There is little doubt blood thinners can cause uncontrolled internal bleeding and other bleeding-related complications, but some new-generation drugs may significantly increase this risk. The manufacturer of blood thinning drug Pradaxa, Boehringer Ingelheim, already settled a number of lawsuits out of court. However, it now faces a new wave of accusations that its medication continues to cause uncontrolled bleeding, hemorrhaging, and other major health concerns in some users.
If you or a loved one suffered bleeding complications while on Pradaxa, you need to discuss your situation with a knowledgeable Pradaxa bleeding lawsuit lawyer. The legal team at Gacovino, Lake & Associates, P.C. is here to help you understand if you have a case against the manufacturer of this drug, and how to pursue the payout you deserve. Call us today at 631-600-0000 to schedule a free case review.
What Do I Need to Know About Pradaxa and the Associated Bleeding Risks?
Pradaxa came on the American market after approval by the U.S. Food and Drug Administration (FDA) in October 2010. It is an anticoagulant drug designed to treat individuals diagnosed with atrial fibrillation, or irregular heartbeat, by controlling the clotting response in the body. It may also help reduce risk of stroke. It has since become a major competitor for the decades-old blood thinner warfarin.
Pradaxa does not require the same medical monitoring as warfarin, and it also works differently. Rather than decreasing vitamin K activity in the blood like warfarin, Pradaxa inhibits thrombin, a clotting protein. So, in essence, the two drugs perform the same service but function in different ways.
As with all drugs, there are side effects associated with Pradaxa. All blood thinners have a risk of bleeding-related complications, including uncontrolled internal bleeding.
A major difference between Pradaxa and warfarin is there is no known antidote for uncontrolled bleeding with Pradaxa, leaving emergency room doctors with limited recourse when they admit a patient with internal bleeding. Doctors in the emergency room often can control bleeding associated with warfarin by giving the patient vitamin K, which acts as an antidote.
What Does the Research Show About Pradaxa?
Pradaxa hit the U.S. market in 2010, and the reports of adverse events began almost immediately. Pradaxa had the most reports of complications in 2011 (out of all prescription drug medications). According to a review of these reports by The Institute for Safe Medication Practices, there were almost 4,000 reports filed based on the medication in 2011 alone. Of this total, 63 percent reported hemorrhaging. Pradaxa use resulted in 542 deaths.
In November of 2012, the U.S. Food and Drug Administration (FDA) issued an FDA safety alert about the risk of uncontrolled bleeding with the use of any blood thinning drug. However, it also stated the “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.”
In 2014, it reversed this stance, though. Research conducted in 2014 found Pradaxa did work efficiently to lower a person’s risk of many serious health concerns — including clot-related strokes and bleeding in the brain — and, in fact, worked better than warfarin. However, the study also showed the risk of episodes of major gastrointestinal bleeding are significantly higher with Pradaxa than with warfarin.
The following year, a group of researchers from the University of Pittsburgh published a review of Medicare patient records that looked specifically at the risks and advantages of different types of anticoagulants. The 2015 study found:
Those on Pradaxa had 30 percent more episodes of bleeding. They also suffered 58 percent more major bleeding events, and 85 percent more gastrointestinal bleeding issues. Patients on warfarin had approximately 70 percent more brain hemorrhages than those on Pradaxa, though.
What is the Current Status of the Pradaxa Lawsuits?
In May of 2014, Boehringer Ingelheim agreed to create a $650 million fund to settle all cases in the pending multidistrict litigation regarding Pradaxa bleeding risks. However, it never admitted fault and continues to market the medication.
Since that time, thousands of other patients prescribed Pradaxa have come forward with similar claims. Many of them suffered severe bleeding events after the 2014 settlement, and others lost loved ones because of uncontrolled bleeding since that time. Like many other bleeding lawsuit attorneys, we continue to file claims on behalf of plaintiffs who suffered complications, pain and suffering, and financial damages because of Pradaxa.
While we can certainly pursue this type of case as an individual lawsuit, there is also a chance of the courts consolidating these cases into a multidistrict litigation, as well. Since the pharmaceutical company settled before any bellwether trials in the first round, it is still not clear how a jury will handle these allegations. There is the possibility that the company could offer another mass settlement, or that the court could award an even higher payout for each plaintiff in any pending and future cases.
How Can I Talk to a Pradaxa Bleeding Lawsuit Lawyer about My Case?
If you need help deciding if you have a viable defective drug claim against the manufacturers, the team at Gacovino, Lake & Associates, P.C. can help you review the facts of your case and establish a plan of action. We are ready to build your case and obtain the compensation you deserve based on the physical, emotional, and financial damages you suffered. If you or a loved one suffered serious side effects while taking Pradaxa, you could qualify to file for reimbursement of your medical bills, lost wages, pain and suffering, and other losses.
Our team dedicates ourselves to helping victims of dangerous pharmaceutical drugs rebuild their financial and personal lives. We work to ensure each case receives the attention necessary to ensure a positive outcome for the victim involved. Call our office today at 631-600-0000 to schedule your complimentary consultation with a Pradaxa bleeding lawsuit lawyer.