In 2011, Johnson & Johnson received permission from the United States Food and Drug Administration (FDA) to market and distribute Rivaroxaban, commonly branded and known as Xarelto. The drug is actually produced by Bayer Pharmaceuticals and focuses on blood thinning and blood clot prevention. After oral consumption and absorption within the gut, relief can be felt within a few hours for up to almost half of a day. Initially, it was prescribed for doctors in the limited circumstances of hip and knee replacement surgery. Since then, Johnson & Johnson has tried and successfully appealed to the FDA for a broader application of its product.
Since first releasing the drug, Johnson & Johnson has come under fire for the claims and effectiveness regarding Xarelto. Doctors, agencies, and the government have all questioned the substance and form of its supporting documentation backing up many of the supposed claims of the drug. Also, initial concerns regarding the health of patients prescribed Xarelto have turned into actual and frequent side effects felt by them. From severe bleeding and blood clots, to wound and other prescription complications, the medicine has not had the results has intended.
In Re: Xarelto
After patients or their loved ones were prescribed Xarelto and suffered painful and damaging side effects, many decided to file suit against Johnson & Johnson and Bayer to receive compensation for their injuries. Eventually, dozens of different plaintiffs sought to consolidate their individual trials into one larger action, known as a new multidistrict litigation proceeding. To do this, they had to petition the United States Judicial Panel on Multidistrict Litigation. This body within the federal court system has the authority to bring various civil actions into one district for a combined proceeding. Securing this motion requires the group to establish that all causes of action have a common set of facts. Once this threshold has been cleared, the Panel will pick a district and a judge to handle the consolidated the case. The goal of this process is to save court resources, speed up the process of all cases, and reduce the costs of all parties involved.
This group of plaintiffs tried to accomplish this centralization in the case In Re: Xarelto (Rivaroxaban) Products Liability Litigation. MDL No. 2592 (Filed Dec. 12, 2014). There, eight plaintiffs from Illinois tried to add their case to a pool of approximately one dozen others (two from Florida, two from Kentucky, one from Louisiana, five from New York, one from Utah, one from Vermont, and one from West Virginia). In response to this action, the defendants (Bayer Pharmaceuticals, Johnson & Johnson, etc.) unsuccessfully argued that consolidation was unnecessary because of factual inconsistencies, alternative means to reduce redundant discovery, a lack of merit within some of the individual cases, and the dangerous precedent set that might encourage many other filings.
The court rejected these proffers and stated that all the cases shared fundamental, common issues such as the possibility of an inadequate warning as well as an unreasonably unsafe medication. The mere fact that each case may have had different causal circumstance should not be trumped by these commonalities, according to the judge. Therefore, the Panel selected a district in Louisiana to hear this combined group and any more that might be filed in the future.
Potential Claims of the Plaintiff Pool in the Xarelto MDL
Simply looking through the Panel’s decision to allow the plaintiff class to move ahead as one combined group, one can begin to gain a sense of the nature of claims likely to be made against the defendants. The first and arguably strongest argument is that the makers and distributors of Xarelto failed to adequately warn patients of the risks associated with taking the medication. For instance, there should have been additional and obvious disclosures on the actual label about such recurring and significant side effects including: internal bleeding, blood clots, wound aggravation, and complications related to the taking of other medications. The FDA has even criticized Johnson & Johnson for these absences on several occasions. So, it seems likely that they will resurface once the combined trial begins in Louisiana.
The other potential claim the plaintiffs will likely raise is that Xarelto is an unreasonably unsafe medication. Drug manufacturers are supposed to produce and distribute drugs that do not cause harm or danger patients. Furthermore, they are required by law to substantially research and inform the public about any potential side effects that the medication might cause. Many organizations, including relevant government agencies, think that Xarelto did neither. Also, receiving the stamp of approval from the FDA to market the drug does not absolve it from all of these responsibilities or any future damage it might produce.
Even at the beginning of Xarelto’s young product life, government officials questioned whether it could reasonably protect against internal bleeding, blood clotting, and organ damage. Johnson & Johnson failed to adequately answer these questions. Also, in the face of more and more people complaining about significant side effects, it sought an extension of its product application instead of cautiously considering the safety of the product in the first place. All of these considerations suggest that the makers and manufacturers of Xarelto will have a difficult time defending against the claims made in the lawsuits involving these plaintiffs and the many more that are sure to file.
Rosenfeld Injury Lawyers LLC is actively reviewing Xarelto cases. If you or a loved one suffered an injury following Xarelto use, contact our office for a free case review.
For additional information on our Xarelto practice, review the pages below: