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FDA refuses expanded use of Xarelto as lawsuits climb

The maker of the anticoagulant Xarelto requested that the U.S. Food and Drug Administration expand the drug's approved uses, and the FDA declined the request. The agency's rejection earlier this year happened as the number of Xarelto victims, some of whom have been represented by the product liability attorneys at Reich & Binstock, has continued to climb.

The FDA's nay came in the form of a "complete response letter" to the manufacturer; in this case it was Johnson & Johnson's Janssen Pharmaceuticals.

As the federal code explains, "FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in [federal regulations]. A complete response letter will describe all of the specific deficiencies that the agency has identified in an application or abbreviated application..."

Janssen since 2011 already received FDA approval to market Xarelto for the following purposes:

  • To reduce the risk of deep vein thrombosis, or DVT, and pulmonary embolism, or PE, that might occur following knee replacement or hip replacement surgery
  • To actually treat DVT and PE and to reduce their recurrence following initial treatment
  • To reduce the risk of stroke in people who have a type of abnormal heart rhythm called non-valvular atrial fibrillation

The corporation tried to expand Xarelto's use "to reduce the risk of secondary cardiovascular events - defined as heart attack, stroke or death - in patients with acute coronary syndrome and to reduce the risk of stent thrombosis in the same population, in combination with standard anti-platelet therapy." The FDA said no.

Growing Xarelto product liability litigation may not have had anything to do with the FDA's most recent decision regarding the applicability of the blood thinner. But the Xarelto lawsuits linked to the drug's alleged bleeding risk have certainly gotten the defendants' attention.

Cases have been grouped together in state and federal courts. Since the Philadelphia-based Pennsylvania Court of Common Pleas in January set up a Xarelto Mass Tort program to handle Xarelto lawsuits en masse, plaintiffs have filed more than 200 Xarelto lawsuits there.

In the meantime, since a federal judicial panel centralized federal Xarelto lawsuits in December 2014 before U.S. District Court for the Eastern District of Louisiana, a torrent of litigation has poured in. On Jan. 22, there were 86 Xarelto lawsuits before this multidistrict litigation court, or MDL, and more than 400 were pending there as of April 15.

Xarelto has certainly paid off for the manufacturer. Johnson & Johnson noted in its annual report for the year 2014 that Xarelto sales topped $1.5 billion for the calendar year. But some Xarelto patients, who helped to boost those sales, paid a price far higher than the co-pay for the drug.

Many Xarelto victims want to hold the manufacturer accountable for serious injuries. As the federal panel of judges wrote in regard to Xarelto lawsuits, "These actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding or other injuries as a result of taking Xarelto (rivaroxaban) and that defendants did not adequately warn prescribing physicians or consumers of the risks associated with Xarelto, including the potential for severe or fatal bleeding and the unavailability of a reversal agent to counteract Xarelto's anticoagulation effects."

Anyone who suffered a bleeding injury that may be linked to the use of Xarelto may want to contact an attorney to explore all of the legal options. An attorney with considerable experience in handling pharmaceutical product liability law is a good choice.

As the founding partners of Reich & Binstock, Robert J. Binstock and I are skilled in mass tort, multidistrict and class-action litigation. Mr. Binstock was recognized this year by Elite American Lawyers for his dedication, achievement and leadership in personal injury.

The mass tort, multidistrict and class-action litigation cases our attorneys have been involved with include property damage and environmental contamination, product defects, pipeline system accidents, oil spills, stimulant and laxative addiction, pharmaceutical injuries and managed care litigation.

Although Mr. Binstock and I are board certified in Personal Injury Trial Law by the Texas Board of Legal Specialization, our law firm operates in all 50 states,

For a free consultation, contact Reich & Binstock either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.

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