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Pradaxa MDL 2385: Consolidation Imminent

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What is an MDL?

The term MDL is an acronym for multidistrict litigation. While multidistrict litigation may appear to function in some ways like a class action, it is in fact very different. A class action is a lawsuit where a few people sue on behalf of themselves and a large group with similar claims in one lawsuit resolving all class member claims.

Multidistrict litigation is very different from a class action. Most multidistrict litigation is conducted in the federal courts when enough suits are filed against the same defendant for the same or similar injury. When this happens, a moving party will ask the Judicial Panel on Multidistrict Litigation (JPML) to decide whether or not the cases should be consolidated into an MDL proceeding, and where it will be located. If an MDL is established, all federal courts with cases will transfer their dockets to the MDL court before one judge who will manage all cases as one case.

What is Pradaxa?

Pradaxa is the brand name for dabigatran etexilate. It is relatively new, having only been approved by the FDA in late 2010, and is a prescription blood thinner used to prevent stroke and blood clots in patients with non-valvular atrial fibrillation.

Pradaxa is manufactured by German pharmaceutical company Boehringer Ingelheim and marketed as an alternative to Coumadin (warfarin), a widely used oral anticoagulant. It is the first oral blood thinner approved by the FDA in more than 50 years.

From October 2010 through August 2011 about 1.1 million prescriptions were dispensed in the U.S. and about 371,000 patients received the prescriptions from U.S. outpatient retail pharmacies. Since then, the drug has reached blockbuster status, hitting the $1 billion sales range and helping Boehringer report a significant earnings increase.

Unfortunately, along with its skyrocketing sales, prevalent use of Pradaxa led to more FDA reports of fatalities of than any other drug last year. Pradaxa side effects so far have included deaths (542), hemorrhages (2,367), acute renal failure (291) and strokes (644), according to the Institute for Safe Medication Practices' QuarterWatch program, which gets its data from the FDA MedWatch reporting system.

Will There Be a Pradaxa MDL Consolidation?

At last count, 48 Pradaxa side effects lawsuits had been filed in federal courts across the United States. The largest group of these cases exists in the United States District Court for the Southern District of Illinois, East Saint Louis Division. United States District Court Judge David Herndon is presiding over at least 18 of these cases. The Illinois litigation is moving forward, with significant rulings already having taken place.

On July 26, 2012, the JPML heard arguments from multiple parties concerning the venue for the potential national consolidation of Pradaxa cases. Our firm represented the movant in the consolidation proceedings, and we requested transfer to the Southern District of Illinois. Other parties argued for the Northern District of Ohio, the Southern District of Florida, and the Eastern District of New York. The defendants do not opposed the consolidation of Pradaxa cases.

The parties involved anxiously await the JPML decision on where the cases will be handled going forward.