Xarelto Lawsuit Information
By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed March 05, 2024
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Xarelto (rivaroxaban) is a blood-thinner or anticoagulant. The U.S. Food and Drug Administration (FDA) approved Xarelto in July 2011, and its sales have steadily grown. Johnson & Johnson and its subsidiary Janssen Pharmaceuticals manufacture Xarelto in the United States. Bayer AG markets the drug in Europe.
Xarelto is part of a wave of new blood-thinning drugs that recently hit the market. Pharmaceutical companies designed these drugs as an alternative to Warfarin. Warfarin is a blood-thinning drug that has been around since the 1950s.
One of Xarelto's direct competitors is Pradaxa. Pradaxa is another new blood thinner by Boehringer Ingelheim. Xarelto, Pradaxa, and similar drugs have become the subject of growing controversy and a rising number of lawsuits.
Here, we'll describe some of the side effects of Xarelto. We'll also review the history of Xarelto litigation. Finally, we'll explain what to do if you suffer an injury after taking the drug Xarelto or any other dangerous drug.
Why Patients Take Xarelto
The FDA initially approved Xarelto for patients recovering from knee and hip replacement surgery. These recoveries involve a risk of developing blood clots or deep vein thrombosis (DVT). Since then, the FDA has approved the drug for other uses.
In 2012, the FDA approved the use of Xarelto for the treatment of DVT and pulmonary embolism. The FDA also approved Xarelto for general use, meaning that doctors can prescribe Xarelto to any patient vulnerable to DVT or pulmonary embolism. This is the case regardless of whether the patient is recovering from surgery.
The FDA also approved Xarelto to treat patients with an irregular heartbeat (atrial fibrillation) to help reduce their risk of stroke. Patients with lung blood clots (pulmonary embolism) may also take Xarelto.
Some doctors use Xarelto in children who have undergone heart surgery. The drug helps prevent blood clots, a standard risk in children post-surgery.
Xarelto and FDA Warnings
According to the FDA, certain patients should avoid taking Xarelto. Taking Xarelto with other medications is also dangerous.
The FDA has warned people with the following conditions against taking Xarelto:
- Renal failure
- Hepatic impairment
- Pregnant women
- Patients with prosthetic heart valves
- People taking other anticoagulants
- Patients taking CYP3A inhibitors
As with most prescription drugs, the FDA has also ordered the drug company that makes Xarelto to post the following warnings on its product labels:
- Increased bleeding risk
- Nosebleeds
- Spinal or epidural hematoma
- Obstetric hemorrhage
- Increased risk of thrombotic events if you stop taking the drug
Healthcare providers must be careful when prescribing Xarelto. They must check for potential adverse drug interactions. They also must warn patients of the severe injuries that can result from taking anticoagulant drugs.
Xarelto and Serious Side Effects
Taking blood thinners such as Xarelto can cause trouble on two fronts. On the one side, most patients who take blood thinners do so because they need them. These patients may face an increased risk of stroke, heart attack, pulmonary embolism, and deep vein thrombosis. Most patients taking drugs like Xarelto are already susceptible to these severe health problems.
On the other side, blood-thinning medications can lead to an increased risk of bleeding-related injuries. The most commonly reported injuries are gastrointestinal bleeding and severe hemorrhaging.
Complications can also arise during surgery or following an accident that results in serious bleeding.
Plaintiff's Claims in Xarelto Lawsuits
Many patients who suffered serious injuries after taking Xarelto have sued the drug manufacturer. Much of the Xarelto litigation has involved class action lawsuits.
Patients have sued Johnson & Johnson for the following injuries:
- Bleeding-related injuries
- Stroke
- Pulmonary embolism
- Deep vein thrombosis (DVT)
- Heart attacks
Most of these lawsuits are product liability lawsuits against the manufacturers Johnson & Johnson and Janssen Pharmaceuticals. The manufacturers of other blood-thinning drugs face similar lawsuits. Thousands have filed Pradaxa lawsuits against Boehringer Ingelheim. These similar lawsuits may provide an early glimpse of the future of Xarelto lawsuits.
Damages Sought in Xarelto Lawsuits
People file lawsuits for many reasons. The most prominent reason is to recover financial compensation for their injuries. Xarelto injuries can require lengthy hospitalization, significant long-term health care costs, and substantial time away from work.
Product liability lawsuits primarily exist to shift the burden of these costs to drug manufacturers. This is especially true in cases where the patient dies or suffers long-term medical issues.
Hundreds of Xarelto patients have died. The victims' loved ones and family members can often file a wrongful death lawsuit. A wrongful death lawsuit can recover compensation for the following:
- Medical expenses
- Burial and funeral costs
- Lost income
- Lost support
- Loss of consortium
- Lost companionship
No lawsuit can replace the loss of a loved one. But it can help surviving spouses and children avoid financial difficulties.
Johnson & Johnson Has Settled Most Outstanding Claims
There have been two waves of Xarelto litigation. More than 32,000 plaintiffs sued both Johnson & Johnson and Bayer for severe injuries caused by Xarelto. The federal courts consolidated these injury cases into multidistrict litigation (MDL) in the Eastern District of Louisiana.
Johnson & Johnson won the first three bellwether trials in the MDL. The same thing happened in the mass tort case plaintiffs filed in Philadelphia, Pennsylvania.
Despite these early victories, J & J anticipated thousands of additional lawsuits. So, they ended up settling all these cases for $775 million in March 2019. The FDA approved an antidote to Xarelto in May 2018. The company was confident that the lawsuits involving severe bleeding would stop due to the approval of the antidote.
In May 2018, the FDA approved Andexxa, a drug that reverses the effects of Factor Xa inhibitors like Xarelto. The drug company believed that so many patients sued because no antidote was available. The plaintiffs sued because the pharmaceutical giant failed to warn them of the severe bleeding risk.
Today, it is harder for plaintiffs to prevail in Xarelto lawsuits. Johnson & Johnson and other anticoagulant drug manufacturers have added numerous warnings to their product labels. They also list the side effects of their drugs on their websites. This makes it nearly impossible to argue that the company should have warned patients and the public about the risks of Xarelto.
Get Legal Help With Your Xarelto Claim Today
A successful Xarelto lawsuit can compensate patients and their loved ones financially. Unfortunately, navigating the legal system can be difficult. If you sustained an injury related to Xarelto, contacting a local lawyer is wise.
An experienced personal injury lawyer will evaluate your claim and help determine your damages. Most law firms offer new clients a free case evaluation. This means you can discuss your case free of charge.
FindLaw's drug and medical devices attorney directory provides an attorney listing. They can explain your legal options.
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