Crayton v. PharMEDium Services, LLC

213 F. Supp. 3d 963, 2016 U.S. Dist. LEXIS 135572, 2016 WL 5717847
CourtDistrict Court, W.D. Tennessee
DecidedSeptember 30, 2016
DocketNo. 15-cv-2270-STA-cgc
StatusPublished
Cited by2 cases

This text of 213 F. Supp. 3d 963 (Crayton v. PharMEDium Services, LLC) is published on Counsel Stack Legal Research, covering District Court, W.D. Tennessee primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Crayton v. PharMEDium Services, LLC, 213 F. Supp. 3d 963, 2016 U.S. Dist. LEXIS 135572, 2016 WL 5717847 (W.D. Tenn. 2016).

Opinion

ORDER PARTIALLY GRANTING AND PARTIALLY DENYING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT AS TO PLAINTIFF RHONDA CRAYTON

S. THOMAS ANDERSON, UNITED STATES DISTRICT JUDGE

Plaintiffs Rhonda Crayton and Sheila Reed filed this action against their former employer PharMEDium Services, LLC (“PharMEDium”), and PharMEDium employees, Keri Kjellin and John Toth,1 pur[968]*968suant to 28 U.S.C. § 1981.2 (ECF No. 1.) Defendants have filed a motion for summary judgment as to Plaintiff Crayton. (ECF No. 60), Plaintiff has filed a response to the motion (ECF No. 68), Defendants have filed a reply to the response (ECF No. 79), and Plaintiff has filed a sur-reply.3 (ECF No. 81-1.) For the reasons set forth below, Defendants’ motion is PARTIALLY GRANTED and PARTIALLY DENIED.

Standard of Review

Summary judgment is proper “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.”4 When deciding a motion for summary judgment, the court must review all the evidence and draw all reasonable inferences in favor of the non-movant.5 In reviewing a motion for summary judgment, the Court views the evidence in the light most favorable to the nonmoving party, and it “may not make credibility determinations or weigh the evidence.” 6 When the motion is supported by documentary proof such as depositions and affidavits, the nonmoving party may not rest on his pleadings but, rather, must present some “specific facts showing that there is a genuine issue for trial.”7 These facts must be more than a scintilla of evidence and must meet the standard of whether a reasonable juror could find by a preponderance of the evidence that the nonmoving party is entitled to a verdict.8 When determining if summary judgment is appropriate, the Court should ask “whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.”9 The Court must enter summary judgment “against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case and on which that party will bear the burden of proof at trial.”10

Statement of Facts

The following facts are undisputed unless otherwise noted:

PharMEDium Services, LLC, is a limited liability company organized under the laws of the State of Delaware. It provides compounding services to hospital pharmacies, including the formulation of pain-[969]*969management medication used in the administration of epidural anesthesia. One of PharMEDium’s facilities is located at 6100 Global Drive in Memphis, Tennessee. The Memphis facility compounds admixtures that are narcotic.11

During the relevant time period, Defendant John Toth, Caucasian, was the Director of Quality Operations at the Memphis facility. As the Director of Quality Operations, Toth was responsible for the quality groups in each facility, including the laboratory. Toth reported directly to Tom Rasnic, the Vice President of Quality Regulatory and Research and Development.12

During the relevant time period, Defendant Keri Kjellin, Caucasian, was the EPA Lab Manager at the Memphis facility. As the EPA Lab Manager, Kjellin was responsible for assigning work in the lab and selecting employees for particular projects in the lab. She also was responsible for ensuring that the lab’s methods and procedures were followed and that the instrumentation was operating appropriately. Kjellin reported directly to Toth.13 Kjellin supervised ten employees, which included five chemists—Plaintiffs Sheila Reed and Rhonda Crayton, African-American; Dustin Hall, Caucasian; Tanika Aurora, East Indian; and Elizabeth Simpson, Caucasian.14

The Memphis lab is charged with testing the identity and potency of final drug products. Once the drug products are compounded on site, a sample of the product goes to the lab for testing. The testing equipment in the lab consists of HPLC (high pressure liquid chromatography) and UPLC (ultra performance liquid chromatography). Balances, water purification systems, and different types of glassware to measure solutions are part of the equipment used in the lab. The testing is done to monitor the operation and to ensure that the processes are staying within a state of control. The Memphis lab is a highly regulated environment by both state and federal regulations.15

PharMEDium is committed to developing quality processes that facilitate the highest level of safety for patients who are recipients of critical intravenous and epidural preparation. Accordingly, because public safety, is dependent upon PharMEDium’s services, adherence to its Standard Operating Procedures is important.16

PharMEDium’s Code of Conduct prescribes goals for employees to follow its policies and procedures.17

PharMEDium Policy CPS-016 requires chemists to document their tests at the time the testing is performed (“All performance tasks are to be documented at the time the task is performed.”) This requirement is included in the section which states, “All entries are to be made in ink” and “All entries are to be legible and sized appropriately for the space provid[970]*970ed.”18 CPS-016 also provides that “Falsification of documentation will not be tolerated. Any confirmed incident of falsification of documentation must result in a thorough investigation of the circumstances and a written statement by the manager assessing the potential impact the situation may have had on product.” The policy identifies the following as falsification of documentation: “It must never be documented on any form or chart that a check, inspection or test was performed when, in fact, it was not. If a particular check cannot be done ... Manager must be contacted immediately and told why the check cannot be done.” CPS-016 is in place to comply with the regulatory requirements of the FDA, which is the governmental agency charged with regulating the pharmaceutical industry.19 Section 5.14 lists examples of “Falsification of Documentation.” 20

PharMEDium values correct documentation because it is the only evidence PharMEDium has showing that it complied with the FDA’s testing requirements. Because PharMEDium is under scrutiny by the FDA and a negative audit could result in fines and/or ultimately a shutdown of PharMEDium’s operations, PharMEDium takes a serious view of violations of CPS-016.21

PharMEDium’s handbook states that it is committed to providing a work environment free from discrimination and harassment.22

Additionally, PharMEDium’s handbook outlines prohibited conduct.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
213 F. Supp. 3d 963, 2016 U.S. Dist. LEXIS 135572, 2016 WL 5717847, Counsel Stack Legal Research, https://law.counselstack.com/opinion/crayton-v-pharmedium-services-llc-tnwd-2016.