NEW YORK – Former Magellan Diagnostics CEO Amy Winslow pleaded guilty to violating the federal Food, Drug and Cosmetic Act in a case related to the malfunctioning of Magellan's lead-testing devices.
In a plea agreement dated March 9 and filed with the US District Court for the District of Massachusetts, the US Department of Justice said that Winslow would plead guilty to a charge of introducing misbranded medical devices into interstate commerce. Following the sentencing of Winslow, five other counts of the federal indictment would be dismissed, according to the agreement.
Reuters reported that Winslow pleaded guilty on Monday.
The malfunction of Magellan's tests produced inaccurately low lead-testing results for patients, and Winslow's charge related to allegations that Magellan sent customers a letter after discovering the malfunction that advised them to incubate blood samples for 24 hours before using one of its lead-testing devices. Those instructions were contrary to the device's label and were altered without telling the US Food and Drug Administration.
Winslow was indicted in 2023 and was the last of three former Magellan executives to plead guilty rather than proceed to trial next month, according to Reuters.
The maximum penalties include incarceration for three years, supervised release for one year, a fine of $10,000, and a mandatory special assessment of $100. The US Attorney for the District of Massachusetts recommended incarceration for one year and one day, a fine of $10,000, one year of supervised release, and a mandatory special assessment of $100, according to the plea agreement.
Winslow's sentencing is set for July 23.
Magellan is now owned by Meridian Bioscience, which was acquired by Korean firms SD Biosensor and SJL Partners in 2023. Magellan agreed to pay $42 million and plead guilty to resolve related charges last year. It also agreed to compensate all patients who were demonstrably harmed for the financial damages they suffered as a result of the malfunction.
The malfunction was discovered in 2013 and affected three testing devices in Magellan's LeadCare line, including the LeadCare Ultra, LeadCare Plus, and LeadCare II tests. According to prosecutors, Winslow and the other two executives — Hossein Maleknia, former chief operating officer, and Reba Daoust, former manager and director of quality assurance and regulatory affairs — never reported the issue to the FDA and only told the agency after Meridian acquired the company in 2016.
Magellan launched a recall of almost 1.1 million devices in 2017 after a warning from the FDA. Later that year, the FDA issued a warning letter to Magellan alleging that the company violated federal law by marketing "significantly modified versions" of its lead-testing systems without approval or clearance from the agency. It also alleged that Magellan did not submit medical device reports to the agency after becoming aware of customer complaints involving discrepancies in the test results.