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' 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.
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 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.
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.
Supremacy Clause and Pre-emption
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 ...