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In re Xarelto (Rivaroxaban) Products Liability Litigation

United States District Court, E.D. Louisiana

April 13, 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' failure to warn claims under the Louisiana Products Liability Act (“LPLA”). (R. Doc. 5110). 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 of Defendants' failure to warn. La. Rev. Stat. § 9:2800.57. Plaintiffs contend that Xarelto's label should have instructed physicians that Neoplastin PT tests can be used to identify plaintiffs with high risk of bleeding, to inform treaters that the INRatio device used in the ROCKET AF trial was recalled, and to advise prescribing doctors about U.S.-specific bleeding risk. Under Wyeth, Plaintiffs aver, drug companies have the responsibility to draft adequate warnings - not the Food and Drug Administration (“FDA”) - and they are responsible for updating them as new evidence comes to light. Further, Plaintiffs claim that Defendants failed to provide sufficient evidence that the FDA would have rejected a label change. To prove that the FDA would reject a label update, Defendants must press their position with the FDA; it is not enough that the FDA believed the label change was false or misleading or that the change was not necessary. There must be clear evidence that the FDA would rescind Defendants' change to the label. Plaintiffs aver there is no such evidence of this.

         Defendants seek partial summary judgment on Plaintiffs' failure to warn claims, arguing they are preempted because they are based on the same information that the FDA considered, thoroughly vetted and analyzed, and rejected for inclusion in Xarelto's label. Defendants argue the claims are preempted because they would require Defendants to take improper unilateral or independent action and because there is clear evidence that the FDA would have rejected (and did reject) the labeling changes Plaintiffs propose.


         A. The Supremacy Clause and Pre-emption

         “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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