Pradaxa Settlement Reached with Thousands of Injured Plaintiffs
Just one day before, U.S. District Judge David R. Herndon of the Southern District of Illinois convened a team of attorneys to help negotiate a settlement agreement between the makers of Pradaxa and the several thousand users alleging injuries as a result of using the drug. The resulting settlement will likely alleviate the need for thousands of individual trials across the country – which is the goal often contemplated by multi-district litigation consolidation.
Pradaxa settlement to address undisclosed bleeding risk
At the heart of the litigation between Boehringer Ingelheim is the issue surrounding Pradaxa and its increased risk for causing severe bleeding in patients with atrial fibrillation. Patients prescribed Pradaxa were allegedly not informed of the possibility that the anti-coagulant could cause fatal uncontrollable bleeding – a factor considered vital to disclose.
Pradaxa was considered a strong competitor against the drug warfarin, also known as Coumidin. However, in the event of uncontrollable bleeding in patients taking warfarin, a dose of vitamin K could usually stop the event. There is no such antidote available for Pradaxa patients and it did not take long for the FDA to begin receiving thousands of complaints of injuries and death associated with the use of the drug.
Details of settlement with Boehringer Ingelheim
The settlement with Boehringer Ingelheim addresses over 4,000 lawsuits arising from Pradaxa injuries. According to attorneys familiar with the negotiations, each patient involved in the Pradaxa settlement should expect to receive approximately $165,000. This settlement will help those struggling with mounting medical bills, missed time from work or other expenses incurred as a result of a Pradaxa injury.
In a statement released by the drug maker, it reiterates its position that the settlement does not admit wrongdoing and was reached in an effort to allow the company to focus solely on the mission of “improving patients’ lives” – as opposed to focusing time and resources on lengthy and uncertain litigation. Moreover, the company included data evidencing a positive risk-benefit profile for the drug Pradaxa as revealed by the FDA following a study of 134,000 Medicare enrollees.
The settlement was finalized approximately six months before the trial against the drug maker was scheduled to begin.
Pradaxa to remain on the market
The drug Pradaxa was first introduced to the American drug market in 2010 following rigorous clinical trials with the FDA. It was approved as a blood thinner to be used in stroke patients in order to prevent deadly blood clots.
Notwithstanding several thousand complaints lodged by consumers to the FDA, it recently concluded that additional, stronger warnings are not necessary and has continued to allow for the use and sale of Pradaxa. In fact, a recent study of the drug conducted by the FDA revealed that, among 134,000 Medicare patients aged 65 or older, Pradaxa was associated with a decreased risk of clotting in the brain, strokes and death than patients taking warfarin.
However, the study revealed a higher risk of gastrointestinal bleeding in patients taking Pradaxa as opposed to those prescribed warfarin.
- FDA: Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm397179.htm
- Boehringer Ingelheim: Boehringer Ingelheim announces comprehensive settlement of U.S. Pradaxa® (dabigatran etexilate) litigation http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/28_may_2014_dabigatranetexilate.html