Janssen Pharmaceutical and Bayer Healthcare have been named as defendants in thousands of Xarelto lawsuits for their roles in making and marketing the drug, respectively. These legal actions stem from claims that Xarelto patients have experienced severe bleeding and other side effects after taking the drug.
Why Xarelto Lawsuits are Being Filed
Xarelto (rivaroxaban) is an anticoagulant – a type of drug commonly known as a blood-thinner. It works by inhibiting an enzyme known as “factor X,” which prevents blood from clotting. People often take Xarelto after surgery or if they have a high risk of developing blood clots—such as those diagnosed with atrial fibrillation.
Unfortunately, Xarelto does not have an antidote to reverse its effects. That means, if somebody is cut or injured while taking the drug, they could bleed to death even from a relatively minor cut, since there is no way to stop the bleeding.
Because Xarelto side effects can be so severe, people who have experienced uncontrollable bleeding after taking Xarelto are suing Bayer and Janssen—a subsidiary of Johnson & Johnson—for putting them at risk and causing injury. In cases where individuals have died of blood loss after taking Xarelto, their family members have brought wrongful death claims against these companies.
Medical Journals Misled About Xarelto
One of the claims being made by the lawyers of individuals filing lawsuits against Bayer and Johnson & Johnson over Xarelto is that a letter from Duke University academics to The New England Journal of Medicine left out important data from laboratory experiments. The legal theory is that the drug companies were responsible for this deception by failing to speak up and correct the data themselves, even though the university researchers insist they were working independently.
Nonetheless, omitted research data has been a huge problem in the pharmaceutical industry for many years. Without complete data, it is impossible for other medical professionals to verify the results of clinical trials, and it can put people’s lives in danger.
Problems with Medical Devices in Xarelto Trial
Another point of contention in Xarelto lawsuit filings is the fact that a number of medical devices that were used to test the drug’s blood clotting capabilities were found to have manufacturer defects. Specifically, investigators from the European Medicines Agency discovered that results may have been compromised in the control group using warfarin, another blood thinner that has been in use longer and which has an antidote (unlike Xarelto).
Researchers from both Bayer and Duke University claim that the faulty devices did not have an effect on the ultimate conclusions of the clinical trial. However, a review by the BMJ showed that the pharmaceutical companies were aware of the faulty devices while the trial was being conducted and knowingly withheld that information in their report to the U.S. Food & Drug Administration. Ultimately, however, a separate review by the FDA concluded that the faulty monitoring devices did not meaningfully affect trial results.
Compensation Recovered from Xarelto Claims
There are several types of compensation injured Xarelto users might receive by filing a claim:
Recover medical expenses: The detrimental effects of Xarelto often leads to other health problems that require follow-up visits or even emergency care. These expenses can rack up quickly and may not always be covered by insurance.
Lost income: The medical visits described above may have a secondary effect of causing someone to miss work or otherwise lose out on income-generating activities.
Pain and suffering: There is a distinct physical and emotional toll of being subjected to the adverse effects of Xarelto. Damages may be awarded to help compensate a victim for their pain and suffering.
Punitive action: Xarelto has brought these large pharmaceutical companies billions of dollars in revenue. Punishing them financially lets them know that they need to take better care to ensure their drugs are safe and effective for the people taking them.
Funeral expenses: In the tragic cases where Xarelto has contributed to someone’s death, their surviving family members may be able to recoup costs related to their untimely death and burial.
Xarelto Multidistrict Litigation
Most Xarelto lawsuits are being handled by a special federal court process known as multidistrict litigation (MDL). An MDL allows many people who have the same (or very similar) complaints to follow an established process for filing their claims, which are reviewed by justices familiar with the intricacies of the case.
Xarelto is handled under MDL No. 2592 in the Eastern District of Louisiana. It was established on December 12, 2014, when the Judicial Panel on Multidistrict Litigation issued a transfer order for 21 cases from 8 different states into the MDL.
The transfer order lists several common complaints among those who filed Xarelto claims:
- The inadequacy of labels on Xarelto packaging about the potential for severe bleeding (as well as other harmful effects);
- The omission of results from some clinical trials on the warning label;
- The need for monitoring a patient’s blood while taking the drug.
Janssen and Bayer tried to prevent these cases from being centralized under a single MDL by arguing that each individual case was different, among other things. However, the judicial panel overseeing MDLs ultimately denied the big pharmaceutical companies’ claims and went ahead with the transfer order.
As of 2017, more than 18,000 Xarelto lawsuits have been filed.
Xarelto Bellwether Trials
Given that there are thousands of Xarelto lawsuits waiting to be tried, judges overseeing MDL cases generally hold one or more “bellwether” trials that can highlight the primary arguments, motions, and other issues that are likely to arise in later cases. While these trials might take a little longer to complete, it can help all the trial participants – including plaintiffs, defendants, lawyers, and judges – smooth out the procedures for later lawsuits, ultimately making the entire process more efficient. It can also help each side determine whether it makes sense to settle rather than bring the case to trial at all.
Given the complexity of the issues at hand, Judge Eldon E. Fallon scheduled three bellwether trials for the Xarelto MDL in 2017.
Joseph Boudreaux (April 2017)
The first bellwether trial for Xarelto was the case of Joseph Boudreaux, a Louisiana security guard who required a week-long stay in the hospital after being prescribed Xarelto by his cardiologist. Mr. Boudreaux’s case relied on witness testimony that Johnson & Johnson and Bayer failed to disclose the fact that a certain blood test could help predict who might experience adverse reactions to rivaroxaban. Ultimately, the jury sided with the drug companies, determining that they had provided enough information to doctors to make appropriate determinations about Xarelto’s risks when prescribing the medication.
Sharyn Orr (June 2017)
The second Xarelto bellwether trial was brought by Joseph Orr on behalf of his deceased wife Sharyn, who died of a stroke in May 2015 after being prescribed Xarelto. Like the Boudreaux case, Orr’s attorneys argued that doctors in the U.S. were not given the same instructions as those in other countries about a relatively simple blood test that could have predicted whether Sharyn might react poorly to the medication. However, after only a few hours of deliberation, the jury came back with a verdict for the defendants.
The third bellwether trial for Xarelto is scheduled for August 2017.