Johnson & Johnson Seeks to Expand Xarelto Use Despite Lawsuit Losses

J & J Attempting to Expand the Use of Xarelto Despite Lawsuits

On the heels of a recent $27.8M jury verdict, and with lawsuits rising in number, Johnson & Johnson is attempting to obtain a label change to include additional uses associated with Xarelto. A new drug application was submitted to the FDA, seeking approval to add a cardiovascular risk reduction claim as well as an acute limb ischemia risk reduction claim to Xarelto labeling.

Serious Risks Associated with Xarelto

Since some very serious risks have been associated with Xarelto, it seems almost unbelievable that the FDA will allow the pharmaceutical giants to expand the uses for the drug. Xarelto potentially has very serious risks regarding uncontrolled bleeding, particularly because there is no antidote doctors can use when the drug does cause an uncontrolled bleed. Older blood thinners, like Warfarin, had certain drawbacks as far as the need for frequent blood monitoring, and the inability to eat certain foods with the drugs, however a simple shot of Vitamin K could effectively halt an uncontrolled bleed caused by one of those older drugs.

No such antidote exists for Xarelto, and in some cases, patients have bled to death while at the hospital, while doctors were able to do nothing other than watch helplessly. The FDA previously rejected three attempts on the part of Bayer and Johnson & Johnson to obtain additional indications for Xarelto, however it remains to be seen whether they will approve the latest application.

Jury Awards $27.8 Million in Xarelto Lawsuit

Little more than a month ago, a Philadelphia state jury ordered Bayer AG and Johnson and Johnson—two of the biggest pharmaceutical corporations in the world—to pay $27.8 million to an Indiana couple after the plaintiff in that lawsuit was prescribed Xarelto for her diagnosis of atrial fibrillation. She took the drug for about a year, then was hospitalized with severe gastrointestinal bleeding. Although Hartman eventually recovered, she blamed her uncontrolled bleeding on Xarelto.

Thousands of Xarelto Cases Pending

This trial was the first of more than 1,400 Xarelto cases which are pending in the Philadelphia court, along with more than 18,500 federal cases which have been consolidated into an MDL in the Eastern District of Louisiana. This was the first Xarelto win, as juries cleared J & J and Bayer of liability in three prior Xarelto trials. In the recent Hartman Xarelto settlement, the jury awarded $1.8 million in compensatory damages to the Hartmans and a staggering $26 million in punitive damages.

Bayer, J & J and Janssen Say They Will Appeal the Decision

A Bayer spokesman stated there was no basis for the verdict and that the company would almost certainly appeal. Janssen, a subsidiary of Johnson & Johnson, also issued a statement, saying the verdict was contradictory to years and years of scientific studies, and noted that the FDA approved the drug, therefore must believe in its safety.

On the flip side, lawyers for the Plaintiff believe Xarelto is one of the very worst in this relatively new class of blood thinners, since thousands of patients taking the drug have experienced serious health complications. Many believe these health issues could have been avoided entirely if Bayer AG, J & J and Janssen had informed doctors of the potential risk of uncontrolled bleeding associated with the drug—and the fact that no antidote existed for such an event. If the pharmaceutical companies were aware of those risks, they could be charged with failure to warn in the upcoming Xarelto lawsuits.

Xarelto Brings in Billions of Dollars Per Year for Manufacturers

For those who wonder why a huge corporation would knowingly continue to market a drug which could potentially cause uncontrolled bleeding, remember that Xarelto is Bayer’s best-selling drug. In 2016, Xarelto netted $3.41 billion in revenues for Bayer, and $2.2 billion for J & J and Janssen. Xarelto was approved by the FDA in 2011, as a treatment not only for atrial fibrillation, but also as a means of reducing the risk of deep vein thrombosis and pulmonary embolism.

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If you or a loved one have been injured by a drug or medical device manufactured by J & J or one of its subsidiaries, it could be beneficial to speak to a product liability attorney as soon as possible.

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