Lawsuits filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Corp. over the blood thinner Xarelto have been consolidated in Louisiana federal court. Xarelto has been linked to serious side effects including internal bleeding, gastrointestinal bleeding, brain bleed and death.
The Xarelto lawsuits come on the heels of the recent $650 million Pradaxa settlement. Researchers linked Pradaxa, also a blood thinning medication, to more than 500 deaths. Xarelto blood thinner litigation has been consolidated into multidistrict litigation (MDL) before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, who presided over suits against Merck & Co. over its medication Vioxx. The Vioxx litigation resulted in a $4.85 billion settlement in 2007.
Andy Birchfield, who is head of the firm’s Mass Torts Section, was appointed in 2015 as Co-Lead Counsel for the Plaintiffs Steering Committee in the Xarelto MDL. Andy was instrumental in the Vioxx litigation as well.
What is Xarelto?
Xarelto, known chemically as rivaroxaban, is a next-generation blood thinner manufactured by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer. It was approved by the Food and Drug Administration (FDA) in 2011. Xarelto is approved by the FDA for six indications including reducing the risk of stroke in patients with nonvalvular atrial fibrillation; treating deep vein thrombosis and pulmonary embolism, and reducing the reoccurrence of these conditions; and preventing blood clots in patients following knee or hip replacement surgery.
Since its approval, more than 13 million Xarelto prescriptions have been written in the U.S., making it the country’s most prescribed blood thinner in its class. Xarelto is intended to be a more convenient alternative to the long-used blood thinner warfarin, which requires patients to have their blood monitored regularly. Xarelto has fewer interactions and does not require patients be monitored while taking the drug.
Xarelto bleeding risks
Blood thinners can make patients more prone to bleeding events, some of which can be serious and life threatening including gastrointestinal bleeds and brain hemorrhages. While bleeding risks with Xarelto are similar to warfarin, unlike warfarin, there is no antidote to reverse the blood thinning properties of Xarelto in the event of a bleeding emergency.
A drug company has developed a Xarelto reversal agent but it has yet to obtain clearance from the FDA. The agency is expected to decide by May 2018 whether to approve the potential antidote.
Patients taking Xarelto should seek immediate medical attention if they experience unexpected bleeding such as frequent nose bleeds, unusual bleeding from the gums, heavier than normal menstrual or vaginal bleeding, or bleeding from the rectum.
Patients should also contact their doctors if they experience any of the following symptoms of possible bleeding:
- Red, pink or brown urine
- Bright red or black, tarry stools
- Coughing up blood or blood clots
- Vomiting blood or what resembles coffee grounds
- Headaches, dizziness, or weakness
- Pain, swelling, or new drainage in areas of the body where there are wounds
Xarelto warnings and precautions
Boxed warnings – also called black box warnings – are the most serious type of warning the agency requires and is reserved for drugs and medical devices in which there is reasonable evidence that use could cause serious or life threatening adverse events.
When Xarelto was approved in 2011, the FDA required the manufacturers to include two boxed warnings on its label. The first advises patients not to discontinue Xarelto prematurely as doing so can cause adverse thrombotic (blood clot) events, like strokes. The warning also cautions patients with atrial fibrillation of an increased risk in stroke when switching from Xarelto to warfarin.
The second boxed warning advises patients that epidural or spinal hematomas (clotting of blood within the body’s tissues) have occurred in patients treated with Xarelto who were also receiving neuraxial anesthesia (epidural) or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. The warning advised doctors to monitor patients frequently for signs and symptoms of neurological impairment and, if observed, treat immediately.
More than 20,000 lawsuits have been filed against Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer alleging they did not adequately warn of the bleeding risks with Xarelto, failed to recommending monitoring and dose adjustments, and didn’t adequately test or research the drug before marketing it.
In December 2014, a multidistrict litigation was created transferring all complaints filed through the federal court system to U.S. District Judge Eldon Fallon in the Eastern District of Louisiana. There are current more than 20,000 Xarelto lawsuits pending in the federal court system.
The Xarelto multidistrict litigation (MDL) is overseen by U.S. District Judge Eldon Fallon for the Eastern District of Louisiana, the same judge who presided over the landmark Vioxx painkiller litigation, which resulted in a $4.85 billion settlement with Merck & Co. Inc., in 2007.
In January 2015, a mass tort program was created for Xarelto lawsuits in the Philadelphia County Court of Common Pleas. Judge Michael Erdos is overseeing the 1,700 Xarelto cases pending in that program.
Johnson & Johnson’s Janssen Pharmaceuticals and Bayer have yet to address a global settlement for Xarelto cases, but similar lawsuits against another next-generation blood thinner were resolved.
Boehringer Ingelheim’s Pradaxa hit the market in 2010 and quickly became the subject of thousands of lawsuits alleging the company did not adequately warn of serious and life threatening bleeding events with its anticoagulant. Researchers linked Pradaxa to more than 500 deaths.
In 2014, Boehringer Ingelheim agreed to pay $650 million to settle about 4,000 lawsuits.
Beasley Allen is currently taking cases involving serious injuries or deaths related to Xarelto use. If you or a loved one has been injured by Xarelto, or someone has died following Xarelto use, we would like to talk with you about a possible claim. Contact us by filling out the contact form on this website for a free, no-obligation evaluation of your claim.