The oral anticoagulant Pradaxa, also known under the generic name of Dabigatran, has been the subject of numerous studies and thousands of lawsuits alleging everything from uncontrolled bleeding to kidney failure and stroke. From the very start, there have been reports of serious complications and death to patients taking the drug.
The U.S. Food and Drug Administration approved Pradaxa in 2010, and within a year 540 people had died and thousands suffered severe side effects. According to claims from that time, the drug caused a higher rate of life-threatening bleeding than the strokes and systemic embolisms that that Pradaxa was supposed to treat. Most lawsuits allege that the drug causes:
- Rectal bleeding
- Gastrointestinal bleeding
- Brain bleeding
Although the maker of Pradaxa, Boehringer Ingelheim Pharmaceuticals, allegedly had developed a bleeding remedy in 2010, the company did not submit it for approval to the FDA until 2015, when it was released on the market as Praxbind.
Why Pradaxa is so dangerous
Pradaxa is a safe and effective drug if the correct dosage is used for each patient. The problem is that there is no accurate way to check the drug levels. The patient does not know how much clotting has occurred or if the blood is in the therapeutic range. With too high a dosage, uncontrolled bleeding will result.
There is no simple way to reverse the process outside of emergency dialysis, and for patients who are in an unstable condition, this is not an advisable option. Over-thinning can also cause hemorrhaging after a simple fall, or stroke from a ruptured cranial blood vessel.
Sadly, when Boehringer Ingelheim agreed to pay out $650 million to settle over 4,100 federal lawsuits in 2014, it also denied any wrongdoing for the defective drug design. As a result, litigants have stopped filing claims against the company in federal court.
Filing a lawsuit after suffering injury or death from Pradaxa side effects
Although the multidistrict litigation against Boehringer Ingelheim have reached settlements, residents of Texas and elsewhere who have suffered harm from Pradaxa may still file a lawsuit. In a defective drug lawsuit, an experienced legal team will look for evidence of malfeasance on the part of corporate drug companies and pharmaceutical manufacturers that are willing to endanger public health for profit. Settling claims without admitting negligence does not protect patients in need. If you or a loved one has been injured because of a defective drug interaction, the first step is to find out what legal options you have.