Mallon v. Hologic CA6

CourtCalifornia Court of Appeal
DecidedFebruary 13, 2025
DocketH050917
StatusUnpublished

This text of Mallon v. Hologic CA6 (Mallon v. Hologic CA6) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mallon v. Hologic CA6, (Cal. Ct. App. 2025).

Opinion

Filed 2/13/25 Mallon v. Hologic CA6 NOT TO BE PUBLISHED IN OFFICIAL REPORTS California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions not certified for publication or ordered published, except as specified by rule 8.1115(b). This opinion has not been certified for publication or ordered published for purposes of rule 8.1115.

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

SIXTH APPELLATE DISTRICT

VICTORIA MALLON, H050917, H051465 (Santa Clara County Plaintiff and Appellant, Super. Ct. No. 18CV326938)

v.

HOLOGIC, INC.,

Defendant and Respondent.

Appellant Victoria Mallon sued her former employer, Hologic, Inc. (Hologic), alleging among other claims that Hologic engaged in unlawful retaliation under Labor Code1 section 1102.5 after Mallon reported regulatory violations in Hologic’s research and development (R&D) department. Mallon claimed that, after the department head reacted poorly to her protected report, Hologic subjected her to a series of adverse employment actions that culminated in her termination. The trial court granted summary judgment in favor of Hologic after deciding the evidence failed as a matter of law to support Mallon’s whistleblower retaliation and other claims. The court found that no reasonable trier of fact could conclude Mallon’s protected reports were a contributing factor to her eventual termination, which transpired

1 All further unspecified statutory references are to the Labor Code. more than a year and a half later, and because there was no causal link connecting the alleged chain of adverse employment actions to Mallon’s protected acts. Mallon appeals from the judgment in favor of Hologic and separately appeals the trial court’s postjudgment costs award granting Hologic costs for certain parts of the litigation. For the reasons explained below, we decide that Mallon has not established reversible error as to either the summary judgment or cost orders and affirm the judgment. I. FACTS AND PROCEDURAL BACKGROUND2 A. Mallon’s Employment at Hologic 1. Mallon’s Site Manager Role Hologic designs and manufactures medical devices. In 2006, Mallon was hired as a lab manager at a company acquired by Hologic. Mallon became Hologic’s Sunnyvale site lab manager and held the position until 2013, when she was promoted to senior manager in the diagnostics laboratory. Mallon’s supervisor was Suzanne Werneke. Mallon received positive performance reviews and pay raises during that time. Hologic maintains a quality management system that is mandated by federal law3 and includes an internal audit program. According to company documents, internal site audits are conducted to determine whether Hologic’s quality management system “ ‘is in

2 We draw the facts recited here from the record that was before the trial court when it ruled on the motion for summary judgment (Yanowitz v. L’Oreal USA, Inc. (2005) 36 Cal.4th 1028, 1037 (Yanowitz)), including the parties’ separate statements of undisputed material facts, evidence judicially noticed in conjunction with the motion for summary judgment, and admissions in the parties’ appellate briefs. (See Kim v. County of Monterey (2019) 43 Cal.App.5th 312, 316, fn. 1.) We liberally construe the evidence in support of Mallon, as the party opposing summary judgment, and resolve doubts concerning the evidence in her favor. (Yanowitz, at p. 1037.) 3 Federal law requires manufacturers of finished medical devices to establish a quality management system to ensure safe and effective products. (See 21 C.F.R. § 820.1.) 2 compliance with all applicable regulations, procedures, and standards and is effectively implemented and maintained.’ ” Mallon’s job duties and responsibilities in her role as the senior manager of the diagnostics laboratory included supporting the quality department “for the purpose of audits, both internal and vendor related” and implementing corporate environmental health and safety guidelines, processes, and protocols for the Sunnyvale office. Mallon performed internal audits as part of this role. In March 2015, in connection with an internal audit, Mallon identified a potential discrepancy between the qualifications of a new quality engineer, Ricky L.,4 and Ricky’s job description and duties. She communicated her concern to Robert Kielinen, the senior director of corporate quality engineering. Mallon pointed out that a lack of conformity between an engineer’s qualifications and job description could violate federal regulations, including title 21 Code of Federal Regulations section 820.25. Although Ricky L. initially declined to provide Mallon with the information she requested, he and Mallon ultimately agreed on a method to verify his qualifications. Mallon deemed the issue “resolved.” In an e-mail to Mallon’s supervisor Werneke, Kielinen wrote that he “appreciate[d] [Mallon]’s continued support and assistance with the Sunnyvale internal audit process” and found her to be “very conscientious in her approach and very committed to helping us ensure compliance.” The following month, Mallon identified a violation in the product development (also referred to as R&D) department. She reported the violation in an April 2015 audit report as a Tier 1 nonconformance related to the maintenance and documentation of training records in R&D. According to Hologic’s internal audit report rating key, a Tier 1 nonconformance represents a failure to comply with an applicable regulation, standard, or procedure. It is the “[m]ost severe” type of nonconformance and requires corrective

4 We refer to certain nonparties by first name and last name initial to protect their privacy interests. (Cal. Rules of Court, rule 8.90(b)(10).) 3 action to prevent recurrence. By contrast, a Tier 2 nonconformance is “[a]n isolated observation that is in conflict with contractual or procedural requirements but does not represent a systemic” compliance failure. Jerome Lapointe, site leader and head of product development, questioned the identified nonconformance in an e-mail to senior director Kielinen. On April 17, 2015, Lapointe wrote to Kielinen: “Have you seen this? I’m struggling to understand if this is helpful, or poses a risk. Are we following our own procedures by doing this, and I’m not sure why our SDS lab manager [Mallon] is conducting internal audits!” Kielinen responded that he was looking into it and explained to Lapointe that Mallon “has helped with auditing for a number of years now (both internal and supplier)” and he believes Mallon “is committed to performing a thorough audit with the aim of improving compliance.” Concurrently, Mallon reported to Kielinen that she was “facing resistance for a Tier 1” nonconformance she had identified in the April 2015 audit, stated that she believed the objective evidence supported the nonconformance observation, and expressed concern that Hologic would be “at regulatory risk” if the nonconformance were to be downgraded. Kielinen responded to Mallon in an e-mail on April 17, 2015. Kielinen stated that after reviewing the issue, he agreed she had “identified a gap” but believed it did not represent a “systemic failure” so much as a limited one. Kielinen recommended downgrading the observation to Tier 2. In an e-mail response, Mallon reiterated her concern that “there is a failure of the quality system to comply with applicable regulations” and registered her disagreement with the Tier 2 rating. She requested an addendum documenting the change from Tier 1 to Tier 2 be added to the internal audit report “so that the original rating is preserved in the audit history.” Kielinen and quality engineer Ricky L. signed an addendum to the April 2015 audit report documenting the reclassification.

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Mallon v. Hologic CA6, Counsel Stack Legal Research, https://law.counselstack.com/opinion/mallon-v-hologic-ca6-calctapp-2025.