An Ohio man is taking Bayer and Janssen Pharmaceuticals to court over what he says was a dangerous episode of blood in urine.

Plaintiff Roger S. says he took Xarelto for just a few weeks, from August to September 2014. On September 7, he suffered a hemorrhagic cystitis that he says was a direct result of Xarelto.

Hemorrhagic cystitis is an inflammation of the bladder accompanied by blood in urine.

It commonly occurs in conjunction with a bladder infection, and it can lead to more serious complications if that infection spreads to the kidneys.

Frequent symptoms include a greater-than-normal urge to urinate or a burning sensation while urinating. Blood in urine may be a sign of cystitis in conjunction with an internal hemorrhage.

Internal bleeding similar to what Roger suffered is a known risk associated with anticoagulants like Xarelto. Patients who are at risk for blood clot-related injuries sometimes use these drugs to reduce the risk of such injuries.

While Xarelto may be effective at reducing that risk, the flip side of its anticoagulant effect is that it increases the risk of dangerous internal bleeding, like the blood in urine Roger suffered from.

According to Roger’s Xarelto lawsuit, Xarelto entered the U.S. market in 2011 as one of a group of new medications known as new oral anticoagulants.

This group was introduced to the market to compete with warfarin, which for decades had been the go-to choice for patients who needed an anticoagulant medication to reduce the risk of stroke and systolic embolism.

Plaintiff Says Defendants Failed to Warn About Blood in Urine, Other Symptoms

The gist of Roger’s legal claims is that defendant Janssen Pharmaceuticals and Bayer, the purported makers of Xarelto, ignored evidence that the drug caused dangerous side effects like blood in urine while simultaneously over-promoting Xarelto as being safer and more effective than it actually is.

He argues that, among other publicly available information, reports in the FDA’s adverse events database showed “staggering, serious events” that have been associated with Xarelto. In the twelve months prior to June 30, 2012, he says, there were 1,080 Xarelto-related reports lodged with the FDA, including at least 65 cases that ended in death.

Roger claims that by the end of fiscal 2012, Xarelto’s first year on the market, no less than 2,081 such reports had been filed, with 151 such reports involving patient deaths.

At the same time, he claims, defendants aggressively over-promoted Xarelto as a safe and effective alternative to warfarin. He believes they overstated Xarelto’s efficacy at preventing stroke and systolic embolism, “failed to disclose the need for dose adjustments, failed to disclose the need for blood monitoring, and failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Xarelto, and, that such irreversibility could have permanently disabling, lifethreatening and fatal consequences.”

Roger’s Xarelto lawsuit raises claims for strict liability, manufacturing defect, design defect, failure to warn, negligence, breaches of express and implied warranties, negligent misrepresentation, fraud, and violation of state consumer protection laws.

He seeks an award of damages in excess of the jurisdictional minimum, including punitive damages, plus court costs and attorneys’ fees.

Roger has filed this Xarelto lawsuit as part of the Xarelto multidistrict litigation now being overseen by U.S. District Judge Eldon Fallon in a federal court for the Eastern District of Louisiana.