Lytle v. United States Department of Health & Human Services , 612 F. App'x 861 ( 2015 )

United States Court of Appeals
For the Eighth Circuit
___________________________
No. 14-3715
___________________________
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
___________________________
No. 15-1214
___________________________
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
____________
Appeals from United States District Court
for the District of South Dakota - Rapid City
____________
Submitted: June 12, 2015
Filed: August 21, 2015
____________
Before WOLLMAN, LOKEN, and BENTON, Circuit Judges.
____________
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
-2-
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.
-3-
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.
______________________________
-4-