Attorneys are well into the discovery phase with each side producing tens of thousands of documents, and depositions should begin soon for the multidistrict litigation (MDL) case against Boehringer Ingelheim, maker of the blood thinner Pradaxa. Defendants allege that the drug maker did not adequately warn users that the drug put them at greater risk for life threatening bleeding events. They say they were also not warned that no antidote has yet been produced to counter the effects of the drug.
“We’re really starting now to get to the meat of the litigation. The pace is picking up more,” Chief Justice David Herndon, who is presiding over the case, said to the Madison Record.
Pradaxa was approved in 2010 as the first blood thinner since warfarin to prevent strokes in patients with a type of irregular heartbeat known as atrial fibrillation. Warfarin had been the long-held treatment for atrial fibrillation patients, but patients required regular monitoring because the drug had numerous contraindications putting patients at risk for bleeding events.
Pradaxa was thought to be safer, but 14 months after the drug was approved, it was tied to more than 900 gastrointestinal bleeds and 500 bleeding deaths. When patients experienced bleeds, there was no reversal agent to counter the effects of Pradaxa, leaving doctors nearly helpless. There are antidotes available for warfarin.
The Pradaxa MDL now includes 176 member cases and 192 plaintiffs. There is also litigation against Boehringer Ingelheim pending in state courts across the country.
Source: Madison Record