Xarelto is an anticoagulant manufactured by Bayer and Janssen which is a division of the behemoth health care company, Johnson & Johnson. The drug was first approved for use by the FDA in 2011. Within months of the drug going to market reports of life-threatening and fatal side effects began to surface. Soon thousands of patients and their families were reporting that they experienced these deadly side effects. In March 2017, roughly 4,500 federal lawsuits have been consolidated in a multi-district litigation (MDL) in Louisiana. This will serve as a bellwether trial. The bellwether trials will serve to help the attorneys and judges involved in the now massive number of lawsuits to determine how the following cases may go. Over the past few years, claims against Bayer and Johnson & Johnson, the massive healthcare company and the makers have begun to stack up. Now it is estimated that the number of lawsuits against the healthcare juggernaut has grown to around 10,000.
Plaintiffs in these cases are alleging that the company failed to provide patients with an adequate warning as to the severity of side effects that can accompany taking the drug. They are also claiming that the company fraudulently claimed the drug was safer than other drugs that are used for the same conditions through false advertising. It is alleged that the company also did not make consumers aware of the fact that there is not an antidote to treat the most severe and deadly side effect of Xarelto which is internal bleeding. In addition, it is alleged physicians were encouraged to prescribe the medication without proper knowledge of the severity of the risks of life-threatening side effects.
A Controversial FDA Approval
When the FDA first evaluated it for approval there were several concerns that they expressed to the makers of the drug. One of the primary concerns centered around a study called the “ROCKET-AF study” that compared Xarelto’s safety and potency to its largest competitor and long-standing anticoagulant, Warfarin. There were questions about the drug’s effectiveness in comparison to Warfarin. The FDA felt like the study did not do enough to prove that the drug was as effective as what was listed on the label.
Another major point that has come out of the controversial study is that due to the long half-life, single daily dosing, and consistent coagulation, the drug eliminated the need for regular blood monitoring or dosage adjustments. Warfarin requires both of those actions for its users. These issues have become points of contention within the litigations against the makers of Xarelto.
The most controversial aspect of the study has turned out to likely be the most deadly finding in the study’s results. The ROCKET-AF study claimed that Xarelto was non-inferior to Warfarin for the composite endpoint of stroke or systemic embolism, without increasing the bleeding rates. It has become rather obvious that Xarelto is not a safer option in relation to internal bleeding.
In the aftermath of thousands of injured or deceased patients and a rising tide of litigation against Johnson & Johnson, the statistical methods, and validity of the study have come under severe scrutiny. A device used in the study to gauge a patient’s international normalized ratio (INR), which is an international parameter used to adjust dosages has now been found to have been defective. The malfunction of this device skewed the study’s results which showed to be non-inferior to Warfarin, likely due to the fact that the doctors were administering the incorrect dosages of Warfarin to the patients in the study.
Side Effects and Elevated Bleeding Risks
Since approval and the subsequent issues a Xarelto Lawsuit has followed, several new studies have been published concerning the drug’s dangerous side effects and effectiveness. A recent study published in the British Medical Journal reported that patients treated with Xarelto showed a much greater risk for life-threatening bleeding issues than patients who were treated with Warfarin. It was reported that users were at nearly double the risk for bleeding events including:
- Brain Hemorrhaging
- Rectal Bleeds
- Abdominal/Intestinal Bleeds
- Intracranial Bleeds
- Nose Bleeds
- Retinal Hemorrhaging
In 2014, the FDA forced the makers to add new warnings to its label. Xarelto was required to place the “black box” label on the medication, which is the strongest and highest priority of warning requirement the FDA can enforce. The warnings informed patients of the potentially fatal side effects.
More recently, the makers of Xarelto have tried to quell fears of patients using the drug and physicians prescribing by funding additional studies concerning the drug’s safety. These subsequent studies are problematic in that they are not comparative studies to determine that it is safer than alternatives. In addition, it is problematic that they were designed and funded by Johnson & Johnson. These studies were performed in order to try and prove that Xarelto is as safe and effective as was shown in the original ROCKET-AF study.