SHUKER et al v. SMITH & NEPHEW, PLC et al

Filing 88

MEMORANDUM. SIGNED BY HONORABLE JUAN R. SANCHEZ ON 3/31/2015. 4/1/2015 ENTERED AND COPIES E-MAILED.(amas)

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
WALTER SHUKER, et al.
v.
SMITH & NEPHEW PLC, et al.

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CIVIL ACTION
No. 13-6158

MEMORANDUM
Juan R. Sánchez, J.

March 31, 2015

Plaintiffs Walter and Vivian Shuker, husband and wife, bring this products liability action
against Smith & Nephew, Inc. (S&N) and Smith & Nephew plc (PLC), seeking damages for
injuries Walter Shuker sustained after undergoing hip replacement surgery with artificial hip
components designed and manufactured by one or both Defendants.1
damages for Vivian Shuker’s loss of consortium.

Plaintiffs also seek

S&N has filed a motion for summary

judgment,2 asking this Court to grant judgment in its favor as to most of Plaintiffs’ claims on the
basis that the claims are preempted by the Federal Food Drug and Cosmetic Act (FDCA), as
amended by the Medical Device Amendments of 1976 (MDA). Insofar as Plaintiffs assert
potentially nonpreempted claims based on Defendants’ alleged violations of common-law duties
that parallel federal requirements applicable to the hip components in question, S&N asks the
Court to dismiss the claims as inadequately pleaded. Plaintiffs oppose S&N’s motion and also
seek leave to file a Second Amended Complaint. For the reasons set forth below, the Court will
grant Plaintiffs’ motion for leave to amend and consider Defendants’ arguments for summary
judgment and/or dismissal as to Plaintiffs’ Second Amended Complaint. Because the Court
1

PLC is the ultimate parent company of S&N. PLC denies that it conducts any business related
to medical devices and has moved to dismiss this action for lack of personal jurisdiction. PLC’s
motion will be addressed by separate order.
2

While styled as a motion for summary judgment, S&N’s motion is actually a motion for
summary judgment and/or dismissal.

agrees with S&N that the claims set forth in the Second Amended Complaint are either
preempted by the MDA or inadequately pleaded, S&N’s motion for summary judgment and/or
dismissal will be granted, and Plaintiffs’ Second Amended Complaint will be dismissed in its
entirety. The Court will, however, grant Plaintiffs leave to amend insofar as they seek to pursue
parallel claims based on Defendants’ off-label promotion of the hip components at issue.
BACKGROUND3
Defendants design and manufacture medical devices for use in hip replacement and hip
resurfacing procedures. In a hip replacement, the surgeon covers the patient’s hip socket (or
acetabulum) with a cup and replaces the ball of the thighbone (the femoral head) with a metal
ball attached to a long metal stem, which is inserted into the thighbone. See Pls.’ Summ. J. Ex.
A at 9050, 9052.4 In a hip resurfacing procedure, the surgeon covers the hip socket with a cup
and covers, rather than replaces, the femoral head with a cap. See id.
Defendants’ hip replacement systems include the R3 Acetabular System (R3 System),
which, according to Plaintiffs, consists of four main components: (1) an acetabular shell, (2) a
cross-linked polyethylene (or poly) liner, (3) a femoral head, and (4) a femoral stem. See Second
Am. Compl. ¶ 17. The R3 System is a Class II5 medical device which the Food and Drug

3

The following facts are drawn from the allegations of Plaintiffs’ Second Amended Complaint
and the evidence in the summary judgment record, all of which the Court construes in the light
most favorable to Plaintiffs, drawing all reasonable inferences in their favor. See Ashcroft v.
Iqbal, 556 U.S. 662, 678-79 (2009); Hugh v. Butler Cnty. Family YMCA, 418 F.3d 265, 267 (3d
Cir. 2005).
4

Exhibits to Plaintiffs’ opposition to S&N’s motion for summary judgment are cited herein as
“Pls.’ Summ. J. Ex. __.”
5

Under the MDA, medical devices are classified in three categories, with different levels of
federal oversight, based on the degree of risk they pose to the public. Class I is the lowest risk
category; Class III is the highest.
2

Administration (FDA) has authorized Defendants to market in the United States pursuant to what
is known as the § 510(k) process.6 Under the § 510(k) process, the FDA conducts a “limited
form of review” of a new device and may permit the device to be marketed without further
regulatory analysis if it determines, based on the manufacturer’s submission, that the device is
“substantially equivalent” to a preexisting device. See Medtronic, Inc. v. Lohr, 518 U.S. 470,
478 (1996).7
Defendants also manufacture the Birmingham Hip Resurfacing (BHR) System, a Class
III hip resurfacing system consisting of two main components: (1) a socket in the shape of
shallow cup (the acetabular component), which replaces the damaged surface of the hip socket,
and (2) a cap in the form of a ball head (the femoral resurfacing component), which covers the

6

The FDA’s authorization with respect to the R3 System is reflected in a series of notifications
pertaining to different components of the System. See Pls.’ Summ. J. Ex. A at 13354-55
(September 12, 2006, notification of § 510(k) authorization for “Smith & Nephew Modular
Femoral (Hemi) Heads”); id. at 13433-44 (October 17, 2005, notification of § 510(k)
authorization for “ANTHOLOGY Hip Stem”); Rouss Decl. Ex. F (June 6, 2007, notification of
§ 510(k) authorization for “Smith and Nephew REFLECTION 3”). There is no single 510(k)
notification covering all four components Plaintiffs identify as part of the R3 System, and S&N’s
“510(k) Summary” for the System describes it as consisting only of “Acetabular shells and
liners.” Rouss Decl. Ex. G. Nevertheless, the Court assumes, for purposes of this Memorandum,
that the R3 System consists of all of the components identified by Plaintiffs. See Pls.’ Summ. J.
Ex. A at 10002 (PMA supplement excerpt for the Birmingham Hip Resurfacing System
describing a Smith and Nephew “total hip replacement system . . . consisting of the R3
Acetabular Shell, poly liner, femoral stem and femoral head” as a Class II device); id. at 12535
(March 2012 FDA email suggesting the agency’s § 510(k) review of S&N’s “R3 XLPE
Acetabular Liners” includes review of the compatible femoral heads and stems that are part of
the same hip system).
7

Class I and Class II devices are subject to the § 510(k) process. See Lohr, 518 U.S. at 478.
Class III devices are generally subject to the separate premarket approval process, described in
greater detail below, but a Class III device may enter the market via the § 510(k) process if the
FDA finds it is substantially equivalent to a grandfathered device, i.e., a device already on the
market before the MDA’s effective date and permitted to remain on the market until the FDA
promulgates a regulation requiring premarket approval. See Riegel v. Medtronic, Inc., 552 U.S.
312, 317 (2008).
3

femoral head. See Pls.’ Summ. J. Ex. A at 9050-51; Rouss Decl. ¶ 5. The cap has a small stem
that is inserted into the top of the thighbone. See Pls.’ Summ. J. Ex. A at 9051. Both the
acetabular component and the femoral resurfacing component of the BHR system are made of
metal; hence, the System is referred to as having a metal-on-metal coupling or articulation. In
contrast to the R3 System, which entered the market via the § 510(k) process, the BHR System
underwent the substantially more rigorous premarket approval (PMA) process, whereby approval
is granted only if FDA finds, after reviewing the manufacturer’s voluminous application
materials, that “there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’” 8 See
Riegel v. Medtronic, Inc., 552 U.S. 312 317-18 (2008) (quoting 21 U.S.C. § 360e(d)). The FDA

8

To obtain premarket approval, a manufacturer must submit to the FDA “what is typically a
multivolume application,” including, inter alia,
full reports of all studies and investigations of the device’s safety and
effectiveness that have been published or should reasonably be known to the
applicant; a full statement of the device’s components, ingredients, and properties
and of the principle or principles of operation; a full description of the methods
used in, and the facilities and controls used for, the manufacture, processing, and,
when relevant, packing and installation of, such device; samples or device
components required by the FDA; and a specimen of the proposed labeling.
Riegel, 552 U.S. at 317-18 (citation and internal quotation marks omitted). In reviewing a PMA
application—a process on which the FDA spends an average of 1,200 hours per application—the
agency may request additional data from the manufacturer and may seek input from outside
experts. See id. As noted, the FDA grants premarket approval “only if it finds there is a
‘reasonable assurance’ of the device’s ‘safety and effectiveness,’” id. (quoting 21 U.S.C. §
360e(d)), after weighing “any probable benefit to health from the use of the device against any
probable risk of injury or illness from such use,” id. (quoting 21 U.S.C. § 360c(a)(2)(C)). Once
premarket approval is granted, “the MDA forbids the manufacturer to make, without FDA
permission, changes in design specifications, manufacturing processes, labeling, or any other
attribute, that would affect safety or effectiveness.” Id. at 319.
4

granted Defendants’9 application for premarket approval of the BHR system in May 2006.
Rouss Decl. Ex. A.
The following year, in April 2007, Defendants filed a PMA application supplement,
seeking approval for a line extension to the BHR System consisting of a modular version of the
BHR cup. Rouss Decl. ¶ 6 & Exs. B & C. The modular BHR cups, referred to as R3 Metal on
Metal Cups, consist of an R3 acetabular shell made of titanium alloy and an R3 metal liner made
of cobalt-chromium alloy. Rouss Decl. Ex. C. The PMA supplement represented that the metalon-metal articulation of the BHR System with the modular cups would be unchanged from that
of the System with the one-piece cups the FDA had previously approved. See id.; Pls.’ Ex. A at
9999. On November 13, 2008, the FDA approved the PMA supplement and granted Defendants
permission to distribute the BHR System with the modular cups. Rouss Decl. Ex. B. The FDA
also approved labeling10 associated with the line extension, including a surgical technique
addendum covering use of the modular R3 Metal on Metal Cups within the BHR System. Rouss
Decl. ¶ 8 & Ex. D. The surgical technique addendum specifically notes that “in the US, the R3
metal liner is intended for use as part of the BHR system only,” cautioning that if the resurfacing
procedure is abandoned “in favor of a total hip replacement, the R3 acetabular shell must be used
with a mating R3 poly liner.” Rouss Decl. Ex. D at 12157, 12159. The addendum also cautions
that if, post-operatively, “the BHR resurfacing head must be revised to a total hip arthroplasty
[i.e., replacement], . . . the R3 acetabular shell can remain in place if well-fixed,” but “the R3

9

The Court notes that the FDA directed its notification that the BHR System had received
premarket approval to “Smith & Nephew Orthopaedics” at the same Memphis, Tennessee,
address where S&N is located. See Rouss Decl. Ex. A.
10

For purposes of the FDCA, the term labeling means “all labels and other written, printed, or
graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying
such article.” 21 C.F.R. § 321(m).
5

metal liner must be replaced with an R3 poly liner, which can be used with any compatible
legally marketed Smith & Nephew femoral stem and mating ceramic or metal femoral head
component.” Id. at 12159.
In February 2009, four months after the R3 Metal on Metal Cup received premarket
approval as part of the BHR System, S&N issued a press release announcing “the introduction of
a metal liner option for its R3 Acetabular System, an advanced multi-bearing cup system used in
hip replacement and resurfacing procedures.” S&N’s Opp’n to Pls.’ Mot. for Leave to Amend
Ex. A;11 see also Second Am. Compl. ¶ 91. The press release noted the FDA had recently
approved the metal liner for use with the BHR System, but said nothing about the regulatory
status of the liner for use in total hip replacements.12 S&N’s Opp’n to Pls.’ Mot. for Leave to
Amend Ex. A. The press release touted the R3 System’s unique capacity to “accommodate[] the
major advanced bearing options, including metal-on-metal, ceramic-on-ceramic, cobalt chrome
on cross-linked polyethylene (XLPE), and the company’s exclusive OXINIUMTM Oxidized
Zirconium on XLPE,” and described the R3 System’s multi-bearing cup as providing
“intraoperative flexibility for surgeons” and “solutions designed to reduce wear and the
subsequent need for revision surgery.” Id.

11

Although the Second Amended Complaint quotes from the press release, the press release is
not included as an exhibit to the Complaint, nor is it part of the summary judgment record. S&N
has produced a copy of the press release as an exhibit to its opposition to Plaintiffs’ motion for
leave to amend. Because Plaintiffs’ claims are based on the press release, the Court may
properly consider it, even in evaluating the sufficiency of Plaintiffs’ claims. See Tellabs, Inc. v.
Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007) (holding a court may consider
“documents incorporated into the court by reference” in evaluating a motion to dismiss).
12

Defendants did not seek FDA approval to use the R3 optional metal liner with the R3 System.
See Second Am. Compl. ¶ 96. Outside the United States, however, the liner received regulatory
approval for use in a total hip replacement. See S&N’s Opp’n to Pls.’ Mot. for Leave to Amend
9 & Ex. C.
6

On April 29, 2009, Walter Shuker underwent right total hip replacement surgery in which
his surgeon, Kevin Terefenko, M.D., implanted the following components manufactured by
Defendants: (1) a modular femoral head made of cobalt-chrome, (2) a modular head sleeve
made of cobalt-chrome, (3) a femoral stem component, (4) an R3 no-hole hemispherical
acetabular shell, and (5) an R3 acetabular liner made of cobalt-chrome, i.e., an R3 metal liner.
Pls.’ Summ. J. Ex. C at 2; Pls.’ Summ. J. Ex. E. The first four components used in Mr. Shuker’s
hip replacement surgery were cleared by the FDA pursuant to the § 510(k) process.13 The R3
metal liner component, however, did not receive FDA § 510(k) clearance as part of the R3
System. Rather, the metal liner was part of the R3 Metal on Metal Cup that received premarket
approval as part of the BHR System. See Rouss Decl. ¶ 9; compare Pls.’ Summ. J. Ex. E (chartstik labels), with Rouss Decl. Ex. D at 12161 (catalog numbers for R3 metal liners). The FDA
did not approve the R3 metal liner for use with the R3 System in a total hip replacement
procedure. Dr. Terefenko’s use of the metal liner component in Mr. Shuker’s surgery was thus
an “off-label” use, i.e., a use for a purpose other than “that for which it has been approved by the
FDA.” See Buckman Co. v. Pls.’ Legal Comm., 531 U.S. 341, 350 (2001).
Approximately 21 months after his surgery, Mr. Shuker began developing increasing pain
and discomfort in his buttocks, groin, and thigh, limiting his daily activities. Second Am.
Compl. ¶ 110. On May 23, 2011, he underwent an aspiration procedure, performed by Dr.
13

Compare Pls.’ Summ. J. Ex. E (chart-stik labels showing catalog numbers for components
used in Mr. Shuker’s surgery), with Pls.’ Summ. J. Ex. A at 13354-55, 13361, 13433-34, 13466
(§ 510(k) notifications and catalog numbers for femoral head, head sleeve, and femoral stem
component), id. at 12188, 13178 (catalog numbers for R3 no-hole acetabular shell), and Rouss
Decl. Ex. F (§ 510(k) notification for acetabular shell). The R3 acetabular shell used in Mr.
Shuker’s surgery also appears to have received premarket approval as part of the BHR System.
See Rouss Decl. ¶ 9; compare Pls.’ Summ. J. Ex. E (chart-stik labels), with Rouss Decl. Ex. D at
12161 (catalog numbers for R3 no-hole acetabular shell component of the R3 modular
resurfacing acetabular cup, i.e., the R3 Metal on Metal Cup).
7

Terefenko, during which a milky brown tinged fluid and metallic debris were removed from his
body. Id. ¶ 111. Dr. Terefenko determined Mr. Shuker’s pain was caused by metal sensitivity
due to the degeneration of the metal-on-metal articulation of his artificial hip and decided that
replacement of the metal-on-metal articulation was necessary to relieve the pain. Id. On July 6,
2011, Mr. Shuker underwent a further hip surgery during which Dr. Terefenko replaced the
existing metal-on-metal articulation with an Oxinium head and a polyethylene liner. Id. ¶ 112.
After the surgery, Mr. Shuker again developed extreme pain in his right hip. Id. ¶ 113. Dr.
Terefenko performed a second aspiration procedure on November 12, 2012, and determined that
Mr. Shuker had developed an infection at the surgery site. Id. In December 2012 and January
2013, Mr. Shuker underwent further surgeries to remove and replace the R3 System. Id. ¶¶ 11415.
In June 2012, almost a year after Mr. Shuker’s surgery to replace the metal-on-metal
articulation of the components originally implanted, Defendants announced they had “chosen to
withdraw the optional metal liner component within the R3 Acetabular System.” Id. ¶ 99; see
also Pls.’ Summ. J. Ex. A at 13963. Defendants explained the withdrawal was a “precautionary
measure” based on data from sources including “Australian and [United Kingdom] patient
registries,” which indicated the metal liner component within the R3 System was not performing
as well as the company would like. Second Am. Compl. ¶ 100. That same month, the Medicines
and Healthcare Products Regulatory Agency (MHRA), the analogue of the FDA in the United
Kingdom, advised surgeons to stop using the R3 metal liner because of the higher revision rates
associated with it than with nonmetal liners.14 Id. ¶ 102. The MHRA also advised surgeons to

14

The MHRA reported the revision rate for the R3 metal liner was 6.4% at four years, which not
only was higher than the revision rate for nonmetal liners, but also exceeded the “4% guidance
figure at four years from National Institute of Health and Clinical Excellence.” Id. ¶ 102.
8

annually monitor those patients who had been fitted with the metal liners to ensure that “any
complications such as pain or swelling [would be] picked up and treated early.” Id. At the time
of the withdrawal, a majority of the R3 metal liners in use globally had been used in hip
replacement, rather than resurfacing, procedures. See Pls.’ Summ. J. Ex. A at 13693.
In September 2013, Plaintiffs commenced the above-captioned action by filing a
Complaint in the Court of Common Pleas of Philadelphia County. S&N removed the case to
federal court the following month and, after answering the Complaint, filed a motion for
judgment on the pleadings. Following a Rule 16 conference at which Plaintiffs indicated their
desire to amend their Complaint, the Court granted Plaintiffs leave to amend and denied S&N’s
motion for judgment on the pleadings without prejudice.
In December 2013, Plaintiffs filed their First Amended Complaint, asserting claims for
negligence/negligence per se, negligence based on violations of various FDA regulations, strict
products liability, breach of express warranty, breach of implied warranties of merchantability,
fraud, and loss of consortium. S&N thereafter filed a motion to dismiss, arguing Plaintiffs’
claims were expressly preempted by the preemption provision of the MDA, 21 U.S.C. § 360k,
and were inadequately pleaded insofar as Plaintiffs attempted to assert a nonpreempted
negligence claim premised on violations of FDA regulations. S&N’s preemption argument was
based on the assertion that the R3 metal liner used in Mr. Shuker’s hip replacement surgery
received premarket approval, an assertion that Plaintiffs disputed in their First Amended
Complaint. Although S&N submitted certain FDA documents in support of its position, this
Court found the documents, standing alone, were insufficient to establish the regulatory status of
the metal liner used in Mr. Shuker’s surgery, and the Court therefore denied the motion to
dismiss. Recognizing that the preemption issue was potentially dispositive of most (if not all) of

9

Plaintiffs’ claims, however, the Court amended the scheduling order to permit the parties to take
discovery on the preemption issue, following which S&N could to renew its preemption
argument in a motion for summary judgment. The Court deferred ruling on the sufficiency of
Plaintiffs’ parallel claim pending the re-briefing of the preemption issue.
S&N has now renewed its preemption argument on summary judgment, asserting
Plaintiffs’ claims are preempted and their attempt to plead a nonpreempted parallel claim
remains unavailing. After S&N filed its summary judgment motion, Plaintiffs filed a motion for
leave to file a Second Amended Complaint to clarify the regulatory history and status of the
artificial hip implanted in Mr. Shuker, to refine causes of action based on Defendants’ active
promotion of off-label uses of their products, and to clarify their parallel claims.
APPLICABLE LEGAL STANDARDS
S&N seeks summary judgment as to most of Plaintiffs’ claims on the ground that the
claims are preempted. Under Federal Rule of Civil Procedure 56, summary judgment shall be
granted “if the movant shows that there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). Material facts are
those facts “that might affect the outcome of the suit under the governing law.” Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A factual dispute is genuine if “the evidence is
such that a reasonable jury could return a verdict for the nonmoving party.” Id. “Where the
record taken as a whole could not lead a rational trier of fact to find for the non-moving party,
there is no ‘genuine issue for trial.’” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475
U.S. 574, 587 (1986) (citation omitted).
S&N also seeks dismissal of any nonpreempted claims based on Defendants’ alleged
violation of common-law duties that parallel federal requirements on the ground that such claims

10

are inadequately pleaded and thus fail to state a claim on which relief can be granted. To
withstand a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), “a complaint
must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible
on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly,
550 U.S. 544, 570 (2007)). A claim is facially plausible when the facts pleaded “allow[] the
court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”
Id. In evaluating a Rule 12(b)(6) motion, a district court first must separate the legal and factual
elements of the plaintiff’s claims. See Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir.
2009). The court “must accept all of the complaint’s well-pleaded facts as true, but may
disregard any legal conclusions.” Id. at 210-11. The court must then “determine whether the
facts alleged in the complaint are sufficient to show that the plaintiff has a ‘plausible claim for
relief.’” Id. at 211 (quoting Iqbal, 556 U.S. at 679).
In addition to opposing S&N’s motions, Plaintiffs seek leave to file a Second Amended
Complaint pursuant to Federal Rule of Civil Procedure 15(a). Rule 15 “embodies a liberal
approach to pleading,” and leave to amend “must generally be granted unless equitable
considerations render it otherwise unjust.” Arthur v. Maersk, Inc., 434 F.3d 196, 202, 204 (3d
Cir. 2006); see also Fed. R. Civ. P. 15(a)(2) (directing that courts “should freely give leave [to
amend] when justice so requires”). A district court has discretion to deny a request to amend,
however, “if it is apparent from the record that (1) the moving party has demonstrated undue
delay, bad faith or dilatory motives, (2) the amendment would be futile, or (3) the amendment
would prejudice the other party.” Hill v. City of Scranton, 411 F.3d 118, 134 (3d Cir. 2005).
“An amendment is futile if the amended complaint would not survive a motion to dismiss for

11

failure to state a claim upon which relief could be granted.” Alvin v. Suzuki, 227 F.3d 107, 121
(3d Cir. 2000).
DISCUSSION
Plaintiffs’ First Amended Complaint is based on the faulty premise that the R3 metal
liner was a component of the § 510(k)-cleared R3 System. Discovery has confirmed that the
only regulatory approval the R3 metal liner received in the United States is premarket approval
as part of the BHR System. In their proposed Second Amended Complaint, Plaintiffs seek to
correct their allegations regarding the regulatory status of the metal liner and the other
components used in Mr. Shuker’s hip replacement surgery, and, in light of these changes, to
refine their allegations in support of a nonpreempted parallel claim based on Defendants’ alleged
violations of federal law. S&N opposes Plaintiffs’ motion for leave to amend solely on the basis
that permitting the amendment would be futile because the Second Amended Complaint still
fails to plead a viable claim. Because the regulatory status of the components implanted in Mr.
Shuker is essential to the Court’s determination of what claims Plaintiffs can and cannot pursue,
and because S&N does not suggest it would be prejudiced by the amendment, the Court will
grant Plaintiffs’ motion for leave to amend and will consider S&N’s arguments for summary
judgment and dismissal as to Plaintiffs’ Second Amended Complaint.
S&N argues most of Plaintiffs’ claims are preempted by the MDA’s express preemption
provision, which, subject to an exception not applicable here, provides:
[N]o State or political subdivision of a State may establish or continue in effect
with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under
this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter
included in a requirement applicable to the device under this chapter.
12

21 U.S.C. § 360k(a). The Supreme Court has established a two-step analysis for determining
whether state tort claims with respect to a medical device are preempted under § 360k(a). “Since
the MDA expressly pre-empts only state requirements ‘different from, or in addition to, any
requirement applicable . . . to the device’ under federal law,” a court must first determine
“whether the Federal Government has established requirements applicable to [the device].”
Riegel, 552 U.S. at 321 (quoting § 360k(a)(1)). If it has, the court must then determine whether
the plaintiff’s state-law claims “are based upon [state] requirements with respect to the device
that are ‘different from, or in addition to’ the federal ones, and that relate to safety and
effectiveness.” Id. at 321-22 (quoting 21 U.S.C. § 360k(a)).
As to the first step in the preemption analysis, the Supreme Court has held “[p]remarket
approval . . . imposes ‘requirements’ under the MDA.” Id. at 322. Section 510(k) clearance
does not. Id. In explaining the distinction between the two forms of approval for preemption
purposes, the Court noted that whereas § 510(k) is “focused on equivalence, not safety,” id. at
323 (quoting Lohr, 518 U.S. at 493), premarket approval “is federal safety review” id.
Moreover, while devices cleared under § 510(k) are subject only to general federal regulations
“applicable across the board to almost all medical devices,” premarket approval is devicespecific. See id. at 322-23. Indeed, once premarket approval is granted, the FDA requires the
device “to be made with almost no deviations from the specifications in its approval application,
for the reason that the FDA has determined that the approved form provides a reasonable
assurance of safety and effectiveness.” Id. at 323; see also Horn v. Thoratec Corp., 376 F.3d
163, 170-72 (3d Cir. 2004) (holding premarket approval imposes federal requirements on a
device and noting the FDA’s position that a premarket approval order from the agency
“specifically approves as a matter of law those features set forth in the application and binds the
13

manufacturer to produce and market the product in compliance with the specifications as
approved by FDA” (emphasis omitted)). Medical devices that enter the market via the PMA
process are thus subject to federal requirements for purposes of § 360k(a).
If a device is subject to federal requirements, § 360k(a) preempts those state requirements
“with respect to [the] device” that are “different from, or in addition to,” the federal requirements
and that “relate[] to the safety and effectiveness of the device.” Duties imposed pursuant to state
tort law are “requirements” for purposes of the preemption provision, Riegel, 552 U.S. at 324;
hence, state tort claims relating to the safety and effectiveness of a device are preempted to the
extent that the state duties differ from or add to the federal requirements. Section 360k(a) does
not, however, “prevent a State from providing a damages remedy for claims premised on a
violation of FDA regulations,” as “the state duties in such a case ‘parallel,’ rather than add to,
federal requirements.” Id. at 330. Section 360k(a) thus protects a manufacturer of a PMAapproved medical device from civil liability “to the extent that it has complied with federal law,
but it does not extend protection from liability where the claim is based on a violation of federal
law.” Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010).
After discovery, it is now undisputed that the R3 metal liner used in Mr. Shuker’s surgery
received premarket approval as part of the BHR System, while the rest of the components were
cleared pursuant to the § 510(k) process.15 It is also undisputed that the FDA never approved the
particular combination of components implanted in Mr. Shuker for use together as a single
device. The parties disagree as to whether and how the MDA’s preemption provision applies in

15

As noted, the R3 acetabular shell appears to have been both PMA-approved and § 510(k)cleared.
14

these unusual circumstances in which a physician uses a component from a PMA-approved
device off-label with components from a § 510(k)-cleared device.
S&N argues because the liner received premarket approval as part of the BHR System,
there are federal requirements applicable to the liner, and Plaintiffs’ tort claims, all of which
relate to the safety and effectiveness of the liner in some way, are preempted, with the exception
of Plaintiffs’ claim based on violations of FDA regulations and FDCA provisions.16 S&N
maintains the fact that Dr. Terefenko used the liner off-label with components of a device that
was otherwise § 510(k)-cleared does not deprive the liner of the protections of § 360k(a).
Plaintiffs dispute that the R3 metal liner is itself a device subject to federal requirements
when used outside of the BHR System.

Noting that the FDA approves hip systems, not

individual components, Plaintiffs argue the hip system implanted in Mr. Shuker, which consisted
predominantly of components from the § 510(k)-cleared R3 System, should be regarded for
preemption purposes either as a § 510(k) device or as a new Class III device that has not received
either § 510(k) clearance or premarket approval. Either way, Plaintiffs contend that because the
device at issue—i.e., the entire hip system Mr. Shuker received—never underwent the PMA
process, § 360k(a) is inapplicable. Alternatively, Plaintiffs contend Defendants forfeited the
benefits of preemption by promoting the R3 metal liner for use off-label with the R3 System.
Although there is scant case law addressing how the MDA’s preemption provision
applies with respect to a component of device that has received premarket approval when used
independently of the remainder of the device, two federal district courts in New York have
considered this question with respect to the same Smith & Nephew components at issue here.
See Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246 (E.D.N.Y. 2014); Simon v. Smith &
16

Although S&N does not contend this parallel claim is preempted, it argues the claim should
nevertheless be dismissed because it is inadequately pleaded.
15

Nephew, Inc., 990 F. Supp. 2d 395 (S.D.N.Y. 2013), reconsideration denied, 18 F. Supp. 3d 423
(S.D.N.Y. Mar. 26, 2014).

Both cases involved plaintiffs who, like Mr. Shuker, had hip

replacement surgery in which their surgeons implanted them with the R3 System and the
optional R3 metal liner. Both plaintiffs eventually experienced problems with their artificial hips
and, after undergoing revision surgery, sued S&N, asserting products liability-related claims,
which S&N moved to dismiss as both preempted and inadequately pleaded. With regard to
preemption, in both cases, the courts concluded that because the R3 metal liner had received
premarket approval as part of the BHR System, claims with respect to the liner were preempted.
See Simon, 18 F. Supp. 3d at 428; Bertini, 8 F. Supp. 3d at 254. The courts rejected the
argument that use of the liner outside of the BHR System affected the preemption analysis,
noting the question under § 360k(a) “is not whether there are federal requirements applicable to a
particular use of a device,” but “whether there are federal requirements applicable to the device.”
Simon, 18 F. Supp. 3d at 428 (quoting Riley v. Cordis Corp., 625 F. Supp. 2d 769, 779 (D. Minn.
2009) (internal quotation marks omitted)); see also Bertini, 8 F. Supp. 3d at 255. While both
courts suggested claims relating solely to the § 510(k)-cleared components of the R3 System
would not be preempted, they concluded the plaintiffs had not pleaded any nonpreempted claims,
as the product defects the plaintiffs identified pertained either to the R3 metal liner itself or to the
liner’s interface with other components. See Simon, 18 F. Supp. 3d at 428-29 (holding whether
the plaintiff’s injuries were “understood to have resulted from [the R3 metal] liner alone . . . or
from use of that liner in combination with other components of the R3 Acetabular System . . . ,
the metal liner [wa]s at the heart of each and every one of [plaintiff’s] claims” and the claims
were therefore preempted); Bertini, 8 F. Supp. 3d at 255-58.

16

The Court agrees with the Simon and Bertini courts that insofar as Plaintiffs’ claims
challenge the safety and effectiveness of the R3 metal liner, the claims are preempted under
§ 360k(a). As both of those courts recognized, preemption under § 360k(a) turns on whether
there are federal requirements “applicable . . . to the device” and, if so, whether the plaintiff’s
state tort claims would impose requirements relating to the safety or effectiveness of the device
that are “different from, or in addition to,” the federal requirements. 21 U.S.C. § 360k(a); see
also Riegel, 552 U.S. at 321-22. Upon the FDA’s approval of Defendants’ PMA application for
the multi-component BHR System and PMA supplement for the R3 Metal on Metal Cup,
Defendants were required to produce and market the device, including all of its constituent
components, in accordance with the specifications approved by the FDA. See Riegel, 552 U.S. at
323; Horn, 376 F.3d at 170-72; see also 21 U.S.C. § 321(h) (defining the term “device” to
include “any component, part, or accessory” thereof). Thus, under Riegel, the FDA’s approval
of the PMA supplement for the R3 Metal on Metal Cup imposed federal requirements on the
Cup—and on the R3 metal liner, a component of the Cup—for purposes of § 360k(a). See, e.g.,
Hawkins v. Medtronic, Inc., No. 13-499, 2014 WL 346622, at *5 (E.D. Cal. Jan. 30, 2014) (“The
requirements set forth in the premarket approval for the entire device are just as applicable to the
components that together form the FDA-approved device as the device itself.”); Eidson v.
Medtronic, Inc. (Eidson I), 981 F. Supp. 2d 868, 881 n.3 (N.D. Cal. 2013) (holding premarket
approval of a three-component medical device established federal requirements for two
components of the device when used without the third).
Plaintiffs argue the fact that the R3 metal liner received premarket approval for use with
the BHR System is irrelevant because Dr. Terefenko used it as part of a different hip system,
which was not PMA-approved. Citing a statement from an FDA employee that the agency

17

“review[s] hip systems and not individual components,” Pls.’ Summ. J. Ex. A at 12535, Plaintiffs
argue the Court must look at the hip system implanted in Mr. Shuker as a whole in applying the
preemption analysis. While this approach makes sense in cases in which the FDA has actually
reviewed the particular system at issue, that is not the case here, as the R3 System the FDA
cleared via the § 510(k) process did not include the R3 metal liner. There is thus no basis to
characterize the hip system implanted in Mr. Shuker as the § 510(k)-cleared R3 System.
The fact that the FDA never reviewed the particular hip system Mr. Shuker received via
either the § 510(k) or the PMA process distinguishes this case from the cases Plaintiffs cite in
which courts have held the preemption analysis cannot be applied differently to individual
components of a multi-component medical device, but must be applied to the device as a whole.
In all of those cases, the device as a whole received premarket approval, generally as a result of
the FDA’s approval of a PMA supplement permitting the manufacturer to incorporate a
component that previously received § 510(k) clearance into a PMA-approved device. In that
situation, courts have uniformly rejected the argument that the § 510(k)-cleared component was
not subject to express preemption, holding the approval of a PMA supplement incorporating the
§ 510(k)-cleared component extended premarket approval to the entire device. See Gross v.
Stryker Corp., 858 F. Supp. 2d 466, 485-88 (W.D. Pa. 2012); Duggan v. Medtronic, Inc., 840 F.
Supp. 2d 466, 471-72 (D. Mass. 2012); Lewkut v. Stryker Corp., 724 F. Supp. 2d 648, 656-57
(S.D. Tex. 2010); see also Bass v. Stryker Corp., 669 F.3d 501, 508 & n.1 (5th Cir. 2012)
(upholding a district court’s finding that an acetabular shell that the plaintiff maintained was not
subject to premarket approval testing was part of the PMA-approved hip replacement system at
issue). None of these cases involved a device created by a physician’s off-label use of a PMAapproved component with components of a § 510(k)-cleared system. If anything, the cases

18

reinforce the conclusion that approval of the PMA supplement for the R3 Metal on Metal Cup
imposed federal requirements on the R3 metal liner as a component of the Cup.17
As Plaintiffs note, the FDA’s approval of the R3 metal liner was predicated on
Defendants’ representations regarding its intended use as part of the BHR System. See 21
U.S.C. § 360c(a)(2) (providing that, for purposes of premarket approval, “the safety and
effectiveness of a device are to be determined . . . with respect to the persons for whose use the
device is represented or intended [and] with respect to the conditions of use prescribed,
recommended, or suggested in the labeling of the device”); id. § 360e(d)(1)(A) (providing that in
17

In Huskey v. Ethicon, Inc., a case cited by Plaintiffs as supplemental authority, the court
applied the converse of the principle applied in the cases cited above, holding that “[j]ust as ‘a
device receiving premarket approval cannot be separated into its component parts to avoid
application of express preemption,’ a device receiving 510(k) approval cannot be separated into
its component parts to create express preemption.” 29 F. Supp. 3d 736, 748 (S.D. W. Va. 2014)
(citations omitted). Plaintiffs argue the principle recognized in Huskey applies equally here. But
this argument overlooks the critical fact that the particular assemblage of components Mr.
Shuker received was never cleared as a single device via the § 510(k) process. While it may
“make[] no sense” to apply a different preemption analysis to different components of a device
the FDA has authorized the manufacturer to market as a single medical device, see id. (citation
omitted), this case does not involve such a device, and Huskey is therefore inapposite.
It also bears mention that the preemption argument the court rejected in Huskey was
significantly broader than the argument S&N advances in this case. Huskey concerned a
§ 510(k)-cleared medical device called the Gynecare TVT Obturator (or TVT-O), which
included a mesh tape, or sling, made of Prolene polypropylene filaments, the same material used
in the Prolene suture, a separate, PMA-approved medical device. The manufacturer argued
because the suture, which consisted of single Prolene filament, received premarket approval, the
plaintiffs’ claims that the Prolene filaments in the mesh tended to degrade were preempted.
Although the court rejected this argument on the basis that the TVT-O as a whole had been
cleared via the § 510(k) process and thus could not be separated into its component parts for
purposes of conducting a preemption analysis, the suture was not so much a component of the
TVT-O as a device made of the same material. The court thus rejected the notion that the FDA’s
grant of premarket approval for a device made of a particular material constituted approval of
that material for all purposes, explaining, by way of analogy: “If a specific type of metal were
approved for use in a bone screw via the premarket approval process, it would not follow that
that same type of metal was safe in all medical devices, no matter what their function in the
human body.” Id. at 747 (citation omitted).
The Court also notes that insofar as Huskey rejected the analysis in Simon and Bertini, it
did so based at least in part on the faulty assumption that the R3 metal liner was part of the
§ 510(k)-cleared R3 System. See id. at 749.
19

determining whether to approve or deny a PMA application, “the Secretary shall rely on the
conditions of use included in the proposed labeling as the basis for determining whether or not
there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither
false nor misleading”). But while the FDA considers the intended use of a device in determining
whether to grant premarket approval, the requirements such approval imposes on a device are not
use-specific, as the FDA does not regulate the use of medical devices—or their components—by
physicians, who remain free to use such devices in an off-label manner. See, e.g., Ramirez v.
Medtronic, Inc., 961 F. Supp. 2d 977, 988 (D. Ariz. 2013).

In other words, by granting

premarket approval, the FDA requires the manufacturer of an approved device to place the
device on the market in the form—and accompanied by the warnings and indications for use—
approved by the agency, but does not prevent physicians from using the device in a different
manner. See 21 C.F.R. § 396 (providing “[n]othing in [the FDCA] shall be construed to limit or
interfere with the authority of a health care practitioner to prescribe or administer any legally
marketed device to a patient for any condition or disease within a legitimate health care
practitioner-patient relationship”); Buckman, 531 U.S. at 350 (recognizing “‘off-label’ usage of
medical devices . . . is an accepted and necessary corollary of the FDA’s mission to regulate in
this area without directly interfering with the practice of medicine”). A physician’s decision to
use a PMA-approved device off-label does not change the manufacturer’s obligation to produce
and market the device “with almost no deviations from the specifications in its approval
application,” Riegel, 552 U.S. at 323; hence, the mere fact a device is used off-label does not
render § 360k(a) inapplicable. See id. at 320, 322-23 (holding the premarket approval of a
balloon catheter imposed federal requirements on the catheter under the MDA notwithstanding
that the plaintiff’s physician had used the device in a manner contraindicated by the product

20

labeling); Perez v. Nidek Co., 711 F.3d 1109, 1118 (9th Cir. 2013) (holding a laser system
approved via the PMA process for treating nearsightedness was “subject to device-specific
requirements under the PMAs,” even when used in surgery to treat farsightedness).18 As one
district court has observed, if the law were otherwise,
a manufacturer of a medical device could scrupulously adhere to the FDA’s every
command—and meet every requirement imposed on the design, manufacture,
labeling, and marketing of the device—and nevertheless be sued under the tort
law of any of the fifty states because a health-care provider, without the
manufacturer’s consent or even knowledge, decided to put the device to an offlabel use.
Riley, 625 F. Supp. 2d at 778.19

18

This is true whether the physician uses the entire device in an off-label manner or, as here,
uses a component of the device off-label with components of a separate device. See, e.g.,
Hawkins, 2014 WL 346622, at *5 (rejecting the argument that a component of a PMA-approved
device was not subject to federal requirements when used without the other component of the
device, as use of the one component without the other was “simply an off-label use of the
device”); Houston v. Medtronic, Inc. (Houston I), 957 F. Supp. 2d 1166, 1176 (C.D. Cal. 2013)
(same).
19

Plaintiffs argue that even if off-label use of a device does not render § 360k(a) inapplicable
when such use was the result of a decision by a physician in which the manufacturer played no
part, a different rule applies when the manufacturer actively promotes the off-label use. Citing
Ramirez v. Medtronic, Inc., supra, Plaintiffs urge the Court to hold Defendants forfeited the
protections of § 360k(a) by promoting the R3 metal liner for use off-label with the R3 System.
In Ramirez, the court recognized a limited exception to § 360k(a) for state-law claims based on
off-label promotion. The court distinguished such claims from claims based simply on off-label
use on the ground that the manufacturer’s promotion of an off-label use violates federal law and
creates a new intended use of the device for which FDA approval is required. See 961 F. Supp.
2d at 990 (citing 21 C.F.R. § 814.39, which requires a manufacturer to submit a PMA
supplement to introduce new indications for use of a PMA-approved device). The court
observed that allowing the manufacturer to enjoy the protections of § 360k(a) in these
circumstances would not serve the statute’s purpose to avoid having a state body “arrive at a
determination regarding a device’s safety that conflicts with the conclusion the FDA made after
the rigorous PMA process.” See id. at 991. The court concluded that absent FDA approval of
the new intended use created by the manufacturer’s off-label promotion, there “[wa]s nothing to
preempt state law requirements.” Id. at 993.
As an initial matter, because the holding in Ramirez is limited to claims based on offlabel promotion, the case has no application to most of Plaintiffs’ claims, which are not
specifically based on allegations that Defendants promoted the R3 metal liner for off-label use.
21

Having concluded that the FDA’s approval of the PMA supplement for the R3 Metal on
Metal Cup imposed federal requirements on the R3 metal liner for purposes of § 360k(a), the
Court must next determine whether Plaintiffs’ state-law claims impose requirements “with
respect to” the liner that are “different from, or in addition to” the federal requirements. In their
Second Amended Complaint, Plaintiffs assert variations of the same seven counts included in
their First Amended Complaint: (1) negligence/negligence per se (Count I), (2) negligence based
on violations of FDA regulations and FDCA provisions (Count II), (3) strict products liability
(Count III), (4) breach of express warranty (Count IV), (5) breach of implied warranties of

Off-label promotion is part of both Plaintiffs’ fraud claim and their negligence claim based on
violations of federal law, but, even under Ramirez, § 360k(a) remains applicable to the remaining
claims in Plaintiffs’ Second Amended Complaint. As S&N notes, moreover, the Ramirez
decision has been widely criticized by other district courts reviewing allegations of off-label
promotion of PMA-approved devices. See, e.g., Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp.
3d 1021, 1035 (D. Haw. 2014) (noting “Ramirez has been rejected—for good reason—by
numerous courts”). In Houston v. Medtronic, Inc. (Houston II), for example, the court rejected
Ramirez’s holding that § 360k(a) does not apply when a manufacturer engages in off-label
promotion as inconsistent with the text of the statute, under which preemption turns on whether
there are federal requirements applicable to the device, not to a particular use of the device. No.
13-1679, 2014 WL 1364455, at *5 (C.D. Cal. Apr. 2, 2014) (noting “[i]f § 360k(a) does not
distinguish between uses of a device, it surely does not distinguish between whether a particular
use of a device was promoted by the manufacturer”). The court also found Ramirez was
inconsistent with “the scope of federal requirements imposed on Class III devices,” noting
manufacturers of PMA-approved devices are required to report to the FDA information
reasonably suggesting a device may have caused or contributed to a death or serious injury, and
are prohibited from “making changes in ‘design specifications, manufacturing processes, [or the]
labeling’ of devices without FDA approval, regardless of use.” Id. (quoting Riegel, 552 U.S. at
319). While the court agreed with Ramirez that off-label promotion violates federal law, the
court viewed the federal prohibition as a possible basis for a parallel claim, rather than a
wholesale exemption from preemption. See id. at *8. This Court agrees a manufacturer’s
promotion of off-label uses of a PMA-approved device does not affect whether the device is
subject to federal requirements for purposes of § 360a(k). Rather, consistent with Houston, the
Court will consider Plaintiffs’ allegations regarding off-label use as the basis for a potentially
nonpreempted parallel claim.
22

merchantability (Count V),20 (6) fraud (Count VI), and (7) loss of consortium (Count VII).
Plaintiffs acknowledge Count II represents their attempt “to articulate parallel claims,” i.e., statelaw claims based on violations of federal law, “should the Court find preemption.” Oral Arg. Tr.
80, July 16, 2014. S&N argues the Complaint should be dismissed in its entirety because Counts
I and III-VI are preempted,21 Count II fails to state a plausible parallel claim for violations of
state common-law duties that parallel the federal requirements applicable to the R3 metal liner,
and Count VII is derivative of, and thus cannot survive dismissal of, the remaining counts.
The claims in Plaintiffs’ Second Amended Complaint are broad-ranging and extremely
general. For their negligence claim, Plaintiffs allege Defendants failed to exercise ordinary care
in “the designing, researching, manufacturing, marketing, labeling, supplying, promoting,
packaging, sale, testing, quality assurance, quality control, and/or distribution of the R3
Acetabular System, and components such as the R3 metal liner that foreseeably would be used
with it.” Second Am. Compl. ¶ 119. Plaintiffs’ strict liability claim alleges “[t]he R3 Acetabular
System, both with and without components such as the R3 metal liner that foreseeably would be
used with it,” was “defective in design or formulation,” id. ¶ 141, and that “[t]he R3 Acetabular
System and components such as the R3 metal liner that foreseeably would be used with it” were
“manufactured defectively” and were defective due to inadequate warnings, instructions, testing,
and/or post-marketing surveillance, see id. ¶¶ 149, 153-55. The breach of implied warranty
claim rests on allegations that Defendants breached implied warranties that “the R3 Acetabular
System and components such as the R3 metal liner that foreseeably would be used with it” were
20

The Second Amended Complaint mistakenly refers to the breach of implied warranties claim,
which follows Count IV, as Count VI.
21

As to Count IV, S&N also argues that insofar as the MDA does not preempt claims for breach
of express warranty claims, Plaintiffs have failed to plead a plausible express warranty claim in
this case.
23

“safe and of merchantable quality, and fit for the ordinary purpose for which said product[s]
w[ere] to be used.” See id. ¶¶ 173, 178.
All of these claims unquestionably relate to the safety of the R3 System and the R3 metal
liner when used together, and insofar as the claims are directed to the PMA-approved liner, they
are expressly preempted by § 360k(a). See Riegel, 552 U.S. at 320, 324-25 (holding § 360k(a)
preempted state-law claims of “strict liability; breach of implied warranty; and negligence in the
design, testing, inspection, distribution, labeling, marketing, and sale” of a PMA-approved
device). Although Plaintiffs’ claims also purport to challenge the safety of the § 510(k)-cleared
R3 System, the body of the Second Amended Complaint reveals that the liner is at the heart of
each of Plaintiffs’ claims.

The Second Amended Complaint identifies the metal-on-metal

articulation of the R3 metal liner and the femoral head components of the R3 System as the
source of Mr. Shuker’s injuries, alleging this articulation was “prone to wearing down and
releasing metal debris into the body of the user[,] causing adverse health effects,” and also
alleging Dr. Terefenko determined Mr. Shuker’s pain “was caused by metal sensitivity due to the
degeneration of the metal on metal articulation.” Second Am. Compl. ¶¶ 98, 111; see also id.
¶¶ 95, 105, 120(t), 120(x), 183. Moreover, the Second Amended Complaint identifies the metal
liner—not the femoral components—as the source of the problem, alleging Defendants
ultimately withdrew the liner “within the R3 Acetabular System” because it was not performing
satisfactorily within that System,22 see Second Am. Compl. ¶ 100, and that regulatory authorities

22

It is not clear whether the recall covered the liner when used within the PMA-approved BHR
System. See Pls.’ Summ. J. Ex. B (FDA’s subpoena response characterizing the June 2012
withdrawal of “metal liners of the R3 acetabular system” as “a recall for components sold
outside the US,” and stating “[t]here was never a US recall from Smith and Nephew in June
2012); S&N’s Opp’n to Pls.’ Mot. for Leave to Amend Ex. C (stating, as part of a S&N
“Information and FAQs for Health Care Professionals,” that BHR hip implants are not affected
by the recall of the R3 metal liner, but also suggesting that, following the recall, “[s]urgeons who
24

in the United Kingdom advised surgeons to stop using the metal liner because of its unacceptably
high revision rate, see id. ¶ 102. Dr. Terefenko’s operative report for Mr. Shuker’s July 2011
revision surgery confirms that Dr. Terefenko identified the metal liner as the “primary generator
of the metallic debris.” Pls.’ Summ. J. Ex. D at 4.
The only factual allegation in the Second Amended Complaint pertaining to the R3
System, as opposed to the liner, concerns the adequacy of the warnings accompanying the
System.

Plaintiffs allege that while the literature accompanying the BHR System warned

surgeons that “when performing a hip resurfacing procedure, the R3 acetabular shell must be
used only with an R3 metal liner and the BHR femoral head,” Defendants “failed to provide the
reverse admonition for the R3 Acetabular System; namely, when performing a hip replacement
with the R3 Acetabular System’s femoral components, do not mate them with the R3 metal
liner.” Id. ¶ 40 (emphasis omitted); see also id. ¶ 129(q), (s) (noting the individual components
of the R3 System “do not provide warnings to not use these device components with the R3
metal liner leading users to believe it is safe”). A warning against using the R3 metal liner with
the R3 System in a hip replacement procedure is undoubtedly a warning that “relates to the
safety or effectiveness” of the liner, regardless of whether the warning accompanies the liner or
another component. Allowing Plaintiffs to pursue a claim that the components of the R3 System
should have included such a warning would thus effectively impose a state-law requirement
“with respect to” the liner that is “different from, or in addition to,” the warnings the FDA
required. The Court therefore concludes such a claim is no different, for preemption purposes,
than a claim challenging the warnings accompanying the liner itself. Because the undisputed
facts show Plaintiffs’ negligence, strict liability, and breach of implied warranty claims are
had been using a BHR femoral component with an R3 metal liner can immediately switch to the
BHR acetabular component”).
25

preempted, judgment will be entered for S&N as to those claims (Counts I, III, and V). See
Simon, 18 F. Supp. 3d at 428-429 (holding strict liability, negligence, and breach of implied
warranty claims were preempted by § 360k(a) where the plaintiff alleged her injuries “were
caused by the ‘metal-on-metal’ interaction between the metal liner component and the R3
Acetabular System’s femoral head component,” such that the gravamen of the plaintiff’s
complaint was “that her injuries were caused by the [PMA-approved] metal liner”); cf. Bertini, 8
F. Supp. 3d at 256-57 (holding a claim based on S&N’s failure to warn that the R3 System’s
locking mechanism would not properly secure an R3 metal liner to the R3 shell was preempted
because the “interaction between the R3 metal liner and the R3 locking mechanism ma[de] it
impossible for plaintiffs to plead sufficient facts showing that the R3 locking mechanism, on its
own, caused their injuries”).
The MDA does not preempt claims for breach of express warranty as express warranties
“do not independently arise by operation of state law” and claims for breach of such warranties
thus “do[] not involve . . . state ‘requirement[s].’” Bentzley v. Medtronic, Inc., 827 F. Supp. 2d
443, 454-55 (E.D. Pa. 2011); accord Starks v. Coloplast Corp., No. 13-3872, 2014 WL 617130,
at *6 (E.D. Pa. Feb. 18, 2014). Under Pennsylvania law, “[a]ny affirmation of fact or promise
made by the seller to the buyer which relates to the goods and becomes part of the basis of the
bargain creates an express warranty that the goods shall conform to the affirmation or promise.”
13 Pa. Cons. Stat. § 2313. Because express warranties are specifically negotiated, “to create an
express warranty, the seller must expressly communicate the terms of the warranty to the buyer
in such a manner that the buyer understands those terms and accepts them.” Goodman v. PPG
Indus., Inc., 849 A.2d 1239, 1243 (Pa. Super. Ct. 2004), aff’d, 885 A.2d 982 (Pa. 2005).

26

The breach of express warranty claim in Plaintiffs’ Second Amended Complaint is based
on the wholly conclusory allegations that Defendants “expressly warranted that the R3
Acetabular System and components such as the R3 metal liner that foreseeably would be used
with it w[ere] safe and/or well accepted by users,” Second Am. Compl. ¶ 162, and “w[ere] safe
and fit for use for the purposes intended, . . . w[ere] of merchantable quality, . . . did not produce
any dangerous side effects, and . . . w[ere] adequately tested and fit for [their] intended use,” id.
¶ 167. S&N argues this claim is inadequately pleaded. The Court agrees. The Second Amended
Complaint does not identify the source of the warranty (i.e., whether it was made in a
publication, package insert, or advertising) and does not say how Mr. Shuker or Dr. Terefenko
became aware of it, much less how it became the basis of the bargain between Mr. Shuker and
S&N. Nor have Plaintiffs adequately described the content of the warranty, beyond agreeing at
oral argument they were not claiming Defendants expressly warranted that the R3 System was
safe for use in conjunction with the metal liner. See Oral Arg. Tr. 74. Because Plaintiffs have
failed to plead facts supporting a plausible inference that an express warranty was created, their
claim for breach of express warranty (Count IV) will be dismissed with prejudice pursuant to
Rule 12(b)(6). See Starks¸ 2014 WL 617130, at *7 (dismissing a breach of express warranty
claim where the plaintiff failed to “plead any details regarding the content of any express
warranty, how it was made, that it became the basis of the bargain, or that it was directed to
[plaintiff]”); Dougherty v. C.R. Bard, Inc., No. 11-6048, 2012 WL 2940727, at *9 n.15 (E.D. Pa.
July 28, 2012) (holding to plead a plausible breach of express warranty claim, a plaintiff must
allege such facts as “the specific source of the alleged warranty . . . and the specific statements
made”); Kester v. Zimmer Holdings, Inc., No. 10-523, 2010 WL 2696467, at *9-10 (W.D. Pa.

27

June 16, 2010) (dismissing a breach of express warranty claim based on the allegation that
defendants “expressly warranted that [their devices] were safe and well accepted by users”).
Plaintiffs’ remaining claims—their claim for negligence based on violations of FDA
regulations and FDCA provisions and their fraud claim—are premised on Defendants’ alleged
violations of federal law.23 As noted, because § 360k(a) preempts only those state requirements
with respect to a device that are “different from, or in addition to,” the federal requirements
applicable to the device, the statute “does not prevent a State from providing a damages remedy
for claims premised on a violation of FDA regulations,” as “the state duties in such a case
‘parallel,’ rather than add to, federal requirements.” Riegel, 552 U.S. at 330; see also Lohr, 518
U.S. at 495. While a parallel claim must be based on the manufacturer’s violation of federal law
in order to avoid express preemption, the claim must not arise “solely from the violation of
FDCA requirements,” lest it be impliedly preempted as an attempt to privately enforce the
FDCA. See Buckman, 531 U.S. at 352-53 (emphasis added). The claim must still be grounded
in a violation of state-law duty. See id. To plead a parallel claim successfully, a plaintiff’s
allegations must meet the plausibility standard articulated by the Supreme Court in Iqbal and
Twombly. See Bass v. Stryker Corp., 669 F.3d 501, 509 (5th Cir. 2012); Bausch, 630 F.3d at
558. The plaintiff must plead that the manufacturer failed to comply with federal law and that
this failure caused his injury. See Bass, 669 F.3d at 512.
In Count II of their Second Amended Complaint, Plaintiffs allege Defendants were
negligent in that they breached their duty “to comply with the [FDCA] and the regulations
23

As discussed below, Plaintiffs’ fraud claim is based on allegations that Defendants promoted
the sale of the R3 System in combination with the R3 metal liner without disclosing the known
risks associated with the combined use of the products. See Second Am. Compl. ¶¶ 183-85.
Because these allegations relate to off-label promotion, the Court construes Plaintiffs’ fraud
claim one based on Defendants’ violation of federal law.
28

promulgated pursuant to the Act” by violating a host of statutory and regulatory provisions. See
Second Am. Compl. ¶¶ 128-29. Although defendants devote twenty pages—approximately onethird of the Second Amended Complaint—to cataloging these alleged violations, they offer no
legal support for, or explanation of, most of the theories they seek to advance in their briefing of
S&N’s motion for summary judgment or their own motion for leave to amend. As a result, the
Court is left to parse a lengthy laundry list of FDCA provisions and FDA regulations.
The main parallel claim Plaintiffs seek to pursue is a claim based on Defendants’
promotion of the R3 metal liner for use off-label with the R3 System. See Pls.’ Summ. J. Opp’n
15-16; Pls.’ Mot. for Leave to Amend 10. A number of the allegations in Count II are directed to
off-label promotion. For example, Plaintiffs allege Defendants were negligent in “[p]roviding
false and misleading advertising” regarding the R3 metal liner by referring to the liner as
“optional” for the R3 system, thereby “creating the false impression that the R3 [A]cetabular
[S]ystem had a metal liner component that could be used safely in hip replacements,” in violation
of 21 U.S.C. §§ 352(q) and 331(a). Second Am. Compl. ¶ 129(r). Plaintiffs further allege
Defendants were negligent in providing false and misleading information regarding unapproved
uses of the R3 metal liner in hip replacement procedures, in violation of 21 C.F.R. §§ 99.101 and
99.103. See id. ¶ 129(x)-(ee); see also id. ¶ 129(gg). Off-label promotion is also the subject of
Plaintiffs’ fraud claim, which alleges Defendants received notice, “through studies, reports,
and/or experience,” that the metal-on-metal articulation of the R3 metal liner and the femoral
components of the R3 System was capable of producing “deleterious volumes of metallic
debris,” but nevertheless promoted the sale of the R3 System in combination with the R3 metal
liner without disclosing the risks associated with the combined use of the products. See id.
¶¶ 183-85.

29

As S&N acknowledges, and as numerous courts have recognized, off-label promotion
can be a basis for a nonpreempted parallel claim in some circumstances, as federal law has
generally been interpreted to prohibit off-label promotion, at least when it is false and
misleading. See Oral Arg. Tr. 44, 48 (agreeing that “in appropriate circumstances an off-label
promotion claim could go forward”); see also, e.g., Carson v. DePuy Spine, Inc., 365 F. App’x
812, 815 (9th Cir. 2010) (holding “the marketing and promotion of a Class III device for an
unapproved use violates Section 331 of the FDCA”); Schouest v. Medtronic, Inc., 13 F. Supp. 3d
692, 701-02 (S.D. Tex. 2014) (concluding that although federal law “does not expressly . . .
ban[] off-label promotion,” it does bar such promotion “when it is false or misleading”); cf. In re
Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 239-40 (3d Cir.
2012) (noting the FDCA “generally prohibits manufacturers from marketing, advertising, or
otherwise promoting drugs for . . . unapproved or ‘off-label’ uses”). The precise contours of
such a claim are not clear, as the law in this area is continuing to evolve.24

24

Many courts have held that state-law claims based on a manufacturer’s affirmative
misrepresentations in the course of promoting a device for off-label use—e.g., claims for fraud,
breach of express warranty, and negligent misrepresentation—are neither expressly nor
impliedly preempted. See, e.g., Schouest, 13 F. Supp. 3d at 703-05; Houston I, 957 F. Supp. 2d
at 1179-81. As the court in Schouest explained, such claims are not expressly preempted
because “making false or misleading statements about medical devices is prohibited by federal
law,” and are not impliedly preempted because they are rooted in “independent state law duties
that [the manufacturer] allegedly violated after the initial PMA process.” 13 F. Supp. 3d at 70305. While some courts have suggested claims based on omissions in the course of off-label
promotion may also escape preemption, see, e.g., Eidson v. Medtronic, Inc. (Eidson II), 40 F.
Supp. 3d 1202, 1228 (N.D. Cal. 2014) (holding fraudulent and negligent misrepresentation
claims challenging, inter alia, a manufacturer’s omission of information regarding known
dangers associated with the off-label use it was promoting were not preempted); Riley, 625 F.
Supp. 2d at 783-84 (suggesting a claim that, while engaging in off-label promotion, a
manufacturer failed to warn about the off-label use it was promoting might not be preempted),
other courts have disagreed, see, e.g., Schouest, 13 F. Supp. 3d at 705 (holding a negligent
misrepresentation claim was expressly preempted insofar as it was premised on the
manufacturer’s failure to disclose that the promoted off-label use of the device could cause
30

The Court need not determine the bounds of a permissible parallel claim based on offlabel promotion, however, as Plaintiffs have not pleaded facts supporting a plausible inference
that Defendants engaged in off-label promotion of the R3 metal liner that influenced the
selection of the liner for use in Mr. Shuker’s surgery.

While Plaintiffs allege Defendants

promoted and advertised the liner as “optional” for use with the R3 System, the only instance of
such promotion identified in the Second Amended Complaint is the February 2009 press release
in which S&N announced the introduction of “an optional ‘metal liner’ for the R3 Acetabular
System.”25 Second Am. Compl. ¶ 91; see also S&N’s Opp’n to Pls.’ Mot. for Leave to Amend
Ex. A (press release). It is not clear whether the press release amounts to off-label promotion.
While the press release describes the metal liner as an “option” for the “R3 Acetabular System,
an advanced multi-bearing acetabular cup system used in hip replacement and resurfacing
procedures,” it discloses that the FDA approved the metal liner “for use with the
injuries); Hawkins, 2014 WL 346622, at *15 (holding a claim for failure to provide adequate
warnings during off-label promotion was expressly preempted).
25

Plaintiffs also allege Defendants engaged in off-label promotion by publishing an R3
Acetabular System brochure that describes the surgical technique for inserting the metal liner
with the R3 Acetabular System, even though the FDA never approved the metal liner for use
with the R3 System. See Second Am. Compl. ¶¶ 60-66. The brochure itself—which is included
in Plaintiffs’ summary judgment exhibits—belies these allegations. The cover page to the
brochure bears the heading, “Poly up to 44 mm heads,” a reference to the poly liner that received
§ 510(k) clearance as part of the R3 System, and the brochure goes on to describe the procedure
for inserting only a poly (or XLPE) liner into the R3 acetabular shell. See Pls.’ Summ. J. Ex. A
at 13167-90. Plaintiffs seize on the fact that the page of the brochure focused on “R3 acetabular
liner insertion” includes a paragraph setting forth certain procedures to be followed “[b]efore
inserting the R3 acetabular liner,” then specifies further instructions “[f]or XLPE liner
insertion,” arguing the reference to the “R3 acetabular liner” constitutes off-label promotion of
the R3 metal liner for use with the R3 System. See id. at 13175 (emphasis added). This
interpretation is not plausible. While it is possible the paragraph regarding the procedures to be
followed before inserting the R3 acetabular liner includes information generic to all liners of the
R3 System, the brochure nowhere mentions the R3 metal liner, and nothing in it suggests it is
directed to anything other than the technique for inserting the R3 shell and poly liner. That the
brochure is directed to the poly liner is underscored by the six pages it devotes to cataloging
S&N’s various poly liner options. See id. at 13176-77, 13179-80, 13182-83.
31

BIRMINGHAM HIPTM Resurfacing . . . System.” S&N’s Opp’n to Pls.’ Mot. for Leave to
Amend Ex. A. The press release does not represent the metal liner was approved for use in hip
replacement procedures, but states, with respect to hip replacements, that “[s]ince March 2008,
the R3 system has been fitted with cross-linked polyethylene (XLPE) liners for use in total hip
replacement cases, and Smith & Nephew this week received FDA approval of its ceramic liner
option.” Id. Nevertheless, even assuming the press release is misleading in referring to the liner
as an option for use with the R3 System, which, in the United States, “is a total hip replacement
system component,” Pls.’ Summ. J. Ex. B, the Second Amended Complaint alleges no facts
suggesting Dr. Terefenko or Mr. Shuker were even aware of the press release, much less that the
representations in the press release led to Dr. Terefenko’s use of the metal liner in Mr. Shuker’s
surgery. Although Plaintiffs cite Dr. Terefenko’s surgical notes as “allud[ing] to” Defendants’
promotional efforts, the surgical notes indicate only that Dr. Terefenko and Mr. Shuker agreed “a
metal-metal articulation [wa]s appropriate” for Mr. Shuker, in light of his “body habitus and his
activity level.” Second Am. Compl. ¶ 55. The notes say nothing about how Dr. Terefenko came
to select Smith & Nephew components for Mr. Shuker’s surgery. Further, insofar as Plaintiffs
seek to pursue a fraud claim based on off-label promotion, they have not pleaded this claim
within anywhere near the particularity required by Federal Rule of Civil Procedure 9(b). See
Fed. R. Civ. P. 9(b) (“In alleging fraud . . . , a party must state with particularity the
circumstances constituting fraud.”); Houston I, 957 F. Supp. 2d at 1180 (dismissing fraud claims
based on off-label promotion with leave to amend where the plaintiff failed to allege, inter alia,
“to whom [the allegedly fraudulent misrepresentations] were made[,] . . . which parts of the
misrepresentations were misleading, and why they [we]re false”). Accordingly, Plaintiff’s fraud

32

claim (Count VI) and Count II, insofar as it is based on off-label promotion, will be dismissed.
The Court will, however, grant Plaintiffs leave to amend as to these claims.
Plaintiffs also seek to pursue a parallel claim based on Defendants’ failure to report
adverse events associated with use of the R3 metal liner in hip replacement procedures to the
FDA, in violation of 21 U.S.C. § 360i, 21 C.F.R. § 803.50, and other FDA regulations. See
Second Am. Compl. ¶ 129(f), (m)-(p), (jj). The Fifth and Ninth Circuits have held that state-law
failure-to-warn claims based on similar allegations are not preempted. In Hughes v. Boston
Scientific Corp., 631 F.3d 762, 770-71 (5th Cir. 2011), the Fifth Circuit held a claim that a
device manufacturer violated its duty to warn under Mississippi law by failing to accurately
report serious injuries and malfunctions of its device, as required under federal law, was a
nonpreempted parallel claim. Likewise, in Stengel v. Medtronic, Inc., 704 F.3d 1224, 1232-33
(9th Cir. 2013) (en banc), the Ninth Circuit held a claim that a device manufacturer breached a
duty to use reasonable care under Arizona negligence law by failing to perform its federal-law
duty to warn the FDA of adverse events involving its device was not preempted where Arizona
tort law “include[d] a cause of action for failure to warn” and “contemplate[d] a warning to a
third party such as the FDA.” The Eighth Circuit has taken a different view, holding a claim that
a device manufacturer “did not timely file adverse event reports, as required by federal
regulations,” was “an attempt by private parties to enforce the MDA” and was therefore
impliedly preempted under Buckman. In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab.
Litig., 623 F.3d 1200, 1205 (8th Cir. 2010).
S&N argues this claim is inadequately pleaded because Plaintiffs do not specify the
adverse events Defendants failed to report and do not allege how the reports would have reached
Dr. Terefenko and changed his treatment decision. S&N also argues the claim is factually

33

implausible because Mr. Shuker’s surgery occurred only two months after the R3 metal liner was
released in the United States, and it is virtually impossible that adverse events could have
occurred, been reported to the FDA, and found their way to Dr. Terefenko in sufficient numbers
to have affected his treatment decision during this narrow two-month window. As to S&N’s
factual implausibility argument, it not clear that the February 2009 United States launch date for
the R3 metal liner is the appropriate starting point for Defendants’ duty to report adverse events.
Although the metal liner was not released in the United States until February 2009, it received
“approval in Europe for market evaluation in January 2007 and for full launch in December
2007, and it was included on the Australian Register of Therapeutic Goods in January 2007.”
S&N’s Opp’n to Pls.’ Mot. for Leave to Amend Ex. C. At oral argument, Plaintiffs argued the
reportable adverse events were not limited to experience with the R3 metal liner in the United
States, noting the recall of the liner was based on “information globally coming back to Smith &
Nephew in the UK.” Oral Arg. Tr. 82-83. While S&N maintained “the clock started running
again” for purposes of the company’s reporting obligations when the liner received premarket
approval, see id. at 97, the FDA granted premarket approval in November 2008, some six
months before Mr. Shuker’s April 2009 surgery.
The Court agrees, however, that Plaintiffs have failed to plead sufficient facts to render
their claim plausible.

Even if Plaintiffs need not “specify” the particular adverse events

Defendants allegedly failed to report, there must be some factual basis from which it can
plausibly be inferred that such events occurred and that Defendants failed to report them during
the six-month window in question. The fact that Defendants recalled the R3 metal liner in June
2012 based on data indicating the liner was not performing satisfactorily within the R3 System
supports a plausible inference that Defendants became aware of adverse events involving the

34

liner prior to June 2012, but there is nothing in the Second Amended Complaint to suggest that
Defendants failed to report such events to the FDA at any point, much less prior to Mr. Shuker’s
surgery in April 2009. Cf. Stengel, 704 F.3d at 1227 (allegations that device manufacturer failed
to report adverse events to the FDA included the allegation that FDA sent a warning letter to the
manufacturer two years after plaintiff became paralyzed, stating the manufacturer had
misbranded its device by concealing known risks). Plaintiffs have likewise failed to plead facts
supporting a plausible inference that had the undisclosed adverse events been reported to the
FDA during the six-month window in question, information about those events would have
reached Dr. Terefenko in time to prevent Mr. Shuker’s injuries. Plaintiffs allege only that had
Defendants properly reported all adverse events, “Defendants or the FDA would have taken
corrective action,” see Second Am. Compl. ¶ 129(m)-(p), but this is precisely the sort of
conclusory allegation the Fifth Circuit found “entirely speculative” in Hughes. See 631 F.3d at
776 n.12 (rejecting plaintiff’s theory that had the manufacturer properly reported all adverse
events, the FDA would have taken some regulatory action against the device). 26 For these
reasons, Plaintiffs’ parallel claim based on Defendants failure to report adverse events to the
FDA will be dismissed with prejudice.
A number of the allegations in Count II are directed to the labeling for the R3 metal liner
and/or the components of the R3 System, which Plaintiffs assert was insufficient to alert
physicians and patients to the dangers of using the R3 metal liner with the components of the R3
System in a total hip replacement. See Second Am. Compl. ¶ 129(i)-(j), (q), (s)-(v), (hh).
Although couched as violations of federal law, these allegations are directed to the FDA-

26

Plaintiffs’ allegations regarding Defendants’ failure to investigate and take appropriate
corrective action with respect to complaints and returned components suffer from similar
deficiencies. See Second Am. Compl. ¶ 129(e), (g).
35

approved labeling for the R3 liner, which Defendants were precluded from changing without
prior FDA approval. Any claim based on these allegations is therefore expressly preempted. See
Hughes, 631 F.3d at 769 (holding state-law claims that “would question the sufficiency of the
FDA-approved labeling, warnings, and instructions for [a PMA-approved medical device] or
require [the manufacturer] to have included different warnings, labels, or instructions with the
device” were expressly preempted); In re Medtronic, Inc., 623 F.3d at 1205 (holding claim that a
device manufacturer failed to adequately warn consumers of known defects in its device was
preempted by § 360k(a) where plaintiffs “did not allege [the manufacturer] modified or failed to
include FDA-approved warnings”); Horn, 376 F.3d at 177 & n.22 (holding a claim “premised on
the adequacies of the warnings reviewed and approved by the FDA in its PMA approval order”
was preempted). Plaintiffs elsewhere allege Defendants violated 21 C.F.R. § 1.21 by issuing
“brochures, inserts and other materials at variance with what the FDA approved,” but they
provide no explanation of any such deviation. See Second Am. Compl. ¶ 129(ii).
The remaining allegations in Count II are difficult to categorize and, in many instances,
incomprehensible to the Court. For example, Plaintiffs allege Defendants failed to identify,
capture, and/or correct the “component discrepancy,” in violation of 21 C.F.R. § 820.80, but do
not explain what this term, which does not appear in the cited regulation, refers to. See Second
Am. Compl. ¶ 129(c)-(d). It is not clear whether this allegation is directed to a manufacturing
defect or some other problem, and insofar as Plaintiffs seek to assert a claim based on a
manufacturing defect, it is not clear what facts support the inference that the R3 metal liner
implanted in Mr. Shuker was not manufactured in accordance with federal requirements. While
the liner was recalled, Plaintiffs do not plead facts suggesting the recall was associated with a
manufacturing problem. See id. ¶¶ 100-02 (alleging the recall was based on data indicating the

36

metal liner was not performing satisfactorily within the R3 System); cf. Bausch, 630 F.3d at 559
(holding a plaintiff had pleaded a plausible parallel manufacturing defect claim where the
complaint alleged the device was implanted in the plaintiff’s body six days after the FDA
informed the manufacturer that a device component was “adulterated due to manufacturing
methods . . . not in conformity with industry and regulatory standards” and where the implanted
device was later recalled). The Court likewise concludes any remaining allegations in Count II
are insufficient to state a plausible parallel claim.
Having considered S&N’s arguments for summary judgment and/or dismissal as to
Plaintiffs’ Second Amended Complaint, the Court concludes the claims set forth therein are
either preempted (Counts I, III, and V, and Count II insofar as it challenges the FDA-approved
labeling for the PMA-approved R3 metal liner) or fail to state a claim upon which relief can be
granted (Counts IV and VI, and the balance of Count II). Accordingly, the Second Amended
Complaint will be dismissed.27 The Court will, however, grant Plaintiffs leave to amend as to
their claims based on off-label promotion.
An appropriate order follows.

BY THE COURT:

/s/ Juan R. Sánchez
Juan R. Sánchez, J.

27

.

The dismissal also extends to Count VII, Plaintiffs’ claim for loss of consortium, which is
derivative of their other claims.
37