On July 7, 2017, after having experienced life-threatening bleeding from Xarelto, plaintiff Pamela B., filed a lawsuit in U.S. District Court. With this action, she joins many other former patients who suffered complications after taking this anticoagulant.

Pamela’s complaint is filed in multidistrict litigation (MDL) No. 2592 against Janssen Research and Development Inc., Johnson and Johnson Inc., Bayer Healthcare Inc., and all affiliated companies. This MDL has organized multiple complaints directed toward the developers and distributors of Xarelto.

Xarelto, which was approved for sale in July 2011, belongs to a group of medications known as the new oral anticoagulants (NOACs). Other drugs in this group are Pradaxa and Eliquis. NOACs were highly advertised as supposedly better replacement medications for Coumadin, also known as warfarin.

Coumadin is a blood-thinning medication used to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in joint replacement candidates and stroke in atrial fibrillation patients that has been in use for over 60 years.

While Coumadin requires blood monitoring and diet control to ensure effectiveness, the defendants advertised that Xarelto did not. This marketing claim helped turn the drug into a huge profit machine. According to the legal documentation of this case, the drug reached a record $2 billion in sales within two years of its market approval date.

Uncontrolled Bleeding from Xarelto

Uncontrolled bleeding from Xarelto became a common complaint among users in the first year, however, and resulted in a number of adverse medical event reports to the Food and Drug Administration (FDA).

Prior to the first anniversary of Xarelto’s approval, 1,080 reports had been filed with the FDA about serious adverse events associated with Xarelto, according to Pamela. Of those cases, 65 ended in death. Among cases of bleeding from Xarelto, eight percent resulted in the patient’s death.

Failure to Warn

It was well-known in the medical community that the remedy for bleeding events associated with Coumadin was a rapid infusion of Vitamin K. There was no such remedy for bleeding from Xarelto use, according to the factual background stated in Pamela’s complaint.

Pamela B., who only took the blood-thinning medication for a period of three months between August and October of 2016, says she experienced such an episode of bleeding from Xarelto, and was impacted by the pain and suffering from the event.

The plaintiff had uncontrolled bleeding from the nose called epistaxis on Sept. 25, 2016 while actively taking Xarelto. Since the nose is very dense in blood vessels, it is not uncommon to be impacted by any slight change in internal changes.

Pamela B. brings the following counts against Janssen Research and Development and all affiliated companies named in this lawsuit as follows: Count 1 – Strict Liability; Count 2 – Manufacturing Defect; Count 3 – Design Defect; Count 4 – Failure to Warn; Count 5 – Negligence; Count 6 – Breach of Express Warranty; Count 7 – Breach of Implied Warranty; Count 8 – Negligent Misrepresentation; Count 9 – Fraud; Count 10 – Violation of Consumer Protection/Fraud Laws.

The plaintiff in this Xarelto lawsuit is asking for a trial by jury and compensatory damages for pain, suffering, and related emotional distress.

She is also asking for economic damages to replace lost earnings, pay medical and other out-of-pocket expenses, and punitive damages to discourage such disregard of the public for private gain on the part of the defendants in the future.

The Bleeding from Xarelto Lawsuit is Case No. 2:17-cv-06539-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.