A Kansas resident filed a Xarelto bleeding lawsuit against the makers of the popular blood-thinner Xarelto, alleging that the medication caused her to suffer an internal bleed in her thigh, resulting in significant injuries.

Like many others who have filed product liability lawsuits against Xarelto manufacturer Bayer and Janssen Pharmaceuticals, which markets the drug, plaintiff Melva A. accused the companies of a failure to warn, design defect, negligence, fraud, breach of warranty.

In December, a federal panel approved a request to centralize nearly two dozen Xarelto bleeding cases in the Eastern District of Louisiana. The plaintiffs question the adequacy of Xarelto’s warning label with respect to the risk of severe bleeding and other injuries, the results of certain clinical studies, and the alleged need for blood monitoring.

Xarelto is an anticoagulant (blood thinner) that has been widely prescribed to prevent blood clots in patients suffering from atrial fibrillation (arrhythmia of the heart), deep vein thrombosis (blood clots deep within the body), pulmonary embolism (blood clots in the lungs), stroke, and patients who have recently undergone a knee or hip replacement surgery.

Many doctors prescribe it instead of Warfarin (coumadin), a blood thinner that has been used in the United States since the 1950s. Severe internal bleeding and death are Xarelto’s most commonly reported side effects, but others include thrombosis (blood clots), decreased hemoglobin (a substance that carries oxygen in red blood cells), cerebrovascular accidents (an event that leads to a cerebral hemorrhage), hematoma (a semisolid mass in the blood), peripheral edema (swelling of the lower limbs), and dyspnea (difficulty breathing).

According to Melva’s Xarelto bleeding lawsuit, the intense marketing of Xarelto resulted in approximately 130,000 U.S. prescriptions written for the drug in the first three months of 2012. Xarelto costs about $3,000 a year compared to $200 for generic Warfarin.

The defendants, according to the Xarelto bleeding lawsuit, knew Xarelto had statistically significant increases in irreversible bleeds and other side effects which could result in serious, permanent injury. Xarelto also had not been adequately tested, Melva alleges, and does not have any known reversal agents.

Xarelto bleeds cannot be stopped or controlled by any effective medical processes or medical intervention. The defendants failed to warn that it is difficult or impossible to assess the degree or extent of anti-coagulation in patients taking Xarelto.

Xarelto is not as safe as blood thinners such as warfarin, according the Xarelto bleeding lawsuit. Even those prescribed Xarelto for a brief period of time were at increased risk for developing life-threatening bleeds, the Xarelto bleeding lawsuit states.

“Due to the flawed formulation of Xarelto, which according to Defendants does not require regular blood monitoring or frequent doctor follow-up, raises concerns about the risk of stroke, bleeding, and blood clots if not taken properly or absorbed properly, particularly in patients with poor renal function.”

A suspected 968 patients had “undesirable side-effects including 72 cases of death in Germany in just the first eight months of 2013,” according to Melva’s Xarelto bleeding lawsuit.