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On June 23, 2014, Florida resident Nancy Packard filed a Xarelto wrongful death lawsuit on behalf of her husband, William N. Packard, Jr. She named as defendants the manufacturers of the anticoagulant drug, Johnson & Johnson (J&J) and Bayer AG. The case is currently pending in the U.S. District Court for the Southern District of Florida. The plaintiff seeks in excess of $75,000 in damages.

Plaintiff Dies of Brain Hemorrhage

According to court documents, William N. Packard started taking Xarelto around January 10, 2012. His doctor prescribed it to treat his non-valvular atrial fibrillation. Just a few months later, however, on June 23, 2012, he suffered a subdural hemorrhage and was admitted to the hospital.

A subdural hemorrhage or “hematoma” is excessive bleeding outside the brain. The blood collects between the layers of tissue that surround the brain, increasing pressure on the brain. If this pressure isn’t successfully relieved, it can lead to unconsciousness and even death.

Packard was in the hospital for several days. Doctors tried to relieve pressure by performing a right frontal burr hole with evacuation. A “burr hole” is a drilled hole into the scalp that is often used in brain surgeries. In this case, the goal was to create an avenue by which the blood could drain out. Unfortunately, in Packard’s case, the procedure was not enough to save his life. He passed away on June 28, 2012.

No Antidote to Xarelto Bleeds

Nancy Packard claims in her case that the defendants did not provide adequate warnings about the risks of Xarelto on the product label. She notes that in particular, the drug contained no warnings about the fact that excessive bleeds were irreversible.

Xarelto is one of several anticoagulants that are available for patients like Packard. Others include Pradaxa and warfarin. Patients taking warfarin who suffer from excessive bleeds can be treated with vitamin K injections, which stimulate blood clotting. Neither Xarelto or Pradaxa, however—considered so-called “new generation” anticoagulants—have any such readily available antidote, so doctors have few options when it comes to trying to stop the bleeding. Drug makers are reportedly working on developing a reversal agent, but so far have failed to release one.

Packard also states in her complaint that the defendants marketed and promoted Xarelto without acknowledging the danger of irreversible bleeds, and failed to provide post-marketing warnings and instructions concerning them. In essence, she says they “actively concealed” the true risks associated with the drug.

Plaintiff Seeks Punitive Damages

Despite the rising number of Xarelto lawsuits filed across the country, Bayer and J&J applied to have the FDA approve the drug for the prevention of strokes and heart attacks in patients with existing heart disease. In March 2013, however, the FDA rejected the application, citing concerns about bleeding risks.

Packard brings counts of failure to warn, design defect, negligence, negligent design, negligent misrepresentation, breach of warranties, fraud, and violation of consumer protection laws. She seeks compensatory and punitive damages.

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