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Pradaxa Litigation Growing, JPML Considers Consolidation

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Though approved only two years ago in October 2010, Pradaxa has been the subject of increasing reports of injuries including severe bleeding events, gastrointestinal bleeding, and death. In December 2011, the FDA announced that it was looking into these reports to determine whether or not they are occurring more often than would be expected, based on the clinical trials submitted for the initial FDA approval.

Since then, more patients have filed Pradaxa lawsuits, all making similar claims against drug maker Boehringer Ingelheim. Currently, 21 such cases have been filed by a Pradaxa lawyer in federal courts around the nation. It was only a matter of time before someone suggested consolidation. Now that that has happened, how much will Pradaxa litigation continue to grow?

Plaintiff Files Pradaxa Lawsuit and Motion to Consolidate

Vera Lee Sellers filed her Pradaxa lawsuit on May 14, 2012, in the U.S. District Court for the Southern District of Illinois. Represented by her Pradaxa lawyer, she has now filed a motion to transfer all other federal cases to the same court for consolidated pretrial proceedings before the Honorable David R. Herndon.

According to the motion, consolidation is appropriate because all the cases share similar allegations against Boehringer Ingelheim, including failure to warn and defective design. In addition, each of the cases shares similar questions of fact and law, and discovery has not yet begun in any of them. The U.S. Judicial Panel of Multidistrict Litigation has issued a notice of a hearing session to be held July 26, 2012, during which they will consider the motion.

Critics Call for Increased Warnings

As the number of lawsuits increase, critics claim that Pradaxa still does not adequately warn patients or physicians about the risks of serious bleeding events. In a June 6, 2012 report, the Philadelphia Inquirer noted that Pradaxa led all other medications in 2011 for number of deaths reported to the FDA, including over 500 deaths, while the other major blood-thinner, warfarin, was associated with only 72 deaths.

A March 6, 2012 report in the Journal of Neurosurgery detailed a case of an elderly man that came into the emergency room with Pradaxa bleeding, and doctors had no readily available antidote to stop it. Unlike warfarin, whose anti-coagulant effects can be reversed with injections of vitamin K, Pradaxa has no such reversal agent, making bleeding events particularly dangerous.

FDA Warnings Behind?

In September 2011, the New Zealand pharmaceutical regulatory authority alerted physicians to the risk of gastrointestinal bleeds with Pradaxa, noting it was higher than with warfarin. On August 11, 2011, Japan's pharmaceutical regulatory authority announced it was requiring a boxed warning on Pradaxa to alert patients to the risk of severe bleeding.

The FDA required the manufacturer to update the label in January 2012, adding information concerning the risk of bleeding events and the lack of a reversal agent, but so far has not required a "black-box" warning.

Often these bleeding cases come on quickly, shortly after beginning the drug, sometimes with dire consequences. Many family members have joined Pradaxa litigation, filing on behalf of deceased members who fell victim to Pradaxa bleeding. If the JPML grants the motion to consolidate Pradaxa lawsuits—and it seems probable that they will—lawsuits will likely continue to increase. The results of the FDA investigation will also likely have an impact on how these cases proceed.