Robert Perez, et al v. Nidek Co., Ltd., et al

Filing

FILED OPINION (STEPHEN S. TROTT, ANDREW J. KLEINFELD and M. MARGARET MCKEOWN) AFFIRMED. Judge: MMM Authoring. FILED AND ENTERED JUDGMENT. [8562148]

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FOR PUBLICATION

UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
ROBERT PEREZ; NANCY ART ; BRETT
HARBACH , on behalf of themselves
and all others similarly situated,
Plaintiffs-Appellants,

No. 10-55577
D.C. No.
3:08-cv-01261BTM-JMA

v.
NIDEK CO ., LTD .; NIDEK
INCORPORATED ; NIDEK
TECHNOLOGIES INCORPORATED ;
MANJOV V. MOTWANI, M.D.; GARY
M. KAWESCH , M.D.; LINDA VU , M.D.;
JOSEPH LEE, M.D.; FARZAD
YAGHOUTI, M.D.; RANDA M.
GARRANA , M.D.; THOMAS S. TOOMA ,
M.D.; PAUL C. LEE, M.D.; KEITH
LIANG , M.D.; ANTOINE L. GARABET ,
M.D.; WILLIAM ELLIS, M.D.; GREGG
FEINERMAN , M.D.; MICHAEL ROSE,
M.D.; JOHN KOWNACKI, M.D.;
STEVEN MA , M.D.; ESTATE OF GLENN
A. KAWESCH , M.D.; TLC VISION
CORPORATION , DBA TLC Laser Eye
Center, Inc.; CALIFORNIA CENTER FOR
REFRACTIVE SURGERY , a medical
corporation; LASER EYE CENTER
MEDICAL OFFICE , INC.; SOUTHWEST
EYE CARE CENTER INC.; DOES, 1
through 1000, inclusive,
Defendants-Appellees.

OPINION

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Appeal from the United States District Court
for the Southern District of California
Barry T. Moskowitz, District Judge, Presiding
Argued and Submitted
October 10, 2012—Pasadena, California
Filed March 25, 2013
Before: Stephen S. Trott, Andrew J. Kleinfeld, and
M. Margaret McKeown, Circuit Judges.
Opinion by Judge McKeown

SUMMARY*

Medical Law
The panel affirmed the district court’s dismissal of a
complaint brought by patients who suffered no injuries but
who were subject to the off-label use of a medical device for
eye surgeries, where the Food and Drug Administration status
of the device was not disclosed to the patients.
The panel held that the complaint did not state a claim
under the California Protection of Human Subjects in Medical
Experimentation Act because the surgeries were not “medical
experiments” subject to the protection of the Act. The panel
also held that plaintiff Robert Perez did not have standing to
*

This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.

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sue for injunctive relief under the California Consumers
Legal Remedies Act, and his other substantive claim—a
common law fraud by omission claim—was preempted by the
Federal Food, Drug, and Cosmetic Act. The panel held that
the claim of omission was expressly preempted by the
preemption provision in the Medical Device Amendments;
and even if it were not, it was impliedly preempted because
it amounted to an attempt to privately enforce the Food, Drug
and Cosmetic Act.

COUNSEL
James Richard Patterson, Patterson Law Group, APC, San
Diego, California; Duane A. Admire, Admire & Associates,
Del Mar, California; Alisa Ann Martin, Harrison Patterson &
O’Connor LLP, San Diego, California; Gene Joseph
Stonebarger, Stonebarger Law, Folsom, California; and Jon
R. Williams, Boudreau Williams, LLP; San Diego,
California, for Plaintiff-Appellants.
Thomas S. Arthur and Thomas M. Robins, III, Frandzel
Robins Bloom & Csato, Los Angeles, California, for
Defendant-Appellee Nidek, Inc.
James J. Wallace, II, La Follette Johnson De Haas Fesler &
Ames, APC, San Diego, California, for Defendants-Appellees
Manjov V. Motwani, M.D., and Keith Liang, M.D.
Lisa W. Cooney, Rita R. Kanno, and John Takashi Tsumura,
Lewis Brisbois Bisgaard & Smith LLP, San Diego,
California, for Defendant-Appellee Gary M. Kawesch, M.D.

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Gregory Dale Werre, Bonne, Bridges, Mueller, O’Keefe &
Nichols, Los Angeles, California, for Defendants-Appellees
William Ellis, M.D., Gregg A. Feinerman, M.D., Randa M.
Garrana, M.D., Joseph Lee, M.D., and Linda Vu, M.D.
Gabriel Michael Benrubi, Belsky & Associates, San Diego,
California; and Matthew Levinson, Cole Pedroza, LLP,
Pasadena, California, for Defendants-Appellees Estate of
Glenn A. Kawesch, M.D., and Farzad Yaghouti, M.D.
Albert E. Cressey, III, Reback, McAndrews, Kjar, Warford &
Stockalper, Manhattan Beach, California, for DefendantAppellee Thomas S. Tooma, M.D.
H. Steven Schiffres, Rosoff, Schiffres & Barta, Los Angeles,
California, for Defendant-Appellee Michael Rose, M.D.
Gregory M. Hulbert, Gonzalez and Hulbert, LLP, Glendale,
California, for Defendant-Appellee John Kownacki, M.D.

OPINION
McKEOWN, Circuit Judge:
We are asked to decide whether patients who suffered no
injuries but who were subject to the off-label use of a medical
device for eye surgeries may bring suit solely because the
Food and Drug Administration (“FDA”) status of the device
was not disclosed to them. The Third Amended Complaint
(“the Complaint”) does not state a claim under the California
Protection of Human Subjects in Medical Experimentation
Act (“the Human Subjects Act”) because the surgeries were
not “medical experiments” subject to the protection of the

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Act. Robert Perez does not have standing to sue for
injunctive relief under the California Consumers Legal
Remedies Act (“CLRA”), and his other substantive claim is
preempted by the Federal Food, Drug, and Cosmetic Act
(“FDCA”). We affirm the district court’s dismissal of the
Complaint.
BACKGROUND 1
Robert Perez, Nancy Art, and Brett Harbach (collectively,
“Perez”) each sought and received Laser in Situ
Keratomileusis (“LASIK”) eye surgery with a Nidek EC5000 Excimer Laser System (“the Laser”) to correct
farsightedness. They claim that, at the time of their surgeries,
they did not know the FDA had not approved the Laser for
this use. According to the Complaint, had they known, they
would not have consented to the surgeries.
Perez sued on behalf of himself and a class of similarly
situated individuals who received hyperopic surgery (surgery
to correct farsightedness) with the Laser between February
1996 and October 2006. Perez does not allege any injury
stemming from surgery. Nor does Perez claim that his or any
other surgery was ineffective. Instead, he asserts claims
under the Human Subjects Act and the CLRA, as well as
common-law claims of fraud by omission, civil conspiracy,
and aiding and abetting. Perez brought these claims against
various Nidek corporate entities (“Nidek”), named and
unnamed physicians who allegedly used the Laser for
unapproved purposes on individuals in the purported class

1

This background is taken from the factual allegations in the Complaint,
which we treat as true for purposes of evaluating the motion to dismiss.
See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).

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(“Physician Defendants”), named and unnamed medical
centers where these procedures were allegedly performed,
and other unnamed persons and entities who allegedly
participated in the conduct at issue. Of the named Physician
Defendants, only two performed LASIK surgery on the
named plaintiffs.
The Laser is a Class III medical device under the FDCA,
as amended by the Medical Device Amendments of 1976
(“MDA”). 21 U.S.C. § 360c. For that reason, Nidek was
required to get premarket approval (“PMA”) from the FDA
before it could sell or distribute the Laser. 21 U.S.C. § 360e.
Between 1998 and 2000, Nidek obtained three PMAs for
treating nearsightedness with the Laser, but the Laser was not
approved for treating farsightedness until October 2006. The
PMAs restricted the Laser from being used for hyperopic
corrections outside of approved investigations. During the
class period, use of the Laser for farsightedness was being
investigated in FDA-approved clinical trials, which required
full disclosure of the device’s experimental use and informed
consent from patients receiving treatment.
Perez alleges that the defendants engaged in a nationwide
scheme to modify the approved Laser to enable it to correct
farsightedness before it was approved for that purpose. He
claims that Physician Defendants used the modified Lasers to
perform hyperopic surgeries without informing patients that
the Laser was not approved for that use outside of approved
clinical trials, and that Nidek knew about the improper use of
the Laser. Perez further alleges that the defendants conspired
and aided and abetted each other in their unlawful conduct.
The FDA was aware of claims that the Laser was being
put to unauthorized uses, and it took steps to halt abuses. In

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late 2000, the FDA sent Nidek a letter expressing concern
that chips in Laser units were being replaced with chips that
enable the device for “unapproved applications, such as
hyperopia.” The letter addressed allegations that Nidek
employees were providing the replacement chips and that
Nidek had fired at least one employee for doing so. It also
noted that Nidek had waited several months after becoming
aware that some Lasers had been tampered with before
reporting the problem, in violation of the PMA conditions.
In 2001, the FDA sent two sets of warning letters to
certain physicians after an investigator determined that the
Lasers they were using for hyperopia were manufactured
before Nidek’s PMA was effective and that the Lasers
contained software not approved for commercial distribution
in the United States. The first letter stated, “Because an
approved PMA or an approved IDE [Investigational Device
Exemption] does not cover this laser, it is adulterated within
the meaning of the Act. Therefore, you should not be using
this laser to treat patients.” The second letter reiterated the
information in the first letter and added that the modified
lasers needed to be certified as in compliance with the federal
laser product performance standard. In addition, the FDA
published an Import Alert addressing the problem of Lasers
with software not approved under the PMAs.
Perez alleges that, “[d]espite these actions by [the] FDA,
Defendants continued to sell, distribute, lease, use, service,
and market the Lasers in the United States with the capacity
to perform hyperopic procedures.” He alleges that Nidek
“continued to install, service and enable the Lasers to perform
hyperopic corrections outside of sanctioned clinical trials”
and that Nidek falsified many service records indicating that
it had removed the software. In October 2006, the Laser was

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approved for hyperopic use with improved and updated
software and treatment parameters.
ANALYSIS
I. STANDING
Perez sued two groups of doctors: the two doctors who
performed surgery on the named plaintiffs, and named and
unnamed doctors who performed no surgery on the named
plaintiffs, but who allegedly performed surgery on other
individuals in the proposed class. With respect to the first
group, standing is not at issue, but the second group raises a
serious standing question.2 See Easter v. Am. W. Fin.,
381 F.3d 948, 961–62 (9th Cir. 2004) (holding that borrowers
of second mortgage loans had no standing to sue those
investment trusts that did not hold a named plaintiff’s note
because they could not trace the alleged injury in fact to those
defendants’ actions).
Perez apparently endeavors to sidestep the traceability
hurdle for the second group of doctors through his allegations
of conspiracy and aiding and abetting. A look at those
allegations reveals virtually nothing because they are no more
than conclusory and bare bones words and phrases without
any factual content. Such vacuous claims are insufficient to
establish standing or to survive a motion to dismiss. See
Lujan, 504 U.S at 561 (explaining that the elements of
standing “must be supported in the same way as any other

2

Although Perez, as the party invoking federal jurisdiction, has the
burden of establishing Article III standing, Lujan v. Defenders of Wildlife,
504 U.S. 555, 561 (1992), he did not respond to the argument that he had
no standing to sue the second group of doctors.

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matter on which the plaintiff bears the burden of proof, i.e.,
with the manner and degree of evidence required at the
successive stages of the litigation”); Iqbal, 556 U.S. at 678
(“To survive a motion to dismiss, a complaint must contain
sufficient factual matter, accepted as true, to ‘state a claim to
relief that is plausible on its face.’” (citation omitted)).
Because Perez’s substantive claims fail, amendment
would be futile. For the same reason, we do not need to reach
the more difficult chicken-and-egg question of whether class
certification should be decided before standing. See Easter,
381 F.3d at 962 (explaining that the district court correctly
addressed standing before class certification and that Ortiz v.
Fibreboard Corp., 527 U.S. 815 (1999), “does not require
courts to consider class certification before standing”).
Nor does Perez have standing to sue any of the defendants
under the CLRA. The Complaint requests only injunctive
relief under that statute. Perez has not demonstrated that he
faces “a real or immediate threat of an irreparable injury.”
Hangarter v. Provident Life & Acc. Ins. Co., 373 F.3d 998,
1021 (9th Cir. 2004) (emphasis in original) (citation and
internal quotation marks omitted); see also Los Angeles v.
Lyons, 461 U.S. 95, 105 (1983). Perez does not allege that he
intends to have further hyperopic surgery and, more
importantly, the Laser has been approved for hyperopic use
since 2006. No post-2006 conduct is alleged. Although the
district court dismissed the CLRA claim on the basis of
preemption, we affirm on the alternate ground of standing,
which is a threshold determination. See Thompson v. Paul,
547 F.3d 1055, 1058–59 (9th Cir. 2008) (explaining that we
can affirm a dismissal under Rule 12(b)(6) “on any ground
supported by the record”); Bates v. United Parcel Serv., Inc.,

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511 F.3d 974, 985 (9th Cir. 2007) (en banc) (“Standing is a
threshold matter central to our subject matter jurisdiction.”).
II. CALIFORNIA PROTECTION OF HUMAN SUBJECTS IN
MEDICAL EXPERIMENTATION ACT (“HUMAN SUBJECTS
ACT”) CLAIM
The California legislature enacted the Human Subjects
Act “to provide minimum statutory protection for the citizens
of [the] state with regard to human experimentation and to
provide penalties for those who violate such provisions.”
Cal. Health & Saf. Code § 24171. The Act lays out detailed
guidelines for informed consent, which is required before a
person can be “subjected to any medical experiment.” Id.
§ 24175(a); see id. § 24173. For purposes of the informed
consent provisions, “medical experiment” is defined as
follows:
(a) The severance or penetration or damaging
of tissues of a human subject or the use of a
drug or device, as defined in Section 109920
or 109925, electromagnetic radiation, heat or
cold, or a biological substance or organism, in
or upon a human subject in the practice or
research of medicine in a manner not
reasonably related to maintaining or
improving the health of the subject or
otherwise directly benefiting the subject.
(b) The investigational use of a drug or device
as provided in Sections 111590 and 111595.
(c) Withholding medical treatment from a
human subject for any purpose other than

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maintenance or improvement of the health of
the subject.
Id. § 24174. Perez’s claims do not fit the definition of
“medical experiment” under either provision at issue
here—§ 24174(a) or § 24174(b).
A. SECTION 24174(a)
As to § 24174(a), there is no dispute that the laser eye
surgeries involved the use of a device upon a human subject.
Where the parties disagree is whether the surgeries were
performed “in the practice . . . of medicine in a manner not
reasonably related to maintaining or improving the health of
the subject or otherwise directly benefiting the subject.”3
Only one published California case has addressed the
interpretation of “medical experiment” under § 24174(a).
Trantafello v. Medical Center of Tarzana, 182 Cal. App. 3d
315, 320 n.2 (Cal. Ct. App. 1986). In Trantafello, an
orthopedic surgeon implanted a piece of acrylic in
Trantafello’s neck to fill the space once occupied by a
removed cervical disk. Id. at 318. The surgeon did not
advise Trantafello that he planned to use an acrylic implant or
that this was an innovative procedure not generally accepted
in the United States. Id. at 319. In holding that the patient
could not rely on the Human Subjects Act to extend the
statute of limitations for his medical malpractice claim, the
court stated in a footnote that the Act was “irrelevant” to

3

W ith regard to this and other claims, Nidek raises defenses that are
unique to its corporate entities. Because we hold that Perez’s claims fail
on grounds common to all of the defendants, we do not address Nidek’s
other arguments.

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Trantafello’s claim because the Act “deals with experiments
on human subjects in the course of pure research. . . . Here
[the doctor] used the acrylic implant not in the course of a
medical research program but in a course of therapeutic
treatment for plaintiff.” Id. at 320 n.2 (emphasis added).
Perez quibbles with Trantafello’s restriction of the Act to
experiments done in the course of pure research. According
to Perez, “the fact that a procedure is meant to impart some
benefit to a patient does not mean that it cannot also
constitute a ‘medical experiment’ under the Act.” Without
deciding whether there is any more play in the joints of
§ 24174(a) than Trantafello signals, the eye surgeries fell well
outside the scope of subsection (a). Perez alleges that the
procedures were undertaken “to attempt to correct []
farsightedness.” Perez admits that the surgeries had a
therapeutic purpose. He does not claim that this therapeutic
purpose was merely incidental to a broader research goal—in
fact, he does not claim that there was any research goal
whatsoever. Without doubt, the hyperopic surgeries at issue
here were “reasonably related” to “improving [Perez’s]
health” and “directly benefiting” him. See § 24174(a).
Perez is unable to explain why his broad definition of
“medical experiment” would not swallow up all off-label use.
As the Supreme Court has recognized, “‘off-label’ usage of
medical devices . . . is an accepted and necessary corollary of
the FDA’s mission to regulate [in the area of medical devices]
without directly interfering with the practice of medicine.”
Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341,
350 (2001). The legislative history of the Human Subjects
Act reflects that California purposefully excluded therapeutic
off-label use from the scope of § 24174. The Assembly Bill
originally included off-label use and the use of a drug or

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device for which an application had been denied or
withdrawn by the FDA or the California Department of
Health as falling within the definition of “medical
experiment.” A.B. 1752, Assemb. Reg. Sess. (Cal. 1977–78)
[revisions to AB 1752 as amended in Assembly, May 23,
1977] at 7; Assembly member Herschel Rosenthal, Letter to
Governor Edmund G. Brown, Jr., re Assemb. Bill No. 1752
(1977–78 Reg. Sess.), June 28, 1978, at 2 [“Rosenthal
Letter”]. Those provisions were deleted before the bill
became law, at least in part in response to the California
Medical Association’s opposition to the bill. Rosenthal
Letter 2.
Perez’s remaining arguments—that the eye surgeries were
not “reasonably related” to improving the proposed class
members’ health because the doctors performed the surgeries
“to line their own pockets” and because the surgeries were
elective—are unpersuasive. Both arguments attempt to
import requirements into § 24174(a) that are not found in the
text and have nothing to do with medical experimentation.
The standard under § 24174(a) is objective, not subjective;
the doctors’ alleged motivations do not come into play. Nor
does the statute embody any requirement of altruism. A
doctor’s desire to profit from a procedure hardly transforms
that procedure from therapeutic to experimental. Finally, the
elective nature of a procedure is not a component of the
statutory definition. Many elective surgeries are performed
to improve the patient’s health. The term often is used
merely to distinguish emergency procedures from those that
can be scheduled at the convenience of doctor and patient.4

4

The medical dictionary available through M edlinePlus, a service of the
U.S. National Library of Medicine and the National Institutes of Health,
defines “elective” as “beneficial for the patient but not necessary for

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And even elective surgery that is not health related may be
“reasonably related” to “directly benefiting” a patient. For
example, elective cosmetic surgery that ostensibly has no
health component, that is solely undertaken for aesthetic
reasons, and that may be lucrative for certain physicians
nonetheless may be performed to benefit a patient and thus
fall outside of the Act. Perez is unable to advance a rationale
that places these LASIK surgeries within the requirements of
the Human Subjects Act.
B. SECTION 24174(b)
The term “medical experiment” also includes, under
§ 24174(b), the “investigational use of a drug or device as
provided in Sections 111590 and 111595.” These latter
referenced sections, respectively, govern investigations,
commonly dubbed clinical trials, conducted in accordance
with the requirements of the FDCA, and investigations
conducted under conditions specified by state law.
Perez does not claim that he or any proposed class
member was part of a clinical trial or that Physician
Defendants performed their surgeries under the conditions
specified in § 111595 (such as submitting reports to the state
Department of Health Services). With respect to this claim,
Perez’s undoing is that he affirmatively pled that he and the
proposed class members were not participants in officially
sanctioned clinical trials. The defendant doctor class is
defined as “[a]ll physicians who performed Hyperopic
LASIK and/or PRK in California with the Nidek Laser during

survival”— for example, “an elective appendectomy.” Elective Definition,
MedlinePlus, http://www.merriam-webster.com/medlineplus/elective (last
visited Mar. 13, 2013).

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the Class Period, other than during an approved FDA clinical
trial.” According to the Complaint, those “Defendants knew
and understood that the Lasers were being used on Plaintiffs
and the Class without their informed consent to be subjected
to the investigational use of the Laser, and without including
them in a sanctioned clinical trial.” Perez cannot argue both
that he was not included in clinical trials and that the
procedure falls under the clinical trial provisions of the
Human Subjects Act. See Huntman v. Danek Medical, Inc.,
No. 97-2155-IEG (RBB), 1998 WL 663362, at *6–*7 (S.D.
Cal. July 24, 1998) (explaining that because there was no
evidence that the plaintiff was part of an Investigational
Device Exemption, the defendant did not need to comply with
the informed consent provisions of the IDE regulations).
Perez’s allegation that the “Laser was being
investigated . . . under FDA approved clinical trials by both
NIDEK and independent physician groups” during the class
period does not convert his own surgery—which falls outside
of the provisions of sections 111590 and 111595—into part
of a clinical trial. For this reason, Perez’s reliance on Daum
v. Spinecare Medical Group, Inc., 52 Cal. App. 4th 1285
(Cal. Ct. App. 1997), is misplaced. The plaintiff in Daum
was part of a clinical investigation conducted under the
requirements of the FDCA. Id. at 1308.
Although Perez may find it “perverse and inequitable,” as
he puts it, to provide patients admitted to clinical trials with
“more protection than those who are subjected to the same
experimental procedures outside the gaze of the FDA,”
§ 24174(b), by its terms, applies only to investigations
conducted under the requirements of the FDCA or state law.
Perez was not subject to the “investigational use” of a device
within the meaning of § 24174(b).

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III.

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FRAUD BY OMISSION CLAIMS

Perez also alleges a common-law fraud by omission
claim. The theory is that the defendants misled the proposed
class by failing to disclose that the Laser was not FDA
approved for hyperopic surgeries, even though Nidek and the
doctors knew or should have known that the proposed class
members believed the Laser was FDA approved for such
surgeries. This claim of omission is expressly preempted by
the preemption provision in the Medical Device Amendments
(“MDA”). Even if it were not, it is impliedly preempted
because it amounts to an attempt to privately enforce the
FDCA.
A. EXPRESS PREEMPTION
The FDCA has long provided for premarket approval of
new drugs. Medtronic, Inc. v. Lohr, 518 U.S. 470, 475
(1996). Before 1976, states were left to supervise the
introduction of new medical devices. See Riegel v.
Medtronic, Inc., 552 U.S. 312, 315 (2008). California was
among a number of states that adopted regulatory measures
governing devices. Id. In 1976, Congress enacted the
Medical Device Amendments to the FDCA, which “swept
back some state obligations and imposed a regime of detailed
federal oversight.” Id. at 316. These amendments include an
express preemption provision:
Except as provided in subsection (b) of this
section, no State or political subdivision of a
State may establish or continue in effect with
respect to a device intended for human use
any requirement—

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(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.
21 U.S.C. § 360k(a). An implementing regulation provides
that state and local requirements are only preempted by the
MDA when the FDA “has established specific counterpart
regulations or there are other specific requirements applicable
to a particular device under the act, thereby making any
existing divergent State or local requirements applicable to
the device different from, or in addition to, the specific Food
and Drug Administration requirements.”
21 C.F.R.
§ 808.1(d).
A trio of Supreme Court cases address preemption under
the MDA: Lohr, Buckman, and Riegel. Lohr and Riegel
involved the MDA’s express preemption provision, and
Buckman involved implied preemption. As we explained in
a recent en banc decision, the “rule that emerges from these
cases is that the MDA does not preempt a state-law claim for
violating a state-law duty that parallels a federal-law duty
under the MDA.” Stengel v. Medtronic, Inc., 704 F.3d 1224,
1228 (9th Cir. 2013) (en banc).
In Lohr, the Court held that plaintiffs’ common-law
claims stemming from a pacemaker failure were not
preempted under § 360k. The allegations included claims
that Medtronic had violated FDA regulations, and “[n]othing
in § 360k denies Florida the right to provide a traditional

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damages remedy for violations of common-law duties when
those duties parallel federal requirements.” 518 U.S. at 495
(emphasis added). Although a plurality of the Court
emphasized the generality of the state laws giving rise to the
plaintiffs’ claims, “five Justices concluded that common-law
causes of action for negligence and strict liability do impose
‘requirement[s]’ and would be pre-empted by federal
requirements specific to a medical device.” Riegel, 552 U.S.
at 323–24 (citing Lohr, 518 U.S. at 512 (opinion of
O’Connor, J., joined by Rehnquist, C.J., and Scalia and
Thomas, JJ.); id. at 503–05 (opinion of Breyer, J.)). None of
the federal laws or regulations at issue imposed devicespecific requirements. Lohr, 518 U.S. at 492–94, 500–01.
In contrast, the Court in Riegel held that § 360k
preempted common-law claims challenging the safety and
effectiveness of a medical device that had received premarket
approval from the FDA. Unlike the federal laws and
regulations at issue in Lohr, premarket approval imposes
device-specific requirements. Id. at 322–23. Because the
state common-law claims related to the safety and
effectiveness of the device and because the plaintiffs alleged
that the device violated state tort law notwithstanding
compliance with the federal requirements, the state claims
were preempted. Id. at 323, 330. It did not matter that the
common-law claims involved general tort duties of care
applicable to other products besides medical devices. Id. at
327–29.
In Stengel, we “clarified preemption law under the
MDA.” 704 F.3d at 1233. Plaintiffs’ proposed negligence
claim for failure to warn the FDA was not preempted “insofar
as the state-law duty parallels a federal-law duty under the
MDA.” Id. We distinguished an Eighth Circuit case holding

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plaintiffs’ claims were preempted because, in that case,
“plaintiffs sought to enforce state-law requirements that
would have required Medtronic ‘to give additional warnings,
precisely the type of state requirement that is “different from
or in addition to” the federal requirement.’” Id. at 1232
(quoting In re Medtronic, Inc., Spring Fidelis Leads Products
Liability Litigation, 623 F.3d 1200, 1205 (8th Cir. 2010))
(citation and internal quotation marks omitted). In a
concurring opinion joined by six other judges, Judge Watford
explained that, had the plaintiffs predicated their claim on a
failure to warn doctors directly—an action not required by
FDA regulations—that claim would have been preempted
because it would have been an addition to the federal
requirement. Stengel, 704 F.3d at 1234 (Watford, J.,
concurring).
The teachings from the Supreme Court cases plus our
application of MDA preemption in Stengel lead to an obvious
result: Perez’s fraud by omission claim is expressly
preempted by § 360k(a).
To begin, the disclosure
requirement at issue is “different from, or in addition to” the
requirements applicable to the Laser under the MDA.
§ 360k(a)(1). Like the device in Riegel, the Laser was subject
to device-specific requirements under the PMAs—including
that it was not to be used for hyperopic corrections and was
not permitted to be introduced into commerce for such
corrections unless it was used in connection with an approved
investigational use. And like the claim in Riegel, the claim
here depends on a requirement that is “in addition to” those
federal requirements. Perez effectively seeks to write in a
new provision to the FDCA: that physicians and medical
device companies must affirmatively tell patients when
medical devices have not been approved for a certain use.
We do not pass judgment on whether this would be a wise

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rule for the FDA to adopt. It is sufficient for our inquiry that
it has not done so. Just as significant, the alleged missing
disclosure—that hyperopic use was not within the scope of
the Laser’s PMAs—“relates to the safety or effectiveness” of
the Laser. § 360k(a)(2). In Riegel, the Court explained that
premarket approval “is federal safety review.” 552 U.S. at
323. The sought-after disclosure also relates to “other
matter[s] included in a requirement applicable to the device”:
the Laser’s use in hyperopic surgeries. § 360k(a)(2). In sum,
the fraud by omission claim is expressly preempted under the
FDCA.
B. IMPLIED PREEMPTION
Perez faces another hurdle—even without express
preemption, Perez’s fraud by omission claim is impliedly
preempted because it conflicts with the FDCA’s enforcement
scheme. The FDA is responsible for investigating potential
violations of the FDCA, and the Act provides the agency with
a range of enforcement mechanisms, such as injunction
proceedings, civil and criminal penalties, and seizure.
21 U.S.C. §§ 332–34, 372. Although citizens may petition
the FDA to take administrative action, 21 C.F.R. §§ 10.25(a)
and 10.30, private enforcement of the statute is barred: “all
such proceedings for the enforcement, or to restrain
violations, of [the Act] shall be by and in the name of the
United States.” 21 U.S.C. § 337(a).
In Buckman, the Court held that the plaintiffs’ “fraud-onthe-FDA” claims were impliedly preempted by the FDCA
because they conflicted with the federal statutory scheme,
which “amply empowers the FDA to punish and deter fraud
against the Administration.” 531 U.S. at 348. “[C]omplying
with the FDA’s detailed regulatory regime in the shadow of

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50 States’ tort regimes w[ould] dramatically increase the
burdens facing potential applicants—burdens not
contemplated by Congress in enacting the FDCA and the
MDA.” Id. at 350. The Court distinguished the plaintiffs’
claims from those in Lohr. In Lohr, the claims “arose from
the manufacturer’s alleged failure to use reasonable care in
the production of the product, not solely from the violation of
FDCA requirements.” Id. at 352. In contrast, the fraud-onthe-FDA claims “exist solely by virtue of the FDCA
disclosure requirements.” Id. at 353. Lohr “does not and
cannot stand for the proposition that any violation of the
FDCA will support a state-law claim.” Id.
Like the fraud-on-the-FDA claims in Buckman, Perez’s
fraud by omission claim “exist[s] solely by virtue of the
FDCA . . . requirements,” 351 U.S. 353, with respect to
approved use of the Laser. As in Buckman, “the existence of
these federal enactments is a critical element in their case.”
Id. Although Perez is not barred from bringing any fraud
claim related to the surgeries, he cannot bring a claim that
rests solely on the non-disclosure to patients of facts tied to
the scope of PMA approval.
While courts have
acknowledged that some fraud and false advertising claims
related to FDA status may go forward,5 Perez cites to no case

5

See, e.g., Photomedex, Inc. v. Irwin, 601 F.3d 919, 924–25 (9th Cir.
2010) (explaining that, “[i]f . . . it was clear that an affirmative statement
of approval by the FDA was required before a given product could be
marketed and that no such FDA approval had been granted, a Lanham Act
claim could be pursued for injuries suffered by a competitor as a result of
a false assertion that approval had been granted”); Alpharma, Inc. v.
Pennfield Oil Co., 411 F.3d 934, 940 (8th Cir. 2005) (allowing a plaintiff's
false advertising claims to go forward where the plaintiff “alleged
reasonably clear claims of FDA approval” by the defendant).

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where a court has allowed a plaintiff to bring suit solely for
failure to disclose lack of FDA approval.6
The FDA knew about the allegations that the Laser was
being used for unapproved hyperopic use and took steps to
address the allegations by issuing warning letters and an
Import Alert, but it did not take final action against the
defendants. The district court explained that
[w]hether Defendants’ use of the laser was in
violation of the FDCA depends on, among
other things, the scope of the PMAs, whether
the Lasers were modified so that they were
“adulterated” under section 501(f)(1)(B) of
the FDCA, whether Defendants were engaged
in a permissible “off-label” use of the Laser,
and whether re-certification of the device was
required under 21 C.F.R. § 1040.10. All of
these matters rest within the enforcement
authority of the FDA, not this Court.

6
In Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir.
1993), the Fourth Circuit dismissed a Lanham Act claim where the
plaintiff contended that the very act of placing the drug on the market
falsely implied that the drug had been properly approved by the FDA.
Allowing such a claim would permit the plaintiff to “use the Lanham Act
as a vehicle by which to enforce the [FDCA] and the regulations
promulgated thereunder.” Id. See also Summit Tech., Inc. v. High-Line
Medical Instruments Co., 922 F. Supp. 299, 307 (C.D. Cal. 1996) (holding
that, although “a plaintiff may bring a Lanham Act cause of action for
affirmatively misrepresenting facts, even if the truth of those facts may be
governed by FDA regulations,” he may not sue for “failure to disclose a
‘fact,’ the truth of which is currently being reviewed and determined by
the FDA”).

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The Eighth Circuit has aptly described the “narrow gap”
through which a state-law claim must fit to escape
preemption by the FDCA: “The plaintiff must be suing for
conduct that violates the FDCA (or else his claim is expressly
preempted by § 360k(a)), but the plaintiff must not be suing
because the conduct violates the FDCA (such a claim would
be impliedly preempted under Buckman).” In re Medtronic,
623 F.3d at 1204 (citation and internal quotation marks
omitted). Perez’s fraud by omission claim does not squeeze
through this gap.
AFFIRMED.