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Legal and scientific developments on Pradaxa, Xarelto

As wrongful death and other pharmaceutical injury lawsuits remain pending in regard to the use of two blood thinners, scientists are mercifully closing in on the development of a drug that can stop the bleeding these drugs have been known to cause. The U.S. Food and Drug Administration approved a bleeding stopper for Pradaxa (dabigatran) on Friday. Meanwhile, a drug that would reverse the anticoagulant effects of Xarelto is a little closer to market.

The problem, however, is that people bled internally, in many cases fatally, after taking a drug that the doctors and patients did not know, but the manufacturers should have known, had no reversal agent.

Only more than 100 federal Pradaxa lawsuits are pending out of nearly 2,700 filed at a single multidistrict litigation court in Southern Illinois. These cases do not count Pradaxa lawsuits that were filed in state courts. A lot of death and injury occurred by the time the FDA approved Friday the bleeding antidote Praxbind (idarucizumab) for use in patients who are taking the Boehringer Ingelheim blood thinner.

The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.

"The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug's effects is medically necessary," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Today's [Friday's] approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can't be controlled."

Patients and the surviving loved ones of decedents did not file Pradaxa lawsuits for nothing. Surely, a reversal agent is a good thing, but it came too little too late for a lot of patients, many of whom are no longer with us because they took a drug the risks of which neither they nor their physicians understood.

As the brief of a Pradaxa plaintiff explained in 2012, "The evidence will establish that Defendants knew or should have known that the warnings and other information distributed with regard to the use of Pradaxa were inadequate. Therefore neither the Decedent nor her doctors received adequate warnings relative to the risks associated with the use of Pradaxa. The evidence will establish that such defects were a producing and/or proximate cause of decedent's injuries and death."

Moving on now to the other drug: Xarelto lawsuits are at a different stage. There is still time to file those actions. Indeed, they continue to be filed, and the Xarelto attorneys at Reich & Binstock represent some of these patients. Actually, as of Thursday, about 1,700 Xarelto lawsuits were pending before a federal multidistrict litigation court in the Eastern District of Louisiana.

The panel of federal judges who centralized Xarelto lawsuits before a single court for pretrial coordination wrote the following in December 2014: "These actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding or other injuries as a result of taking Xarelto (rivaroxaban) and that defendants did not adequately warn prescribing physicians or consumers of the risks associated with Xarelto, including the potential for severe or fatal bleeding and the unavailability of a reversal agent to counteract Xarelto's anticoagulation effects. Issues concerning the development, manufacture, regulatory approval, labeling, and marketing of Xarelto thus are common to all actions."

There has been a seemingly tardy yet welcome development in regard to Xarelto as well. A pharmaceutical company announced in September that its scientists have made significant progress toward the production of a reversal agent. Additionally, representatives will present the findings of an ongoing study to an American Heart Association forum in November.

This is good news, to be sure; nevertheless, a lot of pain, suffering and death may have been averted had Janssen Pharmaceuticals promulgated the risk of irreversible Xarelto bleeding before so many people had gotten sick or had passed.

The injured patients deserve justice, and so do the loved ones of decedents. The best way to get it is to work with an attorney with a laudable track record in taking on the big pharmaceutical companies and in getting satisfactory results. Reich & Binstock is such an option, and the consultation is free.

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