PhotoMedex, Inc. v. Irwin

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT

PHOTOMEDEX, INC., 
a Delaware corporation,
Plaintiff-Appellant, No. 07-56672
v.
 D.C. No.
CV-04-00024-JLS
DEAN STEWART IRWIN, an
individual; RA MEDICAL SYSTEMS, OPINION
INC., a California corporation,
Defendants-Appellees.

Appeal from the United States District Court
for the Southern District of California
Janis L. Sammartino, District Judge, Presiding

Argued and Submitted
June 4, 2009—Pasadena, California

Filed April 14, 2010

Before: William A. Fletcher, Richard R. Clifton and
Milan D. Smith, Jr., Circuit Judges.

Opinion by Judge Clifton

5539
5542 PHOTOMEDEX, INC. v. IRWIN

COUNSEL

John J. Leonard and Michael R. Matthias, Baker & Hostetler
LLP, Los Angeles, California; Thomas D. Warren (argued),
Baker & Hostetler LLP, Cleveland, Ohio, for the plaintiff-
appellant.
 PHOTOMEDEX, INC. v. IRWIN 5543
Alan K. Brubaker, James A. Mangione, and Tracy L. Nation,
Wingert Grebing Brubaker & Goodwin LLP, San Diego, Cali-
fornia; John S. Addams (argued), Law Offices of John S.
Addams, San Diego, California, for the defendants-appellees.

OPINION

CLIFTON, Circuit Judge:

Plaintiff PhotoMedex, Inc. appeals the district court’s grant
of summary judgment in favor of Defendants Dean Stewart
Irwin and Ra Medical Systems, Inc. on Lanham Act claims
for misleading advertising and on California state law claims
for false advertising and unfair competition. These claims are
based on allegations of three separate misrepresentations
made by Defendants regarding: (1) clearance by the Food and
Drug Administration (FDA) to market their laser device, (2)
the anticipated date their laser would be available for pur-
chase, and (3) Irwin’s role as inventor of PhotoMedex’s laser
device.

The first alleged misrepresentation requires us to address
the question of whether a medical device manufacturer who
is not permitted to bring a private action to enforce the Food,
Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq.,
may nevertheless maintain a suit under the Lanham Act based
on a claim that a competitor violated the FDCA by misrepre-
senting that its product had received FDA clearance, when the
FDA declined to make a finding that there was no valid clear-
ance or to bring an enforcement action itself. Under the par-
ticular circumstances of this case, where the FDA permits
Defendants to determine in the first instance whether their
laser device was covered by clearance previously given to a
similar device and to market their device without an affirma-
tive statement of approval by the FDA, we conclude that the
claim by PhotoMedex may not proceed.
5544 PHOTOMEDEX, INC. v. IRWIN
We conclude, however, that claims based on the other two
alleged misrepresentations are potentially viable, including
claims alleging a false projection of when a product would be
available on the market. Though a forecast of future events
may ordinarily be a statement of opinion upon which such
claims cannot be based, we conclude that such a statement
may be actionable if the speaker knew at the time the state-
ment was made that it was false or did not have a good faith
belief in the truth of what was said. The commercial depiction
of Irwin as inventor of Photomedex’s laser is also actionable
because it may misrepresent his actual contribution.

We affirm the summary judgment for the claim based on
alleged misrepresentations regarding FDA clearance but
vacate summary judgment on the claims based on alleged
misrepresentations regarding the release date for Ra Medi-
cal’s laser and Irwin’s role as the inventor of PhotoMedex’s
laser.

I. Background

PhotoMedex directly competes with Ra Medical in the pro-
duction and sale of lasers for use in dermatological treat-
ments. These dermatological lasers are regulated by the FDA
and must pass what is known as the “510(k)” clearance pro-
cess, described below, before being placed on the market.
PhotoMedex’s product is the “XTRAC Excimer Laser Sys-
tem” (XTRAC), the first excimer laser the FDA cleared for
the treatment of the skin disorders psoriasis and vitiligo.

Irwin served on the development team for the XTRAC sys-
tem during his employment with PhotoMedex from February
1998 to July 2002. Following his departure from Pho-
toMedex, Irwin co-founded Ra Medical in September 2002.

Ra Medical entered into a licensing agreement for a com-
peting laser product with SurgiLight, Inc. on March 13, 2003.
SurgiLight had received FDA 510(k) clearance in March 2002
 PHOTOMEDEX, INC. v. IRWIN 5545
for its “EX-308” excimer laser for the treatment of psoriasis
and vitiligo, though at the time of the agreement it had not
actually manufactured or marketed the cleared laser. In
exchange for royalties, SurgiLight gave Ra Medical the “ex-
clusive manufacturing rights and exclusive marketing rights
for [the FDA-cleared EX-308 device], including any deriva-
tive devices, substantially conforming to the specifications[,]
as well as the exclusive right to use its mark EX-308 on
devices [Ra Medical] intends to manufacture and market.”

After securing the license from SurgiLight, Irwin appeared
on Ra Medical’s behalf at a trade show held by the American
Academy of Dermatology in March 2003. At the show,
Defendants distributed a brochure which proclaimed that Ra
Medical’s “Pharos EX-308 Excimer Laser” (Pharos) was
“FDA Approved for Psoriasis & Vitiligo.” This brochure also
described Irwin as “inventor of the first FDA approved
excimer laser for phototherapy,” i.e., PhotoMedex’s XTRAC
laser. Defendants’ subsequent marketing materials made simi-
lar promotional claims.

Word spread that the Pharos would be available for pur-
chase within a few months. The record includes evidence that
a person attending the trade show heard that the Pharos was
scheduled for sale in August 2003. SurgiLight issued a press
release, also in March 2003, announcing that “Ra Medical
anticipates the introduction of its PHAROS EX-308, Excimer
laser system for treatment by dermatologists of psoriasis and
vitiligo (pigmentation loss) this summer.” Defendants did not
actually ship the first Pharos laser until September 2004, more
than a year after the projected introduction date. The Pharos
laser differed in some respects from SurgiLight’s already-
cleared EX-308 laser.

PhotoMedex filed the present action against Defendants,
asserting violations of the Lanham Act and California laws
prohibiting untrue and misleading advertising and unfair com-
petition. The district court granted summary judgment in
5546 PHOTOMEDEX, INC. v. IRWIN
favor of Defendants on each of these claims. The court held
PhotoMedex lacked standing to challenge whether Defendants
improperly promoted their laser as “FDA approved” because
the FDA retains exclusive jurisdiction over FDCA enforce-
ment. The court determined Defendants’ predicted release
date for its laser was a non-actionable forward-looking state-
ment. Defendants’ assertion that Irwin invented Pho-
toMedex’s laser was held to be a matter of opinion and not
misleading. PhotoMedex timely appealed.

II. Discussion

We review the district court’s grant of summary judgment
as well as its statutory interpretations de novo. United States
v. Able Time, Inc., 545 F.3d 824, 828 (9th Cir. 2008). We
must determine whether, viewing the evidence in the light
most favorable to PhotoMedex as the nonmoving party, there
are any genuine issues of material fact and whether the district
court correctly applied the relevant substantive law. McClung
v. City of Sumner, 548 F.3d 1219, 1223 (9th Cir. 2008).

[1] Section 43(a)(1)(B) of the Lanham Act, 15 U.S.C.
§ 1125(a)(1)(B), explicitly furnishes a private right of action
“against persons who make false and deceptive statements in
a commercial advertisement about their . . . product.” Jarrow
Formulas, Inc. v. Nutrition Now, Inc., 304 F.3d 829, 834-35
(9th Cir. 2002).1 “Under the Lanham Act, a prima facie case
1
The statute states, in relevant part:
(1) Any person who, on or in connection with any goods or ser-
vices, or any container for goods, uses in commerce any . . . false
or misleading description of fact, or false or misleading represen-
tation of fact, which —
...
(B) in commercial advertising or promotion, misrepresents the
nature, characteristics, qualities, or geographic origin of his or her
or another person’s goods, services, or commercial activities,
shall be liable in a civil action by any person who believes that
he or she is or is likely to be damaged by such act.
15 U.S.C. § 1125(a).
 PHOTOMEDEX, INC. v. IRWIN 5547
requires a showing that . . . the defendant made a false state-
ment either about the plaintiff’s or its own product . . . .”
Newcal Indus., Inc. v. Ikon Office Solution, 513 F.3d 1038,
1052 (9th Cir. 2008) (internal quotation marks omitted).

A. Claims Regarding FDA Clearance

[2] The FDCA, as amended by the Medical Device Amend-
ments of 1976 (MDA), 90 Stat. 539, (codified at 21 U.S.C.
§ 301 et seq.), imposes a comprehensive set of requirements
upon medical devices. See Buckman Co. v. Plaintiffs’ Legal
Comm., 531 U.S. 341, 344 (2001). The FDA is charged with
investigating potential violations. 21 U.S.C. § 372. The
FDCA provides the FDA with a number of enforcement rem-
edies that may be sought. Buckman, 531 U.S. at 349; Heckler
v. Chaney, 470 U.S. 821, 835 (1985); see, e.g., 21 U.S.C.
§§ 332 (injunction proceedings), 333 (civil and criminal pen-
alties), 334 (seizure). Citizens may petition the FDA to take
administrative action. 21 C.F.R. §§ 10.25(a), 10.30.

[3] Section 337(a) of the FDCA bars private enforcement
of the statute, stating that “all such proceedings for the
enforcement, or to restrain violations, of this [Act] shall be by
and in the name of the United States.” 21 U.S.C. § 337(a).
The Supreme Court has observed that Section 337(a) “leaves
no doubt that it is the Federal Government rather than private
litigants who are authorized to file suit for noncompliance
with the medical device provisions.” Buckman, 531 U.S. at
349 n.4.

[4] The Supreme Court made clear in Buckman that this
section also limits the ability of a private plaintiff to pursue
claims under state law theories where such claims collide with
the exclusive enforcement power of the federal government.
Id. at 343, 349-50, 353 (holding that a state tort claim based
on alleged fraudulent representations made by a medical
device manufacturer in the course of seeking market approval
from the FDA “would exert an extraneous pull on the scheme
5548 PHOTOMEDEX, INC. v. IRWIN
established by Congress, and it is therefore pre-empted by that
scheme”).

[5] Our court has not previously spoken to the question of
whether the FDCA limits claims under the Lanham Act.2 We
conclude, in the circumstances of this case, that it does.
Because the FDCA forbids private rights of action under that
statute, a private action brought under the Lanham Act may
not be pursued when, as here, the claim would require litiga-
tion of the alleged underlying FDCA violation in a circum-
stance where the FDA has not itself concluded that there was
such a violation.

To be clear, we do not suggest that the Lanham Act can
never support private party claims involving FDA approval or
clearance of drugs or medical devices. That is not the case. If,
for example, 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. But this case does not fit that pat-
tern.
2
We have recognized that a Lanham Act claim might be barred as
inconsistent with another federal statute. In Sybersound Records, Inc. v.
UAV Corp., 517 F.3d 1137 (9th Cir. 2008), we held that “a party lacking
standing to bring a copyright infringement suit under the Copyright Act,
but who complains of competitive injury stemming from acts of alleged
infringement, may [not] bring a Lanham Act claim . . . whose successful
prosecution would require the litigation of the underlying infringement
claim.” Id. at 1141. In that case, the plaintiff, a karaoke record producer,
sued competitors for purportedly misrepresenting to consumers that they
had obtained licenses from every copyright holder of the songs on their
records. We declined to construe the Lanham Act “to cover misrepresenta-
tions about copyright licensing status” because doing so “would allow
competitors engaged in the distribution of copyrightable materials to liti-
gate the underlying copyright infringement when they have no standing to
do so because they are nonexclusive licensees or third party strangers
under copyright law.” Id. at 1144.
 PHOTOMEDEX, INC. v. IRWIN 5549
Permitting PhotoMedex’s Lanham Act claim to proceed in
the circumstances of this case would intrude on the exclusive
government enforcement authority established under the
FDCA. Explaining why PhotoMedex may not pursue its claim
in this instance requires some understanding of how the
FDCA, in conjunction with the MDA, operates in the context
of this kind of medical device.

[6] “The MDA separates devices into three categories:
Class I devices are those that present no unreasonable risk of
illness or injury and therefore require only general manufac-
turing controls; Class II devices are those possessing a greater
potential dangerousness and thus warranting more stringent
controls; Class III devices present a potential unreasonable
risk of illness or injury and therefore incur the FDA’s strictest
regulation.” Buckman, 531 U.S. at 344 (internal quotation
marks and alteration omitted); see also Mendes v. Medtronic,
Inc., 18 F.3d 13, 14 (1st Cir. 1994) (“The MDA reflects Con-
gress’s balancing the need for regulation to protect public
health against its interest in allowing new and improved
devices to be marketed expeditiously without the costs attrib-
utable to an excess of regulation.”). The dermatological lasers
involved in this case are all Class II devices. See 21 C.F.R.
§ 878.4810 (issuing a Class II designation for these types of
lasers).

[7] Unlike a manufacturer of a Class III device, which must
go through the “rigorous” process of obtaining “premarket
approval” from the FDA before being allowed to market its
device, a manufacturer of a Class II device need only submit
a “premarket notification” to the FDA, in accordance with the
less burdensome “510(k) process.” Medtronic, Inc. v. Lohr,
518 U.S. 470, 477-79 (1996) (contrasting the two proce-
dures); see 21 U.S.C. § 360c(a)(1)(B), (C). Under the 510(k)
process, if the Class II device is deemed “substantially equiv-
alent” to a pre-existing device with prior clearance, “it can be
marketed without further regulatory analysis.” Medtronic, 518
U.S. at 478; see also 21 U.S.C. § 360(k); 21 C.F.R.
5550 PHOTOMEDEX, INC. v. IRWIN
§ 807.100. In other words, that device receives “510(k) clear-
ance” and can be put on the market.3

FDA regulations provide that a manufacturer who has suc-
cessfully navigated the 510(k) process for a device must make
a new 510(k) submission whenever the device “is about to be
significantly changed or modified in design, components,
method of manufacture, or intended use.” 21 C.F.R.
§ 807.81(a)(3).4 An FDA guideline document makes clear that
responsibility is placed on the manufacturer to decide whether
device changes necessitate a new 510(k) submission. FDA,
Deciding When to Submit a 510(k) for a Change to an Exist-
ing Device, 1997 WL 33793777 (Jan. 10, 1997). That docu-
ment explains:

When making the decision on whether to submit a
510(k), the manufacturer’s basis for comparison of
any changed device should be the device described
by the cleared 510(k) . . . . That is, manufacturers
may make a number of changes without having to
submit a 510(k), but each time they make a change,
3
Unlike premarket approval, 510(k) clearance “does not in any way
denote official approval of the device.” 21 C.F.R. § 807.97. PhotoMedex
does not argue that Defendants’ “FDA approved” statement is in itself
false or misleading on the ground that the FDA does not “approve” Class
II devices in the way that it reviews and provides premarket approval of
Class III devices, as described above, perhaps because it too advertised its
XTRAC laser as “FDA approved.” Rather, PhotoMedex asserts Defen-
dants falsely touted the Pharos as having 510(k) clearance. We do not
address whether representing a Class II medical device as having “FDA
approval” may be actionable on the grounds that these devices are not sub-
ject to the premarket approval process.
4
The following are designated significant changes or modifications
requiring premarket notification: “(i) A change or modification in the
device that could significantly affect the safety or effectiveness of the
device, e.g., a significant change or modification in design, material,
chemical composition, energy source, or manufacturing process [or] (ii) A
major change or modification in the intended use of the device.” 21 C.F.R.
§ 807.81(a)(3).
 PHOTOMEDEX, INC. v. IRWIN 5551
the device they should compare it to is their most
recently cleared device . . . . In effect, manufacturers
need to submit a new 510(k) only when a change, or
the sum of the incremental changes exceeds the
§ 807.81(a)(3) threshold, “could significantly affect
the safety or effectiveness of the device.”

Id. (quoting from 21 C.F.R. § 807.81(a)(3)). Acknowledging
that “[m]anufacturers may make modifications to a cleared
device that do not require submission of a new 510(k),” the
FDA instructs its reviewers “not [to] request information
regarding changes observed in a new 510(k) that were previ-
ously implemented by industry without the requirement for
510(k) clearance, unless the lack of information regarding the
previous modification(s) does not allow the [substantial
equivalency] determination to be made.” FDA, The Least
Burdensome Provisions of the FDA Modernization Act of
1997: Concept and Principles; Final Guidance for FDA and
Industry, 2002 WL 32811431 (Oct. 4, 2002).

[8] It is significant that under the regulatory structure estab-
lished by the FDA for the medical devices at issue in this
case, clearance to market a given device did not necessarily
require an affirmative statement of approval by the FDA. The
FDA’s previous clearance of the SurgiLight laser covered
Defendants’ Pharos device as well, as long as the Pharos was
not significantly modified from the SurgiLight device. It was
Ra Medical, as the manufacturer, that had the responsibility
in the first instance for gauging whether the Pharos’s depar-
tures from SurgiLight’s cleared laser warranted a new 510(k)
application. An affirmative confirmation by the FDA of the
correctness of Defendants’ decision not to submit an addi-
tional 510(k) application was not required.

Defendants argue that their license to produce a version of
SurgiLight’s FDA-cleared laser justified their statements that
their Pharos laser had been cleared by the FDA. PhotoMedex
argues, however, that there were “significant technological
5552 PHOTOMEDEX, INC. v. IRWIN
differences” between SurgiLight’s cleared laser and the Pha-
ros, making a separate 510(k) submission necessary before it
could be cleared for market.

The issue was presented to the FDA, but it does not appear
that the agency ever reached the conclusion sought by Pho-
toMedex. Starting in August 2003, PhotoMedex, through its
attorneys, wrote the FDA “to file a complaint” against Ra
Medical for promoting the Pharos laser without FDA clear-
ance, arguing the Pharos did not come within SurgiLight’s
license. PhotoMedex contacted the FDA numerous times over
the following years, furnishing comparisons of the SurgiLight
and Pharos lasers and urging the FDA to “take immediate
enforcement action against Ra Medical.” Each time the FDA
responded by promising nothing more than that “we will eval-
uate this matter to determine what follow-up action is appro-
priate.”

The FDA did write Irwin in September 2005, stating it
noticed Ra Medical was marketing the “Pharos EX-308
Excimer Laser” for the treatment of psoriasis and vitiligo and
asking him to provide the clearance number or explain why
one was not needed since FDA records did not contain a
clearance number for the Pharos. Irwin replied that the Pharos
was cleared through its licensing agreement with SurgiLight,
and he identified SurgiLight’s associated FDA clearance
numbers.

In October 2005, the FDA conducted an inspection of Ra
Medical’s manufacturing facility. The resulting “Establish-
ment Inspection Report” specifically discussed the “compara-
bility of the Pharos EX-308 Excimer Laser System with the
SurgiLight EX-308 Excimer Laser System and whether [Ra
Medical] needed to submit a new 510(k) for the Pharos EX-
308.” The investigating FDA agent noted:

Mr. Irwin said he felt he was manufacturing essen-
tially the same excimer laser, with insignificant dif-
 PHOTOMEDEX, INC. v. IRWIN 5553
ferences. When asked about the differences in
specifications, Mr. Irwin explained that they were
irrelevant differences or in some cases the specifica-
tions in the SurgiLight 510(k) were not accurately
reported. Because of the complexity in explaining
the differences in specifications between the Pharos
EX-308 and the SurgiLight EX-308, I asked Mr.
Irwin if he would write an explanation of why he felt
the specification differences did not warrant another
510(k) filing. Mr. Irwin said he would happily pre-
pare such a document, and it [was] provided . . . . I
said I could not make the determination as to
whether or not the Pharos EX-308 Excimer Laser
System needed a new 510(k) for going beyond the
scope of the SurgiLight 510(k), but I would forward
his comments to the reviewing division.

...

Mr. Irwin said he planned to file a 510(k) expanding
the indications for the Pharos Excimer Laser System
in the near future.

The FDA subsequently sent Irwin a copy of the Establishment
Inspection Report dated February 2006, explaining it had
closed its inspection.

In September 2006, Ra Medical submitted a 510(k) notifi-
cation to the FDA stating the Pharos “is intended for use in
the treatment of psoriasis, vitiligo, atopic dermatitis, and leu-
koderma.” Defendants argue that they filed this 510(k) sub-
mission only to gain clearance for the latter two uses since, in
their view, the former two uses were already cleared based on
the 501(k) clearance of SurgiLight’s laser. In November 2006,
the FDA responded by notifying Irwin that “you may not mar-
ket your device until it has been cleared for marketing by the
FDA.” In January 2007, the FDA wrote Irwin saying it had
“information that suggests” Ra Medical was manufacturing
5554 PHOTOMEDEX, INC. v. IRWIN
and marketing the Pharos without marketing clearance in vio-
lation of the FDCA. Neither letter was explicit in stating
whether it referred to marketing of the device for all four
medical conditions or only the two new ones.

In early April 2007, the FDA responded to Ra Medical’s
510(k) notification by stating that the Pharos could “proceed
to the market” since it was substantially equivalent to legally
marketed predicate devices. In this 510(k) clearance letter, the
FDA also noted the Pharos “will be indicated for use for the
treatment of psoriasis, vitiligo, atopic dermatitis and leukoder-
ma.” In the end, therefore, the FDA did not take any action
against Defendants or limit the marketing of their Pharos
device.

Nonetheless, PhotoMedex maintains that prior to the
FDA’s April 2007 letter Defendants did not have clearance to
market the Pharos for treatment of psoriasis and vitiligo. Pho-
toMedex’s Lanham Act claim depends upon its contention
that the Pharos varied enough from SurgiLight’s cleared laser
to require a separate 510(k) filing. If a separate filing was not
required, then the FDA’s previous clearance of SurgiLight’s
device covered the Pharos, and Defendants’ statements
regarding FDA clearance of the Pharos were not false or mis-
leading.5

[9] The statute assigns to the FDA the responsibility for
taking enforcement action against Defendants. FDA action
could have taken different forms, including a clear statement
that the Pharos was not covered by the prior clearance of the
SurgiLight laser, an effort to stop Defendants from marketing
their Pharos device, or action to impose a civil monetary pen-
alty. The FDA did none of those things, however.
5
PhotoMedex’s expert admits as much, opining that “the only device
RA Medical could distribute as of March 13, 2003 was the SurgiLight EX-
308 Excimer Laser, or a laser that only exhibited an insignificant modifi-
cation of that device.” (Emphasis added)
 PHOTOMEDEX, INC. v. IRWIN 5555
[10] PhotoMedex is not permitted to circumvent the FDA’s
exclusive enforcement authority by seeking to prove that
Defendants violated the FDCA, when the FDA did not reach
that conclusion. In a context where the statute and regulations
place responsibility in the first instance on the manufacturer
to determine whether its device is covered by a previous FDA
clearance and permit marketing of the product without an
affirmative statement of clearance by the FDA, it is impossi-
ble for PhotoMedex to prove that Ra Medical’s device had not
been cleared by the FDA when the FDA itself did not take
that position. Accordingly, we affirm the district court’s grant
of summary judgment on this claim.

Our decision is consistent with other decisions refusing to
allow private actions under the Lanham Act premised on
enforcement determinations that the FDA and other regula-
tory agencies did not themselves make. For instance, the
Third Circuit rejected a Lanham Act false advertising claim
based on a cough syrup’s label listing a demulcent ingredient
as “inactive,” a regulatory matter the FDA had not deter-
mined. Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902
F.2d 222, 230-32 (3d Cir. 1990). The court reasoned that “the
Lanham Act does not create indirectly, at least not in cases
requiring original interpretation of [the FDCA] or [its] accom-
panying regulations[,]” what the FDCA does not create
directly. Id. at 231. Sandoz rightly observed that it would be
inappropriate “for a court in a Lanham Act case to determine
preemptively how a federal administrative agency will inter-
pret and enforce its own regulations.” Id.; see also IQ Prods.
Co. v. Pennzoil Prods. Co., 305 F.3d 368, 372-74 (5th Cir.
2002) (concluding the defendants’ failure to label a product in
keeping with Federal Hazardous Substances Act regulations
was not actionable under the Lanham Act since the former
does not authorize a private right of action); Summit Tech.,
Inc. v. High-Line Med. Instruments Co., 933 F. Supp. 918,
934 (C.D. Cal. 1996) (affirming dismissal of a Lanham Act
claim since “in order for this Court to test the truth of Defen-
dant’s apparent claim that it can legally import the Summit
5556 PHOTOMEDEX, INC. v. IRWIN
lasers, the Court would be required to perform an ‘original
interpretation’ of the FDA regulations governing this area”
(quoting Sandoz, 902 F.2d at 231)). Testing the truth of Pho-
toMedex’s claim would similarly require a court to usurp the
FDA’s prerogative to enforce the FDCA and to decide
whether, under the FDCA and its regulations, the Pharos was
similar enough to SurgiLight’s laser to permit Defendants to
rely on its 510(k) clearance.

Along similar lines, the D.C. Circuit concluded a cab com-
pany’s statements that it was authorized to provide particular
services under regulations promulgated by the D.C. Taxicab
Commission could not form the basis of a Lanham Act claim.
Dial A Car, Inc. v. Transp., Inc., 82 F.3d 484, 488-90 (D.C.
Cir. 1996). Rather, unless the regulations lack ambiguity, the
court held alleged misrepresentations must have been pre-
ceded by “a clear and unambiguous statement from the Taxi-
cab Commission regarding [defendants’ legal] status before a
Lanham Act claim can be entertained.” Id. at 489 & n.3. The
Dial A Car court finally noted that “[i]nstead of bringing this
claim in federal court, [plaintiff] should be forced to take its
argument to the D.C. Taxicab Commission and lobby the
Commission to crack down on [defendants’] activities, assum-
ing they are proscribed under [the regulations].” Id. at 490.

As in Dial A Car, the appropriate forum for PhotoMedex’s
complaints is the responsible regulatory agency. Permitting
PhotoMedex to bypass the FDA and instead bring suit would
require the court to make a decision the FDA chose not to
make. See Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1139
(4th Cir. 1993) (dismissing a Lanham Act claim asserting
manufacturers impliedly falsely promoted their drugs as FDA
approved by placing the drugs on the market); see also Sum-
mit Tech., Inc. v. High-Line Med. Instruments Co., 922 F.
Supp. 299, 305-07 (C.D. Cal. 1996) (deciding that failing “to
disclose that [defendants’] re-imported used and/or modified
Summit Excimer Laser Systems are not approved by the
FDA” was not actionable under the Lanham Act when “the
 PHOTOMEDEX, INC. v. IRWIN 5557
FDA has not yet determined whether or not the re-imported
Summit devices need further approval at all”).

PhotoMedex cites Alpharma, Inc. v. Pennfield Oil Co., 411
F.3d 934 (8th Cir. 2005), in support of its claim, but we do
not view our conclusion to be at all inconsistent with that
decision. The plaintiff in that case brought a Lanham Act
claim against its competitor for falsely advertising that its
antibiotic animal feed additives had been approved for certain
uses by the FDA. Both the plaintiff and defendant had previ-
ously received interim FDA approval to market their respec-
tive additive products for certain uses, and that approval had
been codified in a regulation. That regulation did not itself list
the uses for which each company’s product had been
approved, however, but instead incorporated a statement of
uses found in a different regulation. In the years that followed,
the plaintiff obtained additional FDA approval to market its
product for several new uses, which the FDA added to the list
in the second regulation, naming the plaintiff as the only man-
ufacturer who submitted information in support of approval.
However, the first regulation was never amended to account
for the FDA’s later approval of new uses for the plaintiff’s
product. That gave the appearance of expanding the number
of uses for which the defendant’s product had been approved
as well, though the defendant had never applied for or
obtained such approval from the FDA for its product. The
plaintiff brought an action against the FDA to remedy this sit-
uation. That action was resolved with a stipulated order of
dismissal in which the FDA made it clear that there was no
record of the defendant obtaining the FDA’s approval for the
additional uses. In addition, the FDA published notices of
proposed rulemaking to eliminate the now obsolete first regu-
lation and of the opportunity to be heard on the extent of the
approvals given to defendant’s product. See id. at 936-37. The
Eighth Circuit reversed the district court’s dismissal of the
plaintiff’s Lanham Act claim of false advertising, reasoning
that in light of the FDA’s prior guidance on the precise dis-
pute, the claim would not require a preemptive interpretation
5558 PHOTOMEDEX, INC. v. IRWIN
by the court of FDA regulations. Id. at 940; accord Rhone-
Poulenc Rorer Pharms. v. Marion Merrell Dow, 93 F.3d 511,
516 (8th Cir. 1996) (affirming Lanham Act remedy where
pharmaceutical company gave the false impression that its
drug was FDA approved for a use the FDA admittedly had
not approved).

Although the facts in Alpharma are complicated, the
court’s holding is clear. In that case, the FDA explicitly made
clear that it had not given the defendant’s product the affirma-
tive approval required for expanding its list of permissible
uses. Therefore, the court held, the plaintiff could bring a
Lanham Act claim based on the defendant’s false statements
in its advertisement that the uses had been approved. In con-
trast to Alpharma, the FDA never concluded or clearly stated
that the Pharos lacked premarket clearance for psoriasis and
vitiligo. As described above, the regulatory 510(k) clearance
scheme for Class II devices put the responsibility on Ra Medi-
cal to decide in the first instance whether and when a new
510(k) application had to be filed. That the FDA may have
asked questions about the Pharos’s clearance status does not
demonstrate that the FDA ever concluded that Ra Medical
was wrong in its determination that the clearance given to
SurgiLight’s laser device covered the Pharos laser as well.
Instead, the FDA closed its inspection in February 2006 with-
out speaking to the Pharos’s clearance status or taking disci-
plinary action.

After Defendants submitted a 510(k) submission in Sep-
tember 2006, the FDA wrote in January 2007 that it had “in-
formation that suggest[ed]” the Pharos was being marketed
without clearance. Cf. Alpharma, Inc., 411 F.3d at 936 (noting
in response to plaintiff’s lawsuit against it, the FDA filed a
stipulation stating it lacked any record of approving the defen-
dant’s product for the uses in question). About two months
later, the FDA completed its review of Defendants’ 510(k)
notification and made a substantial equivalence determina-
tion, thereby clearing the Pharos laser for marketing without
 PHOTOMEDEX, INC. v. IRWIN 5559
stating or even suggesting that there had been any prior period
of noncompliance.

Validating PhotoMedex’s position “would require us to
usurp [the FDA’s] responsibility for interpreting and enforc-
ing potentially ambiguous regulations.” Sandoz, 902 F.2d
231. That PhotoMedex engaged in an extensive campaign to
try to convince the FDA to act on Ra Medical’s supposed
misstatements and violations demonstrates that PhotoMedex
understood that this subject fell within the FDA’s domain.

The actions the FDA took in this case do not indicate that
the agency ever concluded that the clearance for SurgiLight’s
device did not cover the Pharos device.6 The FDA ultimately
cleared the Pharos, elected not to find any violation, and did
not seek to impose any other penalty on Defendants. The
FDCA explicitly says that enforcement power is reserved to
the federal government. To permit PhotoMedex to proceed
with a claim that Defendants violated this law when the FDA
did not so determine would, in effect, permit PhotoMedex to
assume enforcement power which the statute does not allow
and require the finder of fact to make a decision that the FDA
itself did not make.

We therefore affirm the order of summary judgment for the
claims based on Defendants’ statements that the Pharos had
FDA clearance.7
6
Because the FDA never took action regarding Ra Medical’s device, we
need not address the question of whether later action by the FDA might
have permitted PhotoMedex to pursue a claim under the Lanham Act
based on statements made by Ra Medical prior to the FDA’s action.
7
PhotoMedex does not argue that it would be able to pursue state law
claims for false advertising of FDA clearance even if its Lanham Act
claim fails.
5560 PHOTOMEDEX, INC. v. IRWIN
B. Claims Regarding the Pharos Release Date

PhotoMedex asserts that Defendants knowingly misrepre-
sented in March 2003 that the Pharos laser would be available
that summer, within just a few months. Defendants admit they
did not ship the first Pharos until September 2004, more than
a year later, but argue that they were delayed in part by hav-
ing to defend against PhotoMedex’s multiple lawsuits.

The district court interpreted the predictions of the Pharos’s
release date to be mere statements of opinion regarding future
events, which are generally not actionable. See Bayview Hunt-
ers Point Cmty. Advocates v. Metro. Trans. Comm’n., 366
F.3d 692, 698 (9th Cir. 2004) (“[P]redictions as to future
events are ordinarily non-actionable expressions of opinion
under basic principles of the tort of fraudulent misrepresenta-
tion.” (internal quotation marks omitted)); see also Coastal
Abstract Serv., Inc. v. First Am. Title Ins. Co., 173 F.3d 725,
731 (9th Cir. 1999) (“Statements of opinion are not generally
actionable under the Lanham Act.”); Richard P. v. Vista Del
Mar Child Care Serv., 165 Cal. Rptr. 370, 373 (Cal. Ct. App.
1980) (noting that ordinarily “predictions as to future events
are deemed expressions of opinion, and thus not actionable”).

[11] There is, however, a well-established exception — if
“the speaker has knowledge of facts not warranting the opin-
ion.” Id., 165 Cal. Rptr. at 373. An honest or sincere state-
ment of belief about a future event is not actionable, but a
statement known at that time by the speaker to be false, or a
statement by a speaker who lacks a good faith belief in the
truth of the statement, may constitute an actionable misrepre-
sentation. See id.; see also Harris v. United States, 48 F.2d
771, 781 (9th Cir. 1931) (holding defendant’s misrepresenta-
tion that a stock purchase was a good investment was action-
able fraud rather than a mere expression of opinion or
statement of a future event “where the buyers have no inde-
pendent knowledge of any of the facts with relation to the
[investment]”) In this instance, Defendants may be liable for
 PHOTOMEDEX, INC. v. IRWIN 5561
misrepresentation if they said that the Pharos would be avail-
able in August 2003 but knew that it would not or could not
actually be available until a substantially later date.

Typically, “[w]hether a statement is nonactionable opinion
or actionable misrepresentation of fact is a question of fact for
the jury.” Furla v. Jon Douglas Co., 76 Cal. Rptr. 2d 911, 918
(Cal. Ct. App. 1998). The district court determined Pho-
toMedex “offer[ed] no evidence of malfeasance surrounding
Defendants’ [release] estimation” on which a jury could find
for it. Our review of the evidence, which on summary judg-
ment must be viewed in favor of the non-moving party, in this
case PhotoMedex, indicates otherwise.

Irwin informed FDA officials that “Phase II was started in
March 2003, at which time [Ra Medical] developed a design
plan.” PhotoMedex’s expert opined that:

In my experience, to move a medical laser from the
beginning of design Phase II to production would
typically require 12 to 18 months, assuming that the
Phase I work was complete and well-documented.
My review of the documentation generated before
March 2003 shows no evidence . . . that the Phase I
work was complete and well-documented. Ra Medi-
cal’s documentation primarily shows only rudimen-
tary documentation of internal laser research and
development. It is therefore my opinion that Ra
Medical would have found it impossible to bring the
Pharos laser through the remaining design Phases II,
III and IV, the preproduction phase and enter pro-
duction by either the ‘summer’ or August of 2003.
It is also my opinion that it was unreasonable and
misleading for the Defendants to project the esti-
mated delivery date of the Pharos laser for any time
in 2003, but would have been reasonable for the
Defendants to project their estimated delivery date of
the Pharos laser to be sometime in the latter half of
5562 PHOTOMEDEX, INC. v. IRWIN
2004. Ra Medical did, in fact, ship its first laser in
September 2004. . . . It is also my opinion that a per-
son with experience in medical device development
and manufacturing, specifically the development and
manufacture of excimer lasers, would and should
know the reasonable timetable for completion and
shipment of a new excimer laser product.

We conclude that this evidence suffices to raise a genuine
issue of material fact as to whether Defendants intentionally
misrepresented the Pharos’s release date.

[12] The potential motivation for and harm from such a
misrepresentation is obvious. By telling prospective purchas-
ers that the Pharos would be available soon, Defendants might
have persuaded them not to buy PhotoMedex’s device, which
was already available, leaving them open to consider and pos-
sibly purchase Defendants’ competing product later. Accord
Newcal Indus., 513 F.3d at 1053-54 (reversing dismissal of
Lanham Act claims involving a copier machine lessor’s state-
ment that its contract terms were limited to 60 months, hold-
ing whether the lessor knew at the time that it would extend
the contractual terms was a factual question). Accordingly, we
vacate summary judgment for the claims based on Defen-
dants’ statements that the Pharos would be available in the
summer of 2003 and remand those claims for further proceed-
ings.

C. Claims Regarding Irwin’s Role as the Inventor of
PhotoMedex’s Laser Device

PhotoMedex asserts that Defendants deceptively pro-
claimed Irwin was “inventor” of the XTRAC, i.e., that Irwin
was the only, or at least the primary, inventor of the entire
XTRAC laser system. Defendants respond that Irwin served
as vice president of engineering at PhotoMedex where he
“was intimately involved in the development of the XTRAC
 PHOTOMEDEX, INC. v. IRWIN 5563
system.” Defendants also identify Irwin as the inventor of par-
ticular components of the XTRAC in patents.

[13] Defendants’ commercial depiction of Irwin as “inven-
tor” of the XTRAC is actionable to the extent it misled con-
sumers into believing that Irwin was the sole inventor or made
more than his actual share of inventive contributions. See
Cook, Perkiss & Liehe, Inc. v. N. Cal. Collection Serv., Inc.,
911 F.2d 242, 245 (9th Cir. 1990) (“[A] false advertising
cause of action under the [Lanham] Act is not limited to lit-
eral falsehoods; it extends to false representations made by
implication or innuendo.”); see also Ariz. Cartridge Remanu-
facturers Ass’n, Inc. v. Lexmark Int’l, Inc., 421 F.3d 981, 985-
86 (9th Cir. 2005) (same for California state law actions).
Calling Irwin the “inventor of the XTRAC” might have been
misleading. Evidence supplied by PhotoMedex shows that
Irwin was only named as an inventor in patents for XTRAC’s
cooling apparatus and that other individuals designed the bulk
of the XTRAC system. Thus, we vacate summary judgment
for the claims relating to Defendants’ representations that
Irwin was the inventor of the XTRAC and remand those
claims for further proceedings.

III. Conclusion

In sum, we affirm summary judgment on PhotoMedex’s
claim that Defendants misrepresented the FDA’s clearance of
their product. We conclude, however, that summary judgment
should not have been granted on PhotoMedex’s claims based
on Defendants’ alleged misrepresentations about when its
Pharos product would be put on the market and Irwin’s role
as inventor of PhotoMedex’s laser device. Those claims are
remanded for further proceedings.

Each party shall bear its own costs on appeal.

AFFIRMED in part; VACATED in part; and
REMANDED for further proceedings.