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Pradaxa Patients Await Word On MDL

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Pradaxa patients, involved in about 12 dozen lawsuits in Illinois alone, are awaiting word on multidistrict litigation (MDL) concerning injuries they allege are linked to the controversial blood thinner.

The 12 Illinois lawsuits represent about half of what Boehringer Ingelheim Pharmaceuticals, Inc., and some other foreign corporations in the United States, face. Boehringer is the maker of Pradaxa. The cases have been filed since May of this year in the U.S. District Court for the Southern District of Illinois, said the Madison Record; plaintiffs are waiting to learn if an MDL will be created to handle the claims. Eight complaints were filed against Boehringer in May in the East St. Louis federal court; three were filed in June, and another was filed this month, the Madison Record explained.

Pradaxa was approved by the U.S. Food & Drug Administration (FDA) and launched in North America in 2010 for the prevention of stroke and blood clots in patients diagnosed with atrial fibrillation, a heart rhythm condition, explained NewsInferno previously.

In a recent complaint, filed by Leeta Witt, she alleges that she suffered from cerebral bleeding in May 2011 that needed two surgeries to resolve. Witt claims her injuries were the result of taking Pradaxa, which she began taking in February 2011 for long-term treatment and maintenance of a heart rhythm disorder, said the Madison Record. Other patients’ lawsuits allege that Pradaxa caused a number of side effects including internal bleeding that led to death. Plaintiffs claim, among other issues, that Boehringer neglected to appropriately warn consumers about risks linked to Pradaxa.

Believed to be the first drug of its kind since warfarin—also known as Coumadin—which was developed some 60 years ago, Pradaxa has been associated with about 260 fatal bleeds, worldwide, from March 2008 through October 2011, said the Madison Record.

The cases could either be heard in federal court or transferred to an MDL if the U.S. Judicial Panel on Multi District Litigation (JMPL) approves the request. In late June, U.S. District Judge David Herndon, who is presiding over all of the local Pradaxa complaints, denied Boehringer’s motion for a stay of proceedings, said the Madison Record. Judge Herndon’s order was issued in about seven of the 12 cases in East St. Louis; he wrote that he was not persuaded by Boehringer’s claim that it would both suffer hardship from inconsistent rulings and waste resources if proceedings were not stayed.

“Presently, 27 Pradaxa actions are pending in 13 different district courts across the country. This Court, by far, carries the largest number of these actions,” Herndon wrote. “This is far too many cases to ignore the issues that are of concern to this Court while the MDL motion is being resolved.” Pradaxa cases have also been filed in federal courts in Connecticut, Florida, Kentucky, Louisiana, Oklahoma, and Tennessee.

Meanwhile, NewsInferno wrote that some cardiologists have expressed concern that the new class of heart drugs that include Pradaxa could be associated with stroke, serious bleeding, and blood clots, especially in patients with poor kidney function—Pradaxa can build up in kidneys that do not function well. Doctors interviewed by Reuters suggested that patients taking Pradaxa and other drugs in this class should first be tested to ensure their kidneys are functioning well; be advised about Pradaxa’s possible dangers; and be seen regularly by their doctors, especially if switching from warfarin.

Blood thinners like Pradaxa can cause serious internal bleeding; however, unlike warfarin, there is no known antidote for Pradaxa bleeding, noted NewsInferno.

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