Over the past seven (7) years, more than 32,000 lawsuits have been filed against the manufacturers of the popular drug, Xarelto. Is it too late to file a Xarelto lawsuit? Xarelto was approved by the Food and Drug Administration (FDA) in 2011 to be used in the prevention of blood clots. Unlike most of the existing blood thinner medications on the market, Xarelto could be taken just once a day. Other drugs, such as Warfarin, have to be taken several times a day. It would soon be considered a blockbuster drug for people with blood clotting issues.
When Xarelto was first released, it gained popularity really fast. Xarelto was marketed as being able to prevent blood clots, reduce the risk of stroke, and prevent deep vein thrombosis. Millions of patients have been prescribed the drug in the first year. In 2018 alone, Johnson and Johnson, one of the manufacturers of the drug, made more than $1.8 billion.
It wasn’t until 2014 that people started to notice just how dangerous Xarelto is. Not only does the drug carry terribly dangerous side effects, but it also has no antidote. Most blood thinner drugs have an antidote on file with the FDA. This way, if a patient did start to suffer from uncontrollable bleeding, they could take the antidote and recover rather quickly. For example, the antidote for Warfarin is Vitamin K. Up until 2018, there was no antidote for Xarelto. If a patient started to bleed out, there was nothing they could do to stop it.
Many patients started to experience negative side effects. When they consulted their attorneys, they were advised to file suit. To date, more than 32,000 have done just that. If you or your spouse have been taking Xarelto and feel that you have been harmed, you should call an experienced personal injury lawyer as soon as possible.
Why Would Xarelto Be Prescribed to a Patient?
People who have problems with blood clots are often prescribed an anticoagulant. This is a drug that helps people at risk of blood clots. These blood clots can be dangerous because they can cause a stroke or heart attack.. Before Xarelto came along, thousands of patients were prescribed a drug called Warfarin. Of course, there were other anti-coagulants as well but none were as popular as Warfarin. The problem with Warfarin is that you had to take it more than once per day. For people who have to take multiple medications, it can be difficult to keep track of their pills. Being able to take a pill once a day instead of two or three is a huge convenience.
When Xarelto was approved by the FDA in 2011, it became popular right away. It was marketed as a drug that could not only prevent blood clots but also prevent deep vein thrombosis. Thousands of people started taking it right away. Many people suffering from knee replacement surgeries or atrial fibrillation were excited to try the new drug. They had no idea what the dangerous risks were because the pharmaceutical companies never told them. These manufacturers included Johnson and Johnson, Bayer Corporation, and Janssen Pharmaceutical.
Once patients started becoming hospitalized as a result of the side effects of Xarelto, people started to get worried. They asked their doctor if the drug was safe. Apparently, there had been additional research done after the drug’s initial FDA approval. These drug trials showed that Xarelto could cause a person to suffer a variety of negative side effects. These side effects included:
- Internal bleeding risks
- Uncontrolled bleeding
- Brain hemorrhage
- Wound leakage
- Infection
Thankfully, most patients who sought treatment for these conditions survived. However, they still had to deal with a lot of pain. Most had to undergo extensive medical treatment for their injuries. Sadly, there were many patients taking Xarelto who did not survive. It wouldn’t be long before the wrongful death claim lawsuits against the manufacturers would start to get filed. Soon, thousands would be demanding compensatory damages.
When Were the First Xarelto Lawsuits Filed?
The first lawsuits against the manufacturers of Xarelto were filed back in 2014. In December of 2014, a federal judge ordered the cases to become part of multidistrict litigation (MDL) cases out of the Eastern District of Louisiana. As of this year, more than 32,000 cases were included in the MDL. There were an additional 2,000 cases that were filed in Philadelphia.
Most of the lawsuits claimed that the three defendants – Johnson and Johnson, Janssen Pharmaceutical, and Bayer Corporation – marketed the drug knowing that there were deadly side effects. Not only did they fail to warn patients of these negative side effects, but they also didn’t warn them of the fact that there was no antidote. A lot of patients would not have taken Xarelto if they had known there was no antidote available. If someone experiences uncontrollable bleeding, it’s critical that they have an antidote to their anti-coagulant available immediately. Even if these patients went to the emergency room, there wasn’t anything they could have done for them.
Plaintiffs in the cases filed against Johnson and Johnson, Janssen, and Bayer alleged that they had suffered specific damages. Some damages include:
- Increased medical bills
- Funeral expenses – For those patients who died after taking Xarelto, their families demanded the defendants cover their funeral and burial expenses.
- Pain and Suffering – For patients who survived their injuries, they would be entitled to pain and suffering. For the families of those who died after taking the drug, these damages would be limited to the pain and suffering experienced by the decedent – not their family.
- Lost wages – Anybody who ended up in the hospital would be eligible for lost wages. The injuries caused by Xarelto were quite serious. Plaintiffs would likely have missed weeks or even months from work. The defendants should have to reimburse them for any time missed from work. For those plaintiffs who became permanently disabled as a result of taking Xarelto, they could demand lost future income as well.
Many of the claims filed against the drug manufacturers demanded punitive damages as well. This isn’t unusual when dangerous drugs enter the market. If the plaintiffs can show that the drug companies intentionally and willfully marketed drugs that they knew could harm or kill their customers, they may be able to collect punitive damages. However, there is no guarantee that a judge would order punitive damages. If they did, any sort of judgment or settlement agreement would likely bankrupt the defendants and the plaintiffs would end up with nothing.
Drug Manufacturers Were Required to Make Numerous Label Updates
When a new drug receives FDA approval, it’s common for the FDA to order further clinical trials. Some of this testing is done under the watchful eye of the FDA. Additional testing is done by the drug manufacturer and the results are reported to the administration. Depending on the results, the FDA may order the drug companies to change the labels on their medication. This is not uncommon. However, it isn’t common for a drug company to be ordered to change their labels half a dozen times in less than ten (10) years. For Xarelto, there were more than five (5) label updates ordered between 2013 and 2018.
- August of 2013: The drug manufacturers were ordered to put a black box label on their product letting customers know that the medication may cause an increased risk of spinal bleeding. A black box label is the most serious type of label the FDA will require. The purpose is to ensure that a customer sees the warning. This way, they have the option of asking their doctor to prescribe something else.
- January 2014: The FDA once again ordered the defendants to put language on their packaging letting people know there was no antidote for Xarelto. They were also required to warn patients not to take the drug if they had a prosthetic heart valve.
- December 2014: The drug companies were told they had to put additional warnings on their labels. This time, they were ordered to tell the public that their drug had adverse events such as hepatitis and thrombocytopenia (deep vein thrombosis).
- May 2016: Johnson and Johnson, Janssen Pharmaceutical, and Bayer were told that they had to warn their customers that Xarelto carried a high risk of bleeding for people who were taking SSDI and anti-depression medications.
- June 2018: The FDA finally allowed Xarelto manufacturers to put language on their labels that they did have an antidote to the drug. The hope was that this would alleviate a lot of their customers’ concerns over the drug. It didn’t work.
Is it Too Late to File a Xarelto Lawsuit? What is the Most Recent Update on the Xarelto Lawsuits?
Of the more than 32,000 lawsuits that were filed against the drug companies, about 25,000 of them have been settled. A judge in Louisiana approved a settlement for $775 million in March 2019. Johnson and Johnson agreed to pay half as did Bayer Corporation. The third defendant, Janssen Pharmaceutical, was not involved in this settlement. There are still thousands of cases pending in the MDL and at least 2,000 cases are still pending in Philadelphia.
If you or your loved one have been taking Xarelto and fear that you may have been harmed, contact our office right away. Contact McDonald Worley lawyers in Houston to review your case and let you know how to proceed. Schedule your free, initial consultation as soon as possible.