Weston v. Kim's Dollar Store

731 S.E.2d 864, 399 S.C. 303, 2012 WL 3205150, 2012 S.C. LEXIS 150
CourtSupreme Court of South Carolina
DecidedAugust 8, 2012
DocketNo. 27155
StatusPublished
Cited by10 cases

This text of 731 S.E.2d 864 (Weston v. Kim's Dollar Store) is published on Counsel Stack Legal Research, covering Supreme Court of South Carolina primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Weston v. Kim's Dollar Store, 731 S.E.2d 864, 399 S.C. 303, 2012 WL 3205150, 2012 S.C. LEXIS 150 (S.C. 2012).

Opinion

Justice KITTREDGE.

We granted a writ of certiorari to review the court of appeals’ decision in this matter. Weston v. Kim’s Dollar Store, 385 S.C. 520, 684 S.E.2d 769 (Ct.App.2009). Petitioner Monica Weston purchased a pair of prescription decorative, colored contact lenses without a prescription from Respondent Kim’s Dollar Store, an unauthorized seller. The lenses were manufactured by Respondent CIBA Vision (CIBA). Petitioner developed an eye infection which led to the loss of vision in her left eye. Thereafter, Petitioner brought an action against Kim’s Dollar Store and CIBA alleging six causes of action. The trial court granted partial summary judgment in favor of CIBA as to three of the six causes of action based on federal preemption, and the court of appeals affirmed.

On certiorari, Petitioner concedes the lenses she purchased are Class III medical devices but argues her claims are not preempted because CIBA failed to show the lenses were approved by the Food and Drug Administration (FDA) through the pre-market approval (PMA) process. Having carefully canvassed the voluminous record, we find these lenses were FDA approved through the PMA process. Accordingly, we affirm the court of appeals to the extent partial summary judgment was granted on claims that would impose common-law requirements “different from, or in addition to” applicable FDA requirements. As to the remaining causes of action, we remand for further proceedings consistent with this opinion.

I.

PROCEDURAL HISTORY

The underlying facts are set forth in the court of appeals’ well-reasoned opinion. For ease of reference, we reiterate only that the contact lenses Petitioner purchased were Fresh-Look Colors brand lenses with ultraviolet (UV) protection, to be sold by prescription only, and approved for extended wear. The lenses were non-corrective, or “piano” lenses.

[307]*307Petitioner filed suit against Kim’s Dollar Store and CIBA alleging six causes of action and seeking damages for her injuries.1 Essentially, Petitioner claimed CIBA knew its piano lenses were frequently sold without a prescription and by unauthorized sellers, yet CIBA failed to take steps to ensure customers received lenses by prescription only and with appropriate warnings and instructions. CIBA moved for summary judgment on the basis that Petitioner’s claims were preempted by federal law. Following a hearing, the trial court granted partial summary judgment in favor of CIBA as to Petitioner’s claims based on “warning, labeling, design, marketing, misbranding, or similar claims.”

The court of appeals affirmed the partial grant of summary judgment, finding CIBA demonstrated that no genuine issue of material fact existed as to whether FreshLook Colors piano lenses underwent the PMA process and were subject to device-specific FDA requirements. As to Petitioner’s state common-law claims, the court of appeals found “[a]ny state requirements imposed by a jury verdict in favor of the causes of action at issue would be in addition to or in contradiction of federal requirements, and therefore ... were properly dismissed by the circuit court.” Weston, 385 S.C. at 537, 684 S.E.2d at 778.

Before now, Petitioner has vigorously claimed that the contact lenses she purchased should be considered a cosmetic, not a medical device, and substantial portions of the trial court’s order and the court of appeals’ opinion were devoted to that issue. However, Petitioner now concedes the piano lenses she purchased are Class III medical devices. Thus, the [308]*308sole issue before this Court is Petitioner’s claim that a genuine issue of material fact exists as to whether FreshLook Colors UV piano lenses were subject to FDA approval through the PMA process.

II.

STANDARD OF REVIEW

A trial court may grant summary judgment “if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Rule 56(c), SCRCP. “Summary judgment should be granted only where it is perfectly clear that no genuine issue of material fact exists and inquiry into facts is not desirable to clarify application of the law.” Wortman v. Spartanburg, 310 S.C. 1, 4, 425 S.E.2d 18, 20 (1992). “An appellate court applies the same standard used by the trial court under Rule 56(c) when reviewing the grant of a motion for summary judgment.” Epstein v. Coastal Timber Co., 393 S.C. 276, 281, 711 S.E.2d 912, 915 (2011). “In determining whether summary judgment is proper, the court must construe all ambiguities, conclusions, and inferences arising from the evidence against the moving party.” Byers v. Westinghouse Elec. Corp., 310 S.C. 5, 7, 425 S.E.2d 23, 24 (1992).

III.

ANALYSIS

The applicable law regarding federal regulation of contact lenses is set forth in the court of appeal’s well-researched and reasoned opinion. Here, we reiterate only that Congress included an express preemption provision in the Medical Device Amendments of 1976(MDA),2 which provides:

[309]*309[N]o State or political subdivision of a State may establish or continue with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 860k(a) (emphasis added). The United States Supreme Court made clear in its recent decision in National Meat Ass’n v. Harris, that express preemption provisions should be construed broadly, with an eye towards a federal agency’s extensive authority and responsibility of ensuring the safety and effectiveness of consumer products.3 — U.S. —, 132 S.Ct. 965, 181 L.Ed.2d 950 (2012). Although Harris examined a different federal regulatory scheme, we believe that opinion is instructive as to the broad manner in which [310]*310express preemption provisions should be construed, particularly where, as here, the federal regulatory scheme at issue does not contain a saving clause.

As to federal requirements, pre-market approval imposes device-specific requirements as contemplated by the MDA. Riegel v. Medtronic, Inc., 552 U.S. 312, 322, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). “Absent other indication, reference to a State’s ‘requirements’ includes its common-law duties.” Id. at 324, 128 S.Ct. 999. However, “State requirements are pre-empted under the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law.” Id. at 330, 128 S.Ct. 999.

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731 S.E.2d 864, 399 S.C. 303, 2012 WL 3205150, 2012 S.C. LEXIS 150, Counsel Stack Legal Research, https://law.counselstack.com/opinion/weston-v-kims-dollar-store-sc-2012.