The wife of a Florida man who allegedly died from uncontrollable internal bleeding caused by Xarelto has filed a lawsuit on his behalf, alleging that the drug maker that developed and sold the blood thinning medication made inadequate warnings regarding the potential for fatal hemorrhaging.

According to the Xarelto lawsuit, William N. Packard, Jr. began taking the medication for atrial fibrillation in January 2012 and six months later, in a desperate attempt to stop Xarelto bleeding complications, doctors attempted to drill a hole directly into the man’s skull to allow the blood to drain with no success. He died five days later.

Like Pradaxa side effects, a blood thinner that acts in a similar fashion and is the subject of litigation, part of the issue with the use of Xarelto (rivaroxaban) is that there is no antidote for bleeding should it occur, unlike the generic warfarin (coumadin). While Johnson & Johnson marketed Xarelto as a superior option compared to warfarin because of its easy dosing and lack of regular testing, the Xarelto lawsuit argues that medical research indicates that all patients should be tested because of differences in body fat percentage, weight and other factors.

The Food and Drug Administration also evidently had doubts about Xarelto bleeding incidents, as clinical reviewers have stated that “rivaroxaban should not be approved unless the manufacturer conducts further studies to support the efficacy and safety of rivaroxaban” and the FDA website notes that “[a]dverse event reports of thrombocytopenia and venous thromboembolic events were identified” in relationship to Xarelto.

It might have helped Packard, the Xarelto lawsuit goes on to note, if the drug makers had included similar information in their warning labels as he would have likely chosen an alternative treatment, but that continues to not be the case even as the Institute for Safe Medication Practices reports that “as with other coagulants, the rate of clinically relevant bleeding in clinical studies was high–15% per year of treatment.”

The Xarelto lawsuit is Nancy Packard v. Janssen Research & Development, LLC, et al., Case No. 14-cv-61448, U.S. District Court for the Southern District of Florida.