United States District Court, E.D. Louisiana
IN RE XARELTO (RIVAROXABAN) PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO: ALL CASES
ORDER AND REASONS
E. FALLON JUDGE.
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
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.
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.
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.
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
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.
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.
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