Xarelto Seeking FDA Approval for Lower Dosage While Litigation Posturing Continues


Towards the end of May plaintiffs embroiled in some 18,000 Xarelto lawsuits consolidated in multidistrict litigation were pushing back against a move by defendants Janssen Pharmaceuticals Inc. (Janssen, a division of Johnson & Johnson) and Bayer HealthCare Pharmaceuticals Inc. (Bayer) to escape claims that relied on allegations plaintiffs had previously dropped.

According to court documents, the defendants were seeking to dismiss with prejudice “abandoned allegations” on the part of the plaintiffs. However, plaintiffs assert that the defendants can only move for summary judgement on formal claims, not on so-called abandoned allegations.

“Defendants contend that several ‘facts’ have been ‘abandoned’ and they are therefore entitled to having these facts dismissed,” the filing said. “Thus, what defendants are seeking ‘is the elimination of particular facts from the jury’s consideration,’ which is not permitted through a motion for partial summary judgment.”

Plaintiffs assert that it would have been more appropriate to file a dispositive motion, rather than a motion in limine with regard to the matter. However, according to the plaintiffs in their Xarelto lawsuit, the deadline for dispositive motions had already passed (in January), and thus is no longer possible. What the plaintiffs are saying is that the defendants’ lone qualifying pathway to a motion for summary judgement is no longer valid due to a deadline that has already expired.

Among the so-called abandoned allegations from which the defendants are seeking to escape, is the assertion that defendants failed to adequately test rivaroxaban (Xarelto), that its labeling should have told physicians to monitor patients’ prothrombin time routinely and for the purpose of adjusting doses, and that Xarelto’s label didn’t sufficiently warn of bleeding risks, according to the filing.

Plaintiffs have also asserted that Xarelto dosages of 15mg and 20mg were too high, and posed too high a risk for a Xarelto bleeding issue.

There may be a lower dose coming. At the end of June the US Food and Drug Administration (FDA) granted Janssen and Bayer a priority review of a once-daily 10mg dose of the blood thinner. According to Velawcity (08/03/17), priority reviews are granted for medicines that may offer significant improvements to diagnoses, treatment or prevention of a serious condition.

And much like the FDA’s 510(k) Clearance protocol, which excuses manufactures from full-blown clinical trials if a drug is “substantially equivalent” to products already on the market, priority reviews also give manufacturers a break by reducing the review period from ten months, to six months. Critics of the 510(k) Clearance protocol have long since claimed that the protocol allows substantially equivalent drugs onto the market without proper testing and with the potential for hidden flaws that can hit consumers without warning – effectively turning the general public into unwitting clinical trial participants.

The basis for which Janssen and Bayer wish to introduce a lower dosage for Xarelto rivaroxaban includes the potential for a reduction of risk for recurrent Venous Thromboembolism, which often includes Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). Janssen believes the 10mg dosage will help physicians customize treatment plans and manage patients over time.

Xarelto was originally introduced as a much sought-after alternative to Coumadin (warfarin), a blood thinner that had been the standard for decades, and proved effective provided strict monitoring regimens were maintained. The thinning properties of warfarin could also be reversed by way of an infusion with Vitamin K.

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Xarelto (rivaroxaban) was hailed as a vast improvement over warfarin in that ongoing monitoring was less important, couching the drug as a worthy alternative that was easier for both patient and health care provider. However, in practice rivaroxaban was soon associated with Xarelto bleeding complications which for some patients led to Xarelto death. Rivaroxaban also does not respond to Vitamin K in the same way as warfarin, suggesting that Xarelto was allowed onto the market without an effective antidote in place.
Many an Xarelto lawsuit has asserted that not only is rivaroxaban a defective product that leads to a higher risk for Xarelto bleedout, but that manufacturers were negligent in suggesting that less-stringent monitoring was acceptable for the drug to be effective when, in practice and given the lack of an antidote, increased monitoring was more appropriate.

The case is In re: Xarelto (Rivaroxaban) Products Liability Litigation, Case No. 2:14-md-02592, in the US District Court for the Eastern District of Louisiana.