Xarelto®: A Year in Review
In November, 2015, the U.S. District Court for the Eastern District of Louisiana announced that the first of the Xarelto® bellwether trials, stemming from the Xarelto® multidistrict litigation, would begin in February, 2017. Since that announcement, there have been many updates in the ongoing legal battle against Xarelto® manufacturer Bayer AG and distributer Janssen Pharmaceuticals.
Background Information
In July of 2011, Bayer AG in conjunction with Janssen Pharmaceuticals, began marketing Xarelto® —a prescription blood thinner used to prevent blood clots. Xarelto® was initially approved by the FDA for prevention of deep vein thrombosis following knee and hip surgeries, and was later approved for the prevention of stroke in patients with atrial fibrillation and prophylactic prevention of reoccurring clots. Both Bayer and Janssen have marketed the medication as a safer and more convenient alternative to previous industry standard Warfarin.
While Xarelto® provides patients with a convenient, once-a-day option for preventing blood clots, it also poses great risks. There is also no antidote for Xarelto®, therefore, internal bleeding in patients taking the drug cannot be controlled. Adverse events associated with the consumption of Xarelto® have involved bleeding in the form of brain hemorrhaging, rectal bleeding, intestinal bleeding, and death caused by the former.
Ongoing Legal Battles
These adverse events have been the basis for more than 9,000 lawsuits filed against both Bayer and Jansen Pharmaceuticals. Patients’ claims allege that the companies were negligent in providing accurate information about the serious side effects of the drug, and in marketing of the drug. Families of deceased patients maintain that Janssen Pharmaceuticals and Bayer should have been more vigilant in testing Xarelto® and that the companies should be held accountable for introducing a dangerous drug to the market.
February 2016: Reports Suggest Defective INR Device Used in Xarelto® Clinical Trials
In February, BMJ, a medical journal based in the United Kingdom, published a report detailing the use of a faulty device in the Xarelto® clinical trials. The Alere international normalized ratio (INR) monitoring device was used to measure blood clotting in patients taking warfarin during the ROCKET-AF clinical trials. The report revealed that the device was recalled 3 years after the trials due to a defect that dated back to 2002 —nine years before the ROCKET-AF Xarelto® trials were published.
The BMJ report asserted that the defect could have made Xarelto® appear safer to doctors and patients than warfarin in terms of the risk of bleeding. Considering this information, critics of the medication called for an independent investigation to be conducted.
August 2016: Bellwether Trials Selected
In August, four bellwether cases were selected to move to trial in 2017—two will be tried in Louisiana, one in Texas and one in Mississippi. Bellwether trials are used as a method of measuring complex court cases in an attempt to expedite future proceedings. These trials allow both plaintiff’s and defense attorneys to present evidence before a jury so that they may observe reactions and alter their approach in subsequent cases.
December 2016: Philadelphia Mass Tort Establishes Bellwether Process
The mass tort in Philadelphia was initially consolidated to ensure consistent and efficient resolution for the 75 Xarelto® cases that were originally filed. Now, the mass tort contains over 1,000 lawsuits against Bayer and Janssen Pharmaceuticals. The court recently indicated that it will instill a process, similar to the bellwether selection methods used in the U.S. District Court for the Eastern District of Louisiana, to select the cases that are representative of the majority of lawsuits as a whole. The selected cases will then be heard by the court, and used to gauge future proceedings.
This decision is a departure from standard procedure for mass torts in Pennsylvania, which are typically heard on a first-to-file basis.
What’s Next?
Plaintiffs and their attorneys have long anticipated the commencement of the Xarelto® bellwether trials, as the evidence and insights gained from these trials can guide future litigation. However, new cases continue to be filed by patients and their families who have suffered because of Bayer and Janssen’s negligent practices.