Overview: A lawsuit is being filed over Boehringer Ingelheim’s Pradaxa, a blood thinner that has undergone scrutiny due to reports of dangerous, uncontrollable bleeding complications. Parker Waichman LLP is filing the suit on behalf of a user who developed cerebral hemorrhage following its use.
- Parker Waichman LLP is filing a Pradaxa lawsuit on behalf of a Tennessee resident who suffered a cerebral hemorrhage after using Pradaxa for about two months
- Unlike other blood thinners, there is no antidote for the bleeding that occurs in Pradaxa users
- Last November, at least 260 Pradaxa-related deaths were reported around the world
- Last December, the FDA announced a safety review of Pradaxa
Product: Pradaxa (dabigatran)
Manufacturer: Boehringer Ingelheim Pharmaceuticals
Side Effects & Complications
- Cerebral hemorrhaging
- Gastrointestinal (GI) hemorrhaging
- All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas
National Law Firm Files Pradaxa Case
The plaintiff is a male resident of Greenville County, Tennessee who took Pradaxa for about two months before experiencing a cerebral hemorrhage. According to the complaint, he also endures other negative long-lasting effects due to Pradaxa, such as physical pain, mental anguish, diminished quality of life and lifelong medical monitoring. The suit, filed by the national law firm of Parker Waichman LLP, names manufacturer Boehringer Ingelheim as the defendant, and is charging the company with Strict Products Liability, based on:
- Failure to warn
- Marketing and manufacturing defects
- Breach of express and implied warranties
- Fraudulent misrepresentation
- Negligent misrepresentation
- Deceptive trade practices
- Gross negligence
Although all blood thinners carry some risk of bleeding, Pradaxa is particularly dangerous because there is no antidote to stop the bleeding once it starts. According to the complain, Boehringer Ingelheim hid this fact from the public and medical community by failing to include this information in the warning label, putting countless patients at a potentially fatal risk
Pradaxa began raising serious medical concerns last November, when at least 260 bleeding-induced deaths were reported among Pradaxa users between March 2008 and October 2011. In response to these developments, the U.S. Food and Drug Administration (FDA) issued a safety review of the drug last December. Shortly afterwards, the Institute for Safe Medication Practices (ISMP) revealed that the FDA had received over 500 reports of bleeding in Pradaxa patients. In March, the Journal of Neurosurgery published a case study of an elderly Pradaxa patient who died of a cerebral hemorrhage following a ground-level fall in his home; the publication emphasized the vital importance a reversal agent.
Pradaxa was approved by the FDA in October 2010 to treat non-valvular atrial fibrillation (AF), or abnormal heart rhythm. The drug was seen as a superior alternative to Coumadin (warfarin), an older medication with several food and drug interactions that required frequent blood testing; advocates boasted that Pradaxa had neither of these conditions. However, it is now clear that Pradaxa’s bleeding risks can be a serious deterrence for AF patients. In Coumadin users, bleeding can be treated with Vitamin K, while Pradaxa patients can only hope for an early, successful bout of dialysis.