A woman who is a resident of Arizona filed a lawsuit on February 18th, 2016 under case number 2:16-cv-01359, alleging that side effects of the blood thinner Xarelto caused her serious physical harm.
The plaintiff took Xarelto for a very short period of time, from May 8th, 2014 to May 18th, 2014. During this ten-day period, she developed hemorrhagic pericardial effusion, pericardial tamponade, and pleural effusion. She alleges that Janssen Pharmaceuticals and Bayer AG, the manufacturers of the drug, “failed to investigate, research, study, and define, fully and adequately, the safety profile of Xarelto”. She also claims that the companies failed to provide medical professionals with the necessary instructions on how to help a patient who is suffering from the side effects of the drug.
Xarelto’s Side Effects
Xarelto, which was released on the market on July 1st, 2011, has several well-known side effects which have impacted numerous patients. These side effects include:
- GI Bleeding
- Brain Hemorrhage
- Pulmonary Embolism
- Spinal Bleeding
- Rectal Bleeding
- Liver Dysfunction
Arguably, however, the most dangerous of these side effects is the fact that at this time, there is no approved reversal agent for the blood thinner. This means that if a patient suffers from an adverse side effect or begins to bleed due to a physical trauma, doctors are unable to restart the clotting properties in the blood. If the patient is unable to form clots in their blood there is a very large chance that they may bleed out. Doctors usually attempt to prevent this by performing blood transfusions, however, this treatment is not guaranteed to work.
Recently it was announced that the U.S. Food and Drug Administration had named a drug undergoing clinical trials a “Breakthrough Therapy”, so that the development of this drug – a potential reversal agent for Xarelto – could be fast-tracked. This doesn’t mean that it will ultimately be approved and those who are taking Xarelto are still at risk.
Thousands of patients who have suffered from these side effects have decided to take action against the manufacturers by filing personal injury lawsuits.
The Ongoing Litigation
More than 5000 Xarelto lawsuits have been filed by plaintiffs across the country, each one containing similar allegations. In fact, so many complaints were filed with such similar allegations, that the Judicial Panel on Multidistrict Litigation agreed to consolidate federally-filed lawsuits into MDL 2592, to be overseen by the honorable Judge Eldon E. Fallon in the Eastern District of Louisiana.
By performing this consolidation, the panel is allowing plaintiffs to go through the discovery phase together and prevents judges from around the country making different rulings. Most importantly, it saves the plaintiffs and the defendant precious time and money.
Wrongful Death Claims
Not all of the plaintiffs involved in MDL 2592 are the patients themselves. Tragically, around 500 of the cases are wrongful death lawsuits.
A wrongful death lawsuit is filed by the family and loved ones of someone who has passed away due to the alleged negligence of another party. In order to establish that they do indeed have a claim, plaintiffs must prove:
- A death occurred
- That the death was caused by another party’s negligence
- That the surviving family members are suffering in a monetary way due to the loss of their loved one
By choosing to pursue legal action, the plaintiffs stand to recover compensation for funeral and burial expenses, lost earnings, medical expenses for treatments their loved one required before death, and the services and support that the deceased offered their loved ones.
Has The FDA Recalled The Drug?
No. Despite the number of reported side effects and the issues with the drug, the FDA has not recalled Xarelto. The department has, however, issued several “black box” warnings regarding the side effects.