More than 1,700 personal injury lawsuits are pending against pharmaceutical company Boehringer Ingelheim in Illinois. Plaintiffs filing in the in federal multidistrict litigation allege that the company’s blood-thinning medication Pradaxa caused internal bleeding.
These lawsuits are part of multidistrict litigation in U.S. District Court, Southern District of Illinois. On November 4, the court established a protocol for selecting bellwether cases, directing both sides to select up to three lawsuits as possible candidates. In January 2014, the court will select four of those cases for the first bellwether trials, which are scheduled to commence in August 2014.
According to court records, at least 1,767 lawsuits are pending in the litigation. The complaints allege that Boehringer Ingelheim failed to adequately warn doctors and patients about internal bleeding as a side effect of Pradaxa and about the lack of an available antidote.
The Food and Drug Administration recorded more than 582 deaths and 3,292 reports of other adverse events involving Pradaxa in 2012, according to the Institute for Safe Medicine Practices. The figure exceeds the adverse reports of any other drug tracked in 2012.
According to news reports, regulators in several countries have issued warnings regarding the side effects of the drug, especially concerning internal bleeding.
Pradaxa has been sold as an alternative to warfarin, an established blood-thinning medication. Blood-thinning medications are prescribed to prevent strokes caused by blood clots. Some research has found Pradaxa to be more effective than warfarin at preventing such strokes. However, internal hemorrhaging caused by warfarin can be treated with vitamin K; there is no such effective treatment for stopping internal bleeding caused by Pradaxa.
U.S. District Judge David Herndon recently ruled that Boehringer Ingelheim must pay a fine of almost $1,000,000 for withholding or failing to preserve “countless” files sought by the plaintiffs. Judge Herndon said that the company acted in bad faith and that its efforts to safeguard the documents were grossly inadequate.
The documents in question concerned the drug maker’s development and marketing of Pradaxa. Judge Herndon said that the failure to preserve them was “egregious.”
Boehringer Ingelheim said that there were unintentional and unexpected discovery problems in the litigation, and that the plaintiffs were not prevented from obtaining access to the central documents in the case.
A key allegation in the lawsuits is that Boehringer executives were aware of the risk of death from internal bleeding when they brought the drug to market in 2010. Pradaxa has generated sales of more than $1,000,000,000 for the German, family-owned firm.