Overview: A multidistrict litigation (MDL) has been established for federal lawsuits claiming that Pradaxa caused severe, potentially fatal bleeding events. The cases will be consolidated in the U.S. District Court for the Southern District of Illinois before Judge David R. Herndon.
- Pradaxa lawsuits are consolidated into an MDL in the U.S. District Court for the Southern District of Illinois
- Plaintiffs are claiming that the anticoagulant caused serious, irreversible bleeding events; there is no antidote to stop the bleeding in Pradaxa patients
- In April, Parker Waichman LLP filed a lawsuit on behalf of a man who suffered cerebral hemorrhage after taking the drug
Product: Pradaxa (dabigatran)
Manufacturer: Boehringer Ingelheim Pharmaceuticals
Side Effects & Complications
- Cerebral hemorrhaging
- Gastrointestinal (GI) hemorrhaging
- All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas
Panel Issues Transfer Order
On Wednesday, the U.S. Judicial Panel on Multidistrict Litigation issued a Transfer Order centralizing all Pradaxa injury lawsuits to the U.S. District Court for the Southern District of Illinois. The case will be known as In Re: Pradaxa (dabigatran etexilate) Products Liability Litigation. According to the transfer order, “all the responding parties support centralization, but disagree as to the location of the transferee district”.
A multidistrict litigation (MDL) is often established in mass tort litigation when there are many lawsuits that share common issues against a Defendant. Consolidating the cases before one court and one judge helps streamline the legal process and typically makes the litigation more efficient.
In general, the lawsuits allege that Pradaxa caused bleeding events such as gastrointestinal or cerebral hemorrhaging, and accuse the manufacturers of failing to warn users about these serious risks. The national law firm of Parker Waichman LLP filed one such lawsuit in April on behalf of Tennessee man who suffered from a brain bleed after taking Pradaxa.
Pradaxa Bleeding Risks
Pradaxa is an anticoagulant used to prevent blood clot, stroke and heart attack in patients with atrial fibrillation. The U.S. Food and Drug Administration (FDA) approved the drug in October 2010. Although Pradaxa is a new drug, it appears to have a significant drawback. Unlike older anticoagulants, there is no way to stop the bleeding if a patient begins to hemorrhage.
Pradaxa raised serious safety concerns last November, when approximately 260 Pradaxa-related deaths were reported to the European Medicines Agency (EMA) database. The following month, the FDA initiated a safety review of the drug.
According to the Institute for Safe Medication Practices’ (ISMP) latest QuarterWatch report, the FDA received reports of injuries related to Pradaxa than any other drug last year. The drug was associated with the greatest number of deaths, hemorrhage, acute renal failure and stroke.