A plaintiff from Kentucky has joined the larger litigation over alleged Xarelto bleeding incidents.

Xarelto is an anticoagulant or blood thinner, a drug designed to make it harder for blood clots to form within the body, reducing the risk of stroke. But this Xarelto lawsuit alleges that Xarelto side effects are a serious risk.

Plaintiff Linda S. of Kentucky has filed the Xarelto lawsuit. Per the text of her Xarelto lawsuit, Linda S. was prescribed Xarelto and took the drug between Dec. 4, and Dec. 24, 2013, taking the drug for less than a month.

On Dec. 23, the Xarelto lawsuit alleges, Linda S. experienced a gastrointestinal bleed, requiring emergency medical care. The Xarelto lawsuit goes on to state that she required “transfusions, surgery, and extensive hospitalization from the use of Xarelto.” Her claim holds that this was the result of taking the medication.

The Xarelto lawsuit states that the very trials used to approve Xarelto suggested that the drug could be dangerous. In fact, the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism studies, abbreviated RECORD, found that Xarelto had a higher rate of bleeding compared with similar drugs, requiring transfusions.

The Xarelto lawsuit reports that the clinical trial used to approve Xarelto for use in patients at risk for stroke and embolism from atrial fibrillation found that the drug carried a risk of major bleeding. Her lawsuit also noted that Xarelto lacked an “antidote.”

All blood thinners carry some risk of working too well and causing gastrointestinal bleeding and other forms of uncontrollable bleeding. However, as the text of this Xarelto lawsuit points out, older anticoagulants have known reversal agents.

For example, if a patient taking Warfarin suffers from gastrointestinal bleeding, a second drug, an “antidote” or “reversal agent,” can be administered to effectively turn off the drug. The Xarelto lawsuit notes that there is no such fix for Xarelto, and the original US drug information label does not note this in a special warning section.

The Xarelto lawsuit also asserts that despite these alleged risks associated with Xarelto, the drug’s makers aggressively promoted the drug. The Xarelto lawsuit states that the manufacturers spent more than $11 millon in 2013 on ads for Xarelto alone, and pulled in $582 million in global sales the first year Xarelto was on the market.

The Xarelto lawsuit alleges that in the advertising, “defendants [Xarelto’s makers] overstated the efficacy of Xarelto with respect to preventing stroke and systemic embolism, failed to adequately disclose to the patients that there is no drug, agent, or means to reverse the anticoagulation effects of Xarelto, and that such irreversibility could have permanent, disabling, life-threatening, and fatal consequences.”

The Xarelto lawsuit holds that aggressive marketing, coupled with the alleged dangers of Xarelto, led to the drug’s makers enriching themselves while endangering patients like Linda S.

The individual Xarelto Lawsuit is Linda S. vs. Janssen Research and Development LLC, et al, Civil Action No. 1143, filed within the larger MDL In Re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, filed in the United States District Court for the Eastern District of Louisiana.