- Posted January 28, 2014 by
Washington DC, District of Columbia
Court Fines Pradaxa Maker Nearly $1 Million for Document Mishandling in Bleeding Lawsuits
For over a year, German drug maker Boehringer Ingelheim has faced litigation from patients alleging it failed to warn of potential internal bleeding dangers in its popular blood thinner Pradaxa.
Now, as new studies suggest use of the drug may be set to increase with wider prescription applications, a federal judge has fined the drug maker nearly $1 million for withholding or failing to preserve key information sought in the litigation.
Pradaxa is an anticoagulant medication approved by the FDA in 2010 to prevent blood clots and strokes in patients with atrial fibrillation. With its release, Boehringer targeted the multi-billion dollar blood thinner market, and the traditional drug warfarin that required regular blood testing of patients.
Within 2 years, Pradaxa had achieved blockbuster status, meaning sales of more than $1 billion per year. It is also now prescribed in over 70 countries.
Experts disagree, however, about whether Pradaxa carries higher risks for internal bleeding than warfarin. At issue is the fact that, unlike other blood thinners, Pradaxa has no antidote to stop bleeding in cases of emergency. Boehringer is currently working to develop such measures.
The FDA has advised Pradaxa is no more dangerous than warfarin. However, for the past two years, The Institute for Safe Medication Practices has ranked it among the highest on the market for injury and death reports to the FDA.
The ISMP also released a study this year warning that those taking Pradaxa may be almost 5 times as likely to die from internal bleeding than those taking warfarin*.
A separate study published from The Netherlands this year also suggested patients taking newer blood thinners like Pradaxa may be 55% more likely to suffer internal bleeding**.
A growing number of patients have filed lawsuits alleging internal bleeding injury or death from Pradaxa in a special federal multidistrict litigation court in Illinois. The latest court records show 1,936 had filed suit as of December 16, a rise of nearly 11% in a month. (MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.)
Now, as the start of trials approaches next August, U.S. District Judge David Herndon, who presides over the Pradaxa lawsuits, has fined Boehringer Ingelheim $931,000 for failing to preserve documents and information which may have been critical to the litigation.
In his 51 page ruling, Herndon called Boehringer’s actions “egregious,” and “grossly inadequate.” He said executives had acted “in bad faith” by not ensuring that data on the drug’s development and marketing were preserved and had “made misrepresentations” about their efforts to do so.
Lawyers for patients alleged in court filings that Boehringer couldn’t gather data from a senior Pradaxa researcher, or files from consultants who worked on the marketing plan. The drug maker also did not require employees to save phone messages about their work on the drug.
Boehringer responded in court filings that it had produced 32 million pages of material so far, and has been bombarded with “overly burdensome” document requests by patients’ lawyers. They also claimed much of the information sought was not relevant.
This week, Boehringer announced a new study showed Pradaxa was effective at the treatment of deep vein thrombosis (DVT) and pulmonary embolism. The company has previously asked regulators with the European Medicines Agency to allow expanded use of the drug for the prevention of blood clots in all patients, not just those with atrial fibrillation.
More information on the research, side effects and litigation news related to Pradaxa is available at drug safety sites like DrugNews.net.
*Institute for Safe Medication Practices, 1/9/13; ismp.org/quarterwatch/pdfs/2012Q2.pdf
**Gastroenterology, July 2013; gastrojournal.org/article/S0016-5085(13)00290-4/fulltext