The Risk About Xarelto Suit Alleges Failed Warning. A lawsuit filed on behalf of a South Florida woman alleges that Xarelto, a new generation anticoagulant manufactured by Janssen Pharmaceuticals and Bayer Healthcare, is to blame for her husband’s fatal bleeding injuries.
The suit alleges that the drug makers failed to warn the plaintiff and her physician about the risks of Xarelto, including the risk of uncontrollable bleeding.
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2010 to reduce the risk of blood clots and related injuries, such as stroke and heart attack, for patients with atrial fibrillation.
Atrial fibrillation is a type of irregular heart rhythm that can cause a blood clot. The lawsuit states that the plaintiff had atrial fibrillation and took Xarelto in order to reduce his risk of stroke.
Warfarin has been used as an anticoagulant for decades
The lawsuit alleges that Bayer and Janssen, a subsidiary of Johnson & Johnson, marketed Xarelto as superior to warfarin. Warfarin has been used as an anticoagulant for decades, but it requires patients to undergo frequent blood testing and dietary restrictions.
Xarelto and other new generation anticoagulants do not carry these limitations, but the plaintiff alleges that manufacturers failed to warn about the lack of an antidote.
This means that if a patient suffers excessive bleeding, a risk that is present to some degree with all blood thinners, there is no way to reverse the drug’s effects. The lawsuit states that bleeding in warfarin patients can be reversed with vitamin K.
More than 2,800 lawsuits have been consolidated
A federal multidistrict litigation (MDL) has been established in the Eastern District of Louisiana before U.S. District Judge Eldon Fallon. More than 2,800 lawsuits have been consolidated. MDLs are created when there are a number of lawsuits with similar allegations.
They streamline the legal process and make proceedings more efficient. In addition to the MDL, some 550 lawsuits have been consolidated into a mass tort program in Philadelphia.
The first lawsuit in the MDL is expected to go to trial in February 2017. The Philadelphia litigation is slated for trial in 2017. The first lawsuits in a mass tort litigation selected for trial are known as bellwether cases.
They are chosen to go first because they represent the entire litigation. The outcome of bellwether trials is used to gauge the rest of the cases. They sometimes facilitate settlement talks.
defective and later recalled device was used in the trials
At trial, plaintiffs will likely bring up the ROCKET-AF clinical trials used to approve Xarelto. Last year, it was discovered that a defective and later recalled device was used in the trials to measure the amount of warfarin in a patient’s blood.
According to a December 2015 BMJ report, the device gave inaccurately low readings which could have skewed results to favor Xarelto inadvertently.
The lead investigator published a letter in the New England Journal of Medicine in 2016 stating that the faulty device did not affect overall conditions.
However, Dr. Harlan Krumholz, of Yale Medical School and author of the BMJ report, said he would like the researchers to release all the trial data so that other researchers could review the findings.