Xarelto (rivaroxaban) is an anticoagulant (blood thinner). The drug was developed by Bayer AG and Johnson & Johnson.
Approved by the U.S. Food and Drug Administration (FDA) in 2011, the agency has since received thousands of adverse event reports. The manufacturers of Xarelto now face thousands of personal injury lawsuits.
Our national litigation lawyers at Hotze Runkle recognize that many patients and families members may have questions and concerns about Xarelto. That’s why we would like to provide you with the necessary information and resources to keep you informed.
The Basics Of Xarelto
Xarelto is an anticoagulant. These types of drugs prevent the blood from coagulating and forming dangerous blood clots that can block major arteries and blood vessels. Blood clots can lead to serious damage in the brain, heart or lungs.
Xarelto is generally prescribed to patients who suffer from a high-risk of deep vein thrombosis (DVT) or pulmonary embolism (PE). The drug has also been prescribed to patients who suffer from an abnormal heart rhythm disorder known as Atrial Fibrillation (AFIB).
A Brief History of Xarelto
Before the advent of Xarelto, a medication known as Warfarin (or Coumadin) was considered the gold standard blood thinner. Warfarin was the most prescribed blood thinner from as early back as the 1950’s.
While the drug was highly regarded as the go-to option for blood thinners, it did come with a difficult treatment plant that required dietary restrictions and frequent lab testing.
Xarelto was marketed as a better option for patients than Warfarin as it did not require constant blood monitoring, held no dietary restrictions, and treatment consists of a single daily dose.
While there were initial safety concerns because of a clinical trial known as Record 4, the FDA finally approved Xarelto in 2011.
Xarelto’s Serious Side Effects
Xarelto, like other anticoagulant medication, comes with potentially serious side effects that include internal bleeding. One of the biggest concerns that comes with Xarelto is that there are currently no antidotes to stop internal bleeding if a patient is taking the drug.
Unlike other anticoagulants and blood thinners, Xarelto does not respond to Vitamin K, a traditional blood thinner antidote.
Xarelto users have filed suits against the manufacturer claiming they have suffered from:
- Internal hemorrhaging
- Vomiting blood
- Blood stools
- Wound infections and complications
- Excessive drainage
- Chronic pain
- Intracranial and abdominal hemorrhages
- Retinal hemorrhages
- Issues with heartbeat
- Dizziness and fainting
- Breathing difficulties
- Gastrointestinal or bladder dysfunction with red or dark brown urine
- Back pain
- Muscle spasms
Hospitalization may be required to deal with these serious side effects especially when uncontrolled bleeding or a stroke occurs.
The FDA and Xarelto
While there has not been a total recall on Xarelto, the FDA has issued two “black box warnings”. These warnings are issued as reasonable evidence of a hazard and are meant to warn consumers of the potential risks associated with the drugs.
The history of Xarelto and the FDA includes:
- 2011 – The FDA approves of the drug with several post-market requirement changes. The agency issues concerns that their is no true evidence of Xarelto as an effective alternative to Warfarin.
- 2012 – The FDA approves expanded use of the drug for deep vein thrombosis and pulmonary embolism.
- 2013 – FDA warns the company of its marketing strategies.
- August 2013 – FDA issues first black box warning.
- January 2014 – FDA requires Xarelto manufacturers to include additional warnings and precautions to its black box warning.
- December 2014 – FDA issues “Adverse Reaction” report on Xarelto. Warns against drug interactions with Xarelto.
The FDA has noted over 2,100 adverse events concerning Xarelto and over 1,800 reports citing Xarelto as the main culprit of an adverse event.
Drugs To Avoid While Taking Xarelto
As previously mentioned, the FDA issued an Adverse Reaction warning in 2014. This report listed a number of drugs which had adverse interactions with Xarelto. They included:
Xarelto, as a prescription drug, falls under product liability.
Depending on the specifics of the situation, a product liability claim can be made if you can establish:
- The pharmaceutical product (medication) was defectively manufactured.
- The drug was falsely marketed and there was failure to provide adequate warnings about harmful side effects.
- This warning does not have to come directly from the pharmaceutical company. Warning can come from learned intermediaries or the individuals the patient comes into contact with. This can include doctor(s), pharmacist(s), sales rep(s), or some other medical provider.
- The product (medication) was defectively designed. In this situation, the drug was manufactured correctly but still has dangerous side effects not reported.
While pharmaceutical companies can be held liable for injury caused by dangerous side effects, there are limitations to liability. Pharmaceutical manufacturers must warn customers of the known side effects.
But they are not liable for unknown side effects. Though they are responsible for disclosing adverse effects as they become known.
What To Do Next
If you believe you or a loved one has directly suffered as a result of taking the anticoagulant, Xarelto, there are a number of steps to take to file a suit.
- The first step you need to take is to talk with your doctor if you are suffering any side effects from taking the medication. You will want to get any health issues under control.
- Consult with your doctor to find out more about the causes of your side effects. Your physician can help you to determine if Xarelto is the cause of your internal bleeding or other serious side effect.
- You should document your symptoms, treatments, medical costs, and any conversations you have with any medical professionals you are dealing with. Note any financial losses caused by your medical expenses and treatments that cause you to miss work.
- If you believe you are the victim of personal injury caused by Xarelto, contact Hotze Runkle. Our experienced attorneys can help you to determine if you have a product liability and/or personal injury case.
- You need to file before the statute of limitation expires. This time frame varies by case and by state. To find out more about your statute of limitation, contact Hotze Runkle.
What To Expect After Filing A Xarelto Lawsuit
Xarelto litigation is in its initial stages with a few bellwether trials having taken place during the Spring and Summer of 2017.
Time frames to obtain a settlement will vary case by case.
At Hotze Runkle, we will work diligently to help you recover damages for your pain and suffering caused by Xarelto. Damages may include:
- Recovery of past and future medical expenses.
- Lost income and diminished future earnings.
- Physical and emotional pain and suffering.
- Punitive damages.
In cases of wrongful death, we will seek additional compensation for you and your family including:
- Funeral expenses.
- Loss of future financial earnings.
- Emotional anguish.
Our national litigation lawyers at Hotze Runkle are dedicated to guiding and supporting you every step of the way. When a settlement is offered we will work to provide the best advice to you concerning accepting or rejecting the offer.