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In re Xarelto (Rivaroxaban) Products Liability Litigation

United States District Court, E.D. Louisiana

April 12, 2017


         SECTION L

          MAG. JUDGE, NORTH



         Before the Court is a Motion for Partial Summary Judgment filed by Defendants Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, Janssen Ortho LLC, Johnson & Johnson, Bayer Pharma AG, and Bayer Healthcare Pharmaceuticals Inc. (collectively, “Defendants”) arguing that federal law preempts Plaintiffs' dosing, monitoring, and other design-related claims. (R. Doc. 5109). Plaintiffs oppose the motion. Having considered the parties' briefs and the applicable law and having heard the parties on oral argument, the Court now issues this Order and Reasons.

         I. BACKGROUND

         This matter arises from damages Plaintiffs claim to have suffered from the manufacture, sale, distribution, and/or use of the medication known as Xarelto, an anti-coagulant used for a variety of blood-thinning medical purposes. The Plaintiffs have filed suits against Defendants throughout the nation. The Plaintiffs allege that they or their family members suffered severe bleeding and other injuries due to Xarelto's allegedly defective design and inadequate warning label, among other things.

         The Judicial Panel on Multidistrict Litigation determined that the Plaintiffs' claims involved common questions of fact, and that centralization under 28 U.S.C. § 1407 would serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. Therefore, on December 12, 2014, the Judicial Panel on Multidistrict Litigation consolidated the Plaintiffs' Xarelto claims into a single multidistrict proceeding (“MDL 2592”). MDL 2592 was assigned to Judge Eldon E. Fallon of the United States District Court for the Eastern District of Louisiana to coordinate discovery and other pretrial matters in the pending cases. Subsequent Xarelto cases filed in federal court have been transferred to this district court to become part of MDL 2592 as “tag along” cases. The Court has appointed committees to represent the parties, and discovery has commenced. The Court adopted a discovery plan and set bellwether trials to begin in April 2017.


         Plaintiffs bring their claims in the first two bellwether trials under the Louisiana Products Liability Act (the “LPLA”). Specifically to this motion, they claim Xarelto was unreasonably dangerous because it was defectively designed. Defendants filed this motion for partial summary judgment, arguing that Plaintiffs' defective design claims are preempted by federal law. The two parties frame Plaintiffs' claims slightly differently. It is the Court's understanding that Plaintiff's design defect claim is as follows.

         Xarelto markets itself as a one-size-fits-all anticoagulant. Patients take one 20-milligram dose of Xarelto once a day[1] and do not need to undergo routine monitoring. Plaintiffs contend that, because each person processes and metabolizes Xarelto at a highly-individualized rate, each patient's reaction to the drug is decidedly variable, causing some patients to experience major bleeding events. Plaintiffs acknowledge that the Food and Drug Administration (the “FDA”) approved Xarelto's dosing and monitoring scheme. However, they claim that, given the high inter-patient variability, Xarelto is unreasonably dangerous in design because (1) Defendants should have designed, but failed to design, a Xarelto-specific Anti-Factor Xa assay so doctors could monitor Xarelto's anticoagulation effect on each patient and could, along with the patient, weigh the risks and determine whether to continue taking Xarelto; (2) because Defendants have not designed and marketed an antidote to counteract a major bleeding event; and (3) in the absence of a Xarelto-specific Anti-Factor Xa assay, Xarelto's label should have warned doctors about the availability of the Neoplastin PT test to measure patient's anticoagulation. Because Defendants did not take any of the above three actions, Plaintiffs claim Xarelto is unreasonably dangerous under the LPLA.


         A. The Supremacy Clause and Preemption

         “The Supremacy Clause of the Constitution prohibits state laws from conflicting with federal law.” Gomez v. St. Jude Medical Daig Div. Inc., 442 F.3d 919, 928-29 (5th. Cir. 2006) (citing U.S. CONST. art. VI, cl. 2). Therefore, “[a] ‘state law that conflicts with federal law'” is federally preempted and “‘without effect.'” Id. at 929 (quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992)).

         Inevitably, “‘[t]he purpose of Congress is the ultimate touchstone' in every pre-emption case.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 106 (1963)). Congressional intent is primarily “discerned from the language of the pre-emption statute and the ‘statutory framework' surrounding it.” Id. at 486 (quoting Gade, 505 U.S. at 111, 112). However, the Court should also review the “‘structure and purpose of the statute as a whole'” in order to determine “the way in which Congress intended the statute and its surrounding regulatory scheme to affect business, consumers, and the law.” Id. (quoting Gade, 505 U.S. at 98). Furthermore, “[i]n all pre-emption cases, and particularly in those in which Congress has ‘legislated . . . in a field in which the States have traditionally occupied, ' . . . we ‘start with the ...

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