April 21, 2015 — Approximately 100 lawsuits involving uncontrollable bleeding from Xarelto were filed in the last month, bringing the total number of federal cases to 402.
The lawsuits have been centralized in a federal Multi-District Litigation (MDL No. 2592) in the U.S. District Court for the Eastern District of Louisiana, where Judge Eldon E. Fallon presides.
Approximately 200 additional lawsuits are pending at the state level in Pennsylvania.
All of the lawsuits accuse Bayer and Janssen Pharmaceuticals of downplaying the bleeding risks associated with Xarelto, which boosted corporate profits but jeopardized patient safety. Xarelto is still marketed as an easy-to-use medication because “there is no need for routine blood tests” to adjust dosage.
However, a study published last month in JAMA questioned these marketing claims, “patient safety can be further improved through individualized dosing.”
Another problem with Xarelto is that it lacks an effective reversal agent. Other blood-thinners, such as Coumadin (warfarin), can be de-activated in an emergency with a simple dose of Vitamin K. If patients on Xarelto have a bleeding emergency or need unexpected surgery, there is a risk that they could bleed to death because it cannot be de-activated.
Lawsuits claim Xarelto is an “unreasonably dangerous” medication that was improperly marketed as a “one-size-fits-all” medication. Bayer and Janssen are also accused of failing to warn about the risk of irreversible bleeding “to prevent any chances of their product’s registrations being delayed or rejected by the FDA.”
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