Three former executives of Magellan Diagnostics, Inc., a medical device company based in Billerica, Massachusetts, have admitted guilt in connection with hiding a device malfunction that resulted in inaccurately low lead test results for numerous children and patients. The individuals were indicted by a federal grand jury in April 2023.
Amy Winslow, aged 53 from Needham Heights, Massachusetts, has pleaded guilty to one felony count of introducing misbranded medical devices into interstate commerce. Her sentencing is set for July 23, 2025, as scheduled by U.S. District Court Judge Patti B. Saris.
Hossein Maleknia, aged 66 from Bonita Springs, Florida, has pleaded guilty to two felony counts related to the same charge. His sentencing is planned for June 26, 2025.
Reba Daoust, aged 68 from Amesbury, Massachusetts, has admitted guilt to one felony count of making false statements and will be sentenced on June 24, 2025.
The LeadCare II and LeadCare Ultra devices produced by Magellan were designed to detect lead levels in blood samples taken either through venous or fingerstick methods. LeadCare II was primarily used for fingerstick samples and accounted for over half of all blood lead tests conducted nationwide between 2013 and 2017. LeadCare Ultra was mainly used for venous samples.
Winslow (CEO), Maleknia (COO), and Daoust (Director of Quality Assurance and Regulatory Affairs) misled both customers and the FDA about a significant malfunction affecting Magellan's LeadCare devices when testing venous blood samples. This concealment led to many children receiving inaccurately low lead test results.
U.S. Attorney Leah B. Foley stated: “We trust that medical devices provide accurate results... These convictions should make one thing clear: corporate fraud that puts public health at risk will not go unpunished.”
Jodi Cohen from the FBI 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 added: “These corporate executives knew about a serious flaw... These convictions serve as a strong reminder that we will continue to work tirelessly...”
The FDA determined that the LeadCare devices could not accurately test venous samples leading to their recall and warnings against their use for such tests due to malfunctions.
Court documents reference CDC information stating there is no safe level of lead in blood; exposure can cause irreversible health issues especially affecting young children and pregnant women living in older housing likely containing lead-based materials.
Individuals concerned about potential inaccurate test results between 2013-2017 are advised to visit www.fbi.gov/MagellanCaseInquiry or check updates on https://www.justice.gov/usao-ma/press-highlights.
The charges carry potential sentences including up to three years imprisonment for introducing misbranded devices or five years for making false statements along with fines reaching $250,000 depending on case specifics evaluated by federal judges under U.S Sentencing Guidelines.
This announcement came from U.S Attorney Foley alongside Fernando McMillan (FDA), Jodi Cohen (FBI), Roberto Coviello (HHS-OIG). The case prosecution involves Assistant U.S Attorneys Kelly Lawrence & Leslie Wright within Healthcare Fraud Unit.
