What changed in this filing

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Item 3. Legal Proceedings

2025-02-28 compared with 2024-02-20 · 25 added, 61 removed, 62 unchanged (58% of the section changed)

Legal Proceedings

O&M Halyard N95 Mask FDA Release

On April 5, 2023, we received a communication from the National Institute for Occupational Safety & Health (NIOSH) that products from one lot of a model (No.

46827) of surgical N95 respirator manufactured by O&M Halyard did not pass laboratory tests for fluid resistance and for filtration efficiency, and that products from one lot of another model (No.

46727) did not pass fluid resistance testing, but did pass filtration efficiency testing.

Our investigation determined that a limited number of lots were potentially implicated by the results of the NIOSH particulate filtration testing on model No.

46827, and that the vast majority of the products in those lots remained in our possession and under our control.

Those lots have been segregated for disposal.

We also determined that a limited quantity of products from one lot did reach the market.

Although products from that lot passed internal and external follow-up testing for filtration efficiency, we initiated a voluntary recall of the lot on August 9, 2023 out of an abundance of caution.

O&M Halyard has confirmed to NIOSH that the particle filtration issue was isolated to the identified lots.

On April 12, 2023, the FDA recommended that consumers, health care providers, and facilities not use the two models (model numbers 46827 and 46727) of O&M Halyard surgical N95 respirators due to concerns about fluid resistance performance.

In addition, the FDA also recommended against using certain of our surgical, procedure and pediatric face masks when fluid resistance is required.

On or about that date, we voluntarily stopped the sale in the U.S.

of the above-referenced surgical N95 respirators and similar models pending our investigation of the performance issues identified by the FDA and NIOSH.

Regulatory bodies in other non-U.S.

markets where we sell our facial protection products have inquired about the relevance of the FDA notification to products sold in their countries.

The FDA updated its recommendation on April 21, 2023, to permit use of the model No.

46727 of Halyard N95 respirators when fluid resistance is not required.

These items are included in our Products & Healthcare Services segment.

On September 29, 2023, the FDA updated its previous recommendation to consumers, health care providers and facilities regarding the above-referenced models of O&M Halyard surgical N95 respirators based on extensive testing and performance data provided by O&M Halyard.

Specifically, the FDA stated that both O&M Halyard respirator models could be used according to the product labeling for respiratory and fluid barrier protection to the wearer

(excluding the one lot of products that O&M Halyard voluntarily recalled on August 9, 2023).

Following the FDA’s update, we published a user notice on our website announcing the resumption of sales and shipments of O&M Halyard surgical N95 respirators, noting that the data provided to the FDA and NIOSH demonstrated that our products provide the levels of particle filtration and fluid resistance for which they are rated.

NIOSH reviewed and concurred with the facts set forth in our user notice published on September 29, 2023.

While the FDA recommendation did not materially affect our results of operations for 2023, there is a risk that these matters and any other safety concerns could have a material adverse effect on our results of operations, financial condition, or cash flows, including as a result of a significant volume of customer product returns and/or recall of products, implementation of corrective action plans, and/or other costly remedial actions in the U.S.

and elsewhere.

In addition, these matters could potentially have other negative impacts including:

government investigations and enforcement actions by the FDA or other U.S.

or international regulators or governmental entities;

the suspension or revocation of the authority to produce, distribute or sell products, and other sanctions;

losses due to patient claims, including product liability claims and lawsuits;

and customer claims related to their direct costs arising from supply disruption.

Other Litigation

We are party to various legal claims that are ordinary and incidental to our business, including ones related to commercial disputes, employment, workers’ compensation, product liability, regulatory, cybersecurity and other matters.

Certain legal proceedings in which we are involved are discussed in Note 15, “Commitments, Contingent Liabilities, and Legal Proceedings”, in Notes to Consolidated Financial Statements in this Annual Report.

We are party to various legal claims that are ordinary and incidental to our business, including ones related to commercial disputes, employment, workers’ compensation, regulatory, cybersecurity, environmental tort, product liability, and other matters.

We maintain insurance coverage for cybersecurity, employment, product liability, workers’ compensation and other personal injury litigation matters, subject to policy limits, applicable deductibles and insurer solvency.

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Executive Vice President, Chief Financial Officer

Executive Vice President & Chief Financial Officer of Owens & Minor since October 2022.

Previously, Mr.

Bruni served as the senior finance partner of the Patient Direct segment and prior to that, as the senior finance partner of the Products & Healthcare Services segment after joining the Company in April 2020.

Prior to joining the Company from 2019 to 2020, Mr.

Bruni served as Chief Financial Officer & Chief Operating Officer for Centerline Communications, a services company providing infrastructure solutions to the wireless telecommunications industry.

From 2018 to 2019, Mr.

Bruni was Chief Financial Officer and Chief Operating Officer for Torque Therapeutics, an immuno-oncology company, where he led finance, manufacturing and corporate operations.

Prior to joining Torque Therapeutics, Mr.

Bruni served from 2012 until 2018 in multiple vice president positions including Finance, Corporate FP&A, Continuous Improvement and Corporate Development at Patheon, a pharmaceutical services company.

Executive Vice President, Business Excellence

Executive Vice President, Business Excellence since March 2023.

Executive Vice President and Chief Financial Officer of Owens & Minor since September 2024 and served as interim Chief Financial Officer since June 2024.

Previously Mr.

Starck served as Executive Vice President, President of Patient Direct Segment, & Chief Executive Officer of Apria since the Apria Acquisition on the Acquisition Date.

Prior to that, Mr.

Starck served as Chief Executive Officer of Apria, Inc.

since February 2015.

Leon served as Senior Vice President, Corporate Treasurer of the Company since May 2018.

Prior to that, Mr.

Starck served as the Chief Executive Officer of Apria’s home respiratory therapy and home medical equipment segment since he joined Apria in April 2012.

From 2007 to 2012, Mr.

Starck served as Chief Executive Officer of CorVel Corporation (CorVel), an Orange County, California-based national provider of industry-leading workers’ compensation solutions for employers, third-party administrators, insurance companies and government agencies seeking to control costs and promote positive outcomes.

Starck joined CorVel in 2006 as President and Chief Operating Officer after serving Apria and a predecessor company in a series of progressively more responsible operations roles from 1992 to 2006.

Leon served as Vice President, Treasurer, after joining Owens & Minor

in January 2017.

Before joining Owens & Minor, Mr.

Leon worked for Universal Corporation and The Brinks Company for 18 years where he served as Vice President and Treasurer.

Executive Vice President & Chief Executive Officer of Products & Healthcare Services Segment

1 unchanged sentence

Previously Mr.

Long served as Chief Financial Officer of Owens & Minor since joining the Company on November 11, 2019.

Long served as Chief Financial Officer of Owens & Minor since joining the Company in November 2019.

Prior to that, Mr.

1 unchanged sentence

(Insys) , from April 2019 to November 8, 2019.

Insys filed for Chapter 11 bankruptcy protection in June 2019.

Prior to that, Mr.

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Prior to that, Mr.

Galloway served as Assistant General

Counsel after joining Owens & Minor in February 2013.

Galloway served as Assistant General Counsel after joining Owens & Minor in February 2013.

Prior to joining Owens & Minor, Mr.

Galloway worked at Williams Mullen for nine years.

Senior Vice President, Corporate Treasurer

Senior Vice President, Corporate Treasurer of Owens & Minor since May 2018.

Prior to that, Mr.

Leon served as Vice President, Treasurer, after joining Owens & Minor in January 2017.

Jennifer Stone (54)

Executive Vice President & Chief Human Resources Officer

Executive Vice President & Chief Human Resources Officer of Owens & Minor since June 2024.

Prior to that, Ms.

Stone served as Vice President, Human Resources, Medical Surgical Portfolio at Medtronic, a global medical device company.

Prior to Medtronic, Ms.

Stone also spent more than 20 years at Target Corporation, a retail company, in various roles of increasing responsibility, including most recently as Head of Talent Management.

Snehashiah Sarkar (50)

Executive Vice President & Chief Information Officer

Executive Vice President & Chief Information Officer of Owens & Minor since May 2024.

Sarkar joined the Company in 2022 as Senior Vice President & Chief Information Officer.

Before joining Owens & Minor, Mr.

Leon worked for the Brinks Company for 19 years, beginning in 1998, where he served as Treasurer.

Sarkar worked for Varian, a Siemens Healthineers Company, as Senior Vice President, Head of Business Transformation Office, and Chief Information Officer.

Be fore that, Mr.

Sarkar spent 13 years with Varian Medical Systems in various leadership roles.

Senior Vice President, Corporate Controller & Chief Accounting Officer

6 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 3. Legal Proceedings