The number of lawsuits filed against the manufacturer of the blood thinning agent Pradaxa has increased dramatically over the last month.  According to the Food and Drug Administration (FDA), Pradaxa is an anticoagulant (blood thinner) medication prescribed specifically to reduce the risk of strokes and blood clots in patients who suffer from atrial fibrillation (AF), not caused by a heart valve problem.  AF is the most common type of heart rhythm abnormality.

Based on reports available from the Judicial Panel on Multi-District Litigation (JPML), the number of lawsuits increased 6%, from 1,643 suits in October 2013, to the current 1,748 as of November 18, 2013.  Due to the volume of cases against the manufacturer, the cases were consolidated into a multi-district litigation or MDL (see our explanation of MDL), which is proceeding in the Southern District of Illinois, presided over by Judge David R. Herndon, under the designation of MDL 2385.

The FDA indicates that shortly after the medication was approved for use in 2010, they received a large number of reports of internal bleeding in users of the preparation.  Approximately 3.7 million prescriptions have been filled for Pradaxa since it was approved for use in October, 2010.  Users of the drug have reported symptoms such as coughing up blood, nose bleeds at a higher frequency than normal, heavy menstrual bleeding, pink or brown urinations, and red or black stools.

In 2011, the first full year of Pradaxa use, the FDA received nearly 4,000 reports of serious injuries associated with the drug.  Almost 2,500 patients who used the drug suffered hemorrhage, and over 500 died.  Results in 2012 were consistent with the 2011 statistics, with 582 deaths.   The Institute for Safe Medication Practices (ISMP) reported this was higher than any other medication it had monitored.

Until recently, there was no known antidote for this medication, which could be used to stop bleeding in patients who have developed problems.  However, earlier this week, the manufacturer presented results of an early trial of a preparation which may immediately and completely stop the anticoagulant effects of Pradaxa.  This preparation, however, is years away from approval or use.

The drug is manufactured by Boehringer Ingelheim, a pharmaceutical company headquartered in Ingelheim Germany.

Additional Resources:

http://www.fda.gov/drugs/drugsafety/ucm332912.htm

http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-November-18-2013.pdf

http://www.ismp.org/QuarterWatch/pdfs/2011Q2.pdf

http://www.aboutlawsuits.com/pradaxa-lawsuits-mdl-early-trial-dates-54742/

http://www.virtual-strategy.com/2013/11/22/drugrisk-update-november-court-records-show-growing-pradaxa-lawsuits