Alexis Degelmann, et al v. Advanced Medical Optics Inc.
Filing
FILED OPINION (JOHN T. NOONAN, N. RANDY SMITH and RANER C. COLLINS) AFFIRMED. Judge: JTN Authoring, FILED AND ENTERED JUDGMENT. [7908344]
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FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
ALEXIS DEGELMANN; JOSEPH LIN, on
behalf of themselves and all those
similarly situated,
Plaintiffs-Appellants,
v.
ADVANCED MEDICAL OPTICS INC., a
Delaware corporation,
Defendant-Appellee.
No. 10-15222
D.C. No.
4:07-cv-03107-PJH
OPINION
Appeal from the United States District Court
for the Northern District of California
Phyllis J. Hamilton, District Judge, Presiding
Argued and Submitted
April 11, 2011—San Francisco, California
Filed September 28, 2011
Before: John T. Noonan and N. Randy Smith,
Circuit Judges, and Raner C. Collins, District Judge.*
Opinion by Judge Noonan
*The Honorable Raner C. Collins, District Judge for the U.S. District
Court for Arizona, Tucson, sitting by designation.
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COUNSEL
Jahan C. Sagafi, San Francisco, California, for the plaintiffsappellants.
Ben D. Whitwell, San Francisco, California, for the
defendant-appellee.
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DEGELMANN v. ADVANCED MEDICAL OPTICS
OPINION
NOONAN, Circuit Judge:
Alexis Degelmann and Joseph Lin (“Degelmann and Lin”)
represent a putative class (“the class”) of purchasers of contact lens solution. They appeal the district court’s order granting summary judgment for the defendant, Advanced Medical
Optics, Inc. (“AMO”). They brought suit alleging AMO violated California’s Unfair Competition Law (“UCL”), Cal.
Bus. & Prof. Code § 17200 et seq., and False Advertising
Law (“FAL”), id. at § 17500 et seq., by marketing Complete
MoisturePlus (“MoisturePlus”) as a product that cleans and
disinfects lenses. The district court ruled that Degelmann and
Lin lack standing. AMO argues that the ruling was not error,
and that even if it was, the suit was properly dismissed
because the class’ claims are preempted under 21 U.S.C.
§ 360k(a) of the Medical Devices Amendments of 1976
(“MDA”), 21 U.S.C. § 360c et seq.
The district court had jurisdiction pursuant to the Class
Action Fairness Act, 28 U.S.C. § 1332(d)(2)(A). We have
jurisdiction under 28 U.S.C. § 1291, and we affirm.
BACKGROUND
Between 2003 and 2007, AMO marketed and sold MoisturePlus. In May 2007, the Food and Drug Administration
(“FDA”) and the U.S. Centers for Disease Control and Prevention reported an increase of a serious eye infection called
Acanthamoeba keratitis (“AK”) associated with use of MoisturePlus. AMO recalled MoisturePlus and instituted a refund
program for unused product.
Contact lens users who contracted AK after using MoisturePlus filed suit in various venues. The class of plaintiffs in
this case were MoisturePlus users, but no member of this
class contracted AK. The class members also did not lose
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money by discarding unused MoisturePlus. Rather, Degelmann and Lin filed suit under California laws that proscribe
false advertising and misleading marketing practices. Degelmann and Lin allege that AMO marketed MoisturePlus as an
effective contact lens disinfectant and cleaner, but that in fact
its users were seven times more likely than users of other contact lens solutions to suffer an AK infection. They also claim
that AMO knew that MoisturePlus was a poor disinfectant
compared to other similar products, and that the company
misled consumers into believing MoisturePlus was as effective as other solutions. Degelmann and Lin aver that but for
the inaccuracy of AMO’s labeling practices, they would not
have purchased MoisturePlus.
The district court invited AMO to file an “early motion for
summary judgment” regarding standing and preemption. The
court granted AMO’s motion, ruling that the class does not
have standing. The court found that the class members have
not suffered an injury in fact because (1) they never contracted AK, so they suffered no harm from use of MoisturePlus, (2) they were not forced by the product recall to discard
unused product, and (3) they did not lose money because if
they had not bought MoisturePlus, they would have bought
another lens solution. Because the district court ruled that the
class does not have standing, it did not reach the issue of
whether the class’ claims are preempted.
This appeal followed.
STANDARD OF REVIEW
This Court’s review of the district court’s summary judgment order is de novo. Papike v. Tambrands Inc., 107 F.3d
737, 739 (9th Cir. 1997). “In reviewing the court’s order we
must view the evidence in the light most favorable to [the
non-movant] and determine whether there are any genuine
issues of material fact and whether the court correctly applied
the relevant substantive law.” Id.
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ANALYSIS
I.
Standing
The jurisdiction of federal courts is limited by Article III of
the Constitution to cases or controversies in which the plaintiff has standing. Standing requires an injury in fact, which is
traceable to the defendant’s acts and redressable by a court
decision. See Lujan v. Defenders of Wildlife, 504 U.S. 555,
560-561 (1992). Injury in fact results from the “invasion of a
legally protected interest which is [ ] concrete and particularized.” Id. at 560 (citations omitted).
[1] A UCL plaintiff with standing is a person who “has
suffered injury in fact and has lost money or property as a
result of the unfair competition.” Cal. Bus. & Prof. Code
§ 17204. “This provision requires [plaintiffs] to show that
[they have] lost ‘money or property’ sufficient to constitute an
‘injury in fact’ under Article III of the Constitution.” Rubio v.
Capital One Bank, 613 F.3d 1195, 1203-1204 (9th Cir. 2010)
(citing Birdsong v. Apple, Inc., 590 F.3d 955, 959-60 (9th Cir.
2009) (internal footnote omitted)). Thus a UCL plaintiff must
always have Article III standing in the form of economic
injury.
Here, Degelmann and Lin, the class representatives,
averred that they bought MoisturePlus, relying on the representation that it would disinfect their lenses, and would not
have bought it had they known how poorly it actually worked.
They have shown injury in fact, economic harm.
The California Supreme Court analyzed the economic harm
suffered by a consumer who purchases a product based on
misrepresentation in Kwikset Corp. v. Superior Court, 51 Cal.
4th 310 (2011). In that case, plaintiffs brought UCL and FAL
claims based on a lock manufacturer labeling its product as
“Made in the U.S.A.” when in fact some parts were foreign
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made or involved foreign manufacture. The court’s standing
analysis is persuasive:
For each consumer who relies on the truth and accuracy of a label and is deceived by misrepresentations
into making a purchase, the economic harm is the
same: the consumer has purchased a product that he
or she paid more for than he or she otherwise might
have been willing to pay if the product had been
labeled accurately. This economic harm—the loss of
real dollars from a consumer’s pocket—is the same
whether or not a court might objectively view the
products as functionally equivalent.
Id. at 329.
[2] Here, as in Kwikset, the plaintiffs allege that they paid
more for a product due to reliance on false advertising. The
district court in this case was likely correct that Degelmann
and Lin would have bought other contact lens solution had
they not purchased MoisturePlus. However, as elucidated by
the Kwikset court’s discussion, it does not necessarily follow
that they did not suffer economic harm. Degelmann and Lin
presented evidence that they were deceived into purchasing a
product that did not disinfect as well as it represented. Had the
product been labeled accurately, they would not have been
willing to pay as much for it as they did, or would have
refused to purchase the product altogether. The district court’s
reasoning—that class members would have bought other contact lens solution, and therefore suffered no economic harm—
conceived of injury in fact too narrowly.1
1
The inquiry into injury in fact in this case, where the class makes
claims under both the UCL’s fraud prong and the FAL, is not controlled
by Birdsong v. Apple, Inc., 590 F.3d 955 (9th Cir. 2009). In that case, purchasers of iPod headphones pursued a claim under the UCL’s “unfair” and
“unlawful” prongs, asserting that listening to loud music on the headphones could result in hearing loss. They did not allege economic harm
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[3] The district court’s grant of summary judgment on
standing grounds was in error.
II.
Preemption
Though AMO argued below that this case was preempted,
the district court did not address the issue. “The prevailing
party may, of course, assert in a reviewing court any ground
in support of his judgment, whether or not that ground was
relied upon or even considered by the trial court.” Dandridge
v. Williams, 397 U.S. 471, 476 n.6 (1970) (citations omitted).
This Court may address any issue “raised sufficiently for the
trial court to rule on it. . . . [so long as the issue is] supported
by the record, even if the [trial] court did not consider it.” In
re E.R. Fegert, Inc., 887 F.2d 955, 957 (9th Cir. 1989) (citations omitted).
AMO argues that the FDA provides criteria for a contact
lens solution to be labeled as a “disinfecting solution.” AMO
contends these criteria preempt any claims that AMO’s use of
the term “disinfects” was false or misleading.
[4] The Medical Device Amendments of 1976 (“MDA”) to
the Food, Drug, and Cosmetic Act (“FDCA”), contain a provision that expressly preempts some state and local causes of
action regarding medical devices. It says that:
from having purchased headphones in reliance on false advertising, but
rather claimed that the inherent risk of the headphones reduced the value
of their purchase and deprived plaintiffs of the benefit of their bargain. Id.
at 961. The court in that case found that the claim of economic harm was
not sufficient to plead injury in fact in part because, in distinct contrast to
the MoisturePlus labeling at issue in this case, Apple had not represented
that the headphones were safe at high volume. Rather, “Apple provided a
warning against listening to music at loud volumes.” Id. Because there is
allegedly false labeling and advertising at issue in this case, Birdsong does
not aid our disposition here.
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[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 [the FDCA] 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).
[5] Under that provision, in order for a state law cause of
action to be statutorily preempted, there must be (1) a federal
requirement imposed on the device under the FDCA, and (2)
the challenged state or local rule must impose a requirement
that is different from, or adds additional obligations to, the
federal requirement.
The first step of our preemption analysis is deciding
whether the FDA has promulgated a specific requirement that
applies to contact lens solution. See Riegel v. Medtronic, Inc.,
552 U.S. 312, 321-322 (2008).
[6] “The [MDA] classifies medical devices in three categories based on the risk that they pose to the public.” Medtronic,
Inc. v. Lohr, 518 U.S. 470, 476 (1996). Lens care products for
soft contact lenses, such as MoisturePlus, are classified as
Class II devices. 21 C.F.R. § 886.5928. “Use of Class II
devices involves some risk of injury . . . .” Papike, 107 F.3d
at 739. Class II devices are not subject to the intensive premarket approval (“PMA”) process. See Lohr, 518 U.S. at 477.
In the PMA process, producers of Class III devices must provide the FDA with “reasonable assurance” that the device is
both safe and effective. Id. In contrast, Class II devices are
regulated through “special controls” issued by the FDA and
must receive § 510(k) clearance, so named for the original
number of the section in the MDA. See id. at 478; Papike, 107
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F.3d at 739; see also Riegel, 552 U.S. at 322-23. The FDA
reviews a device under § 510(k) to ensure only that it is substantially equivalent to a product that is already on the market.
Lohr, 518 U.S. at 478.
The fact that lens solution is a Class II device that has come
to market via the § 510(k) process, as opposed to the PMA
process, does not necessarily determine whether it is subject
to federal “requirements” for the purpose of § 360k. For
example, Papike involved labeling requirements for tampons,
which are Class II devices. 107 F.3d at 739. However, the
FDA also requires tampon manufacturers to include a specific
warning about Toxic Shock Syndrome in their packaging. Id.
This court reviewed the regulations mandating those labeling
requirements and found them to contain specific, substantive
content on the risks of Toxic Shock Syndrome. Id. at 740.
This court distinguished the kind of “general federal requirements” applicable to the device in Lohr from the device- and
disease-specific labeling regulations the FDA had imposed on
tampon producers, finding they were “requirements” for
§ 360k preemption purposes. Id. at 741.
A.
Federal Requirement
AMO argues the “special controls” to which MoisturePlus
was subject are federal requirements that apply to the testing,
manufacture, and labeling of multipurpose contact lens solutions. AMO notes that the FDA has issued a document containing the special controls for lens solutions: Guidance for
Industry: Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products (“Guidance Document“) with which contact lens solution manufacturers must
comply to receive § 510(k) clearance.
It mandates:
In order for a contact lens care solution to be labeled
as a contact lens “disinfecting solution,” [1] it should
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meet the primary performance criteria of the standalone procedure for contact lens disinfecting products . . . . [2] This criteria [sic] may also be satisfied
by a hydrogen peroxide (H2O2) disinfecting solution.
. . . [3] An alternative approach may be used if such
approach satisfies the requirements of the applicable
statute, regulation, or both. . . . If alternative procedures are used, the applicant should be prepared to
demonstrate the substantial equivalence in terms of
safety and effectiveness to the predicate device.
Ctr. for Devices and Radiological Health, U.S. Dep’t of
Health and Human Servs., Guidance Document, 30, cover, 2
(1997).
AMO chose the first route to FDA approval of its labeling
MoisturePlus as “disinfecting.” It is undisputed that MoisturePlus met the primary performance criteria of the stand alone
procedure. In doing so, MoisturePlus showed the prescribed
level of efficacy in killing five representative microorganisms: Pseudomonas aeruginosa, Staphylococcus aureus,
Escherichia coli, Candida albicans, and Aspergillus niger. Id.
at 89.
[7] Accordingly, with regard to the labeling at issue in this
law suit, the FDA has promulgated specific requirements,
which MoisturePlus met.
B.
Different or Additional State Requirement
[8] In order for the class to recover in this lawsuit, a court
would have to hold that California’s UCL and FAL required
something different than what the FDA required in order for
AMO to label MoisturePlus a disinfectant. Those California
laws would have to require that AMO test for Acanthamoeba,
and show that MoisturePlus kills it in sufficient quantities.
That is, California law would have a requirement that is additional to the federal requirements.
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[9] Accordingly, the class’ claims are expressly preempted
by § 360.
The district court was incorrect to conclude that this class
of plaintiffs lacked standing, but “[w]e may affirm the district
court’s summary judgment on any ground supported by the
record.” Hawn v. Exec. Jet Mgmt., 615 F.3d 1151, 1155 (9th
Cir. 2010) (citation omitted). Here, the record demonstrates
that the class’ claims are preempted, so we affirm that grant
of summary judgment.
CONCLUSION
For the reasons stated the judgment of the District Court is
AFFIRMED.
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