Hundreds of Xarelto lawsuits have been filed over allegations that patients taking the popular blood thinner were not sufficiently warned about its internal bleeding risks or lack of reversal agent, with many complaints currently consolidated as part of two litigation processes in Louisiana and Pennsylvania.
Plaintiffs who file suit against the drug’s manufacturer and marketing agent (Bayer Pharmaceuticals and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson) charge that they fraudulently marketed the drug as safer and more convenient than older blood thinners on the market.
At The Jeffcoat Firm, we represent clients who have been harmed by dangerous drugs and can assist you in filing a Xarelto lawsuit. Patients who have suffered bleeding complications or lost a loved one are encouraged to contact our firm for a free case review.
Marketing claims about Xarelto
The Xarelto lawsuits join an even larger number of complaints associated with Pradaxa, introduced in 2010 as the first of the so-called “next generation” of anticoagulants. Like Pradaxa, Xarelto (Rivaroxaban, approved by the FDA in 2011) and other drugs of this category initially seemed to offer the promise of more convenient, more effective treatment for patients at risk for deep vein thrombosis and pulmonary embolism compared to older drugs.
Previously, the “go-to” anticoagulant for physicians had been warfarin (marketed under the brand name Coumedin); warfarin required strict monitoring, frequent blood tests, and the maintenance of a careful lifestyle of diet and exercise. Xarelto was marketed as requiring fewer restrictions with the same results. The popularity of such drugs quickly skyrocketed, with Bayer netting $1.3 billion in Xarelto sales for 2013 alone.
Xarelto bleeding problems
The problem with Xarelto, however, is that it lacks a reversal agent to stop bleeding events. Bleeding associated with warfarin could generally be treated with a dose of Vitamin K; this method does not work for Xarelto, leaving physicians with few options when confronted with serious bleeding problems.
The following Xarelto bleeding complications, some fatal, have been reported:
- Intracerebral (brain) hemorrhage (ICH)
- Spinal or epidural hematomas
- Intestinal bleeding
- Abdominal bleeding
- Rectal bleeding
2,081 serious adverse events (SAEs) were reported to the FDA during the 2012 fiscal year alone, with 151 involving fatalities (three times the number connected with warfarin during the same period). Many who have experienced Xarelto-related injuries have sought legal action with the assistance of experienced product liability attorneys.
Studies challenge initial claims about Xarelto’s safety
Recent studies call into question the initial marketing claims about Xarelto:
- A study of 901 patients in Ontario found that the risk of strokes and bleeding events was equally low for patients taking warfarin, Xarelto, or Pradaxa.
- A Journal of Neurosurgery article from August 2014 points out that a lack of antidote has grave implications for treating ICH, when a rapid response can have life or death implications.
- The Canadian study cited above has also suggested that patients taking Xarelto are at far less risk for serious bleeding events if they are monitored much more closely than manufacturers suggest, undercutting claims that the “new generation” drugs are easier to use than warfarin.
FDA concerns about Xarelto are clear
- The agency rejected three separate requests from Bayer to broaden the uses of the drug beginning in 2013 because of specific concerns about bleeding risks.
- They sent a warning letter to Bayer in June of 2011 for downplaying the risk associated with spinal hemorrhage.
- They required a more specific warning label in January of 2014, stating that a “specific antidote for rivaroxaban is not available” and that vitamin K and other agents do not “affect the anticoagulant activity of rivaroxaban.” This language adds to the black box warning regarding the risks of spinal hematoma and associated paralysis.
Reasons for filing a Xarelto lawsuit
Patients who have filed a Xarelto lawsuit with The Jeffcoat Firm contend that they suffered injuries as a direct result of the following:
- The company did not adequately test or monitor Xarelto for safety
- Bayer made false claims about the safety and convenience of their drug
- The company failed to warn about the risks associated with the lack of antidote
Those filing a lawsuit seek compensation for the following losses:
- Medical expenses (past, present, and/or future)
- Loss of income and/or earning expenses
- Diminished earning capacity
- Loss of spousal consortium
- Pain and suffering
- Wrongful death
Future of Xarelto litigation
The first Xarelto wrongful death lawsuit was filed in April of 2014. As the number of plaintiffs filing individual claims about the injuries and losses they have suffered in association with Xarelto has steadily grown, the court system has approved two consolidated litigations that process cases more efficiently:
- A multidistrict litigation (MDL 2592 – Xarelto Products Liability Litigation) in the Eastern District of Louisiana established in December of 2014. The MDL currently includes more than 300 lawsuits.
- A mass tort in the Philadelphia Court of Common Pleas under Judge Kevin Dougherty established in January of 2015. The mass tort currently has close to 200 lawsuits.
The federal and state-level Xarelto litigations allow parties to share in the discovery process. At some point, preliminary (or “bellwether”) trials will likely be scheduled in order to set precedent, determine a likely jury response in subsequent trials, and encourage large-scale settlements.
How The Jeffcoat Firm can help
Those filing a Xarelto lawsuit with our firm can count on highly credentialed personal injury lawyers who will provide thorough background and preparation work, aggressive representation, and accessibility during all stages of litigation. You need legal advocates on your side who can take on Big Pharma successfully, negotiate a fair settlement or try your case before a jury. We get results for our clients, as attested by our strong track record in the area of product liability litigation. Call our offices today for a free and confidential case review.
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