United States District Court, M.D. Florida, Fort Myers Division
NOEL D. ROMER and HOLLY ROMER, Plaintiffs,
STRYKER CORPORATION, CORIN GROUP, PLC, and CORIN USA LIMITED, Defendants.
OPINION AND ORDER
E. STEELE, UNITED STATES DISTRICT JUDGE.
matter comes before the Court on defendants Corin Group, PLC
and Corin USA Limited's Motion to Dismiss (Doc. #3) filed
on January 18, 2018. Plaintiffs filed a Response in
Opposition (Doc. #20) on March 5, 2018. For the reasons set
forth below, the Motion is granted in part with leave to
amend Counts III-V.
a products liability case in which plaintiffs allege that an
artificial hip replacement designed, manufactured, and
marketed by defendants was defective, causing metallic
contaminants to release into the patient's body. On July
9, 2009, plaintiff Noel D. Romer underwent surgery to implant
the Cormet Advanced Hip Resurfacing System (the “Cormet
System”) in his left hip. (Doc. #2, ¶ 34.) After
surgery, Mr. Romer experienced significant pain during
recovery and in the months that followed, as well as
loosening of the hip. He also experienced high metal levels
in his blood. (Id., ¶ 36-37.) Due to these
problems, Mr. Romer required another surgery on August 26,
2016. (Id., ¶ 38.)
Cormet System is a Class III medical device that receives the
highest level of federal oversight under the current
premarket approval (PMA) process allowed under the Medical
Device Amendments of 1976 (MDA). (Doc. #2, ¶ 14.) As a
Class III medical device, the Cormet System requires
premarket approval from the Food and Drug Administration
(FDA) before it can be made commercially available. The FDA
gave this approval for the Cormet System on July 3, 2007, but
set conditions, namely that the manufacture of each Cormet
System must adhere to “Approved Design Standards”
in order to ensure the device is able to withstand the
stresses of ordinary use without releasing dangerous levels
of metal into the body.
December 6, 2017, plaintiffs initiated this action in state
court, seeking to recover damages from defendants based on
five theories of products liability under Florida law:
negligence per se, manufacturing defects (Count I);
negligence per se, improper quality control testing
procedures (Count II); strict liability, failure to warn
(Count III); strict liability, malfunction theory (Count IV);
negligence (Count V). Plaintiff Holly Romer also brings a
claim for loss of consortium (Count VI).
removal, the Corin defendants (hereinafter
“defendants”) moved to dismiss, arguing that the
FDA device regulations preempt plaintiffs' state law
claims, relying on Riegel v. Medtronic, Inc., 552
U.S. 312 (2008). Under Riegel, the MDA preempts state law
requirements that are “in addition to, or different
from” federal requirements for Class III medical
devices that undergo the PMA process. Thus, defendants argue
that all of plaintiffs' claims must be dismissed because
they are expressly preempted by, or are derivative of, the
MDA pursuant to Riegel, and plaintiffs fail to properly
allege any parallel state law claims.
Federal Rule of Civil Procedure 8(a)(2), a Complaint must
contain a “short and plain statement of the claim
showing that the pleader is entitled to relief.”
Fed.R.Civ.P. 8(a)(2). This obligation “requires more
than labels and conclusions, and a formulaic recitation of
the elements of a cause of action will not do.”
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)
(citation omitted). To survive dismissal, the factual
allegations must be “plausible” and “must
be enough to raise a right to relief above the speculative
level.” Id. at 555. See also Edwards v.
Prime Inc., 602 F.3d 1276, 1291 (11th Cir. 2010). This
requires “more than an unadorned,
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)
deciding a Rule 12(b)(6) motion to dismiss, the Court must
accept all factual allegations in a complaint as true and
take them in the light most favorable to plaintiff,
Erickson v. Pardus, 551 U.S. 89 (2007), but
“[l]egal conclusions without adequate factual support
are entitled to no assumption of truth.” Mamani v.
Berzain, 654 F.3d 1148, 1153 (11th Cir. 2011) (citations
omitted). “Threadbare recitals of the elements of a
cause of action, supported by mere conclusory statements, do
not suffice.” Iqbal, 556 U.S. at 678. “Factual
allegations that are merely consistent with a defendant's
liability fall short of being facially plausible.”
Chaparro v. Carnival Corp., 693 F.3d 1333, 1337
(11th Cir. 2012) (internal citations omitted). Thus, the
Court engages in a two-step approach: “When there are
well-pleaded factual allegations, a court should assume their
veracity and then determine whether they plausibly give rise
to an entitlement to relief.” Iqbal, 556 U.S. at 679.
Federal Preemption Law
Eleventh Circuit has recently provided guidance on Federal
Preemption Law in the context of the MDA. See Mink
v. Smith & Nephew, Inc., 860 F.3d 1319
(11th Cir. 2017) (discussing metal-on-metal hip replacements
such as the one at issue here); Godelia v. Zoll Services,
Inc., 881 F.3d 1309 (11th Cir. 2018). The MDA
established the federal regulatory regime for medical
devices. 21 U.S.C. § 360c et seq. “Any company
wanting to sell a metal-on-metal hip replacement system is
required to undergo the FDA's ‘premarket approval
process.'” Mink, 860 F.3d at 1325 (citing
21 C.F.R. § 814.1). This is a rigorous process that
evaluates a medical device's safety and effectiveness.
includes an express preemption provision (§ 360k) for
Class III medical devices, which protect manufacturers from civil
liability to the extent that they comply with federal law.
Section 360k states: “no State ... may establish ...
any requirement which is (1) different from, or in addition
to, any requirement applicable under this chapter to the
device, and (2) which relates to the safety and effectiveness
of the device ...” 21 U.S.C. § 360k(a). In Riegel,
the Supreme Court held that the MDA preempted state law
products liability restrictions, including common law
requirements, which were in addition to or different from
federal regulations used to evaluate Class III medical
devices that underwent the PMA process. 552 U.S. 312 (2008).
Reigel, a plaintiff injured due to use of a Class III device
approved through a PMA can escape preemption only if he
asserts a “parallel” state law claim.
Mink, 860 F.3d at 1326. In Wolicki-Gables v.
Arrow Int'l, Inc., 634 F.3d 1296, 1300-01 (11th Cir.
2011), the Eleventh Circuit found that plaintiffs cannot
effectively state a “parallel claim” absent
allegations that the defendant violated a “particular
federal specification.” Id. (noting that
recitation of “magic words” is insufficient and
parallel claims must be “specifically stated in the
initial pleadings”). Thus, the Wolicki-Gables panel
concluded that the claims asserted by plaintiff were
expressly preempted because nothing “specifically
stated in the initial pleadings” what ...