United States v. Scotty's Inc.

173 F. Supp. 3d 549, 2016 WL 1182725, 2016 U.S. Dist. LEXIS 39819
CourtDistrict Court, E.D. Michigan
DecidedMarch 28, 2016
DocketCase No. 14-14450
StatusPublished
Cited by1 cases

This text of 173 F. Supp. 3d 549 (United States v. Scotty's Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Michigan primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Scotty's Inc., 173 F. Supp. 3d 549, 2016 WL 1182725, 2016 U.S. Dist. LEXIS 39819 (E.D. Mich. 2016).

Opinion

ORDER GRANTING PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT

ROBERT H. CLELAND, UNITED STATES DISTRICT JUDGE

Now before the court is Plaintiff United State’s Motion for Summary Judgment (Dkt. # 22), seeking injunctive relief pursuant to 21 U.S.C. § 332 for violations of the federal Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. §§■ 331(a) and (k). The matter is fully briefed, and the court finds that a hearing is unnecessary. See E.D. LR 7.1(f)(2). For the reasons stated below, the court will grant the government’s Motion.

I. BACKGROUND

For fifty-five years, the Bruce family has owned and' operated Defendant Scotty’s, Inc.; a small, Detroit-based company that manufactures, sells, and distributes ready-to-eat sandwiches, to gas stations and convenience stores located throughout Michigan and Ohio. (Dkt. # 22, Pg. ID 588; Dkt. # 26, Pg. ID 641, 653.) On five separate occasions over the last decade, the Food and Drug Administration (“FDA”) inspected Defendants’ headquarters located at 3426 Junction Street: first in August 2006, then subsequently in August 2008, August 2009, October 2010, and January-February 2014. (Dkt. # 22, Pg. ID 590-605.) On each of these occasions, inspectors discovered multiple violations of the Seafood Hazard Analysis and Critical Control Point (“HACCP”), 21 C.F(R. § 123.6, and Current Good Manufacturing Practice (“CGMP”), Id. at § 110.5, regulations. (Id.) The HACCP regulations govern all establishments that “process fish and fishery products” and apply to Defendants because they manufacture and sell tuna salad sandwiches. Id. at § 123.6. Similarly, the CGMP is applicable to all food processors, except those harvesting, storing, or distributing raw agricultural commodities. Id, at § 110.19. .

Among others, Defendant Scotty’s was cited for the following violations: (1) failing “to have a written HACCP plan to control the food safety hazards reasonably likely to occur during the processing of tuna salad sandwiches,” (Dkt. # 22, Pg. ID 590; Dkt. # 26, Pg. -ID 643); (2) storing tuna salad sandwiches in reduced oxygen packages, (Id.); (3) failing to maintain the requisite sanitation control record, (Id. at Pg. ID 591; Dkt. # 26, Pg. ID 643); (4) main[552]*552taining the plant in state of disrepair, as evidenced by the moldy ceiling tiles in the walk-in cooler where Defendants store sandwiches, (Dkt. # 22, Pg. ID 592; Dkt. # 26, Pg. ID 643); (5) failing to “properly identify toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food,” (Dkt. # 22, Pg. ID 593; Dkt # 26, Pg. ID 644); (6) allowing personnel to process food with bare hands without removing jewelry, (Dkt. # 22, Pg. ID 593); (7) lacking “adequate hand-washing facilities,” (Id. at Pg. ID 594); (8) storing production materials such as bread buns in plastic trays and plastic wrap directly on the' floor, (Dkt. # 19-5, Pg. ID 398-99); and (9) failing to “remove litter and Waste that serves as an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant building,” (Id. at Pg. ID 595).

After each inspection, FDA investigators issued Forms FDA 483 to Defendant Sandra J. Jackson, Scotty's co-owner and manager, and discussed each of the observed violations with her. (Id. at Pg. ID 605.) Each time, Jackson “promised to make the necessary corrections.” (Id,) Additionally, at the conclusion of the 2008, 2009, 2010, and 2014 inspections, “Defendant Jackson promised that Defendants would stop processing tuna salad sandwiches, so as to avoid the obligation to comply with the seafood HACCP regulations.” (Dkt. # 22, Pg. ID 605; Dkt. # 26, Pg. ID 651). Nevertheless, few of the promised improvements were made year-to-year between inspections, and Defendants continue to make tuna salad sandwiches. (Dkt. • # 22, Pg. ID 605-06; Dkt, # 26, Pg. ID 651.)

In addition, the FDA has sent Defendants three follow-up letters. First, in a December 5, 2006 letter, agency officials “detailed] Defendants seafood HACCP violations[,].. .discussing] in detail what the seafood HACCP regulations require and referring] Defendants to additional resources on the FDA’s website.” (Dkt. # 22, Pg, ID 607; Dkt. # 26, Pg. ID 653.) Defendants did not respond. (Id.} Then, on November 19, 2009, the FDA sent Defendants a warning letter which elaborated on many of the regulatory violations and reminded Jackson “that she told EDA investigators during the August 2009 inspection, that she would stop processing tuna salad sandwiches as of August 27, 2009.” (Dkt. # 22, pg. ID 606.) Jackson responded in kind with a letter ten days later, “promising corrective actions,” but suggesting “that she was continuing to process tuna salad sandwiches.” (Id.), The agency responded with a follow-up letter two. months later, stating that “Defendants’ response was inadequate because Defendants failed to address the issues in the Warning Letter in sufficient detail.” (Dkt. # 22, Pg. ID 607.). Defendants, once again, did not respond. (Dkt. # 22, Pg. ID 607; Dkt. # 26, Pg. ID 653.)

After Defendants failed their fifth inspection, in 2014, Plaintiff United States commenced the present action for injunc-tive relief pursuant to 21 U.S.C.- § 332.

II. STANDARD

Summary judgment is proper “if the movant shows that there is no genuine dispute as to any material fact and the movant'is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). “In deciding a motion for summary judgment, the court must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.” Sagan v. United States, 342 F.3d 493, 497 (6th Cir.2003). The movant has the initial burden of showing the absence of a genuine dispute as to a material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). [553]*553“[T]hat burden may be discharged by showing.. .that there is an absence of evidence to support the nonmoving party’s case.” Bennett v. City of Eastpointe, 410 F.3d 810, 817 (6th Cir.2005) (internal quotation marks omitted).

The burden then shifts to the nonmov-ant, who must put forth enough evidence to show that there exists “a genuine issue for trial.” Horton v. Potter, 369 F.3d 906, 909 (6th Cir.2004) (citation omitted). Summary judgment is not appropriate when “the evidence presents a sufficient disagreement to require submission to a jury.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 243, 106 S.Ct. 2506, 91 L.Ed.2d 202 (1986). In evaluating a summary judg-' ment motion, “the judge’s function is not himself to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial... credibility judgments and weighing of the evidence are prohibited.” Moran v. Al Basit LLC, 788 F.3d 201

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Bluebook (online)
173 F. Supp. 3d 549, 2016 WL 1182725, 2016 U.S. Dist. LEXIS 39819, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-scottys-inc-mied-2016.