There are so many lawsuits against the maker of the blood thinning drug, Pradaxa, that the United States Judicial Panel on Multidistrict Litigation (JPML) has issued an order to consolidate all Pradaxa lawsuits – more than 500 in all- to a single federal court in the Southern District of Illinois.
The drug was introduced in October 2010 amidst a $464 million marketing campaign aimed at doctors and consumers, and the drug quickly broke the billion dollar “blockbuster” sales status, according to one complaint filed against Boehringer Ingelheim Pharmaceuticals (BIPI,) its parent company Boehringer Ingelheim International, and Bidachem S.P.A.
Patient Arthur Gabriel says he suffered severe hematoma just months after being prescribed Pradaxa. From October 2010 through August 2011, more than a million prescriptions were written in the U.S.
But in late 2011, after receiving more than 2,000 reports of hemorrhage and reports of more than 500 patient deaths involving Pradaxa, the FDA announced an investigation into the anticoagulant. The Institute for Safe Medication Practices reports that Pradaxa led all other medications in 2011 for reports of death or bleeding to the FDA.
Pradaxa (dabigitran) was introduced by BIPI as an alternative to Coumadin (warfarin) for stroke prevention in those with abnormal heart rhythms. But whereas bleeding problems caused by Coumadin can be cured with simple doses of vitamin K, there is no antidote whatsoever for users of Pradaxa who may begin bleeding from something as small as a bump on the head. The problem is, it appears BIPI never disclosed that information in its extensive marketing campaign.
BIPI moved to dismiss Pradaxa bleeding lawsuits on the grounds that the drug label did warn of internal, sometimes fatal bleeding. However, Judge David Herndon, who will oversee the federal litigation, ruled against dismissal based on a complaint made by plaintiff Eva Smith. Smith alleges the Pradaxa marketing campaign willfully misled patients and physicians about the fact that should a serious bleeding event occur, there is no effective means for reversing the anticoagulation effects of Pradaxa, and that, among other things, BIPI failed to adequately warn about the increased risk of uncontrollable bleeding in patients taking Pradaxa.
The New England Journal of Medicine has published studies from New Zealand researchers who confirmed the lack of any antidote for bleeding problems from Praxada.
Despite all this, the FDA has not issued any recall of the pharmaceutical.