The blood-thinner Xarelto can cause uncontrolled bleeding, a dangerous side effect that leads some users and family members to seek compensation through the court system. Internal bleeding can be fatal.
- Financial hardship caused by emergency visits, ongoing care, and lost wages.
- Emotional distress from caring for loved ones suffering medical problems
- The burden of funeral expenses because of uncontrolled bleeding caused by Xarelto.
- Holding Bayer and Janssen Pharmaceuticals accountable for releasing a dangerous drug.
|Some injuries that lead patients and their families to file blood thinner lawsuits include:|
|Death caused by uncontrolled bleeding||Intestinal bleeding|
|Rectal bleeding||Brain hemorrhaging|
These wrongful death lawsuits also accuse the defendant of concealing important safety information and of not thoroughly testing the drug before it was put on the market. If you or a loved one suffered from bleeding, blood clots or other side effects caused by Xarelto, you may be able to file a Xarelto lawsuit against Bayer and Janssen Pharmaceuticals. If you need help figuring out your legal options, call or email our legal advocates.
- Internal Bleeding
- Blood Clots
Xarelto and Uncontrolled Bleeding
Thousands of serious adverse events, hundreds of which were bleeding events, have been 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.
Deaths Attributed to Xarelto
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.
Dangerous Blood Clots
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. That is where a consolidated group of plaintiffs say Xarelto caused severe bleeds and other side effects.
“[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.”
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 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.
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.
“It is our belief that the Xarelto warning did not sufficiently warn of the magnitude of the risk of the bleeding as well as the problems of it being this one-size-fits-all kind of crude treatment,” Relkin said.
Blood Thinner Lawsuits
Multidistrict Litigation (MDL)
There is no current class action related to Xarelto, but the number of lawsuits against Bayer continues to grow. 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, 2015, the MDL contained 400 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.
McGowan v. Janssen
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
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.
Dealing with health problems caused by a bad drug is emotional and draining, and it affects the entire family. Mounting medical bills wreaks 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.
If you or a loved one took Xarelto and suffered severe bleeding, you may have legal options. Let Drugwatch help you find a qualified attorney. 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.
- Institute for Safe Medication Practices. (2012, October 3). Why reports of serious adverse drug events continue to grow [Report]. Retrieved from http://www.ismp.org/quarterwatch/pdfs/2012Q1.pdf
- Institute for Safe Medication Practices . (2013, January 9). QuarterWatch data from 2012 Quarter 2 [Report]. Retrieved from http://www.ismp.org/quarterwatch/pdfs/2012Q2.pdf
- Food and Drug Administration (FDA). (2011, November 4). FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm.
- Pierson, R. (2012, June 14). Pradaxa and Xarelto: Top heart doctors concerned over new blood thinners. The Huffington Post. http://www.huffingtonpost.com/2012/06/14/pradaxa-xarelto-blood-thinner-doctors-heart_n_1595971.html
- Helen Jean Hawkins and John Edward Hawkins v. Boehringer Ingelheim Pharmaceuticals, Inc. (2012).
- Bertha Bivens, as Next of Kin Estate of Nancy Brummett, Deceased Plaintiff, v. Boehringer Ingelheim Pharmaceuticals, Inc. (2012).
- Krajelis, B. (2013, January 10). Herndon reports steady progress in Yaz, Pradaxa litigation. The Madison-St. Clair Record. Retrieved from http://madisonrecord.com/issues/895-product-liability/251351-herndon-reports-steady-progress-in-yaz-pradaxa-litigation