Three former top executives of Billerica, Mass.-based Magellan Diagnostics Inc. have pleaded guilty to charges they concealed a device malfunction that could have possibly endangered patients’ health.

Former Magellan Diagnostics CEO Amy Winslow, Chief Operating Officer Hossein Maleknia, and Director of Quality Assurance/Regulatory Affairs Reba Daoust admitted their respective roles in hiding a medical device malfunction that produced inaccurately low lead test results for thousands of children and other patients. The trio was indicted by a federal grand jury in April 2023.

Winslow, 53, of Needham Heights, Mass., pleaded guilty to one felony count of introduction of misbranded medical devices into interstate commerce. Her sentencing is scheduled for July 23.

Maleknia, 66, of Bonita Springs, Fla., pleaded guilty to two felony counts of introduction of misbranded medical devices into interstate commerce. He is scheduled to be sentenced on June 26. Daoust, 68, of Amesbury, Mass., pleaded guilty to one felony count of making false statements. She will be sentenced on June 24.

The introduction of misbranded medical devices charges carry a maximum three-year prison sentence, up to one year of supervised release, and a maximum $250,000 fine. The making false statements charge is punishable by up to five years in prison, up to three years of supervised release and a maximum $250,000 fine or twice the gross gain from the offense, whichever is greater.

“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,” U.S. Attorney Leah B. Foley said. “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.”

Magellan’s LeadCare II and LeadCare Ultra devices detected lead levels and lead poisoning in the blood of children and adults using either venous (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 misled Magellan customers and the U.S. Food and Drug Administration (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 defect, the defendants caused an estimated thousands of children and other patients to receive inaccurately low lead test results.

“Medical device makers have an obligation to provide truthful information to protect patients. By deliberately concealing and consistently misleading consumers and the FDA about device malfunctions, Magellan acted with gross disregard for its responsibility to comply with FDA requirements and put patients at risk,” stated Fernando McMillian, special agent in charge, FDA Office of Criminal Investigations, New York Field Office. “We will continue to thoroughly investigate those whose actions undermine the integrity of the FDA regulatory process which exists to protect consumer health.”

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 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.

“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.”

Last spring, Magellan Diagnostics agreed to pay $42 million to resolve a six-year federal investigation into the malfunctioning blood testing devices. The use of venous blood samples was discontinued in 2018, and the product-related issues involved in the investigation were fully remediated at that time. As part of the resolution, Magellan also agreed to make certain information about the settlement available to the public on its website. The company also agreed to create and fund a Victim Compensation Fund.

“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.”

Assistant U.S. Attorneys Kelly Lawrence and Leslie Wright of the Healthcare Fraud Unit are prosecuting the case.