Report: Xarelto Maker, Suppliers Facing 9,000+ Lawsuits

Gregg Hollander | October 21, 2016 | Defective Products

The manufacturer and distributors of blood-thinning drug Xarelto are, as of this juncture, facing more than 9,000 personal injury and wrongful death lawsuits – and more are continuing to pile up. 

Defendants Bayer AG (a German company) and distributor Janssen Pharmaceuticals (a U.S. company that is a subsidiary of Johnson & Johnson) are accused of failing to adequately warn the public of the possible danger associated with the drug. Many of those who have filed lawsuits alleged the drug caused them to suffer severe bleeding in their intestines or brain, resulting in severe side effects that ranged from hospitalization to death.

A U.S. District Court in Louisiana is overseeing a multi-district litigation that involves more than 7,000 cases. Of those, four are slated to be heard in the next 12 months. The outcome of these so-called bellwhether cases will determine whether defendants are likely to settle future cases (because it’s unlikely defense will prevail) or whether they will continue to fight the litigation. Those four bellwhether cases stem from cases in Louisiana, Texas and Mississippi. In addition to those 7,000 pending cases, there are another 1,000 Xarelto lawsuits pending in a Delaware multi-district litigation and another 1,000 before a state court in Pennsylvania.

A spokesman for Janssen recently said in an interview with the Louisiana Record that all anticoagulants, including Xarelto, carry the risk of bleeding. Further, the spokesman insisted, the company has always warned of this possibility in its prescribing information. Discontinuation of the medication without first talking to a doctor puts patients at heightened risk of developing a blood clot or suffering a stroke or even death – all of which is stated on the label, the spokesman said.

The first case slated for trial involves a man from Louisiana who suffered nearly lethal gastrointestinal bleeding while taking the drug. The second Xarelto product liability case to go to trial, also in Louisiana, was filed by the husband of a woman who died of a brain hemorrhage after taking Xarelto for just a month. The third case involves a woman whose doctor prescribed Xarelto for blood clots, but she later suffered intestinal bleeding. The fourth case involves a Texas man who died of intestinal bleeding while taking the drug.

Although the outcomes of these cases aren’t binding on future litigation, they do typically determine whether settlements can be reached or, if not, how successful either side is going to be at trial.

Another blood thinning drug, Pradaxa, has come under fire as well. the company that manufactures the drug, Boehringer Ingelheim, recently settled a number of claims for a collective $650 million.

Such litigation is likely to continue, as Xarelto remains on the market and there are serious questions about whether its makers and distributors properly warned patients and doctors. The Institute for Safe Medication Practices reports Xarelto had the most serious injury reports among drugs that are regularly monitored. In an analysis of figures from the U.S. Food & Drug Administration, the institute reports that last year, there were 10,700 reports of Xarelto injury in the U.S., which included more than 1,120 patients who died and another 4,500 who required hospitalization. The two most frequent reports were severe bleeding of the intestines and brain.

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Additional Resources:

Xarelto manufacturer, distributor face more than 9,000 lawsuits, Oct. 10, 2016, By John Breslin, Louisiana Record

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