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Shezad Malik MD JD
Shezad Malik MD JD
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MDL Centralization of Pradaxa Bleeding Lawsuits Pending

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As a Pradaxa Hemorrhage and Bleeding Side Effect attorney, I have been writing about the alleged problems with Pradaxa, a new anticoagulant manufactured by Boehringer Ingelheim.

Pradaxa lawsuits, involve personal injury and product liability claims brought by users of the anticoagulant who suffered uncontrolled bleeding. Pradaxa side effects reportedly include a risk of Pradaxa bleeding, according to reports from the European Medicines Agency. Pradaxa, known generically as dabigatran, has been linked to between 50 and 256 deaths that reportedly involved Pradaxa side effects.

JPML Motion Filed

In May, a Plaintiffs' motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting for the centralization of all Pradaxa bleeding and death cases filed in federal courts throughout the United States.

Pradaxa Bleeding and Death Lawsuits

Many lawsuits alleging bleeding and sometimes fatal problems with Pradaxa have been filed against Boehringer Ingelheim in U.S. District Courts. These lawsuits allege that the drug maker failed to adequately research their medication, warn about the risk of severe bleeding events or provide sufficient information about the lack of a reversal agent to reverse the blood thinning effects of the drug.

What is Pradaxa?

Pradaxa (dabigitran) was introduced by Boehringer Ingelheim in October 2010, as a superior alternative to Coumadin (warfarin) for prevention of stroke among patients with non-valvular atrial fibrillation. Patients with atrial fibrillation may be at a higher risk of blood clots, which can cause a stroke if they travel to the brain. In some countries, Pradaxa is approved to prevent venous thromboembolism, although it is not approved in the US for this use.

Pradaxa Heart Attack

A study published in January 2012 in the Archives of Internal Medicine suggested a link between the use of Pradaxa and a slightly higher risk of heart attack or acute coronary syndrome when compared with similar medicines. Researchers compared the use of Pradaxa to warfarin, enoxaparin or a placebo and found that the relative increase in risk ranged from 27 to 33 percent in patients who used Pradaxa.

Researchers recommended that further study be done on the increased risk of heart attacks in patients who take Pradaxa and that clinicians weigh the risks of Pradaxa along with the benefits.

Pradaxa Overdose-No Antidote

Warfarin, can be reversed with a dose of vitamin K. No antidote is available for users of Pradaxa who start to bleed.
Patients have literally bleed to death while doctors and hospitals have no treatment options except for emergency dialysis.

Further compounding the problem, is that there is no standard method with which to measure the anticoagulant effects of Pradaxa, unlike Coumadin.

Pradaxa Bleeding Reports

There were more reports of Pradaxa bleeding problems than were associated with any other medication, including the more widely used warfarin.

According to a report issued last month by the Institute for Safe Medication Practices (ISMP), the FDA received at least 2,367 reports of hemorrhage and 542 patient deaths involving Pradaxa during 2011.

Why MDL?

Centralizing the Pradaxa bleeding side effect cases before one judge is recommended in complex pharmaceutical litigation for coordinated pretrial proceedings to reduce duplicative discovery, eliminate conflicting pretrial rulings from different judges and to have one forum for the parties, the witnesses and the courts.

Although the cases in an MDL would be handled in a coordinated manner, each lawsuit remains an individual case.

Decision for MDL Court Pending

The U.S. JPML has scheduled oral arguments on the formation of the Pradaxa MDL for July 26, at a hearing to be held at the Carl B. Stokes U.S. Courthouse in Cleveland, Ohio.

Read more about Pradaxa side effects and lawsuits here and visit my blog for further information.