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Pradaxa Bleeding Lawsuits Moving Forward in Federal Litigation

Sep 7, 2012 | Parker Waichman LLP

In less than a month, more than 50 cases have been added to the newly-formed Pradaxa Multidistrict Litigation that claims the blood thinner Pradaxa (dabigatran) causes serious and fatal gastrointestiinal  bleeding and cerebral hemorrhaging and is no safer or more effective than its predecessor.

According to a report from The Madison Record, a local legal journal, there are now 78 Pradaxa bleeding lawsuits included in the multidistrict litigation currently in U.S. District Court for the Southern District of Illinois. The Judicial Panel on Multidistrict Litigation approved a Plaintiff motion to have Pradaxa lawsuits consolidated there in early August and at the time there were just 21 lawsuits included in it.

That number is expected to grow considerably as more people realize the new blood thinner drug they’re taking is actually putting them at a greater risk of suffering severe bleeding and death than warfarin, the drug that was for decades the standard bearer for people looking to avoid blood clots that could lead to stroke and death.

U.S. District Judge David Herndon is presiding over the Pradaxa MDL and on Aug. 17 he indicated that he’d like this case to move forward as quickly as possible. Herndon was tapped to preside over this case because of his history with dealing in pharmaceutical lawsuits. He is currently presiding over the Yaz, Yasmin MDL.

In his ruling, according to the report, Herndon said, "It is clear that whether the number of plaintiffs remain static or increase, the allegations that have been made are quite serious.”

The 78 Pradaxa hemorrhaging lawsuits currently on record in the Pradaxa MDL claim that Boehringer-Ingelheim, the German manufacturer of the drug, failed to warn about the dangerous side effects associated with the drug, namely its link to dangerous and uncontrollable bleeding episodes that lead to gastrointestinal bleeding and cerebral hemorrhaging that eventually cause death.

Unlike warfarin, which had been prescribed for years for the same purpose, Pradaxa has no antidote so a person taking the drug who suffers even minor traumatic bleeding could see that problem progress quickly. Those who do suffer severe bleeding while taking Pradaxa must seek immediate emergency medical attention and even then, doctors are nearly powerless to stop the bleeding because there is no antidote like there is for warfarin.

In its short time on the market (approved for use in 2010), Pradaxa has been blamed for at least 250 deaths, many of which could have been avoided had the patient not been taking the drug.

Pradaxa is heavily marketed on television and in other media but those advertisements often fail to mention the serious risk of fatal side effects associated with the drug.

Herndon said his decision to move the Pradaxa MDL along quickly would serve as a benefit to patients and doctors who are faced with the daily dilemma of deciding whether or not the drug is safe and effective. In declaring the intended pace of this MDL, Herndon notified attorneys representing both sides of the case that if they wish to serve in leadership roles, they should be prepared to move quickly. The judge has scheduled an Oct. 3 conference call to establish early procedures in the MDL and to begin picking leaders for both sides.

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