Pradaxa MDL decision due by late July, approval likely

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A decision from the U.S. Judicial Panel on Multidistrict Litigation (JPML, MDL) on whether lawsuits filed against the makers of Pradaxa will be consolidated as part of MDL will be made following a July 26 hearing.

Pradaxa is a relatively new drug on the U.S. market and is prescribed to prevent blood clots that can cause heart attacks, stroke, and sudden death. In its short time on the market, as many as 255 have died and more have suffered serious injuries. Many of these adverse events have been caused by severe bleeding episodes, namely gastrointestinal and cerebral hemorrhaging. The Food and Drug Administration has received more than 2,000 adverse event reports associated with Pradaxa.

Some of those victims have begun filing lawsuits against the makers of Pradaxa, Germany-based Boehringer-Ingelheim, claiming the company does not properly warn the public of these severe bleeding dangers. And unlike its predecessor on the market, Coumadin (warfarin), Pradaxa has no antidote, causing many of the bleeding episodes caused sometimes by even minor falls, to escalate in severity quickly, even leading to death.

Due to the expected high number of cases to be filed against the makers of Pradaxa and because many of the victims of the drug’s side effects suffered similar complications, it is likely these lawsuits will be consolidated as part of MDL. This will expedite and streamline the pre-trial process, reducing the chances any decisions can be reversed on appeals.