Surviving Relatives File Pradaxa Bleeding Lawsuit

Another Pradaxa bleeding lawsuit has been filed against Boehringer Ingelheim Pharmaceuticals, et al. On May 24, 2013, the surviving relatives of Rose Vicari, who are Peter G., Sarah, Kathleen, and Cheryl Vicari, filed a complaint regarding the defendants’ medication, Pradaxa, and its alleged link to the decedent’s death. The case is currently proceeding in the U.S. District Court for the Eastern District of Louisiana.

The plaintiffs are seeking compensatory damages for the decedent’s wrongful death, mental anguish, and physical pain and suffering, as well as for the surviving relatives’ emotional distress and loss of love and affection.

Decedent suffered multiple injuries

Pradaxa (dabigatran) is a direct thrombin inhibitor. It is prescribed to patients with non-valvular atrial fibrillation for the purposes of reducing their risk of stroke and systemic embolism. The decedent was first prescribed Pradaxa in October 2012, and she subsequently noticed weakness in her right leg which limited her mobility and necessitated her use of a walker. The decedent also fell several times and sustained injuries, for which she sought treatment on February 24, 2012.

The physician diagnosed her with contusions and swelling of the right knee, as well as dizziness, weakness, and difficulty with balance. The decedent was diagnosed with internal bleeding on the basis of the appearance of her knee, which was bright red and bruised. The decedent was also treated for a pneumothorax, which is a collapsed lung.

On March 9, 2012, the decedent again sought medical care for another fall, complaining of leg weakness and severe mobility restrictions. The physician noted that the decedent’s right knee indicated internal bleeding. During a follow-up visit with an orthopedist the next day, the physician determined that significant swelling and internal bleeding was a result of the decedent’s use of Pradaxa. The decedent underwent knee arthrocentesis to remove the accumulation of fluid and blood.

On March 24, 2012, the decedent suffered a cerebral infarction, which is an ischemic stroke, as an alleged result of Pradaxa. According to the Pradaxa bleeding lawsuit, Rose Vicari passed away on May 30 as a result of complications from the medication.

Lawsuit alleges over-promotion

According to the Pradaxa lawsuit plaintiffs, the decedent would never have taken Pradaxa had she known of the potentially life-threatening side effects. The complaint indicates that the decedent took the medication as a direct result of the intensive marketing campaign undertaken by the defendants. Rose and her physician received promotional materials that represented Pradaxa as being more effective and convenient than the alternative medication, warfarin. The promotional material did not mention the risk of life-threatening internal bleeding.

Warfarin, which is also prescribed to prevent stroke, requires dietary restrictions and continual monitoring. Pradaxa was marketed as an alternative that did not require such measures. However, unlike warfarin, there is no antidote available to administer in the event of internal bleeding from Pradaxa. This has allegedly resulted in hundreds of complications and deaths.

Pradaxa FDA warning issued

During a 17-month period from 2010 to 2011, the FDA received 932 serious adverse event reports regarding Pradaxa side effects. Out of those reports, more than 500 noted life-threatening internal bleeding, and there were about 120 deaths reported. Additional reports about Pradaxa-related deaths have been filed since that time.

According to the Pradaxa bleeding lawsuit complaint, the defendants failed to update the U.S. labeling information for Pradaxa to include the risk of life-threatening bleeding, despite these adverse event reports.

On December 7, 2011, the FDA announced a safety review of Pradaxa to examine the prevalence of side effects. A safety announcement issued on November 2, 2012 did not change the FDA’s current recommendations regarding the medication; however, it did caution patients to seek emergency medical care for unusual bleeding.