A Texas woman has filed a Xarelto lawsuit against several prominent drug companies, including Johnson & Johnson, Bayer, and Janssen Pharmaceuticals over alleged Xarelto bleeding. Her uncontrollable bleeding lawsuit alleges that she suffered life-threatening Xarelto side effects.

Xarelto is a type of drug called an anticoagulant, more commonly known as a “blood thinner.” Anticoagulants make it harder for blood to clot.

While clotting is a normal part of the healing process after an injury, many serious medical problems go back to this process misfiring. When the clotting process goes haywire, a blood clot can form inside the body, and block the blood supply to important organs and tissues.

For example, strokes, some types of heart attacks, and pulmonary embolisms are all caused by blood clots sticking in the wrong places. Anticoagulants are designed to lessen the chance of dangerous blood clots in at-risk patients. But Xarelto lawsuits like Texas resident Jeanne Jeffcoat’s allege that the drug also carries the risk of serious bleeding side effects.

All anticoagulants carry the risk of uncontrolled bleeding, though Xarelto lawsuits like Jeffcoat’s allege that Xarelto and related drugs have a special risk above and beyond that of other anticoagulants.

Older anticoagulants like Warfarin recommend that patients get regular blood tests to make sure the drug is working properly, reducing the risk of clots but not completely damaging a patient’s ability to clot. Additionally, Warfarin has a reversal agent, drugs that could deactivate the drug in the event of uncontrolled bleeding.

Xarelto and other later generation anticoagulants lack this ability, so if Xarelto bleeding does occur, physicians have few options.

According to Jeffcoat’s Xarelto lawsuit, she took Xarelto from March 2012 through July of 2012. Jeffcoat allegedly stopped using the drug that July of that year because she suffered a major Xarelto bleeding incident, requiring hospitalization. Her Xarelto lawsuit alleges that this could have all been avoided.

The Xarelto lawsuit alleges that that the makers of Xarelto were aware — or reasonably should have been aware — of the risks linked to their drug.

Her Xarelto lawsuit cites the 2012 Institute for Safe Medical Practice (ISMP), which noted that even during the initial Food and Drug Administration (FDA) trials, there were concerns that one pill a day without monitoring was causing problems.

If the allegation is true, this could mean that the makers of Xarelto knowingly marketed the drug as not requiring blood tests even though the drug carried the same risks as older anticoagulants that recommend such testing.

Jeffcoat’s Xarelto bleeding lawsuit further alleges that in spite of this knowledge, drug makers continued to aggressively market the drug. In fact, Xarelto made $582 million in its first year on the market. In 2013, Xarelto made a billion dollars in worldwide sales, a major benchmark for the success of a drug.

The Xarelto Uncontrollable Bleeding Lawsuit is Jeanne Jeffcoat v. Janssen Research and Development, et al., Case No. 4524, in the U.S. District Court for the Eastern District of New York.