Brenda S. Fulmer, a 21-year veteran of drug and medical device litigation and a partner with Searcy Denney, filed an indivdual lawsuit against the manufacturers of Xarelto in federal court in Jacksonvillle this week. The case is a wrongful death claim filed against a number of domestic and foreign drug corporations that are part of Johnson & Johnson and Bayer Corporation, the manufacturers and marketers of the blood thinner Xarelto. This lawsuit was filed on behalf of the surviving famliy members of a Green Cove Springs resident who died in 2013 after suffering a Xarelto-induced bleeding event.

Xarelto was first approved for sale in the United States on July 1, 2011. The drug is jointly marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson, and Bayer Corporation (including the U.S. based subsidiary as well as the German parent company). Xarelto was the second drug in this class of anti-coagulants to be approved; the first was Pradaxa (approved by the FDA in the fall of 2010), which is manufactured by Boehringer Ingelheim, another German pharmaceutical manufacturer.

This new class of anti-coagulants directly impact thrombin and Factor Xa (a protein involved in the clotting process). They were heralded as an improvement over Coumadin (also known as warfarin), which has been used for decades to prevent strokes, but requires frequent blood testing of drug levels as other medications and foods can interfere with how Coumadin works in the body. Coumadin disrupts vitamin K levels, which is essential to the body’s clotting functions. Xarelto was approved for stroke prevention in patients with atrial fibrillation, and for the prevention of blood clots in patients following surgical procedures.

In late 2014, a request was filed before the Judicial Panel on Multidistrict Litigation (JPML) to establish national coordination of the personal injury and wrongful death lawsuits that have been filed against Bayer and Janssen Pharmaceuticals relating to Xarelto. At the time of filing the request for establishment of multidistrict litigation (referred to as an “MDL”), there were 21 individual lawsuits pending in 10 federal district courts in Alabama, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, New York, Utah, Vermont, and West Virginia involving plaintiffs who suffered bleeding-related injuries following their ingestion of Xarelto.

At the hearing before the JPML held in early December in Charleston, the panel of federal judges heard arguments from both plaintiffs and defense counsel regarding the need for establishment of an MDL as well as recommendations as to the best federal court and judge for supervising the MDL proceedings for the Xarelto cases. The defendants requested that the cases be sent to a federal court in New Jersey, and most of the plaintiffs advocated for the cases to be sent to Judge Herndon in the East St. Louis, Illinois. Judge Herndon also oversees two other MDLs: the Yaz and Yasmin birth control lawsuits (which also involve Bayer as a Defendant) and the Pradaxa blood thinner cases (a drug in the same class as Xarelto that has also been the subject of several thousand lawsuits).

Ultimately, the Judicial Panel issued its order establishing MDL No. 2592 on December 12, 2014, which is referred to as “In Re: Xarelto (Rivaroxaban Products Liability Litigation.” The JPML chose United States District Court Judge Eldon E. Fallon in New Orleans to oversee this new coordinated national litigation effort. Judge Fallon is highly-regarded for his successful work in previous MDL pharmaceutical cases involving Propulsid (a heart drug also manufactured by Janssen) and Vioxx (Merck’s popular anti-inflammatory medication). We are thrilled with Judge Fallon’s selection, as he is considered to be one of the best MDL judges in recent history and is industrious and does not tolerate delays or gamesmanship.

In an MDL, individual lawsuits that are pending in federal courts across the country are transferred to a single federal judge who oversees pretrial discovery, the first trials in the national litigation, settlement negotiations, and preparation of the cases for future trials in local federal courts. This process is used to coordinate a number of different types of complex litigation and mass torts where many plaintiffs have been injured by a single event or product. MDL coordination is usually ordered for cases involving pharmaceuticals and medical devices and has also been used for the BP oil spill, hotel fires, airline crashes, and litigation involving the 9/11 terrorist attacks.

The focus of the Xarelto litigation is on the insufficiency of the drug warning labels in several key areas:

• The warning labels fail to properly inform patients and prescribing physicians that certain patients are at higher risk for bleeding events (such as those with a pre-existing history of a bleeding event as well as those with impaired kidney function)
• The warning label downplays the incidence of bleeding events caused by Xarelto while overstating the benefits of Xarelto
• The package insert and professional information fails to inform physicians of the need for routine monitoring of blood levels of Xarelto (which obviates the primary reason why Xarelto would be taken over Coumadin)

The lack of a reversal agent for Xarelto is also a part of the liability case, but less of an issue than the failure to inform physicians and patients of the need for testing to determine how a patient metabolizes Xarelto (in hopes of identifying patients with an intolerance to the drug before they experience a build-up of toxic levels and suffer a bleeding event). There are also concerns about the data from the ROCKET and RECORD studies, which were the limited clinical trials submitted to the FDA in support of the approval of Xarelto in the United States. Similar allegations were made in the litigation over Pradaxa, which began in 2012, and resulted in a $650 million global settlement last year. Pradaxa was also approved after a single clinical trial (Re-LY), and the reliability of the data from that study was a primary focus of that litigation effort.

As of April 15, 2015, the Judicial Panel on Multidistrict Litigation reported that more than 400 indivdiual lawsuits have been direct-filed or transferred into MDL No. 2592, the coordinated proceedings that are pending before Judge Fallon in federal court in New Orleans. There are also parallel state court proceedings pending in Pennsylvania state court in Philadelphia, which is where some of the defendant drug companies are headquartered. These indivdiual lawsuits have been filed on behalf of patients and their survivors who have suferred personal injuries or died due to GI bleeds, intracranial hemorrhages, and other significant bleeding injuries while taking Xarelto. An order was signed in January establishing a mass tort consolidation in Pennsylvania state court, which resembles the MDL process that Judge Fallon will be presiding over for the Xarelto cases.

Janssen and Bayer objected to the coordination of the Xarelto cases in Philadelphia, and claimed that the judge lacks jurisdiction as the drug manufacturers are based in New Jersey rather than Pennsylvania and most of the plaintiffs who filed cases in Pennsylvania reside in other states. Undoubtedly, the first several months of the coordinated litigation in Pennsylvania will be focused on these threshold jurisdictional and venue issues. It is common to have both state and federal court proceedings that are operating on parallel tracks in pharmaceutical litigation involving thousands of injured plaintiffs. Although having too many judges can be detrimental to the efficiency of the litigation process, it is certainly a good idea to have more than just one judge. Having multiple jurisdictions also allows more individual cases to be scheduled for trial, and, at times, allows us to pursue different avenues for discovery. The MDL process specifically directs the assigned federal judge to coordinate with state court judges to ensure that the cases are moving as efficiently as possible in state and federal courts around the country.