What You Need to Know about Xarelto and Its Legal Problems

One of the most common causes of illness and death across the globe is a vascular disease that leads to strokes, heart attacks, deep venous thrombosis (DVT), and pulmonary embolism (PE).

Many other medical conditions predispose to vascular disease including obesity, hypertension, and diabetes. To help combat these conditions, a blood thinner named Xarelto was developed. While it proved to be initially effective, there were many later complications that put the manufacturers in some serious hot water.

Here is what you need to know about Xarelto and its legal problems.

The History of Xarelto

Prior to the licensing of Xarelto in 2011, a very cheap blood thinner, Warfarin, had been the main blood thinner used across the globe for fifty years. However, Warfarin is metabolized very differently by individual patients, and the dose required was affected by other factors such as diet, alcohol consumption, and other medications. This meant the dose of Warfarin required to adequately thin the blood was very different for individual patients. 

To make sure the blood was adequately but not excessively thinned (as the latter would lead to the risk of serious bleeding), regular monitoring via a blood test was required every few weeks for life. This was both inconvenient for the patient and relatively expensive. The main advantages of Xarelto were that it was a once-a-day therapy, was not affected by other factors such as alcohol or other drugs, and hence was the same dose for all patients with no regular blood monitoring required. Thus when first licensed Xarelto rapidly replaced Warfarin for various uses such as:

• The treatment of acute DVT and PE
• The prevention of recurrent DVT and PE, including after surgery
• The prevention of stroke in patients with non-valvular atrial fibrillation which is the most common heart arrhythmia (up to 6 million people in the USA)
• The prevention of heart attacks in acute coronary syndrome
• Prevention of systemic or peripheral embolism

Why Xarelto Attracted Unwanted Attention

With all drugs that thin the blood, the main risk is bleeding which can be very serious and even lead to death. Warfarin monitoring was aimed at reducing the risk of serious bleeding and death, but this was not required for Xarelto. However, one advantage of Warfarin was that should major bleeding occur, there were many readily available antidotes including vitamin K, fresh frozen plasma, and activated factor VII. No such antidote existed for Xarelto until May 2018, seven years after its licensing and rapid uptake in use, when Andexxa with a wholesale price of $27,500 was approved. 

Despite the clinical trials of Xarelto showing there was a risk of up to 28% of bleeding in atrial fibrillation patients, the concern was that up until 2018 the manufacturers of Xarelto, Janssen (a division of Johnson & Johnson) and Bayer, talked up the potential advantages whilst downplaying the risks, especially of prolonged and serious life-threatening bleeding, while knowing there was no effective antidote. In the US in 2016 alone, approximately 117,000 people taking Xarelto and similar drugs, were admitted to hospitals for major bleeding.

The Lawsuits

Up until 2018, over 34,000 lawsuits had been issued in the USA. The attorneys at https://drugguardians.com, who deal with Xarelto lawsuits today, explain that the main accusation was that while the drug manufacturer made huge profits, many patients faced high medical bills, loss of income whilst recovering from prolonged injury, and even death. 32,000 lawsuits were bundled together as multi-district litigation in 2014 to be considered in Louisiana and another 2,000 bundled together to be considered in Philadelphia. In 2017 and 2018, the Louisiana and Philadelphia courts found in favor of the manufacturers in the first six cases, albeit one was initially upheld but later rejected. Other cases continued to be pursued.

However, in March 2019, Johnson & Johnson and Bayer announced a joint $775 million settlement that would resolve approximately 25,000 outstanding Xarelto lawsuits against the two pharmaceutical companies. In keeping with these types of settlements, neither company admitted liability for claims related to severe Xarelto side effects. This settlement has attracted criticism from some as it is less than the manufacturers profits made in a single year from Xarelto (over $6 billion revenue in 2018 alone), caps the payments for anyone who was hospitalized for two consecutive days or less, with the average amount working out at only $31,000 per claim.  

So, if a person feels they have been harmed as a result of the side effects of Xarelto, they can still make a claim directly, or alternatively, they can instruct their own lawyers to act on their behalf to present their case to the Xarelto injury lawyers. However, such has been the demand that several law firms in the USA are no longer taking on new clients.