Pradaxa Wrongful Death Lawsuit Alleges Misleading Advertising

On April 30, 2013, a Pradaxa wrongful death lawsuit was filed against Boehringer Ingelheim Pharmaceuticals, Inc. The complaint was filed on behalf of Henry Parnell as the executor of the estate of Wilma Parnell, deceased. Additional plaintiffs include James and Paul Parnell, and Dawn Woods. The lawsuit claims that misleading advertising resulted in the use of Pradaxa by the decedent, which allegedly led to her death. The plaintiffs are seeking compensatory and punitive damages in excess of $75,000.

The case was originally filed in the U.S. District Court for the Eastern District of Texas under Judge Marcia A. Crone. A conditional transfer order implemented on May 10, 2013 moved the complaint to multidistrict litigation (MDL) No. 2385, which is proceeding in the U.S. District Court for the Southern District of Illinois. The MDL allows multiple plaintiffs to share pretrial proceedings, while retaining their rights to individual jury trials.

Plaintiffs claim inadequate warnings

Pradaxa (dabigatran) is a blood-thinning medication that prevents the blood from clotting. It is commonly prescribed to lower the risk of stroke in patients with heart problems. The decedent was prescribed Pradaxa and took it as directed. Subsequently, she passed away. The cause of death was noted as uncontrollable and excessive bleeding as an alleged result of her use of the medication manufactured by the defendants. The wrongful death lawsuit notes that the decedent was not aware of the risk of Pradaxa bleeding problems. According to the complaint, if Wilma Parnell or her healthcare provider had known that Pradaxa carried the risk of life-threatening bleeding, she would not have taken the medication.

Other lawsuits note Pradaxa bleeding problems

Other plaintiffs, including those who have joined the Pradaxa MDL, have also claimed that Pradaxa led to uncontrollable and life-threatening bleeding. This drug was intended to offer an alternative to warfarin, a time-tested medication that also prevents blood clots. Patients on warfarin were required to follow a special diet and undergo regular monitoring to ensure safety. Pradaxa was marketed as an alternative medication that did not require such measures. Patients taking warfarin could be administered therapeutic doses of vitamin K to clot the blood in the event of a bleeding emergency. However, Pradaxa contains no such safeguard. Doctors have no antidote available to treat patients on Pradaxa who suffer excessive bleeding.

The FDA has received hundreds of adverse event reports regarding Pradaxa bleeding. As of December 31, 2011, more than 500 deaths allegedly linked to the drug had been reported to the agency. At that point, Pradaxa had been on the market for 14 months. Dozens of other adverse events have been reported, including those involving gastrointestinal hemorrhages, rectal hemorrhages, and cerebrovascular accidents.

Pradaxa lawyer alleges misleading advertising

This Pradaxa wrongful death lawsuit charges the defendants with over-promoting the drug to the detriment of patients. The defendants marketed their medication as being more convenient and effective than warfarin. Although the drug was not approved until late October 2010, the defendants had already spent $67 million in advertising for Pradaxa by the end of the year. In 2011, the defendants spent $464 million in detailing sessions, which were marketing sessions for Pradaxa representatives to meet with healthcare professionals. Despite these detailing sessions, the lawsuit alleges that the promotional material available to doctors did not mention the lack of an antidote to address excessive bleeding.