Leiner v. Fresenius Kabi USA, LLC

CourtDistrict Court, W.D. New York
DecidedNovember 1, 2019
Docket1:14-cv-00979
StatusUnknown

This text of Leiner v. Fresenius Kabi USA, LLC (Leiner v. Fresenius Kabi USA, LLC) is published on Counsel Stack Legal Research, covering District Court, W.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Leiner v. Fresenius Kabi USA, LLC, (W.D.N.Y. 2019).

Opinion

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF NEW YORK

PAUL H. LEINER,

Plaintiff, v. DECISION AND ORDER 14-CV-979S FRESENIUS KABI USA, LLC,

Defendant.

I. INTRODUCTION In this action, Plaintiff Paul H. Leiner alleges that his former employer, Defendant Fresenius Kabi USA, LLC (“Fresenius Kabi”), discriminated and retaliated against him based on his age in violation of the Age Discrimination in Employment Act (“ADEA”), 29 U.S.C. §§ 621, et seq., and § 296 of the New York Human Rights Law (“NY HRL”). Pending before this Court is Fresenius Kabi’s Motion for Summary Judgment. (Docket No. 28.) For the reasons discussed below, the motion is granted. II. BACKGROUND A. Leiner’s Employment at Fresenius Kabi Fresenius Kabi develops, manufactures, and markets injectable pharmaceuticals in the oncology, anti-infective, anesthetic/analgesic, and critical care fields. (Defendant’s Rule 56 Statement (“Defendant’s Statement”), Docket No. 30, ¶ 1; Plaintiff’s Rule 56 Statement (“Plaintiff’s Statement”), Docket No. 40-1, ¶ 1.1) It maintains facilities

1This Court has confirmed and is satisfied that the evidence cited in the parties’ Rule 56 Statements supports the assertions therein. Cf. Holtz v. Rockefeller & Co., Inc., 258 F.3d 62, 74 (2d Cir. 2001) (holding that factual allegations contained in a Rule 56 Statement that find no support in the record evidence must be disregarded and the record reviewed independently). 1 throughout the United States, including a manufacturing facility in Grand Island, New York, at which it employs approximately 725 people. (Defendant’s Statement, ¶¶ 2, 3; Plaintiff’s Statement, ¶¶ 2, 3.) Operations at the Grand Island facility include aseptic (sterile) manufacturing and sterilization processes, quality control laboratories,

warehousing, and administrative offices. (Defendant’s Statement, ¶ 4; Plaintiff’s Statement, ¶ 4.) Given the nature of its work, Fresenius Kabi is subject to the federal Food and Drug Administration’s oversight. (Defendant’s Statement, ¶ 5; Plaintiff’s Statement, ¶ 5; Affidavit of Wayne Hopkins (“Hopkins Aff.”), Docket No. 35, ¶ 4.) Leiner began working for Fresenius Kabi as a packager on August 8, 1988, when it was Lifomed. (Deposition of Paul H. Leiner (“Leiner Dep.”), Docket No. 40-6, p. 19; Affidavit of Peter Martinez (“Martinez Aff.”), ¶ 13.) He was promoted several times, including in February 2010, when he became Production Supervisor in the Aseptic and Terminally Sterilized Filling and Capping Department. (Defendant’s Statement, ¶ 6; Plaintiff’s Statement, ¶ 6; Leiner Dep., pp. 19-29, 31.) In that capacity, Leiner supervised

production personnel and processes within his assigned area of responsibility, including supervising production operators to ensure compliance with all company and regulatory requirements. (Defendant’s Statement, ¶ 7; Plaintiff’s Statement, ¶ 7.) In March 2013, Wayne Hopkins, the Senior Manager of Manufacturing, offered Leiner another promotion to a weekend Shift Manager position. (Defendant’s Statement, ¶ 8; Plaintiff’s Statement, ¶ 8; Leiner Dep., pp. 26, 27; Hopkins Aff., ¶ 12.) The parties dispute whether this promotion would have come with a pay raise. (Defendant’s Statement, ¶ 9; Plaintiff’s Statement, ¶ 9.) In any event, Leiner did not believe that Hopkins’s offer was genuine in the sense that he did not believe that Hopkins wanted him 2 in that position. (Leiner Dep., pp. 26, 54, 70-71.) The offered position had other drawbacks as well: 30-, 60-, and 90-day evaluation periods during which Leiner could be removed with no guarantee that he could return to his previous position and shift. (Leiner Dep., pp. 26-27, 68-73.) Leiner therefore declined the promotion. (Defendant’s

Statement, ¶ 10; Plaintiff’s Statement, ¶ 10; Leiner Dep., pp. 26, 27, 69; Hopkins Aff., ¶ 14.) In April 2013, Fresenius Kabi formed a Leadership Team at the Grand Island facility to transform the culture and address issues raised by the FDA, which included prioritizing aseptic practices and environments.2 (Defendant’s Statement, ¶ 11; Plaintiff’s Statement, ¶ 11; Martinez Aff., ¶¶ 9, 11.) Leiner joined this Leadership Team of approximately 30 employees, the majority of whom were in Leiner’s protected age group. (Defendant’s Statement, ¶¶ 12, 13; Plaintiff’s Statement, ¶¶ 12, 13.) Members of the Leadership Team did not receive any additional compensation or other pecuniary benefits. (Defendant’s Statement, ¶ 14; Plaintiff’s Statement, ¶ 14.)

In May 2013, Leiner was removed from the Leadership Team. (Defendant’s Statement, ¶ 15; Plaintiff’s Statement, ¶ 15.) He claims that another employee, Jason Ashbery, told him that he was removed because he declined the promotion that Hopkins offered him in March 2013. (Leiner Dep., p. 28.) Fresenius Kabi maintains that Leiner was removed because he exhibited conduct inconsistent with a leadership role, including

2 Fresenius Kabi had earlier received a warning letter from the FDA in February 2012 concerning procedures for ensuring that all drug products were aseptic. (Defendant’s Statement, ¶ 5; Plaintiff’s Statement, ¶ 5; Hopkins Aff., ¶ 6.)

3 avoidance of responsibility and deflection of supervisory accountability in disciplining a subordinate. (Martinez Aff., ¶ 24; Hopkins Aff., ¶ 17.) Several months later, on July 30, 2013, second-shift operators had trouble loading a batch of Doxycycline (Batch #7035693) into a Lyophilizer, which is a machine used to

freeze-dry pharmaceuticals for transport.3 (Defendant’s Statement, ¶ 16; Plaintiff’s Statement, ¶¶ 16, 18 n.1; Leiner Dep., pp. 146-147.) In connection with this batch, one of the operators noted on the Lyophilization loading tag (“Lyo Loading Tag”) that the shelves were “to [sic] small to load.” (Defendant’s Statement, ¶ 17; Plaintiff’s Statement, ¶ 17.) But the batch was in fact loaded, so the batch needed corrections, which Leiner was tasked with completing.4 (Leiner Dep., pp. 125-127.) After Leiner reviewed the batch before its release, he added the following corrective notation to the Lyo Loading Tag: “From front[,] shelf spacing correct, however, 2 shelves were slightly askew causing appearance of two [sic] small of space to load. Shelf was aseptically manipulated to allow loading.” (Defendant’s Statement, ¶ 18; Plaintiff’s Statement, ¶ 18; Leiner Dep., p. 151.)

Leiner admits that he made this notation but insists that it came in the normal course of corrections that Hopkins asked him to make because of his experience. (Leiner Dep., pp. 125-126.) According to Leiner, Hopkins routinely came to him with notes “indicat[ing] that batch record corrections needed to be done on certain batches to get them released.” (Id. at pp. 125, 132-133.) Almost every batch required written

3 Doxycycline is a pharmaceutical used to treat bacterial infections, including pneumonia and other respiratory tract infections, Lyme disease, and infections of skin and urinary systems, among other ailments. (Huffman Aff., ¶ 5.)

4 Batch corrections were part of Fresenius Kabi’s written procedures for identifying, reporting, investigating, documenting, and approving non-conformance or deviation incidents, and for implementing follow-up actions. (Hopkins Aff., ¶ 5.) These procedures were necessary to comply with FDA requirements. (Id.) 4 corrections. (Id.) Leiner completed most of these corrections because of his experience and “good cross-functional understanding.” (Id. at pp. 126, 133.) As it relates to the batch at issue, Leiner states that he was given a note on August 30, 2013, seeking an explanation for why an operator would write that he was unable to

load 15 trays into the lyophilizer despite documentation that the trays had in fact been loaded. (Leiner Dep., pp.

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

Related

Leibowitz v. Cornell University
584 F.3d 487 (Second Circuit, 2009)
Adickes v. S. H. Kress & Co.
398 U.S. 144 (Supreme Court, 1970)
McDonnell Douglas Corp. v. Green
411 U.S. 792 (Supreme Court, 1973)
Anderson v. Liberty Lobby, Inc.
477 U.S. 242 (Supreme Court, 1986)
St. Mary's Honor Center v. Hicks
509 U.S. 502 (Supreme Court, 1993)
Gross v. FBL Financial Services, Inc.
557 U.S. 167 (Supreme Court, 2009)
Timbie v. Eli Lilly & Co.
429 F. App'x 20 (Second Circuit, 2011)
Joyce Bickerstaff v. Vassar College
196 F.3d 435 (Second Circuit, 1999)

Cite This Page — Counsel Stack

Bluebook (online)
Leiner v. Fresenius Kabi USA, LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/leiner-v-fresenius-kabi-usa-llc-nywd-2019.