Judge Fallon, the federal judge in New Orleans who oversees the MDL coordinated proceedings, held his most recent hearing for all of the pending Xarelto lawsuits on June 10, 2015. At that time, the judge was provided with a status report with regard to a number of recent developments in the discovery efforts, and the judge reviewed the progress in the litigation so far (which has been significant). The next status conference before Judge Fallon for the MDL is scheduled for July 9, 2015.
The judge also held an informal hearing known as “Science Day” on June 11th, where both sides presented information on a number of complex scientific and medical topics that are relevant to the litigation. The topics that were discussed in the presentations and materials previously submitted to the judge by both sides included: atrial fibrillation, coagulation and anticoagulation therapy, changes in coagulation medical treatments over time as newer drugs have become available, FDA-approved indications for use of Xarelto, how Xarelto works, the reasons for prescribing Xarelto to patients, adverse events and injuries that have been associated with Xarelto, clinical trials for approval of the drug, the use of blood test-based dosing for Xarelto, and the pharmacology of Xarelto. These proceedings were handled informally, without a court reporter present, as they were intended to be informational for the judge and not technically part of the litigation process.
There are now more than 558 individual lawsuits filed in the MDL as well as in state court proceedings in Philadelphia on behalf of plaintiffs and the survivors of patients who suffered GI bleeds, intracranial hemorrhages, and other significant bleeding injuries while taking Xarelto. We anticipate that hundreds of additional lawsuits will be filed in the coming months.
The manufacturer of Xarelto will shortly begin producing documents relating to their development and marketing of the drug, as a first step in the discovery phase of the case. There are also pending discovery efforts relating to corporate structure, identifying critical witnesses, the preservation and storage of electronic data, FDA approval process, adverse event reporting, and insurance coverage for injuries caused by Xarelto.
Judge Fallon has also set a relatively fast-paced trial schedule, with the first bellwether trial held on August 1, 2016, the second on August 22, 2016, the third on September 12, 2016, and the fourth on October 17, 2016. The plaintiffs involved in these bellwether trials will likely be chosen from a bellwether discovery pool of fifty plaintiffs. Bellwether trials serve as a very important indicator in mass tort litigation for both sides as to their chances of success at trial.
I am honored to have been appointed to co-lead one of the discovery teams that will be reviewing these documents in preparation for depositions of the manufacturers’ employees in the near future. Production of evidence and depositions of third party witnesses who were involved in the conduct of the clinical trials that were used to substantiate the application for FDA approval of Xarelto are scheduled to begin in July of 2015.
As with the litigation over Pradaxa (the first drug in the same class of anticoagulants as Xarelto which resulted in a nationwide settlement last year), the accuracy of data in the clinical trials that were completed prior to the FDA approval of Xarelto is likely to be a critical issue in the Xarelto litigation, as those early scientific studies did not indicate an excessively high rate of bleeding injuries associated with the drug, whereas adverse event reporting after the drug was approved indicated a significantly increased risk of bleeding events after even short-term use of the medications. Undoubtedly, the FDA would have refused to approve Xarelto if those early, pre-approval studies had shown a higher risk of bleeding over alternative anticoagulants like Coumadin, warfarin, and Pradaxa.