Patients who undergo extensive surgeries are often placed on blood thinners to reduce the risk of strokes and blood clotting disorders. A blood clot after surgery can be fatal, and anticoagulants can be a lifesaving intervention. But for many patients on Xarelto®, the opposite proved true, as over 150 patients were killed and nearly a thousand more were hospitalized due to uncontrollable bleeding.
Xarelto Causes Uncontrollable Bleeding and Patient Deaths
Xarelto is the brand name of the medication rivaroxaban, which was approved for post-surgical use by the U.S. Food & Drug Administration (FDA) in 2011. The blood thinner was first used in patients who were recovering from knee and hip replacement surgeries, and was later approved to treat patients suffering from atrial fibrillation. In both cases, the drug was means to prevent blood from coagulating (clotting) inside the patients’ bodies, reducing the risk of strokes and heart attacks caused by blood clots.
However, Xarelto’s ability to prevent blood from clotting soon turned into a major medical problem. Patients began to suffer uncontrolled bleeding, leading to many adverse effects and injuries such as:
- Cerebral hemorrhage (bleeding inside the brain)
- Hematoma (blood pooling within the tissues of the body)
- Peripheral edema (swelling and inflammation of the lower limbs)
- Dyspnea (Difficult or labored breathing)
- Decreased hemoglobin production
- Thrombosis (Formation of dangerous blood clots)
While the risk of bleeding is always present when taking anticoagulants, many older-generation blood thinners have ways to reverse the bleeding before the patient suffers harm. For instance, doctors can reverse the effects of the blood thinner Warfarin by administering a high dose of Vitamin K. There is no antidote for the type of bleeding caused by Xarelto, making bleeding in these patients more likely to be fatal.
Drugmaker May Have Been Aware of Xarelto Bleeding Risks
Xarelto was created by pharmaceutical giant Bayer AG, but was later sold to Johnson & Johnson subsidiary Janssen Pharmaceuticals for widespread distribution in the U.S. In 2015, sales of Xarelto alone earned nearly $2 billion for Bayer and Johnson & Johnson, and made over $500 million in the first quarter of 2016. These large profits can be attributed to the blood thinner’s marketing campaign, which hailed Xarelto as a convenient option over the already-established anticoagulant Warfarin. Warfarin has been used to prevent clots in patients since the 1950s, but requires constant monitoring by a doctor. Xarelto has been marketed as a better alternative to Warfarin since patient’s blood levels do not need to be checked as often.
According to the FDA’s Adverse Events Reporting System, over 2,000 patients nationwide have suffered serious side effects after taking Xarelto, with 1,800 of these claiming that the medication was the primary reason their injuries occurred. There are currently over 4,500 cases pending in a federal multi-district litigation, with many more cases filed at the state level. Plaintiffs in these cases have made a number of claims against Bayer and Johnson & Johnson, including:
- Failure to warn. Former Xarelto users and family members have claimed that they were not sufficiently warned about the risk of suffering deadly side effects by the drug's manufacturer.
- Unethical marketing. Many patients have claimed that Xarelto’s marketing made little reference to the drug’s lack of antidote. If they had been warned that the drug did not have an antidote, they would have likely chosen a reversible anticoagulant such as Warfarin.
- Withholding clinical trial data. Court documents indicate that Johnson & Johnson and Bayer may have failed to complete proper clinical trial testing before releasing the drug, and may even have attempted to hide clinical trial data from consumers.
- Negligence. Several lawsuits have alleged that the drugmakers committed negligence by placing profits above patients’ lives. Many families are suing to recover the costs of emergency room visits, lost wages, ongoing medical care, emotional distress, funeral expenses, and other undue financial burdens.
The McGartland Law Firm is aggressively pursuing litigation in Xarelto lawsuits, as we believe the drug manufacturers should be held responsible for their negligence. We have recovered multi-million dollar settlements for clients like you who were injured by dangerous drugs, and we do not collect any legal fees unless we win your case. Call the number on this page today to discuss your case with our legal team.