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In re Xarelto (Rivaroxaban) Products Liability Litigation

United States District Court, E.D. Louisiana

April 17, 2017


         SECTION L

          NORTH MAG. JUDGE.



         Before the Court are two Motions 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 Plaintiffs' failure to warn claims are barred by the Learned Intermediary Doctrine. (R. Docs. 5118, 5119). Plaintiffs oppose these motions. 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. The first two trials involve Louisiana residents: Joseph Boudreaux and Sharyn Orr. The Defendants have filed a Motion in each case seeking summary judgment.


         Defendants argue that the Learned Intermediary Doctrine bars the failure to warn claims proposed by both bellwether Plaintiffs: Boudreaux (R. Doc. 5118) and Orr (R. Doc. 5119). Specifically, Defendants argue that both Plaintiffs' prescribing physicians testified that an additional or different warning regarding Xarelto's risks would not have changed their decisions to prescribe Xarelto. Further, Defendants argue the label is legally adequate because it prominently warns of the risk of bleeding and the prescribing physicians testified that they were aware of that risk.

         In their depositions, doctors for both Plaintiffs - Dr. St. James and Dr. Wong - testified that they stand by their decision to prescribe Xarelto. Accordingly, Defendants aver Plaintiffs cannot prove a failure to warn was the cause-in-fact or the proximate cause of their injuries. Both doctors knew there was no antidote for Xarelto and knew the risk of bleeding, yet still chose to prescribe Xarelto. Further, while both doctors aver they would have used a test to monitor anticoagulation, they would only do so if it were FDA-approved. Defendants contend this test does not exist. In addition, the prescribing physicians testified that a PT test still may not have prevented the injury. Specifically, in the Boudreaux case, Defendants aver Plaintiff was administered a different PT test which showed him in the normal range. Accordingly, Defendants argue there is no causal connection between Plaintiffs' injuries and the failure to warn, and the arguments are barred by the learned intermediary doctrine.

         Plaintiffs contend that Defendants miss the crux of the arguments: inadequate instruction. Defendants not only had a duty to warn about the risks of Xarelto, but also a duty to provide adequate instructions for its safe use. This duty extends to any healthcare provider in the position to make the use of the product safe. Plaintiffs contend that PT tests are required for safe use and that Defendants knew that PT tests were useful to evaluate Xarelto exposure.

         Plaintiffs state that they do not argue that Defendants failed to warn of bleeding risk - that risk is obvious - but that Defendants did not adequately instruct doctors regarding available testing. Plaintiffs contend the label should have included instructions regarding Neoplastin PT tests and their use to help evaluate a patient's risk of bleeding on Xarelto and to assess a patients' exposure to Xarelto, for example, how much Xarelto is in a patient's system and whether or not a doctor should wait to perform emergency surgery. Plaintiffs contend Defendants failed to provide this information to doctors and further assert that Defendants had a duty not only to instruct prescribing physicians, but also Plaintiffs' other treating doctors.

         Plaintiffs point to evidence that both doctors would have used PT tests had they been adequately instructed to do so, and therefore would have been equipped to adjust treatment to avoid injury. Specifically for Plaintiff Orr, Dr. Bui, her neurosurgeon, would have known Ms. Orr was not anticoagulated and would have proceeded with her surgery much sooner. Because of the delay, however, Ms. Orr experienced significant medical issues.

         III. ...

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