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, UNITED STATES DISTRICT JUDGE
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
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.
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.
markets itself as a one-size-fits-all anticoagulant. Patients
take one 20-milligram dose of Xarelto once a
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.
Supremacy Clause and Preemption
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)).
“‘[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 ...