As of mid-December 2016, Janssen Pharmaceuticals is facing more than 15,000 lawsuits (most of which have been consolidated into multidistrict litigation in Louisiana with approximately 1,000 scheduled in Pennsylvania) over its “new generation” anti-coagulant medication, Xarelto (riraroxaban).
Federal trials will get underway in March of 2017, while state-level cases won’t be heard until later in the year, barring a settlement. In 2011, German-based Boehringer-Ingelheim settled similar cases over its own anti-coagulant, Pradaxa (dabigatran) for $650 million, averaging $162,500 per claimant.
The problem with such “new generation” anticoagulants is that once coagulation, or clotting, of the blood has been inhibited, if a patient gets so much as a bump on the head, it can lead to fatal hemorrhaging – and until now, there has been no reversal agent or any other way to stop it other than to administer emergency dialysis in order to remove the drug from the system – an unreliable solution at best.
Xarelto is a “Factor Xa (‘Ten-A’) inhibitor.” In simple terms, it stops blood clots from forming by preventing blood cells from adhering to each other. Lawsuits going forward next year allege that Bayer AG and Janssen Pharmaceuticals failed to issue adequate warning to doctors and patients, minimizing the bleeding risks.
The appeal – for physicians and a profit-driven health care system focused on revenue over patient outcomes – is that the newer “Novel Oral Anti-Coagulants” (NOACs) have far fewer interactions and dietary restrictions than the old standby warfarin. Marketed under the brand name Coumadin, warfarin was originally intended for use as a rodenticide. Although warfarin can also cause serious bleeding, copious doses of Vitamin K can reverse the effects.
This has not been true for Xarelto until now. For the last two years, a small, San Francisco Bay Area biotech firm, Portola Pharmaceuticals, has been working on a reversal agent for Xarelto. Called andexanet alfa, it has been demonstrated effective in reversing the effects of Xarelto within a few hours. However, when Portola sought FDA approval in August, it was denied. Furthermore, a recent editorial published in the New England Journal of Medicine raises serious questions about the safety and efficacy of andexnet alfa.
In the meantime, a recent analysis from Bayer and Janssen suggests that Xarelto is still more cost effective and safer to use for cancer patients who run the risk of venous thromboembolism (VTE), or blood clotting in the limbs due to the effects of chemotherapy drugs. Of course, the fact that the analysis in question came from the very companies that manufacture and market Xarelto makes it questionable, especially since the product generated more than $4.3 billion in sales during 2015 alone.