Approved in 2011, Xarelto (rivaroxaban) is one of the newest blood thinners on the market and is manufactured by Bayer and marketed in the U.S. by Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals. Xarelto brought in over $2 billion for J&J in 2016 alone, according to the company’s annual report.
But people injured by the drug say its makers put profit before safety. The most dangerous side effect for people who take Xarelto is internal bleeding. The drug does not have an antidote, and former Xarelto users filed lawsuits saying they were not sufficiently warned about the medication’s risk. Some plaintiffs filed wrongful death suits after loved ones died from Xarelto bleeding.
Lawyers involved in litigation say Xarelto clinical trials have high rates of missing data, fail to address the lack of an antidote and fail to provide adequate evidence of the drug’s benefits. The litigation remains active and plaintiffs continue to file lawsuits.
Consolidated Xarelto Lawsuits
There are currently more than 15,611 cases consolidated in federal multidistrict litigation (MDL) before Judge Eldon E. Fallon in the United States District Court Eastern District of Louisiana under MDL-2592. Hundreds more are pending in state courts. The first bellwether trial in the MDL, Boudreax vs. Bayer et al., is set for April 24, 2017 in Louisiana. The result of this trial could set the tone of future Xarelto trials and possible settlements.
Judge Fallon gathered about 40 cases for the initial bellwether trials, according to court documents. In addition to the first trial set in Louisiana in April, Judge Fallon also scheduled three more trials:
May 30, 2017
Eastern District of Louisiana
To Be Set in June 2017
Southern District of Mississippi
To Be Set in July 2017
Northern District of Texas
Judge Arnold New presides over a second group of consolidated Xarelto lawsuits in Philadelphia’s Complex Litigation Center (CLC). The CLC is set up to handle several mass tort programs. As of March 2017, about 1,300 cases were pending in the CLC.
The results of the first bellwether in the MDL may influence proceedings in the CLC.
Xarelto Lawyer Discusses Why People are Filing Lawsuits
Xarelto is a one-size-fits-all medication, which makes it more convenient and appealing to patients. Unfortunately, that characteristic is precisely what makes Xarelto dangerous — and why the drug is now the target of thousands of legal claims, lawyer Ellen Relkin told Drugwatch. Relkin is a member of the plaintiff’s steering committee overseeing litigation in Louisiana federal court.
Relkin said plaintiffs file claims against Johnson & Johnson and Bayer because warnings attached to Xarelto weren’t strong enough, and many patients didn’t know the drug had no antidote. J&J and Bayer promoted the medication’s benefits and minimized information about the risks.
Low Therapeutic Index
Xarelto can cause serious bleeding, the number one reason people are filing lawsuits. Relkin explains that this problem comes from its low therapeutic index — the ratio of a toxic to therapeutic dose. This means it is easy for a person to get too much or too little of Xarelto because it does not require blood tests. Because of this, plaintiffs claim the design of the drug is faulty and dangerous.
“[A] problem with the medication is it has what is called ‘a low therapeutic index.’ In other words, it can be safe at a certain point and dangerous within a very close range,” Relkin said. “Someone can be 110 pounds or 200 pounds, old or young [and] with varying kidney functions and get the same dose and have a very different impact. Unlike the traditional blood thinner, Coumadin, where you have monitoring of the drug where the patient gets their blood checked periodically so the doctor can assess whether the levels are appropriate, you don’t do that with Xarelto.”
Wound Leakage and Infection
Another issue with Xarelto — though less-publicized than its bleeding complications — is its link to a greater occurrence of wound infections following surgery for total hip or knee replacements. This is another reason people are filing lawsuits. Relkin said the medication increases wound leakage and infection risk by more than 10 times. The complication often sends patients back in for more surgery.
The need for more surgery and treatment increases the damages people seek when filing a lawsuit against Bayer, Janssen and J&J.
“There are safer, equally or more effective ways to prevent clots following a hip or knee arthroplasty that doctors find very satisfactory, aspirin, compression stockings and getting the patients up and walking,” Relkin said, adding that a number of surgeons are prescribing alternative drugs because of the risk.
Allegations against Xarelto Manufacturers
Plaintiffs who filed lawsuits against Bayer, Janssen and J&J claim the drug companies misrepresented the safety and effectiveness of Xarelto. Despite their knowledge of Xarelto’s defects and dangers, defendants did not warn patients or doctors about the severity of side effect risks, according to court documents.
Lawsuits say, “Defendants were negligent in the designing, researching, supplying, manufacturing, promoting, packaging, distributing, testing, advertising, warning, marketing and sale of Xarelto.”
Specific lawsuit allegations say defendants failed to:
- Adequately test, research and study Xarelto
- Provide adequate warnings about Xarelto safety risks, specifically uncontrolled bleeding and complications linked to uncontrolled bleeding
- Adequately warn that it is impossible or difficult to measure the degree of anticoagulation in each patient
- Warn patients and doctors that there is no antidote to reverse Xarelto bleeding
- Provide adequate warning that seniors are at increased risk of Xarelto bleeds
- Adequately warn of the increased risk of gastrointestinal bleeds, especially in patients with a history of gastrointestinal issues
- Include a boxed warning — the FDA’s most serious warning — about serious bleeding events associated with Xarelto
Examples of Xarelto Lawsuits
A large number of plaintiffs in Xarelto lawsuits filed cases because they claim the drug led to the death of a loved one. The common allegations are failure to warn about the risk of bleeding, failure to warn about the lack of a bleeding antidote and misleading the public about the effectiveness and safety of the drug.
McGowan v. Janssen et al.
In 2014, Ruth McGowan filed a lawsuit on behalf of her deceased father, Thomas Dunkley. According to the complaint, Dunkley took Xarelto to reduce the risk of stroke. However, he suffered serious bleeding in his brain after taking the drug for about a month. The lawsuit accuses Janssen and Bayer of concealing safety risks and not properly testing the drug.
Packard v. Janssen et al.
Nancy Packard sued Janssen and Bayer on behalf of her deceased husband, William. Her lawsuit alleges that William took Xarelto for six months for atrial fibrillation and shortly after, he suffered bleeding in his brain. Doctors tried to save him by drilling a hole in his skull to alleviate building pressure but were unable to stop the bleeding. He ultimately died. Packard’s complaint says the drug makers failed to warn about the lack of an antidote.
Peck v. Janssen et al.
Frank Peck filed a lawsuit on behalf of his deceased wife, Ann Peck. Ann took Xarelto for one month. The lawsuit alleges Ann suffered internal bleeding and a hemorrhagic stroke that ultimately led to her death. The “severe and permanent personal injuries, pain, suffering [and] emotional distress” contributed to her death, the lawsuits states. Plaintiff alleges defendants did not mention Xarelto could lead to irreversible bleeds and did not have an antidote.
Griggs v. Janssen et al.
Harry and Joseph Griggs filed a lawsuit on behalf of their deceased father, Charles Griggs. Charles took Xarelto and suffered life-threatening bleeding on or about August 25, 2013. He ultimately died of his injuries on December 6, 2013. Plaintiffs claim Xarelto led to his death. The lawsuit says defendants failed to warn about dangerous side effects of Xarelto and did not warn the public that serious bleeding may be irreversible, permanently disabling and life threatening.
Similar Blood Thinner Settlements
The Xarelto litigation is currently underway and Bayer and J&J have yet to offer a settlement. Some experts were hopeful settlements talks would begin in 2016. Since the parties did not reach an agreement, the cases proceed to trial in 2017.
A similar blood thinner that reached settlement was Boehringer Ingelheim’s Pradaxa (dabigatran). The company agreed to settle 4,000 Pradaxa bleeding lawsuits for $650 million in May 2014. The FDA reported hundreds of people lost their lives to the drug, and thousands complained of bleeding side effects in situations similar to Xarelto.
Attorneys refer to the Pradaxa cases as a possible model for Xarelto litigation and settlement possibility. The size of Xarelto litigation is already more than four times the size the Pradaxa litigation was at the time of settlement.