Xarelto blood thinner lawsuit: A detailed delineation

by | Nov 19, 2022 | Product Liability, Medications | 1 comment

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Every year, approximately 3 million people in the United States use blood thinners. While blood thinners save many lives, they can also cause severe side effects that require immediate medical care.

The well-known blood thinner Xarelto has recently become the target of thousands of product liability claims.

Let’s look more closely at Xarelto, the reasons behind the Xarelto blood thinner lawsuit against its producers, and what you should do if you suffer while taking Xarelto.

What is Xarelto?

Xarelto (generic name: rivaroxaban) is an anticoagulant or blood thinner that has been approved by the US Food and Drug Administration (FDA) to:

  • Treat pulmonary embolism and deep vein thrombosis.
  • Reducing the chance of stroke and blood clots in people with nonvalvular atrial fibrillation (irregular heartbeat) or those who have recently had knee or hip replacement surgery.

Who manufactured Xarelto?

Janssen Pharmaceuticals, Inc manufactured Xarelto. This famous pharmaceutical company also produces several well-known medications, including ElmironInvokana, Risperdal, and Stelara.

Johnson & Johnson and Bayer Corporation are two other companies that collaborate with Janssen to manufacture and distribute Xarelto.

History of Xarelto

The FDA initially licensed Xarelto in 2011 to treat patients who had hip or knee replacement surgery. The FDA also approved the medication to reduce blood clots in individuals with atrial fibrillation in the same year (irregular heartbeats).

With the introduction of Rivaroxaban (sold under the brand name Xarelto) in 2011, the generic drug Warfarin (formerly sold under the brand names Coumadin and Jantoven) lost a significant portion of its market share after nearly fifty years of market dominance in the class of blood-thinning drugs. Doctors have prescribed Xarelto millions of times since then.

Once the FDA approved Xarelto in 2011, thousands of people instantly started taking it. Xarelto brings a significant profit for Janssen Pharmaceuticals, Johnson & Johnson, and Bayer Corporation.

What makes Xarelto different from Warfarin?

The main difference between the two blood thinners is that Xarelto restricts “Factor Xa,” an enzyme required for clot formation in the blood. Warfarin, on the other hand, interacts with vitamin K and six other blood-clotting variables.

Furthermore, Warfarin requires regular blood tests and dietary restrictions, whereas Xarelto does not.

Is Xarelto safe?

Xarelto’s adverse effects can take many different forms. These negative effects may only last a few days or weeks. Consult your physician; nevertheless, if the side effects last longer, irritate you, or get serious.

Common Xarelto blood thinner side effects

The following are merely a few of the most typical side effects that people who took Xarelto in clinical trials reported:

  • Pain in the lower abdomen
  • Chronic pain
  • Itching
  • Fainting
  • Muscle pain (involuntary muscle tightening)
  • Hypersomnia
  • Stress
  • Insomnia
  • Tiredness (lack of energy)
  • Bleeding

However, consult your doctor if the side effects persist or become severe.

Serious Xarelto blood thinner side effects

  • Serious or deadly bleeding
  • Clots after discontinuing Xarelto
  • A lumbar or epidural blood clot
  • Allergic response

FDA black box warning

It’s common for the FDA to demand follow-up clinical trials once a new drug is approved. The FDA monitors some of these trials. The drug company conducts additional testing and submits the results to the administration. If the administration observes any medical issues, it may ask the drug company to change its label.

It’s not relatively rare for a pharmaceutical company to change its label several times in a short period. Still, it’s unusual for it to happen six times in less than a decade. Between 2013 and 2018, Xarelto’s label was changed six times.

August 2013: The FDA would also require a black box label, which is the most serious type of label. The goal is to ensure that the customer notices the warning. This way, they can request that their doctor prescribe something else.

The Xarelto manufacturers were ordered to include a black box label on their product informing customers that the medication may increase the risk of spinal bleeding.

January 2014: The FDA ordered the defendants to properly indicate on their packaging that there was no antidote for Xarelto. They were also required to warn patients with a prosthetic heart valve not to take the drug.

December 2014: The drug companies were told they needed to add more warning labels. This time, they were ordered to notify the public that their drug caused hepatitis and thrombocytopenia (deep vein thrombosis).

May 2016: Johnson & Johnson, Janssen Pharmaceuticals, and Bayer were told that they needed to warn their customers that Xarelto emerged a high risk of bleeding for people taking antidepressant medications.

June 2018: The FDA finally permitted Xarelto manufacturers to indicate on their labels that the drug had an antidote. The hope was that this would decrease many of their customers’ fears about the drug. It was ineffective.

Xarelto-related deaths

The FDA has linked 400 deaths to Xarelto, but there are likely hundreds more. According to healthcare officials, Xarelto has been linked to more severe and fatal bleeding incidents than any other blood thinner.

Is there a lawsuit against Xarelto?

A Kentucky lady who was given Xarelto to treat her atrial fibrillation eventually required hospitalization for serious gastrointestinal bleeding, prompting the first Xarelto lawsuit to be initiated.

Following her, numerous Xarelto lawsuits were filed against the Xarelto manufacturers. The first six attempted cases all resulted in favorable verdicts for the drug companies.

Why is there a Xarelto blood thinner lawsuit?

The majority of the Xarelto blood thinner lawsuit claimed that the three defendants – Johnson & Johnson, Janssen Pharmaceutical, and Bayer Corporation – marketed the drug, knowing it had fatal side effects.

They not only failed to warn patients of these negative side effects, but they also failed to warn them that there was no antidote.

Many patients would not have taken Xarelto if they had known there was no antidote. If someone experiences uncontrollable bleeding, they must have an antidote to their anticoagulant on hand right away.

Even if these patients had gone to the emergency room, there was nothing they could have done for them.

Multidistrict litigation (MDL) brought against Xarelto’s manufacturers

When a federal court determines that a sufficient number of people have a case against one or more defendants, a multidistrict litigation (MDL) replaces personal injury lawsuits.

In December 2014, the MDL consolidated 21 cases in the Eastern District of Louisiana. Since then, more than 20,000 Xarelto lawsuits have been filed by victims and their families.

As of April 2019, over 25,000 Xarelto blood thinner lawsuits were filed in a federal court in Louisiana. As part of multidistrict litigation, the cases had been consolidated there. In state courts, more claims had been filed.

Bellwether trials against Xarelto

JOSEPH BOUDREAUX

The first plaintiff to go to trial was Louisiana’s, Joseph Boudreaux. The trial was held in April 2017. The 75-year-old was prescribed Xarelto in 2014 to treat his heart illness; but, after taking the medication, he had gastrointestinal bleeding that required hospitalization and many blood transfusions.

The judge ruled in favor of the drug’s manufacturers after hearing this information. According to Reuters, after the verdict, Boudreaux’s lawyers said they were “disappointed, but would press on in similar cases.”

JOSEPH ORR

The second federal bellwether trial, held in June 2017, was centered on the widower Joseph Orr’s case, which involved his wife, Sharyn Orr of Louisiana.

Joseph Orr, Sharyn’s husband, sued Janssen Pharmaceuticals for wrongful death. After taking Xarelto, Sharyn Orr passed away in May 2015. Orr claimed that drug manufacturers were to blame for his wife’s hemorrhagic stroke death (bleeding on the brain). Before passing away, she spent ten days in a coma.

Bayer and Janssen won the jury over.

DORA MINGO

In August 2017, the third federal bellwether trial was held in Mississippi. Following hip surgery, the plaintiff Dora Mingo experienced deep vein thrombosis after being prescribed with Xarelto.

Mingo Suffered from gastrointestinal bleeding and sudden blood loss due to the blood thinner. According to her claim, if the drug firms had given her doctor proper instructions, she would have behaved differently. J&J and Bayer won the jury’s support.

Xarelto settlement

Johnson & Johnson and Bayer announced a $775 million joint settlement in March 2019 to resolve approximately 25,000 Xarelto blood thinner lawsuits.

As per the proposed settlement, each company must pay $387.5 million, though at least some of that money will be paid by insurance providers. The settlement amount is far less than what the companies made from the drug in 2018.

The average rate is around $31,000 per plaintiff. However, depending on the severity of the side effects and other factors, each person’s total figure may differ.

What damages can Xarelto victims receive?

The victims might be able to receive damages for:

  • Medical bills – Medical costs from the past and future to treat the injuries
  • Funeral expenses– The defendants were ordered to cover the costs associated with the funeral and burial of the patients whose deaths occurred after taking Xarelto to their families.
  • Pain and Suffering – Patients who survived their injuries would be entitled to pain and suffering compensation. The payment to the families of the individuals who died as a consequence of the drug would have been restricted to the pain and suffering experienced by the descendant-not their family.
  • Lost wages– Anyone hospitalized with severe Xarelto-related injuries would be eligible for lost wages. The defendants would also be required to pay the workers for lost work time if the plaintiffs have been out of work for weeks or months. Plaintiffs who become permanently disabled after taking Xarelto may also seek compensation for lost future earnings.

Many Xarelto blood thinner lawsuits against the drug’s manufacturers also sought punitive damages. When dangerous drugs enter the market, this is not uncommon.

Plaintiffs may be entitled to recover punitive damages if they can show that the drug companies knowingly and intentionally marketed drugs that were known to harm or kill the patients.

Do I have a time limit to join the class action lawsuit against Xarelto?

There is a statute of limitations, or time period, to join the class action lawsuit against Xarelto. The trial judge often sets the statute of limitations in Class Action cases.

Although the time frame varies by state, it typically ranges from one to four years from the moment you took the medicine that led to your injury. If you or your loved one suffered from the medication Xarelto, don’t miss out on your chance to join this lawsuit.

Can I file a Xarelto blood thinner lawsuit?

You can file a Xarelto blood thinner lawsuit against the Xarelto maker if you or a loved one thinks the medication seems too responsible for uncontrollable bleeding or another major side effect.

Factors to know before filing the Xarelto blood thinner lawsuit

Before filing a case, you need to know about the importance of medical records. It assists your attorney in examining your complete medical history and lets him know how Xarelto’s side effects harmed you or your loved one.

Therefore, your Xarelto lawsuit attorneys make your Xarelto blood thinner lawsuit more effective and make sure you receive a fair compensation.

For the best medical record review, choose a company like LezDo techmed from the list of top medical record review companies.

Taking any drug comes with the risk of side effects, and Xarelto is no exception. Medlegal360 advises you on how to handle your lawsuit properly. You can also visit our blogs to know more about litigation similar to the Xarelto blood thinner lawsuit.

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