Next-generation anticoagulant Xarelto (rivaroxaban) is one of the most widely used drugs in its class, and a top-performing product for its manufacturers, Bayer, and Johnson & Johnson subsidiary Janssen Pharmaceuticals. Xarelto sales went through the roof in 2016, bringing in more than $3 billion and driving a 9 percent year-over-year sales increase for Bayer.
The sales increase was good news for a company beleaguered by persistent dangerous drug lawsuits. Despite its popularity, Xarelto is linked to a wide variety of serious, life-threatening and even fatal side effects, the most dangerous of which is uncontrollable internal bleeding. Unlike blood-thinners such as warfarin, Xarelto has no antidote, which makes bleeding events particularly dangerous.
A number of patients have been hospitalized, and some have even died, due to hard-to-control or irreversible Xarelto bleeding.
As a result, thousands of patients who suffered these severe bleeding events—or the family members of those who lost their lives—have filed dangerous drug or wrongful death lawsuits against Bayer and Janssen Pharmaceuticals, claiming the companies failed to inform doctors and patients of the risk of irreversible bleeding and knowingly marketed a dangerous product.
Xarelto Development and FDA Approval History
Xarelto is a member of the novel oral anticoagulant (NOAC) class of medications, which was developed as an alternative to older anti-clotting drugs like warfarin. Bayer and Janssen Pharmaceuticals have marketed Xarelto as a safer, more convenient anticoagulant. Here's the development timeline:
- 2008: Drug regulatory agencies in the European Union approve Xarelto as an anti-clotting treatment.
- 2009: Bayer obtains a new drug application for rivaroxaban from the U.S. Food and Drug Administration (FDA).
- 2011: Bayer submits the new drug application for Xarelto to the FDA; the drug is subsequently approved for the prevention of deep vein thrombosis in patients undergoing knee or hip replacement surgery, and the prevention of stroke in people with common types of abnormal heart rhythm.
- 2012: The FDA approves Xarelto to treat and reduce the recurrence of blood clots.
Early Xarelto Complaints and Lawsuits
Despite its promised convenience and widespread use, Xarelto faced problems right from the start, as shown in the following timeline:
- 2011: Just months after gaining FDA approval, the first Xarelto-related death is reported.
- 2012: Doctors begin voicing concerns about Xarelto's bleeding risks.
- 2013: Reports suggest Xarelto bleeding risks are almost 50 percent higher than those of older anticoagulants.
- 2013: The number of Xarelto-related adverse events reported to the FDA reaches 600.
- 2013: The FDA flags Xarelto for an aggressive advertising and marketing campaign.
- 2014: The FDA blocks a request from Johnson & Johnson to expand Xarelto's approved uses.
- 2014: A second Xarelto death is reported to this FDA and this time, the victim's family files a wrongful death lawsuit.
Xarelto Litigation Moves Forward
In the years since the first Xarelto lawsuit was filed in 2014, the number of lawsuits filed against the drug's manufacturers has risen to more than 15,000. In 2014, the cases were consolidated into a multidistrict litigation (MDL) and will be heard in the U.S. District Court for the Eastern District of Louisiana.
Bellwether cases—a sampling of cases intended to indicate the outcome of the remaining cases—were chosen in 2016 and will be tried in 2017.
Did You Experience Life-Threatening Xarelto Internal Bleeding?
Xarelto thins the blood, preventing clots and other thrombotic events, such as deep vein thrombosis and pulmonary embolism. However, when Xarelto works too well, the results can be deadly. If you experienced severe Xarelto bleeding or lost a loved one to an uncontrollable bleeding event, McGartland Law can help you fight for the compensation you need. Contact our firm today to arrange to discuss the details of your case with a legal professional; we're happy to offer would-be clients a free initial case consultation.