PRADAXA BLEEDING LAWSUITS: LITIGATION UPDATE
On October 19, 2010, the U.S. Food & Drug Administration (FDA) approved PRADAXA (DABIGATRAN ETEXILATE) a novel blood thinner for use in patients suffering from Atrial Fibrillation (AFib) in the United States. Today marks the 2 year anniversary of the drugs approval and a milestone in a troubled history now marked by National litigation and PRADAXA CASES.
Manufactured by Boehringer Engelheim, PRADAXA was intended to compete with WARFARIN and COUMADIN, which have been available and extensively studied for over 50 years. The launch and approval of PRADAXA were also intended to beat other novel blood thinners to the market place in the US and abroad. However, the drugs raised the concerns of International Health Authorities a year ago when a surprising number of deaths were reported internationally.
PRADAXA BLEEDS, or PRADAXA BLEEDING events involve uncontrollable bleeding due to a suspected overdose of the blood thinner, coupled with renal impairment, as well as the fact there is no antidote or quick reversal agent. PRADAXA DOSING in United States is 75 mg or 150 mg (pictured above) and is one factor in a growing number of lawsuits. The bleeding events may manifest themselves as gastrointestinal bleeds or aggravate pre-existing stomach ulcers that were previously inactive or asymptomatic.
The Institute for Safe Medication Practices, (ISMP), A Nonprofit Organization Educating the Healthcare Community and Consumers About Safe Medication Practices, has repeatedly analyzed FDA adverse event data relating to PRADAXA or DABIGATRAN and published results in their QuarterWatch publication that reflect:
- 542 REPORTED DEATHS WERE LINKED TO PRADAXA OR DABIGATRAN
- 817 DIRECT REPORTS TO FDA IN 2011 AS SUSPECT IN EVENT
- 3,781 DOMESTIC SERIOUS ADVERSE EVENTS IN 2011
- 2,367 HEMORRHAGE REPORTS - MORE THAN ANY OTHER DRUG
- 291 EVENTS INVOLVING ACUTE RENAL FAILURE
- 644 STROKES
- 15 CASES OF RENAL FAILURE WHERE IT WAS SUSPECT
It is anticipated that the PRADAXA LAWSUIT litigation process will seek information and revolve around:
- PRADAXA PACKAGE INSERT INFORMATION & DISCLOSURES
- PRADAXA REVERSAL AND THE LACK OF AN ANTIDOTE
- PRADAXA HALF LIFE AND PRADAXA DOSING OF 75MG & 150MG
PRADAXA MDL 2385 -
A PRADAXA MDL, MDL 2385 - PRADAXA DABIGATRAN ETEXILATE PRODUCTS LIABILITY LITIGATION, has been established in the Southern District of Illinois, United States District Court. The centralized proceedings are being overseen by The Honorable David R. Herndon, Chief Judge. Our office personally attended the Initial Conference on October 3, 2012, at which time the court met with counsel for interested parties and entered a number of orders setting important scheduling deadlines.
Our office is actively investigating and representing clients that suffered a PRADAXA BLEEDING event and their families. We are carefully monitoring for any PRADAXA RECALL and will post related information at www.RecallPradaxa.com There have in fact been 2 little known, or publicized, recalls of PRADAXA since October 2010. Please let us know if you need or want additional information regarding this litigation. FREE CASE EVALUATIONS are available through use of the contact form on this website or by using the link below.