A Closer Look at the Xarelto® Lawsuit

Why is Xarelto® Prescribed

Xarelto® is often recommended for patients who have an increased risk of developing blood clots and who suffer from atrial fibrillation (arrhythmia of the heart), deep vein thrombosis (DVT), pulmonary embolism, stroke, and those who have recently undergone a surgical procedure to replace a hip or knee. In 2011, the Food and Drug Administration (FDA) approved the use of Xarelto® for patients who had recently had one of these joint replacement surgeries. Shortly after, the medication was approved for patients suffering from atrial fibrillation.

The Xarelto® Lawsuit

Claims in the Xarelto® lawsuit allege that the manufacturer, Janssen Pharmaceutical, and the company that markets the drug, Bayer Healthcare, failed to warn both doctors and patients of the inherent dangers associated with the medication. If all parties involved had been given the appropriate warnings, they may have opted for another medication with a reduced risk of complications and side effects.

Excessive internal bleeding can cause a number of adverse health concerns, and can even be fatal.

Xarelto®, which is a blood thinner, has been linked to an increased risk of internal bleeding. Another similar medication, Warfarin, which has been in use since 1954, has also been linked to an increased risk of bleeding. However, this risk can be treated with high dosages of Vitamin K. The manufacturers and marketers of Xarelto® claimed that the newer medication was superior to Warfarin because it did not require routine blood tests to protect patients against adverse health events.

The lawsuit alleges that if patients and doctors had received the proper warnings, they would have chosen to take Warfarin because any negative complications could be treated with Vitamin K, or patients would have undergone periodic blood testing while on Xarelto® to decrease their risk of an adverse bleeding event.

Complications and Side Effects Associated with Xarelto®

The primary complication associated with Xarelto® use is the increased risk of internal bleeding. While the internal bleeding that is caused by Warfarin can be treated with higher doses of Vitamin K, there is no antidote to the type of bleeding that may be caused by Xarelto®. Excessive internal bleeding can cause a number of adverse health concerns, and can even be fatal.

ISMP Designation as a Dangerous Drug

The risk of serious bleeding events when taking Xarelto® is so high that it topped the list compiled by the Institute for Safe Medication Practices (ISMP) as the most dangerous of the anticoagulant medications that they observed. Additionally, Xarelto® is also on the ISMP’s list of high alert medications because it has a heightened risk of causing significant patient harm when used in error.

Deaths Attributed to Complications from Xarelto®

According to lawsuits filed around the country, hundreds of patients have died from uncontrolled internal bleeding events caused by the drug. The FDA has reported that three times as many patients have died from complications while taking Xarelto® than those who were taking Warfarin or other similar medications.

Dangerous Blood Clots

Xarelto® is prescribed to prevent the formation of blood clots. However, the FDA has already received numerous reports of patients experiencing clotting events while taking the drug. Similar to the other associated complications, many lawsuits have alleged that the companies that manufacture and market Xarelto® failed to warn both doctors and patients of the inherent dangers with the medication. Had they been appropriately informed, many practitioners would have recommended another drug, and many patients would have chosen an alternative therapy.

Other Complications Associated with Xarelto®

Patients who have been taking Xarelto® have also seen an increase in infections following their hip or knee replacement surgeries. Patients have also seen a decrease in the hemoglobin content of their blood, which is the component of red blood cells that carries oxygen throughout the body. Additionally, Xarelto® has been linked to cerebral hemorrhages, semisolid masses in the blood (hematoma), swelling of the lower limbs, and breathing difficulties.

Finding a Replacement for Warfarin

Almost 7 million patients worldwide suffer from atrial fibrillation. Because of this irregular heart rate, these patients are at an increased risk for developing blood clots that can cause strokes and pulmonary embolisms. Warfarin has long dominated this market, but pharmaceutical companies have been racing to find a replacement because the medication can react negatively with many common foods and requires frequent blood testing to adjust the dosage to prevent bleeding events. The manufacturers of other similar medications have already begun to aggressively market their new drugs in an effort to corner the 20 billion dollar market.

Have Complications from Xarelto® Necessitated a Recall?

As of the publication of this article, there have not been any significant mandatory or voluntary recalls of Xarelto® initiated by the FDA or the manufacturer of the drug. However, the medication is still relatively new to the market and the legal investigations are in their earliest stages. For any type of case involving dangerous drugs, it often takes many years and countless hours of work by teams of attorneys before determining if a recall is the most effective solution.

Why are People Filing Lawsuits?

One of the main problems with the drug Xarelto® is also marketed as one of its main benefits: makers claim it does not require frequent blood tests. However, without these tests, patients do not know if they are at an increased risk for a serious bleeding event. With other anticoagulant medications, patients are required to have at least monthly screenings that would alert them to adjust their dosage to protect against any adverse events.

If you have been injured by a defective drug, Speak with an Attorney

Additionally, the risk of wound leakage and infection for patients who have had knee or hip replacement surgeries has increased when they take this drug. These types of complications often require additional surgeries to correct. Many surgeons have begun prescribing other therapies following these procedures to avoid this risk altogether.

Many of the individual lawsuits have claimed that the manufacturers and marketers of Xarelto® did not sufficiently warn the affected parties of these risks, and are therefore liable for injuries caused.

ISMP Articles Concerning the Use of Xarelto®

• In 2014, the ISMP published findings that although there had been an increase in reports of adverse bleeding events associated with Xarelto® use, the number of patients that the drug had been prescribed to continued to increase rapidly. There conclusions state that while the drug is being marketed for its ease of use, it represents a substantial wrong turn for an important medical treatment.
• In 2012, the ISMP had already begun to track the number of adverse events surrounding anticoagulant medications, and specifically, Xarelto®. Their findings detail the risks of blood clots and embolisms in post-operative patients.

Obtain Experienced Legal Representation

If you have been prescribed Xarelto® and experienced a serious bleeding event, dangerous blood clot, or other complication associated with the drug, please get in touch with an experienced pharmaceutical attorney today. Each state has specific time requirements in which you must file a claim before the manufacturers and marketers of the drug are no longer liable.