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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. So far, Xarelto brought in about $2 billion for Bayer and J&J in 2015 alone. In the first quarter of 2016, J&J reported the drug already made $567 million.
But people injured by the drug say its makers put profit before safety. The most dangerous side effect for people who take Xarelto is uncontrollable bleeding. The drug does not have an antidote, and former Xarelto users filed lawsuits saying they were not warned sufficiently about the medication's risk.
There are currently more than 4,500 cases consolidated in federal multidistrict litigation before Judge Eldon E. Fallon in Louisiana under MDL-2592. Discovery is underway and defendants and plaintiffs are exchanging information. Plaintiffs also filed many more in state courts.
Some of the reasons people file lawsuits, include:
Wrongful death lawsuits accuse the defendant of concealing important safety information and not thoroughly testing the drug before it was put on the market. In addition to death, plaintiffs who filed lawsuits suffered from a number of serious bleeding injuries, including fatal paranchymal hemorrage or brain bleeds. These injuries caused them to incur financial and emotional hardship as well as additional health problems. Many of these people required emergency hospital visits and treatment.
|Some other injuries that lead patients and their families to file blood thinner lawsuits include:|
|Intestinal bleeding||Rectal bleeding|
|Brain hemorrhaging||Wound infections after hip or knee surgery|
The U.S. Food and Drug Administration reported thousands of serious adverse events — hundreds of which were bleeding events — linked to Xarelto. While blood thinners are dangerous in general, Xarelto topped the list released by the Institute for Safe Medication Practices (ISMP) as the most dangerous. The drug is also on its list of high-alert medications, meaning it has a "heightened risk of causing significant patient harm" when used in error.
According to lawsuits, hundreds of patients died because of bleeding caused by the drug. In 2012, the FDA reported that three times more people died from adverse events while on Xarelto compared to warfarin.
In addition, while it is supposed to prevent blood clots, the Food and Drug Administration (FDA) has already received reports of dangerous blood clots in people taking the drug.
People who take older blood thinners must have routine blood tests and make constant adjustments to their dosage. They’re also required to watch the foods they eat. This is part of the appeal of Xarelto: it is a one-size-fits-all medication. Unfortunately, that characteristic is precisely what makes Xarelto dangerous – and why the drug is now the target of thousands of legal claims, according to lawyer Ellen Relkin, 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 that 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.
"[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 told Drugwatch. "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."
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. 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.
"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.
Because of the large number of filed claims, the U.S. Judicial Panel on Multidistrict Litigation consolidated these cases into multidistrict litigation (MDL) in Louisiana and a mass-tort in Philadelphia. As of April 15, 2016, the MDL contained 4,579 cases before Judge Eldon E. Fallon. An MDL simplifies the legal process because many cases can be handled by the same experienced judge and in the same court. People whose lawsuits become a part of an MDL keep their own lawyers, and their suits are still handled as individual cases.
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.
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, and he ultimately died. Packard's complaint says the drug makers failed to warn about the lack of an antidote.
The litigation is currently underway and Bayer and J&J have yet to offer a settlement. Some experts say settlements talks may begin in 2016, and if parties do not agree on terms trials will press forward as scheduled.
In 2014, Boehringer Ingelheim agreed to settle 4,000 Pradaxa bleeding lawsuits for $650 million. The FDA reported hundreds of people lost their lives to the drug, and thousands complained of bleeding side effects in situations similar to Xarelto.
While it is impossible to determine the exact amount plaintiffs may be awarded, there are some factors that attorneys weigh when determining compensation in settlement and jury awards.
There are no current class actions related to Xarelto. In the case of the drug's more than 4,500 lawsuits, each case is treated individually. Each plaintiff retains their own lawyer and can accept or reject settlements. Instead, of a class action, these cases are consolidated into multidistrict litigation (MDL) to help speed up the process. Class actions typically involve just one plaintiff who represents an entire class. People can opt to join the class and whatever settlement is negotiated is split across the entire class and its members do not have a say in the outcome. Typically, these are smaller awards and do not involve serious injuries.
Dealing with health problems caused by a bad drug is emotional and draining, and it affects the entire family. Mounting medical bills wreak havoc on a family's finances. Stress, frustration and depression add up. In the case of Xarelto, some families have also had to deal with funeral expenses for lost loved ones. Sometimes filing a lawsuit is the only way to pay off medical bills – and to secure compensation for pain and suffering. Many patients also turn to the legal system to hold drug companies accountable and to send them a message.
Plaintiffs accuse Xarelto's makers of several counts of negligence and failure to warn. A capable Xarelto attorney can help you get financial assistance for medical bills and other incurred expenses. These attorneys are experienced in dealing with Big Pharma and understand what it takes to go up against drug companies in court.