The judge presiding over hundreds of federal Pradaxa lawsuits has threatened to sanction Boehringer Ingelheim again based on allegations that the drug maker withheld information during discovery.
On Dec. 18, U.S. District Judge David R. Herndon issued a case management order threatening fines against Boehringer Ingelheim based on information found in the files of a former employee who assisted with the development of Pradaxa, Professor Thorstein Lehr. In the order, Judge Herndon claims that Boehringer Ingelheim did not maintain crucial files and cannot provide them, though legally required to do so.
At this time, Judge Herndon presides over more than 1,700 Pradaxa lawsuits against the pharmaceutical giant. The personal injury lawsuits were filed by individuals who claim to have suffered uncontrollable bleeding problems as a side effect of Pradaxa.
All of the Pradaxa lawsuits are based on allegations that Boehringer Ingelheim was negligent in its failure to conduce adequate research into potential Pradaxa side effects, and that it failed to warn of these serious health risks.
Bellwether trials designed to help gauge jury responses to specific testimony and facts are set to begin for the Pradaxa MDL on Aug. 11, 2014.
This potential fine is not the first levied against Boehringer Ingelheim in the Pradaxa MDL. On December 9, Judge Herndon fined the company $931,500 when they failed to produce certain documents crucial to the case. While Boehringer Ingelheim claimed that Professor Lehr’s BlackBerry phone, laptop, and desktop computer are inaccessible, it came to light that the company did have access to his “user share” files. According to Judge Herndon, this failure to provide accurate information suggests that Boehringer Ingelheim has acted “unreasonably, negligently, willfully, and in bad faith.”
“[T]he Court finds the plaintiffs have presented sufficient evidence to establish [Boehringer Ingelheim] destroyed or failed to preserve Dr. Lehr’s laptop, desktop, and blackberry, in bad faith, for the purpose of hiding adverse information,” Judge Herndon wrote.
Pradaxa (dabigatran) was approved by the FDA in October 2010. The anticoagulant is prescribed to prevent blood clots in patients with atrial fibrillation and was touted to be a superior alternative to warfarin (Coumadin). However, Pradaxa soon became the subject of multiple adverse event reports when patients suffered uncontrolled bleeding. While bleeding caused by warfarin can be reversed with a timely dose of Vitamin K, there is no such reversal agent for Pradaxa.
In just the first year Pradaxa was available in the United States, it was the subject of more FDA adverse event reports than any other medication. According to the FDA, the agency received 2,367 reports of Pradaxa hemorrhage and 542 reports of patient deaths linked to Pradaxa in 2011 alone.
If you or your loved one has suffered a bleeding event possibly linked to use of Pradaxa, you may still be eligible to recover substantial compensation in a Pradaxa lawsuit. For more information and a free legal consultation, contact the experienced personal injury lawyers at Berkowitz and Hanna LLC.