuits
Pradaxa® (dabigatran etexilate mesylate) is an anticoagulant or blood thinning medication manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. Pradaxa was approved by the Food and Drug Administration (“FDA”) in 2010 as the first drug in a new class of blood thinning medications. The drug was marketed as a more convenient replacement for older treatments, such as warfarin or Coumadin, which required patients to submit to frequent blood tests and adhere to certain diet restrictions.
Within the first year after Pradaxa was approved, more than 540 deaths in Pradaxa users were reported to the FDA as a result of complications after using the drug. In fact, in 2011 Pradaxa was linked to more injury and death reports than any other drug monitored by the Institute for Safe Medication Practices, a nonprofit that tracks the safety of medications. By 2011, hundreds of Pradaxa users filed lawsuits against Boehringer Ingelheim for damages suffered as a result of gastrointestinal bleeding, as well as brain and rectal bleeding.
These lawsuits claimed that Pradaxa put patients at a greater risk for life-threatening and fatal bleeding events because Boehringer Ingelheim overstated the efficacy of Pradaxa, failed to adequately disclose to patients that there was a lack of a reversal agent to control bleeding in patients, and failed to disclose to patients that blood tests would be required to monitor dosage levels for the safest use of the drug. Pradaxa lawsuits were later consolidated into a multidistrict litigation in the U.S. District Court for the Southern District of Illinois. Eventually, the litigation grew to nearly 4,000 individual cases. After approximately two years of litigation and before any case was tried to a jury, the lawsuits settled. Roger Denton had been appointed as co-lead counsel on behalf of all plaintiffs in the litigation and was instrumental in negotiating the settlement of these cases. In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle these cases.
Contact Schlichter Bogard & Denton for more information about filing a Pradaxa lawsuit.
British Medical Journal Investigation Questions the Safety of Pradaxa
In 2014, the British Medical Journal published an article by Editor Deborah Cohen, who reported that through the litigation it was discovered that Boehringer Ingelheim had withheld internal analysis that would improve the safe use of the drug. This internal analysis involved the company’s awareness of the need to monitor blood levels of Pradaxa in an individual’s blood stream and adjust doses of the drug in order to allow a safer use of the product and reduce the number of bleeding events. According to the BMJ article, the analysis was not shared with regulators because it likely would have affected sales.
If you have been injured or lost a loved one due to excessive bleeding after taking Pradaxa, you may be entitled to compensation through a Pradaxa lawsuit. Contact the experienced Pradaxa lawyers at Schlichter Bogard & Denton to discuss your legal rights.