Philadelphia, PAA blood thinner that lacks an effective reversing agent in the event of uncontrolled bleeding is beginning to have its days in court, but not before the rights holder of Xarelto allegedly attempted to thwart those days in court by having a Xarelto lawsuit removed to federal court from state court before its time.
Janssen Ortho LLC, the subsidiary of drug and medical products giant Johnson & Johnson responsible for Xarelto, attempted to have the Xarelto Side Effects lawsuit moved out of state court in Pennsylvania before all the parties had been served. Janssen is not based in Pennsylvania, and thus had attempted to have the case moved out of state court in Pennsylvania and moved to federal court, where Janssen allegedly preferred to have it brought - and to potentially distance itself from a state Supreme Court decision that will be addressed later…
But US District Judge Joel Slomsky said that Janssen simply can’t move it yet.
“The idea that removability should depend on the timing of service could not have been intended by Congress,” Judge Slomsky said in his ruling back in June. “Allowing a defendant to rush to remove a newly filed state court case before the plaintiff has had a chance to effect service on forum defendants would ‘turn congressional intent to prevent litigant gamesmanship on its head.’”
The judicial smack-down by Judge Slomsky signals that Janssen’s efforts to have the Xarelto Lawsuit removed from state court before other Pennsylvania-based defendants were even served a complaint was an attempt to dodge federal statutes over removal.
In so doing, Janssen was seen to have jumped the gun. The case is now back in state court in Philadelphia.
Xarelto is a Bayer drug that is marketed in the US by Johnson & Johnson and its subsidiary, Janssen Ortho LLC. It is the second anticoagulant, after Pradaxa, to be approved by the US Food and Drug Administration (FDA) as an alternative to Coumadin (warfarin), a blood thinner that has been on the market for practically forever and has been the go-to method for thinning the blood in an effort to prevent strokes. The downside with Coumadin is that constant monitoring is required on behalf of health care professionals. While effective, Coumadin is a lot of work - and the pharmaceutical industry has been searching for an alternative for some time.
They found it in Pradaxa - and not much later, Xarelto (rivaroxaban). The so-called new generation blood thinners carry the benefit of less need for monitoring. But the problem is when the blood thinner works too well, leading to a Xarelto bleeding issue. With warfarin, there has always been a quick and effective way to reverse a bleeding issue before it becomes dangerous.
With Xarelto, that’s not the case. While the industry is working on an effective antidote for Xarelto (and Pradaxa, for that matter), a reversing agent has yet to be found. Like Pradaxa, an uncontrolled bleeding issue can lead to Xarelto death.
Once the tap is on, it can’t be turned off…
Plaintiff Virginia Stuntebeck originally filed her Xarelto lawsuit in February, in the Philadelphia Court of Common Pleas (Stuntebeck v. Janssen Research & Development LLC et al., Case No.140201754, in the Court of Common Pleas of Philadelphia County). One of her claims is that Janssen and Bayer should not have sold the drug due to the high risk over its use, and alleged that the two pharma giants were negligent for doing so.
The timing of Stuntebeck’s lawsuit is a point of interest, in that it came a month following a decision by the Pennsylvania Supreme Court in Lance v. Wyeth that a pharmaceutical company can be held responsible for marketing a drug that is too harmful to be used.
That ruling appears to conflict the overall mandate of the FDA which allows drugs to be approved provided the benefits outweigh the risks for the intended patient constituency. In the case of Xarelto, the advantage of effective blood thinning without the need for the kind of stringent monitoring inherent with warfarin use was interpreted as a benefit, which presumably outweighed the risks.
However, unlike warfarin, once a Xarelto bleedout starts, there is no way to stop it.
Plaintiff Stuntebeck claimed in her lawsuit that a year prior, in February 2013, she was hospitalized for severe internal and gastrointestinal bleeding after her doctor had put her on Xarelto. “As the manufacturers and distributors of Xarelto, defendants knew or should have known that Xarelto use was associated with irreversible bleeds,” she said in court documents. Her complaint also took issue with the warning label.
Xarelto was granted FDA approval in July 2011 with an indication for reducing the risk of blood clots, deep vein thrombosis and pulmonary embolism after knee or hip replacement surgery. The indication was later expanded to include the treatment of abnormal heart rhythms - although it is interesting to note that the FDA approved the latter indication against the recommendation of FDA staff. There were safety concerns.
And in mid-February of this year, the FDA again rejected the manufacturer’s effort to have Xarelto approved for the treatment of acute coronary syndrome. The regulator had turned down that indication twice before.
Stuntebeck’s lawsuit is believed to be the first tort suit to be filed in the Philadelphia Court of Common Pleas - a lawsuit that Janssen tried to have removed to federal court. But a judge nixed the effort.
Pundits expect more Xarelto lawsuits, akin to those filed over Pradaxa. With so much concern over Xarelto bleeding complications, it’s only a matter of time that lawsuits flow just as freely...
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