Xarelto & Pradaxa Lawsuit Information
Thousands of lawsuits have been filed against the manufacturers of the drugs Xarelto and Pradaxa due to patients experiencing excessive bleeding, and sometimes death, after taking the drug. This includes cerebral hemorrhaging, gastrointestinal bleeding, internal bleeding not related to the gastrointestinal tract and bleeding from the kidneys.
The lawsuits allege neither drug came with proper warning labels regarding the potential for severe internal bleeding, leading patients to trust the safety of the pharmaceuticals to treat cases of Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism, as well as other conditions not associated with the drugs' intended purposes.
What are Xarelto & Pradaxa?
Both Xarelto and Pradaxa are blood thinning drugs, known as anticoagulants, prescribed to prevent against blood clots and strokes. There is always a risk of internal bleeding when taking a blood thinner, though the number of severe instances in relation to each drug has far surpassed the expected risk.
Xarelto, which is manufactured by Bayer AG and Janssen Pharmaceuticals, was first approved for use by the FDA in 2011. The drug is intended to protect against blood clots and stroke in patients who suffer from Atrial Fibrillation (Afib), Deep Vein Thrombosis (DVT), and Pulmonary Embolism (PE).
Pradaxa was first introduced in 2010 by Boehringer Ingelheim. It was marketed as a revolutionary medicine for patients suffering from Atrial Fibrillation, designed to thin the blood to prevent against potential strokes.
People diagnosed with Atrial Fibrillation experience an irregular and rapid heartbeat that can lead to shortness of breath, heart palpitations, extreme exhaustion and in worst cases, stroke.
Left untreated, Afib can severely impact a person's quality of life, which is why an anticoagulant is typically prescribed.
Deep Vein Thrombosis, or DVT, is the occurrence of blood clots deep in the body's veins, usually in the thigh or lower part of the leg, such as the calf. If left untreated, the clot can burst and lead to bleeding of the brain.
Pulmonary Embolism, or PE, refers to a blockage of one of the arteries in the lungs that has made its way there from somewhere else in body. PE typically occurs when a blood clot from the legs has traveled to the lungs, and can result in death if not properly treated.
Dangers Associated With The Use of Xarelto and Pradaxa
Lawsuits filed against the makers of Xarelto, which has no antidote and is prescribed in single-dose pill form, allege Bayer AG and Janssen Pharmaceuticals failed to properly warn users of the drug about its potentially deadly side effects, leaving thousands to develop uncontrollable internal bleeding that in some cases, resulted in death.
There are no frequent dosage adjustments or monthly testing required with Xarelto, unlike those necessary when prescribed the blood-thinning drug Warfarin, which is a long-standing anticoagulant administered intravenously. The makers of Xarelto touted this as a breakthrough, claiming the drug to be superior to its competitors because it meant fewer checkups with the doctor.
However, because blood levels with Xarelto are not constant, the single-dose nature of the drug puts patients at much greater risk of a bleed out because they are not being monitored effectively. The drug itself is no more efficacious than other anticoagulants, which is why the manufacturers relied on the single-dose aspect in their marketing strategy while ignoring scientific data that indicated regular monitoring and testing was the safer alternative.
They relied on celebrity endorsements to push the drug, including NBA star Chris Bosh, who appeared in commercials for Xarelto. Standing seven feet tall and looking healthy and full of vigor, Bosh stated he suffered from dangerous blood clots in his lungs, but didn't have time for frequent checkups and tests. He went on to say his doctor had a better "game plan," which included prescribing Bosh the once-daily pill. The results of such endorsements typically equate to greater sales and profits, which in the case of Xarelto, absolutely worked in favor of its manufacturers.
During its first year on the market, Pradaxa reportedly caused 260 deaths due to uncontrollable internal bleeding, with 307 complaints regarding the drug and its side effects reported to the Federal Drug Administration (FDA) within the first three months of its release.
Unlike the blood-thinning drug Warfarin, which is a long-standing anticoagulant administered intravenously or orally, Pradaxa is prescribed only in oral form and, up until October 2015, had no antidote. The FDA approved Praxabind, which was created specifically to reverse the effect of Pradaxa in emergency situations, such as emergency surgeries and urgent procedures and during life-threatening or uncontrolled bleeding episodes.
Pradaxa’s approval for use by the FDA has been the subject of much controversy, with critics stating the clinical trial cited for its approval, known as RE-LY, was deeply flawed and allowed for bias and critical errors to be included in the study.
Users of both Xarelto and Pradaxa claim to have experienced cerebral hemorrhaging, gastrointestinal bleeding, internal bleeding not related to the gastrointestinal tract and bleeding from the kidneys.
Cerebral hemorrhaging, also referred to as brain hemorrhaging, is a type of stroke. It is caused by the bursting of an artery in the brain, which leads to bleeding in the surrounding tissue that effectively kills numerous brain cells and can be life-threatening. Symptoms of a brain hemorrhage include:
- Sudden onset of a severe headache
- Loss of motor functions
- Weakened state of consciousness
Gastrointestinal bleeding refers to bleeding that takes place anywhere in the GI tract from the mouth to the rectum, which can lead to significant blood loss in a short period of time. It is extremely dangerous and can lead to death. Symptoms of gastrointestinal bleeding include:
- Bloody stool
- Black, tar-like stool
- Vomiting bright red blood
- Vomiting dark, black-looking blood
Internal bleeding not related to the gastrointestinal tract relates to the body's vascular system and is a serious emergency. The bleeding can stem anywhere from the lungs, heart, liver, spleen, stomach or elsewhere and should not be ignored. Symptoms of internal bleeding once enough blood has been lost include:
- Abdominal pain
- Swelling near the area affected
Bleeding from the kidneys is specific to the kidneys and can quickly become a life-threatening emergency if left untreated. Symptoms of bleeding from the kidneys should be addressed immediately and include:
- Blood in the urine
- Severe back pain, especially in the lower back and/or either side of the back
- Abdominal pain
- Abdominal swelling
- Inability to urinate
- Drowsiness/severe decrease in energy levels
- Rapid heartbeat
Don't Wait To Take Action
If you or a loved one took Xarelto or Pradaxa and suffered any of the complications listed above, including death, now is the time to act. How long you have to file a lawsuit, also known as the statute of limitations, is different in every state. If you aren't sure if you can still file a claim, don't worry. We are here for you and will do whatever it takes to help you with your case. We're on your side.