OSTON – The former CEO, COO and Director of Quality Assurance and Regulatory Affairs for Magellan Diagnostics, Inc. (Magellan), a medical device company headquartered in Billerica, Mass., have pleaded guilty in connection with concealing a device malfunction that produced inaccurately low lead test results for thousands of children and other patients. The defendants were indicted by a federal grand jury in April 2023.
Amy Winslow, 53, of Needham Heights, Mass., pleaded guilty to one felony count of introduction of misbranded medical devices into interstate commerce. U.S. District Court Judge Patti B. Saris scheduled her sentencing for July 23, 2025.
Hossein Maleknia, 66, of Bonita Springs, Fla., pleaded guilty to two felony counts of introduction of misbranded medical devices into interstate commerce. Judge Saris scheduled his sentencing is scheduled for June 26, 2025.
Reba Daoust, 68, of Amesbury, Mass., pleaded guilty to one felony count of making false statements. She is scheduled to be sentenced on June 24, 2025.
Magellan’s LeadCare II and LeadCare Ultra devices detected lead levels and lead poisoning in the blood of children and adults using either venous (i.e., blood draws through the arm) or fingerstick samples. LeadCare II, which was predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States from 2013 through 2017. LeadCare Ultra was predominantly used to test venous samples.
Winslow, Maleknia and Daoust – Magellan’s former CEO, COO and Director of Quality Assurance and Regulatory Affairs, respectively – misled Magellan customers and the FDA about a serious malfunction that affected Magellan’s LeadCare devices when they were used to test venous blood samples. By hiding the malfunction and later misleading customers and the FDA about when they discovered the malfunction, the nature, extent and frequency of the malfunction, as well as the risks associated with the malfunction, the defendants caused an estimated thousands of children and other patients to receive inaccurately low lead test results.
“We trust that medical devices provide accurate results. We trust that when doctors give us information, it’s based on reliable science. These defendants eroded that trust by misleading regulators and customers about devices they knew could provide inaccurate results, and thereby knowingly endangered the health of children and other patients across the country,” said United States Attorney Leah B. Foley. “These convictions should make one thing clear: corporate fraud that puts public health at risk will not go unpunished. Individuals who choose to mislead rather than uphold the integrity of our healthcare system will be held accountable.”
“What these three senior executives did was downright deceitful and dangerous,” said Jodi Cohen, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. “They concealed a medical device malfunction that resulted in inaccurate lead test results for thousands of children and other vulnerable patients in order to boost Magellan’s bottom line. 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.”
“These corporate executives knew about a serious flaw in Magellan’s lead testing devices that produced inaccurate reporting of lead levels in the blood. They chose to conceal that flaw, completely disregarding the well-being of patients, in their corrupt effort to benefit the corporate bottom line,” said Special Agent in Charge Roberto Coviello of the U.S. Department of Health and Human Services Office of Inspector General. “These convictions serve as a strong reminder that we will continue to work tirelessly to investigate and bring to justice those who engage in dangerous schemes that put patient safety at risk.”
The FDA ultimately found that the LeadCare devices could not accurately test venous samples, leading to a recall of all LeadCare devices using venous samples and a warning to the public not to use the devices for venous blood samples because of the malfunction.
According to court documents, as referenced by the Centers for Disease Control and Prevention (CDC), there is no safe level of lead in the blood. Lead exposure may cause irreversible lifelong physical and mental health problems. Young children and pregnant women are most vulnerable to lead exposure, especially those from low-income households and those who live in housing built before 1978 because those homes are more likely to contain lead-based paint and have fixtures containing lead.
If you or a family member believe you received an inaccurate blood lead test result from a LeadCare device between 2013-2017, please complete the questionnaire located on the FBI’s website at www.fbi.gov/MagellanCaseInquiry. Information about the status of the case is located on the U.S. Attorney’s Office website https://www.justice.gov/usao-ma/press-highlights.
The charges of introduction of misbranded medical devices provide for a sentence of up to three years in prison, up to one year of supervised release and a fine of up to $250,000. The charge of making false statements provides for a sentence of up to five years in prison, up to three years of supervised release and a fine of up $250,000 or twice the gross gain from the offense, whichever is greater. Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and statutes which govern the determination of a sentence in a criminal case.
U.S. Attorney Foley; Fernando McMillan, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office; FBI SAC Cohen; and HHS-OIG SAC Coviello made the announcement. Assistant U.S. Attorneys Kelly Lawrence and Leslie Wright of the Healthcare Fraud Unit are prosecuting the case.
