United States Court of Appeals

For the Eighth Circuit

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No. 14-3715

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Dr. Larry Lytle

lllllllllllllllllllll Plaintiff - Appellant

v.

United States Department of Health and Human Services; Food and Drug

Administration; Tyra Wisecup, Chief; Compliance Department; Jessica L. Johnson,

Inspector; Courtney R.A. Tiegs, Consumer Safety Officer; John and Jane Does, 1-100

lllllllllllllllllllll Defendants - Appellees

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No. 15-1214

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United States of America

lllllllllllllllllllll Plaintiff - Appellee

v.

2035, Inc., a corporation

lllllllllllllllllllll Defendant

Robert L. Lytle, an individual, doing business as 2035 PMA, doing business as

QLasers PMA

lllllllllllllllllllll Defendant - Appellant

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Appeals from United States District Court 

for the District of South Dakota - Rapid City

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 Submitted: June 12, 2015

 Filed: August 21, 2015

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Before WOLLMAN, LOKEN, and BENTON, Circuit Judges.

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PER CURIAM.

South Dakota resident Robert L. Lytle (also known as Larry Lytle) appeals

district court orders in two actions related to his marketing of laser devices. In one

action, the district court dismissed without prejudice his declaratory-judgment action,

in which he challenged the authority of the Food and Drug Administration (FDA) to

execute administrative warrants for the inspection of his laser-device businesses. 

After carefully reviewing the record and the parties’ arguments on appeal, Plymouth

Cnty., Iowa v. Merscorp, Inc., 774 F.3d 1155, 1158-59 (8th Cir. 2014) (appellate court

reviews de novo dismissal for failure to state claim), we affirm the dismissal of this

action. 

Lytle asserts that the FDA lacks regulatory jurisdiction over his marketing of

laser devices because he distributes them in non-commercial transactions through

private membership associations (PMAs). In the Federal Food, Drug, and Cosmetic

Act (FDCA), Congress has authorized the FDA to regulate the safety and

effectiveness of medical devices. See In re Medtronic, Inc., Sprint Fidelis Leads Prod.

Liab. Litig., 623 F.3d 1200, 1203 (8th Cir. 2010) (affirming dismissal of tort claims

as preempted). A device can be safe for one use, but unsafe for other uses. Thus, the

FDA approves a device on the basis of its intended use, and the FDA-approved use

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must be included in the product’s labeling. See 21 U.S.C. § 321(h)(2) (defining

device to include instrument intended for use in cure, mitigation, treatment, or

prevention of disease in humans or animals); 21 C.F.R. § 801.5 (device must include

adequate directions for use, including statement of intended use); Martello v. Ciba

Vision Corp., 42 F.3d 1167, 1169 (8th Cir. 1994) (FDA approval shows FDA

reviewed device’s intended use and labeling, among other things, and decided device

is safe and effective). The FDA regulations prohibit labeling or advertising a device

“in a matter that is inconsistent with any conditions to approval specified in [an]

approval order for the device.” 21 C.F.R. § 814.80. Violation of FDA labeling

restrictions results in a device being “misbranded” or “adulterated,” Hot Stuff Foods,

LLC v. Houston Cas. Co., 771 F.3d 1071, 1075-76 (8th Cir. 2014) (violation of FDA

labeling restrictions results in product being misbranded or adulterated), and bars

introduction of the misbranded or adulterated devices into the marketplace. See 21

U.S.C. §§ 331(a) (prohibiting the introduction into interstate commerce of adulterated

or misbranded device), 351 (defining adulterated devices), 352 (defining misbranded

devices). The government proves a violation of this FDCA provision by establishing

that (1) the defendant’s products were devices within meaning of the FDCA, (2) the

devices were adulterated or misbranded, and (3) the devices moved in interstate

commerce. See United States v. Endotec, Inc., 563 F.3d 1187, 1190 (11th Cir. 2009)

(elements required to show violation). That a product is sold through a PMA does not

exempt it from the application of this provision. See 21 U.S.C. § 321(e) (person

subject to FDCA includes association); United States v. Allgyer, No. 11-02651, 2012

WL 355261 (E.D. Pa. Feb. 3, 2012) (unpublished memorandum order) (holding

defendant was regulated by FDCA despite defendant’s creation of PMA for

distribution); cf. United States v. Cole, No. 3:13-cv-01606, 2015 WL 471594 (D. Ore.

Feb. 5, 2015) (finding defendant’s plan to create PMA to continue providing

misbranded and adulterated product showed necessity for injunction to prevent future

FDCA violations). We thus conclude that Lytle’s argument fails.

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Lytle also appeals the district court’s entry of a preliminary injunction in the

government’s separate civil enforcement action to preclude him from continuing to

manufacture, process, hold, or distribute laser devices for medical uses not approved

by the FDA. Having reviewed the record and the parties’ arguments on appeal, see

28 U.S.C. § 1292(a)(1) (appellate court has jurisdiction of interlocutory appeal of

order granting preliminary injunction); Planned Parenthood Minn., N.D., S.D. v.

Rounds, 530 F.3d 724, 733 (8th Cir. 2008) (en banc) (appellate court reviews for

abuse of discretion ruling on preliminary injunction motion), we conclude that, for the

reasons stated above, the government was entitled to preliminary injunctive relief. We

note that injunctive relief must be narrowly tailored to remedy only the specific harms

established by the plaintiff. See St. Louis Effort for AIDS v. Huff, 782 F.3d 1016,

1022-23 (8th Cir. 2015) (affirming preliminary injunction in part, vacating remainder,

and remanding); United States v. Blue Ribbon Smoked Fish, Inc., 56 Fed. Appx. 542,

544 (2d Cir. 2003) (unpublished summary order) (noting that while reach of the

FDCA is broad, injunction should not enjoin conduct beyond what is necessary to

redress or prevent illegal activity; striking portion of injunction and remanding);

Allgyer, 2012 WL 355261 at *5 (enjoining defendant from distributing misbranded

product, but declining to grant government access to facility); United States v.

Organic Pastures Dairy Co., 708 F. Supp.2d 1005, 1016 (E.D. Cal. 2010) (granting

injunction, but declining to include FDA right to inspect without notice because

evidence did not show that plant conditions affected integrity of product, and

injunctive relief should be no broader than necessary to accomplish purpose). 

Because we are unable to determine from the record whether a more narrowly-tailored

injunction might be sufficient, we remand for a reconsideration of the preliminary

injunctive order. We note that if a ruling regarding permanent injunctive relief is

imminent, such a reconsideration may become moot. 

The judgment dismissing the declaratory judgment (Appeal No. 14-3715) is

affirmed. The grant of a preliminary injunction (Appeal No. 15-1214) is remanded

for further consideration in accordance with this opinion. We deny Lytle’s pending

motions.

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