In 2011, the Food and Drug Administration (FDA) approved a Blood thinner called Xarelto for use in various medical situations. Since Xarelto was approved, manufacturer Janssen Pharmaceuticals has filled over three million orders for the medication. In August 2013, the FDA started issuing warnings about the use of Xarelto after it had received over 2,100 adverse event complaints about the medication. Furthermore, BloodThinnerHelp.com states that by May 2015, 400 lawsuits were transferred to the MDL in Louisiana and nearly 100 lawsuits were filed in Philadelphia.
What Is A Blood Thinner?
A blood thinner prevents the blood from clotting both internally and in open wounds. Xarelto blocks the thrombin in the blood that causes clotting, and that is designed to help patients who are at risk of getting blood clots. Blood thinners are designed to prevent dangerous leg and lung blood clots, and they also help to prevent strokes.
What Went Wrong With Xarelto?
Xarelto has been tagged as the primary cause of serious internal bleeding cases around the country with some of the cases leading to the death of the patient. When the blood cannot clot internally, it collects throughout the body and creates a variety of serious medical issues. While all blood thinners come with inherent risks, it became obvious that Xarelto created more of a risk than the majority of blood thinners on the market.
Has The FDA Done A Recall On Xarelto?
Once the FDA has officially approved a drug for resale, it is very hesitant to recall the drug without proof of significant harm to the public. In the case of Xarelto, the FDA has not yet issued any type of recall as of October 2016. The FDA has issued:
- Two black box warnings (large black labels put on the product packaging as a warning) in August 2013 and December 2014
- A January 2014 warning against the use of Xarelto in certain medical situations and a statement that there is no antidote for Xarelto once it is in the patient's system
- A March 2014 warning recommending that patients on Xarelto wait until the drug is out of their system before having any spinal procedures done
On January 15, 2016, it was reported that there are 2,826 lawsuits pending in regards to internal bleeding issues caused by Xarelto. When the FDA will not recall a drug, the only solution for victims is to file a lawsuit. When an excessive amount of lawsuits are filed, legal authorities will usually try to either create a class action suit or allow certain cases to go forward that are indicative of the majority of the lawsuits filed, also referred to as bellwether trials.
In August 2016, the FDA rejected an application from Portola Pharmaceuticals to move forward with an antidote for Xarelto. To this point, no application by any company to develop an antidote has been accepted.
The first bellwether trials were scheduled to take place in the fall of 2016 in New Orleans. But on September 21, 2016, those trials were officially delayed because the NBA All-Star game was to be played in New Orleans around the time of the trials and officials felt that having those two events taking place at the same time would be a logistical nightmare.
On October 3, 2016, the Journal of the American Medical Association published a side-by-side comparison between Xarelto and the blood thinner Pradaxa. Their conclusion was that serious bleeding events were much more common with Xarelto than with Pradaxa.
It was revealed that 80 bellwether cases are going to be scheduled to be heard in New Orleans at some point in early 2017. At the same time, it is estimated that another 800 lawsuits could start against Janssen Pharmaceuticals in the Philadelphia Complex Litigation Center. Janssen is already involved in several other cases regarding some of its other medications in the Philadelphia Complex Litigation Center.
When the FDA will not ban or recall a drug, victims feel it necessary to file lawsuits to get justice. Starting in early 2017, we will be able to see whether or not victims of Xarelto will get the justice they feel they deserve.
About Michael Monheit, Esq.
Michael Monheit, the managing attorney at Monheit Law, has been working to assist individuals and families who have been harmed by defective drugs and products. In fact, Mr. Monheit served on the Plaintiff’s Steering and Executive Committee for MDL 1148. He understands how stressful it can be to stand up to a major corporation and is committed to making sure that plaintiffs know they have someone on their side.