More than 20,000 people have claimed that the anticoagulant Xarelto caused them injury, particularly in the form of uncontrolled bleeding. They also claim that manufacturers did not adequately warn of the drug’s possible deadly side effects.
While the risk of side effects is always present with any drug, mild or severe, manufacturers, prescribers, and sellers also need to ensure that potential side effects are clearly available for the public to understand.
Legal action against developers Bayer Pharmaceuticals and the company that markets Xarelto, Janssen Pharmaceuticals by Johnson & Johnson, resulted in a $ 775 million settlement in 2019. If a patient or family believes that a drug has caused them harm through illness, injury, or even death, they can bring a lawsuit for damages that can cover expenses such as medical bills, funeral expenses, or loss of income. amongst other things.
What is Xarelto?
Xarelto is a prescription anticoagulant (or blood thinner) that is used to prevent blood clots. It is prescribed to people with atrial fibrillation, a heart condition that causes an irregular or unusually fast heartbeat, and people who are prone to deep vein thrombosis (DVT) or pulmonary embolism. It can also be prescribed to people who have had hip or knee surgery to help prevent blood clots. It is an oral medication that can be found under the generic name of rivaroxaban. How often it is taken depends on the condition being treated. It is usually taken once a day, sometimes with a meal, and more often it can be taken to treat blood clots.
As with most medications, you may experience side effects while taking Xarelto. Some of them may bruise or bleed easily. However, it can also cause severe bleeding in some people, leading to hospitalization or the need for a blood transfusion, and even death. Many drugs have side effects and are prescribed by doctors because the benefits of the drug outweigh the risks involved. Not only did Xarelto claim that the manufacturer failed to properly warn of the risks of taking the drug, but research has shown that the potentially fatal side effects are not outweighed by the benefits.
Xarelto is Bayer’s best-selling drug. Sales of the drug brought the German pharmaceutical company € 3.6 billion in 2018. Johnson & Johnson’s Janssen Pharmaceuticals sells the drug in the United States under a license agreement. It has been approved by the U.S. Food and Drug Administration since 2011. The two companies that developed the drug 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 conducted a study of the benefits of Xarelto that was weighed against the serious side effects. However, the study was suspended after a third-party research group released results showing that Xarelto was no more effective than a normal standard of care for secondary stroke prevention that included the use of aspirin and other over-the-counter drugs. While research showed that there were no greater benefits from using Xarelto, there are some significant risks with the possible side effects. Internal bleeding is one of these, and a side effect Johnson & Johnson did not warn about.
Injuries caused by Xarelto
The FDA says blood-thinning medications have been linked to more than 370 internal bleeding-related deaths. Two common injuries that have been linked to using Xarelto in legal proceedings are bleeding events that required blood transfusions and bleeding events that required hospitalization, serious injury, and even death.
Xarelto is often prescribed after hip or knee surgery. Higher rates of wound infections and complications have been associated with the use of Xarelto after these surgeries. In addition, people taking Xarelto may be at greater risk of going back to surgery within 30 days than people who are not taking Xarelto. Some surgeons choose to use other anticoagulants that are not at risk of such serious complications.
Xarelto can cause severe bleeding if it affects the blood clotting proteins too much. Anyone taking it should look out for signs of serious buildup, such as pain, swelling and discomfort, unusual bruising, persistent bleeding, persistent nosebleeds, coughing up blood, and severe headache.
Side effects of the drug can include:
- Internal bleeding that you cannot control
- Cerebral hemorrhage
- Bleeding from the bowel or abdomen
- Prolonged bleeding from cuts or gums
- Loss of ability to control movement
- Muscles numb or tingly
- Abnormal liver function
- Reduced platelet counts
- Dizziness and fainting
- Bladder and bowel disorders
Other things people should consider before taking the drug are their medical history, especially if they have had any history of bleeding disorders, kidney disease, liver disease, and various other health conditions. Anyone taking Xarelto or rivaroxaban should tell their doctor or dentist before they have an operation or dental procedure.
Current Xarelto lawsuits
With more than 20,000 people claiming Xarelto caused uncontrollable bleeding and the manufacturer failed to provide adequate warning, there has been no shortage of lawsuits against Bayer Pharmaceuticals and Janssen Pharmaceuticals. Many of the lawsuits have been grouped into multiple Louisiana counties.
In addition to the allegations about the drug’s side effects and the alleged lack of adequate warning, criticisms were also raised regarding both the narrow therapeutic index and the lack of antidotes. A narrow therapeutic index means that there is a narrow window between a safe dose and a dangerous dose. Until 2018, there was no antidote to uncontrolled bleeding caused by drugs like Xarelto. Although it is now available, the drug Andexxa is expensive and not widely available.
There have also been similar lawsuits against Boehringer Ingelheim, which makes a blood thinner called Pradaxa. That litigation resulted in a $ 650 million settlement in 2014, which was paid to individuals who served as compensation for injuries related to the use of Pradaxa in more than 4,000 cases. Another oral blood thinner, Pfizer’s Eliquis, has also been the subject of lawsuits, but most of them have been dismissed by judges in the United States
The lawsuits relating to Xarelto were collected from 2014 and consolidated in federal court in New Orleans. In more than four years and six court cases, many people were represented by lawyers who discussed their case both in and out of court.
Three cases were selected to determine the range of compensation and settlement options. These three cases were won by Bayer and Janssen Pharmaceuticals in 2017, followed by three other cases where they were released from liability in 2018.
In March 2019, Bayer and Janssen Pharmaceuticals reached a $ 775 million settlement to resolve approximately 25,000 human cases. This means that among those who claimed Xarelto caused internal bleeding risks and the manufacturer had not warned about it, the average billing amount per person was $ 31,000, even though there was no official estimate of how much people would receive. The agreement also applied to new applicants who were not part of the multi-district litigation but retained an attorney prior to March 11, registered their application by March 28, and filed a lawsuit by April 4, 2019.
Those who filed lawsuits on or after December 1, 2015 stated that payments received would be reduced compared to those who filed lawsuits earlier. Those who suffered an injury on or after March 1, 2016 would also receive reduced payments.
Of the cases brought to trial, Bayer and Janssen Pharmaceuticals won six cases. However, they said the deal would allow them “to avoid the distraction and substantial costs” of continuing litigation related to the use of Xarelto. Janssen Pharmaceuticals stated that the settlement was not a disclaimer and that the asserted claims violated scientific data and the USFDA’s confirmation that Xarelto was and is safe to use.
An agreement in a Xarelto process was reversed in 2018. A Philadelphia state jury originally ordered the payment of $ 27.8 million 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 tight issue related to Hartman’s doctor.
The big deal over Xarelto lawsuits has resulted in many people receiving compensation for injuries allegedly caused by Xarelto. It shows the power of multiple district litigation and class actions. However, this has also meant that future lawsuits against Xarelto may not be wise.