At an ongoing Xarelto trial, a former FDA commissioner told the jury that Xarelto’s warning labels did not give adequate warning about its side effects, including the risk of bleeding.

The Xarelto trial is taking place in front of a Philadelphia jury, and deals with an Indiana plaintiff’s claims that she suffered severe gastrointestinal bleeding due to use of Xarelto.

The plaintiff, Lynn H., took Xarelto as prescribed by a doctor to prevent blood clots linked with her irregular heartbeat. Unfortunately, after using Xarelto for a little over a year, Lynn was hospitalized due to internal bleeding. In the process, she had to undergo two blood transfusions and remained in the hospital for four days.

Because of her hospitalization, Lynn’s doctors took her off Xarelto and switched to Eliquis. Since she made the switch, back in June 2014, Lynn has not suffered from similar bleeding side effects. Lynn decided to file a lawsuit against Xarelto’s manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), alleging the company failed to give adequate warning about these risks.

At the current Xarelto trial, ex-FDA commissioner David Kessler testified that the warning labels for Xarelto were insufficient, understating the risk patients run of significant bleeding events like Lynn’s gastrointestinal bleeding and subsequent hospitalization. On top of this failure to warn patients about serious bleeding risks, they “did not adequately notify physicians that some patients are at higher risk than others.”

Kessler testified at the Xarelto trial that U.S. patients were at a greater risk of suffering bleeding events than patients globally. While the global rate of bleeding events linked with Xarelto is fairly low, at 3.6 percent, the rate in the U.S. alone is much higher. Kessler testified that U.S. patients experienced these bleeding events at a rate of 8.06 percent — more than twice as high.

Lynn’s Xarelto lawsuit is just one of more than 1,500 cases pending in Philadelphia over alleged Xarelto injuries.

Xarelto Bleeding Side Effects

Xarelto (also sold under its generic name, rivaroxaban) is a popular anticoagulant, or blood thinner, approved by the U.S. Food and Drug Administration (FDA) back in 2011. Xarelto and other anticoagulants are used to reduce blood clotting and related issues like stroke and systemic embolism.

Unfortunately, a growing number of patients like Lynn are coming forward with claims of Xarelto bleeding side effects.

Filing a Lawsuit Over Xarelto Side Effects

Xarelto lawsuits allege a number of serious side effects, including gastrointestinal bleeding, brain hemorrhaging, or even Xarelto bleeding death.

According to Xarelto lawsuits, Janssen Pharmaceuticals failed to adequately warn both patients and the medical community about the serious risks linked with Xarelto, including Xarelto bleeding.

If you or someone you love has experienced Xarelto gastrointestinal bleeding or other serious side effects, you may be able to file a Xarelto lawsuit. While filing a lawsuit cannot reverse the pain and suffering caused by these side effects, or bring a loved one back to life, it can help to alleviate the financial burden caused by medical costs, lost wages, and other expenses.