Millions of individuals across the nation have been prescribed blood thinners. In taking them, patients place their trust in the hands of the doctors, pharmacists, and pharmaceutical manufacturers who claim to have their best interests at heart. When that trust is broken and thousands of patients are harmed, victims rightfully take legal action. For the past few years, this has been the case for Xarelto.
Xarelto is a blood-thinning medication that is commonly used to treat or prevent blood clots in patients recovering from joint replacement surgery or dealing with things like deep vein thrombosis and atrial fibrillation. With more than 13 million prescriptions written nationwide, it is the most prescribed blood thinner in its class.
Xarelto is often prescribed as an alternative to Coumadin (a.k.a. Warfarin or rivaroxaban), a blood thinner with effects reversed by the intake of vitamin K. This has long made monitoring of dosages difficult, as vitamin K from patients’ diets can impact the drug’s effectiveness. Xarelto initially presented a solution to this problem, but there was a hidden danger: Unlike Coumadin, there was no known antidote for Xarelto, making it impossible to reverse its effects in cases of emergency. In early 2018, an antidote was finally approved by the FDA.
In December 2014, a federal court consolidated nearly two dozen Xarelto lawsuits involving bleeding complications into a single multi-district litigation. In 2016, four cases were selected to be addressed in four bellwether trials. The first three of these took place in 2017, and they were all won by Xarelto’s manufacturers. The fourth and final bellwether trial is still pending as of October 2018.
The common thread across Xarelto lawsuit cases is the failure of manufacturer Janssen Pharmaceutical, Inc. (owned by Bayer and Johnson & Johnson) to properly recognize, address, and communicate the nature and severity of all possible risks and side effects. This includes providing insufficient information to healthcare providers about safe prescribing methods and failing to appropriately emphasize the need for monitoring and the lack of a reversal treatment.
Whether the manufacturer intentionally downplayed risks or simply failed to explain the side effects and requirements of care clearly, Janssen Pharmaceutical is still responsible for putting thousands of Americans’ lives in imminent danger.
Because Xarelto targets the cardiovascular system, the harmful side effects of the drug can be immediately life-threatening. In Xarelto litigation, patients have reported side effects like the following:
Frustratingly, many of these side effects are precisely the complications the drug is intended to treat.
To date, no settlements have been made and no damages have yet been ordered in any of the Xarelto lawsuits. However, thousands of cases are still pending in court, which means that compensation for injured patients remains a possibility for the future.
In any such case, the compensation amount can be affected by factors like the severity of harm, the degree to which the court finds the drug manufacturer liable, patient medical costs, etc. In a similar blood thinner case involving Pradaxa, manufacturer Boehringer Ingelheim paid $650 million to settle almost 4,000 lawsuits alleging blood clots and bleeding complications.
The FDA has never recalled Xarelto, but it has ordered five separate updates to labeling since 2013, including new warnings about adverse reactions and increased bleeding risk in patients taking certain antidepressants. Currently, the drug remains on the market despite thousands of still-pending lawsuits.
Xarelto’s approval in 2011 had some internal FDA reviewers voicing concerns about the validity of the single study used as the basis for the drug’s approval. In a three-year clinical trial involving over 14,000 patients, researchers compared the number of strokes and bleeding events in patients taking Xarelto to those in patients taking Coumadin. In September 2016—five years after the drug’s approval—news broke that the manufacturer had been aware of a faulty device all along.
Concerns have since been raised about the validity of the 2011 trial results, the safety of the drug, and the ethics of Bayer and Janssen Pharmaceutical. It was also suggested that the companies may have used their influence to conceal data in journal articles to get approval for Xarelto.
If the pharmaceutical companies are indeed exercising their influence to manipulate the legal process, they’re still doing so. Recently, patients and families involved in the first three bellwether cases began fighting back against their losing verdicts. They argue that the entire process was biased toward the manufacturers of the drug, alleging the defense manipulated the case selection process so that they would have a better chance of winning.
Incredibly, even with accusations of court manipulation and a continuing onslaught of Xarelto lawsuits, the drug was approved in October 2018 for a new indication as a treatment for Chronic Coronary Artery Disease.
Have you or a loved one suffered adverse effects like blood clots and bleeding while taking Xarelto? Our firm is currently reviewing Xarelto claims, and we’d be more than happy to discuss your experience with you.
Please note that we at Saunders & Walker P.A. cannot provide medical advice and that you should never discontinue or change the dose of any medication you are taking without first consulting with your prescribing physician. If you have questions about the safety of Xarelto, we urge you to contact your doctor.
At Saunders & Walker P.A., we have a long history of representing patients harmed in pharmaceutical and medical device cases, and we are deeply dedicated to helping victims and their families seek the compensation they deserve for their losses. To schedule an appointment to discuss your experience with Xarelto, contact us online or call us at (800) 748-7115.