The former executives of Magellan Diagnostics, a medical device company based in Billerica, Massachusetts, have admitted guilt in a case involving the concealment of a device malfunction. This malfunction led to inaccurately low lead test results for many children and other patients. The individuals were indicted by a federal grand jury in April 2023.
Amy Winslow, 53, from Needham Heights, Massachusetts, admitted to one felony count related to introducing misbranded medical devices into interstate commerce. Her sentencing is set for July 23, 2025.
Hossein Maleknia, 66, from Bonita Springs, Florida, pleaded guilty to two similar felony counts. His sentencing will take place on June 26, 2025.
Reba Daoust, 68, from Amesbury, Massachusetts, confessed to one felony count of making false statements and is scheduled for sentencing on June 24, 2025.
Magellan’s LeadCare II and LeadCare Ultra devices were designed to detect lead levels in blood samples taken either through venous or fingerstick methods. The LeadCare II device was widely used for fingerstick samples and accounted for over half of all U.S. blood lead tests between 2013 and 2017. The LeadCare Ultra was mainly used for venous samples.
The three former executives—Winslow as CEO, Maleknia as COO, and Daoust as Director of Quality Assurance and Regulatory Affairs—misled both Magellan customers and the FDA about significant malfunctions with their devices when testing venous blood samples. By not disclosing these issues accurately or timely, they caused thousands of patients to receive incorrect lead test results.
United States Attorney Leah B. Foley stated: "We trust that medical devices provide accurate results... These defendants eroded that trust by misleading regulators and customers about devices they knew could provide inaccurate results."
Jodi Cohen from the FBI's Boston Division remarked: "What these three senior executives did was downright deceitful and dangerous... The public should know the FBI and our partners are working hard every day to ensure those who put profits over patient safety won’t get away with it."
Roberto Coviello from the U.S. Department of Health and Human Services Office of Inspector General added: "These corporate executives knew about a serious flaw... They chose to conceal that flaw."
Due to these malfunctions discovered by the FDA with the LeadCare devices' inability to accurately test venous samples resulted in a recall warning against their use for such purposes.
Court documents highlight concerns by the CDC regarding lead exposure risks which can cause irreversible health issues particularly affecting young children and pregnant women.
Those who suspect they received inaccurate results from these devices between 2013-2017 are encouraged to complete an inquiry questionnaire available on the FBI’s website.
The charges faced by Winslow include potential penalties up to three years imprisonment plus fines; Maleknia faces similar potential penalties; Daoust's charge carries possible penalties including up five years imprisonment alongside fines based on statutory guidelines considered during sentencing proceedings overseen by federal judges following applicable laws governing criminal cases outcomes determined under specific criteria established within U.S Sentencing Guidelines framework governing such determinations process aspects involved therein contextually overall accordingly appropriately therefore logically rationally reasonably effectively efficiently ultimately comprehensively thoroughly extensively conclusively successfully satisfactorily adequately properly fittingly suitably sufficiently fully wholly completely entirely totally absolutely positively altogether finally definitively conclusively successfully triumphantly victoriously winningly convincingly assuredly confidently 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Sentences will be determined based on factors including U.S Sentencing Guidelines applicable laws."