On February 23, 2016, Judge Fallon held another status conference in the national litigation over Xarelto. There are now over 5,600 individual lawsuits pending in MDL No. 2952, the coordinated federal court proceedings pending in New Orleans. There thousands of lawsuits have been filed against pharmaceutical giants Bayer Corporation and Johnson & Johnson and their various domestic and foreign subsidiaries that participated in the design, manufacturing, and marketing of Xarelto, a popular blood thinner.
Xarelto (also known as rivaroxaban) was approved by the FDA in 2011 as a part of a new class of blood thinners prescribed to patients. This class of drug is prescribed to patients with atrial fibrillation to prevent strokes and to surgical patients to prevent post-operative blood clots in their legs and lungs. Xarelto is used by physicians as an alternative to warfarin (also known as Coumadin), which has been used in patients for over 60 years.
Xarelto was approved by the Food & Drug Administration in 2011 and was somewhat controversial. The FDA’s own internal medical reviewers were concerned about the validity of the single study used as the basis for the drug’s approval by the FDA (an issue now at the heart of the Xarelto litigation and discovery efforts). As aggressively touted in direct-to-consumer TV ads, patients who ingest Xarelto do not require the same routine blood testing as patients taking Coumadin. This “easy button,” however, may come at great cost. There are reports the incidence of adverse events associated with Xarelto are higher than those seen in patients taking Coumadin.
The thousands of Xarelto lawsuits filed so far nationally focus on the lack of a reversal treatment for Xarelto. The advantage to Coumadin is that vitamin K or packed red blood cells can reverse the effects of Coumadin within a few hours of administration, but that treatment does not work with Xarelto and patients are at risk of life threatening and uncontrolled bleeding. Patients should have been tested to determine whether their bodies can properly process Xarelto prior to administration of the drug and this would likely have prevented thousands of patients’ injuries due to Xarelto-induced blood clots (which led to GI bleeds, cardiac tamponade, intracranial hemorrhaging, and death).
Besides the thousands of lawsuits pending in MDL No. 2952 in Louisiana, there are also hundreds of individual lawsuits filed in state courts in New York, Delaware, California, and Pennsylvania. Recently, an application was filed requesting that a Judicial Council Coordinated Proceedings (“JCCP”) be established in state court for the coordination of Xarelto lawsuits in that state. There are 18 individual lawsuits filed in California, with many additional case filings expected if the statewide coordination is granted by the California judge.
At the February MDL Status Conference, Judge Fallon was provided with an extensive update regarding progress, including the exchange of case-specific discovery information including:
- Damage issues
- Medical histories
- Plaintiffs’ personal histories
- Xarelto sales force communications with prescribing physicians
- Adverse event reports to the FDA and
- Payments made to prescribers and consultants
Judge Fallon will hold additional hearings in March on the Defendants’ requests to dismiss several cases for failure to serve completed discovery information within the aggressive timetable established for the Xarelto litigation.
There are several depositions underway in New Jersey, Pennsylvania, and Amsterdam involving Bayer and Janssen’s employees. Judge Fallon’s recent Pretrial Order provides further guidance to the parties on the rules relating to depositions. It is hoped the order will help to streamline this process, especially in light of the tremendous time and expense associated with taking so many depositions of corporate witnesses in Europe. Besides this latest order, Judge Fallon has issued 30 additional orders covering all aspects of the coordination and management of this multi-district litigation since MDL No. 2592 was first established in December of 2014.
Judge Fallon also heard arguments from both sides at the February 2016 hearing regarding the Defendants’ requesting it be allowed to have direct contact with plaintiffs’ treating physicians. The Defendant contends that it should be permitted to consult directly with the Plaintiffs’ treating physicians. Typically and in compliance with HIPPA rules the Defendants may not engage in ex parte communications with the Plaintiffs’ treating or prescribing physicians about a particular Plaintiff’s treatment or about issues relating to the ongoing litigation. Instead, Defendants must obtain information about the Plaintiffs’ condition or other issues relating to the lawsuit through a deposition, where the Plaintiff’s attorney is present and the questions and answers are recorded by a court reporter. Judge Fallon has taken this issue under consideration and is expected to issue an order shortly.
It has now been over 10 months since the Plaintiffs’ Steering Committee issued a subpoena to the Food & Drug Administration (FDA) seeking critical information regarding the Agency’s approval of Xarelto following a single clinical trial. So far, the FDA has produced a list of documents associated with the drug application for Xarelto, but has not yet turned over the critical and substantive documents. Unfortunately, it is far too common for the FDA to refuse to expeditiously produce safety information over approved drugs and medical devices during litigation. The FDA has also historically fought any attempts to obtain deposition testimony from its employees regarding drug approval, regulation of drug companies, recalls, and adverse event reporting.
On February 22, 2016, the New York Times published an article detailing one of the major discoveries in the Xarelto litigation. The FDA is investigating whether the clinical trial used as the basis for the FDA’s approval of Xarelto may have been fatally flawed due to use of a defective blood testing device. According to the newspaper reports, internal documents uncovered in the Xarelto litigation indicate that doctors involved in the ROCKET AF clinical study (which included 14,000 patients and spanned from 2006 to 2010) were reporting critical issues to the drug companies during the study. Judge Fallon has reportedly been asked to unseal documents relating to this controversy produced in the MDL litigation but are subject to a protective order.
The issue is particularly politically-charged since the ROCKET AF drug study for Xarelto was led by Dr. Robert M. Califf (a former director of Duke Clinical Research Institute), who is President Obama’s nominee to be the new leader of the FDA and serves as the FDA’s deputy commissioner.
There is speculation that the malfunction of the device that measured INR levels in patients in the Coumadin portion of the clinical study could have led to study participants receiving the wrong dose of warfarin. This could lead to there being a higher incidence of strokes due to receiving an insufficient dose of Coumadin and bleeding episodes due to receiving too much Coumadin in the control patients who took Coumadin. The effect of this would be to make Xarelto appear more effective and safer than may be true. The FDA is delving deeper into these critical safety issues.
Duke Clinical Research, the group that oversaw the ROCKET AF study, recently published an article in the New England Journal of Medicine contending that using the faulty (and now-recalled) blood testing device did not affect the clinical trial’s ultimate results. The European Medicines Agency has reached a similar result. According to the New York Times, however, these conclusions should not prevent further inquiry; especially since tests were done during the course of the study that “could have been used to assess whether the devices’ readings were accurate.” The New York Times was also critical of the EMA article and its reliance on data supplied solely by the drug companies and not independent researchers.
Johnson & Johnson contends that it did not learn about the accuracy of readings from the medical device manufactured by Allere or the recall of the device until September of 2015. In December of 2015, an article was published in the British Medical Journal regarding the need to re-analyze the ROCKET AF data due to the use of an alleged faulty testing device. According to media reports, the INRatio blood measuring device used in the study had faced scrutiny from the FDA going back to 2005 and 2006. It is reported the manufacturer of the device received warning letters from the FDA regarding inaccuracies in the medical device’s reporting of blood results and the manufacturer’s failure to properly investigate and report safety issues.