A new lawsuit was filed against Pradaxa maker Boehringer Ingelheim, in the U.S. District Court, Middle District of Pennsylvania on February 4, 2013. The complaint was brought by Pennsylvania resident June Lutz, individually and as a representative of the estate of her late husband, Carl Lutz, and claims that side effects of the Pradaxa blood thinner led to her husband’s death. If you have experienced a serious bleeding complication or another major side effect that you believe to be related to the anticoagulant Pradaxa, contact our knowledgeable attorneys at AMA Law to discuss your legal options. You may have grounds to file a drug injury lawsuit against Boehringer Ingelheim, in order to pursue financial compensation for your injuries, medical expenses, pain and suffering, and other alleged drug-related damages.
SIDE EFFECTS POSSIBLY LINKED TO PRADAXA
Pradaxa (dabigatran) was first approved by the U.S. Food and Drug Administration (FDA) in October 2010, and is designed to lower the risk of stroke in patients who suffer from a medical condition called non-valvular atrial fibrillation. The blood thinner functions by inhibiting an enzyme in the blood, known as thrombin, which is connected to the blood’s ability to clot. Pradaxa has been marketed by Boehringer Ingelheim as a superior medication to the anticoagulant warfarin, after a clinical trial suggested that Pradaxa was more effective in the prevention of strokes in atrial fibrillation patients. However, mounting research suggests that Pradaxa may actually be associated with an increased risk of bleeding side effects in patients, particularly bleeding in the brain.
PRADAXA LACKS REVERSAL AGENT FOR BLEEDING COMPLICATIONS
A Journal of Neurosurgery study published in 2012 highlighted the death of an elderly Utah man, indicating that the massive brain hemorrhage he sustained was a sign that Pradaxa’s blood-thinning effects are largely irreversible. This is due, at least in part, to the fact that there is no antidote for the bleeding side effects possibly related to Pradaxa, while warfarin patients who exhibit internal bleeding complications can be administered vitamin K, which acts as an effective reversal agent. In patients taking Pradaxa, many bleeding side effects result in death since doctors have no means of administering an antidote and reversing the drug’s blood-thinning effects.
INJURY AND DEATH ALLEGEDLY CAUSED BY PRADAXA
In her lawsuit, June Lutz notes that her husband began taking Pradaxa in January 2011, and on February 8, 2011, suffered from an acute intercerebral hemorrhage with subarachnoid extension that required him to spend 16 days in the hospital. Following the hemorrhage, Carl Lutz was unable to return home and was placed in hospice care until March 21, 2011, when he died. Intercerebral hemorrhaging is a form of stroke and occurs when blood leaks in the brain after a diseased blood vessel bursts. The complaint states that, by December 2011, the FDA had received reports of more than 500 Pradaxa-related deaths in the United States, over 200 cerebrovascular accidents, 300 rectal hemorrhages, and 900 gastrointestinal hemorrhages.
OUR EXPERIENCED ATTORNEYS CAN HELP YOU FILE A CLAIM
According to June Lutz, although Boehringer Ingelheim has changed the warning label on its Pradaxa medication to inform consumers and doctors about the risk of Pradaxa side effects, no boxed warning has been added to the drug. A boxed warning, the complaint states, is the only way to adequately inform the public about the potential dangers associated with Pradaxa use. If you took Pradaxa and have since suffered a serious bleeding side effect, or if you lost a loved one to a complication allegedly caused by the blood thinner, consult our reputable lawyers at AMA Law today. You may be entitled to financial compensation for your injuries and medical bills, which you can pursue by filing a lawsuit against Pradaxa maker, Boehringer Ingelheim.