BD (NYSE: BDX) Reaches Resolution with SEC Over Alaris Infusion System Investigation
BD, the company headquartered in Franklin Lakes, New Jersey, has confirmed an agreement with the U.S. Securities and Exchange Commission (SEC) to conclude an inquiry into its Alaris system. The assessment addressed previous public disclosures and SEC filings related to the Alaris infusion pump. BD has agreed to pay $175 million but does not admit or deny the SEC’s conclusions from an order concerning incidences more than four years old.
The Alaris system has been troubled with challenges, including a long-standing halt on shipments in 2020, a scenario unfolding after BD acquired the technology from CareFusion for $12 billion in 2015.
Financial and Legal Background
In addition to this settlement, BD had earlier compensated $85 million to resolve a class action lawsuit in New Jersey a year ago. The company has already accommodated and disclosed this payment in its 2024 Form 10-K and considered it in its 2025 financial plans without necessitating a financial re-statement. Consequently, this settlement does not affect BD’s investment strategies or capital distribution, nor does it require any revisions to its 2025 financial forecasts.
BD emphasized in its statement that resolving the matter with the SEC “is the appropriate step to put the issue to rest and move forward.” Additionally, “BD has introduced numerous enhancements to its operational controls and governance frameworks, demonstrating a steadfast commitment to ethical conduct and excellence,” the company stated.
Progress with Alaris Developments
Concerns regarding the Alaris system trace back to early 2020, when a Class I recall was initiated due to several system, software, and usability errors, resulting in a prolonged halt to its distribution. This impacted BD’s financial projections for the year. The company sought new FDA approvals for the pumps in April 2021 and began remediation efforts by July 2021.
In the summer of 2022, a New Jersey federal judge permitted a lawsuit alleging BD’s poor communication about the Alaris issues to proceed. Post obtaining fresh FDA authorization, BD resumed Alaris distribution in July. Yet, the company faced legal challenges claiming undisclosed flaws and unauthorized product changes.
Following the resumption of its distribution, BD has noted growth in the Alaris system. Their latest quarterly earnings report revealed their BD Medical segment experienced an 11.1% increase compared to the previous year, crediting the climb to advancements in medication delivery technologies, including double-digit enhancements in infusion solutions empowered by Alaris.