In 2010, the Federal Drug Administration (FDA) approved a new anticoagulant drug to treat people with atrial fibrillation. The drug, known as dabigatran and sold under the brand name Pradaxa, is made by the pharmaceutical company Boehringer Ingelheim. It was the first FDA-approved alternative to warfarin for patients with atrial fibrillation not caused by a heart valve problem.
Patients and their doctors met Pradaxa with much excitement. It promised to treat blood clots in the legs and lungs, strokes, and pulmonary embolisms without the regular blood monitoring and dietary restrictions that patients taking warfarin had to endure.
But Pradaxa Has Serious Risks
The most serious risk associated with Pradaxa is uncontrolled bleeding. While there are antidotes for some blood thinners, no such antidote existed for Pradaxa from its 2010 FDA approval until October 2015. Accordingly, when the blood thinned too much there was little that doctors can do to prevent uncontrolled bleeding in the:
Additionally, patients may be at increased risk of suffering heart attacks.
In 2013, the Institute for Safe Medication Practices ranked blood thinners such as Pradaxa as one of the most dangerous types of outpatient medications. Anyone who takes the drug may be at risk, but the elderly may be at a more significant risk of suffering a serious and potentially fatal bleed.
Pradaxa Is Still on the Market In the United States
Pradaxa has not been recalled by the FDA and remains on the market for U.S. patients. However, in 2014 the FDA found that Medicare patients taking Pradaxa had a higher risk of gastrointestinal bleeding than patients taking warfarin.
In October 2015, the FDA granted approval to Praxbind, a fast-acting antidote for Pradaxa, using an accelerated approval process. Praxbind was approved for use during “emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.” Praxbind, like Pradaxa, is made by Boehringer Ingelheim, but unfortunately, it was unavailable to patients who suffered significant bleeds for the first five years of Pradaxa’s approval in the United States.
People Hurt by Pradaxa Have Successfully Settled Their Claims. Could You?
In 2014, Boehringer Ingelheim settled multidistrict litigation (MDL) concerning the side effects of Pradaxa. The company agreed to pay about $650 million to settle approximately 4,000 cases. The average settlement per case was more than $160,000. In order to be included in this round of settlements, an individual’s case against Boehringer Ingelheim must have been filed by May 2014.
You May Still Have a Case
While the multidistrict litigation has been settled, you may still have the right to file a case against Boehringer Ingelheim if you have been hurt or your loved one has been killed by a Pradaxa side effect. This time your case will likely be filed in state court and instead of alleging that Boehringer Ingelheim failed to warn you about the risk of Pradaxa, you and your attorney may allege that Pradaxa’s very design was defective.
Your time to file a case is limited by a law known as the statute of limitations; therefore, it is important that you contact a lawyer as soon as possible to discuss your rights and potential recovery.
How Gray & White Can Help You If You’ve Been Hurt by Pradaxa
The Kentucky lawyers of Gray & White are here to help you. Our team includes experienced attorneys, a staff nurse, and others who are dedicated to each and every client we represent. We know how to gather evidence, we know how to fight for your rights, and we will do everything that we can to get you the fair and just recovery that you deserve.
Our law firm is available to you 24 hours a day, seven days a week, 365 days a year. We know that when you have been hurt or when your loved one has died that you need answers quickly. Accordingly, we encourage you to contact us via this website or by calling 1-888-450-4456 at any time to learn more about your potential Pradaxa claim and about how we can help you.