Florida plaintiff Nancy Packard is suing Janssen Pharmaceuticals for the wrongful death of her husband, William N. Packard, alleging that ingesting the blood-thinning medication, Xarelto, caused her husband suffered fatal bleeding injuries.

According to the Xarelto lawsuit, Packard’s husband was prescribed Xarelto on Jan. 10, 2012 to treat his atrial fibrillation. Ideally, this medication would have prevented certain clotting in his body, and would have prevented stroke or a heart attack. Instead, Xarelto has been accused of inducing fatal side effects, leading to Mr. Packard’s death on June 28, 2012.

Several days before his death, Packard was reportedly admitted to a Pennsylvania hospital in order to undergo major cardiac surgery. He had complained of unexplained pain and other alarming symptoms, alarming his physician to recommend him to the advanced hospital after diagnosing the condition to be internal bleeding. In an effort to stop this injury, Packard underwent a right frontal burr hole with evacuation, according to the Xarelto lawsuit.

Unfortunately, the surgery did little to help Mr. Packard’s condition and proved to be futile at preventing his death. Therefore, the plaintiff and her legal team allege that the defendant is directly responsible for her husband’s death because of the medication’s unlisted side effects. Packard states that there were no warnings or indications on the drug’s warning label, and did not receive any notification of danger from the defendant.

Mrs. Packard insists that if her husband had known about the possibility of internal bleeding injuries, then he never would have agreed to take the medication. In fact, Mrs. Packard and her legal team argue that because the Xarelto side effects were not listed on Xarelto’s label, her husband was unable to make a reasonable decision at the time of his prescription, because he had not been given full disclosure.

This Xarelto Lawsuit is Nancy Packard v. Janssen Pharmaceuticals, Case No. 0:14-cv-61448-JAL, in the U.S. District Court of Southern Florida.

Overview of Xarelto Complications

Xarelto was first approved by the U.S. Food and Drug Administration (FDA) on July 1, 2011 as a blood clot treatment drug for patients who had recently gone under knee replacement surgery. These surgeries often left patients vulnerable to the develop blood clots due to the sensitive nature of the affected area, creating the need for such drugs.

Xarelto was approved for general use as a blood thinner by the federal agency on Nov. 4, 2011 to primarily be used to reduce the risk of stroke systemic embolism in patients with non-valvular atrial fibrillation. While originally marketed by Bayer Pharmaceuticals, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, incurred the rights to manufacture, distribute, and market it.

The anticoagulant market is estimated to be worth between $15 to $20 million but has very few drugs actually approved to be in the competition. Currently, Warfarin and Pradaxa are the only competition to Xarelto, and is doing comparably well with its competitors.

Janssen marketed Xarelto to be a “one size fits all” anticoagulant in their marketing campaigns, stating that is more efficient than Warfarin and safer than Pradaxa. The latter mentioned has been under public scrutiny due to allegations of uncontrollable bleeding injuries leading to patients’ deaths.

Unfortunately for Janssen and Bayer, Xarelto is now facing the same allegations, for deceptive marketing and negligence. Reportedly, there was no mentioning of the possibility of internal bleeding on Xarelto’s label, nor are there any known reversal agents to treat the bleeding injuries.

This has led many patients to file Xarelto lawsuits against Janssen and Bayer, accusing the companies of deliberately concealing this information to protect the drug’s popularity.