More than 20,000 people have alleged that the anticoagulant medication Xarelto has caused them injury, specifically in the form of uncontrolled bleeding. They also allege that the manufacturers have not provided adequate warning of the potential deadly side effects of the drug.
While the risk of side effects is always present in any medication, whether mild or severe, but manufacturers, prescribers and sellers also have a responsibility to make sure that potential side effects are clearly available for the public to understand them.
Legal action against the developers Bayer Pharmaceuticals and the company that markets Xarelto, Johnson & Johnson’s Janssen Pharmaceuticals, has resulted in $775 million settlement in 2019. This settles about 25,000 lawsuits related to internal bleeding risks and failure to warn about them. If a patient or their family believes that a drug has caused them damages through illness, injury or even death, they can choose to bring forth a lawsuit for compensation that might cover the costs of expenses such as medical bills, funeral costs or lost income, among other things.
What Is Xarelto?
Xarelto is a prescription anticoagulant (or blood thinner) drug, which is used to prevent blood clots. It is prescribed to people who have atrial fibrillation, a heart condition that causes an irregular or abnormally fast heart beat, and those who are susceptible to deep vein thrombosis (DVT) or pulmonary embolism. It can also be prescribed to people after hip or knee surgery to prevent blood clots. It is an oral medication, which can be found under the generic name rivaroxaban. How often it is taken depends on the condition being treated. It is usually taken one a day, sometimes with a meal, and might be taken more often to treat blood clots.
Like most medications, there is the potential for side effects to occur when taking Xarelto. Some of them can include bruising easily or minor bleeding. However, it can also lead to serious bleeding in some people, which may lead to hospitalization or the need for a blood transfusion, and can even result in death. Many medications have side effects, and they are prescribed by medical professionals on the basis that the benefit delivered by the medication outweighs the risks that it poses. With Xarelto, not only have lawsuits alleged that the manufacturer failed to properly warn about the risks of taking the drug, but research has also suggested that the potentially fatal side effects are not outweighed by the benefits.
Xarelto is Bayer’s best-selling drug. Sales of the drug brought in 3.6 billion euros ($4.07 billion) for the German pharmaceutical company in 2018. Johnson & Johnson’s Janssen Pharmaceuticals sells the drug in the United States under a licensing agreement. It has been approved by the U.S. Food and Drug Administration since 2011. The two companies that developed the medication believe that the warning label provides accurate and complete information about its benefits and risks.
Xarelto Benefits vs Risks Research
In 2017, Bayer and Johnson & Johnson were carrying out a study on the benefits of Xarelto weighed against the serious side effects. However, the study was suspended after a third-party research group released findings that revealed that Xarelto was no more effective for secondary stroke prevention than a normal standard of care, which includes the use of aspirin and other over-the-counter medications. While the research showed that there was no greater benefit to using Xarelto, there are some significant risks in the potential side effects. Internal bleeding is one of these, and a side effect that Johnson & Johnson failed to warn about.
Injuries Caused By Xarelto
The FDA says that blood thinner medication has been linked to more than 370 deaths related to internal bleeding. Two common injuries that have been associated with the use of Xarelto in lawsuits are bleeding events that have required blood transfusions and bleeding events that have required hospitalization, serious injury and even death.
Xarelto is often prescribed for use after hip or knee surgery. Higher rates of wound infection and complications have been linked to the use of Xarelto after these surgeries. In addition, people who take Xarelto may be at a higher risk of returning to surgery within 30 days compared to people who don’t take it. Some surgeons are choosing to return to using other anticoagulants, which do not have the risk of such serious complications.
Xarelto can cause serious bleeding if it has too strong of an effect on the blood clotting proteins. Anyone who takes it should watch out for signs of serious building, such as pain, swelling and discomfort, unusual bruising, prolonged bleeding, persistent nosebleeds, coughing up blood, and severe headaches.
Side effects of the drug can include:
- Uncontrollable internal bleeding
- Brain hemorrhaging
- Intestinal or abdominal bleeds
- Prolonged bleeding from cuts or the gums
- Loss of ability to control movement
- Numb or tingling muscles
- Abnormal liver function
- Reduced platelet levels
- Dizziness and fainting
- Bladder and bowel dysfunction
Other things for people to consider before taking the medication include their medical history, particularly if they have a history of bleeding disorders, kidney disease, liver disease, and various other health conditions. Anyone taking Xarelto or rivaroxaban should tell their doctor or dentist about it before surgery or dental procedures.
Current Xarelto Lawsuits
With more than 20,000 people alleging that Xarelto has caused them to suffer uncontrollable bleeding and that the manufacturer failed to provide adequate warning, there has been no shortage of lawsuits against Bayer Pharmaceuticals and Janssen Pharmaceuticals. Many of the lawsuits were combined in multidistrict litigation in Louisiana.
In addition to accusations about the side effects of the drug and the alleged lack of adequate warning about them, there have also been criticisms relating to both the narrow therapeutic index and lack of antidote. A narrow therapeutic index means that there is a narrow window between a safe dose and a dangerous one. Until 2018, there had not been an antidote for uncontrolled bleeding caused by medications such as Xarelto. Although it is now available, the medication, Andexxa, is expensive and not widely distributed.
There have also been similar lawsuits against Boehringer Ingelheim, who make a blood thinner called Pradaxa. This litigation resulted in a $650 million settlement in 2014 which was paid out to people involved in more than 4,000 cases in compensation for injuries related to their use of Pradaxa. Another oral blood thinner, Eliquis by Pfizer has also been the subject of lawsuits, but most of them have been dismissed by judges in the U.S.
The lawsuits relating to Xarelto were collected dating back to 2014 and consolidated in federal court in New Orleans. Over more than four years and across six trials, many people were represented by attorneys who were arguing their case both in and out of court.
Three cases were selected to help determine the range of damages and settlement options. These three cases were won by Bayer and Janssen Pharmaceuticals in 2017, followed by a further three cases where they were cleared of liability in 2018.
In March 2019, Bayer and Janssen Pharmaceuticals came to a $775 million dollar settlement to settle about 25,000 people’s cases. This means that of the people who alleged that Xarelto led to internal bleeding risks and that the manufacturer failed to warn about them, the average settlement amount per person was $31,000, although there was no official estimate on how much individuals would receive. The agreement also applied to new claimants who were not part of the multidistrict litigation but who had retained a lawyer before March 11, registered their claim by March 28, and filed suit by April 4, 2019.
Of the people who filed a suit on or after December 1, 2015, it was stated that the payments received would be reduced compared to those who filed earlier. Those who suffered an injury on or after March 1, 2016 would also receive reduced payments.
Of the cases that went to trial, Bayer and Janssen Pharmaceuticals won six cases. However, they said that the settlement would allow them to “avoid the distraction and significant cost” of continuing to face litigation in relation to Xarelto use. Janssen Pharmaceuticals expressed that the settlement was not an admission of liability, and that the claims made went against scientific data and USFDA confirmation that Xarelto is and was safe to use.
One settlement in a Xarelto trial was overturned in 2018. A state jury in Philadelphia originally order $27.8 million to be paid to an Indiana woman, Lynn Hartman, who was hospitalized for gastrointestinal bleeding after using Xarelto for a year. However, the trial judge overturned the verdict, which Hartman’s attorney said was due to a narrow issue relating to Hartman’s doctor.
The large settlement for Xarelto lawsuits has meant that many people have received compensation for injuries alleged to be caused by Xarelto. It shows the power of multidistrict and class action litigation. However, it has also meant that any future lawsuits involving Xarelto may not be wise.