Leah B. Foley United States Attorney for the District of Massachusetts | Department of Justice
Three former executives from Magellan Diagnostics, a medical device company based in Billerica, Massachusetts, have been sentenced in federal court for concealing a malfunction in their blood lead testing devices. The case involved Amy Winslow, the former CEO; Hossein Maleknia, the former COO; and Reba Daoust, the former Director of Quality Assurance and Regulatory Affairs.
Amy Winslow received a sentence of one year of home detention and was fined $10,000 after pleading guilty to one felony count related to introducing misbranded medical devices into interstate commerce. Hossein Maleknia was sentenced to nine months of home detention with a $20,000 fine for two similar felony counts. Reba Daoust was sentenced to one year of probation, including six months of home detention, and ordered to pay a $600 fine after pleading guilty to making false statements.
Magellan’s LeadCare II and LeadCare Ultra devices were widely used across the United States from 2013 through 2017 to detect lead levels in blood samples. The LeadCare II device accounted for more than half of all blood lead tests conducted nationally during that period. Both devices could test either venous or fingerstick samples.
According to federal prosecutors, the three executives misled both customers and the U.S. Food and Drug Administration (FDA) about a malfunction affecting venous blood sample results on these devices. This concealment led thousands of children and other patients to receive inaccurately low test results for lead exposure.
United States Attorney Leah B. Foley stated: “These defendants knowingly misled the FDA about a device malfunction that caused thousands of children and adults to receive inaccurate blood lead test results. They understood the risks: that patients could receive falsely low readings, when their actual blood lead levels met or exceeded CDC intervention thresholds. They knew this failure could delay critical care, allow continued lead exposure and endanger the health of vulnerable families. Yet they chose to conceal the truth, prioritizing corporate profits, job security, and personal gain over patient safety. Regardless of the sentences imposed, their actions jeopardized the wellbeing of thousands,” said United States Attorney Leah B. Foley. “We will continue to uncover and prosecute those who violate the public’s trust and put public health at risk.”
Fernando McMillian from the FDA Office of Criminal Investigations added: “Individuals and companies whose lead testing devices produce inaccurate results can put the health of all patients, especially vulnerable children, at significant risk,” said Fernando McMillian, Special Agent in Charge, FDA Office of Criminal Investigations, New York Field Office. “We will continue to pursue and bring to justice those who endanger public health and safety.”
Ted E. Docks from the FBI Boston Division commented: “Misleading consumers and federal regulators about a significant flaw in a medical device to boost your company’s bottom line is reprehensible. These three executives did exactly that, and in the process ignored the well-being of thousands of children and other patients who received inaccurate test results of the lead levels in their blood,” said Ted E. Docks, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. “Their egregious conduct victimized vulnerable patients and eroded their trust in our healthcare system. The FBI is gratified all involved are being held accountable.”
Roberto Coviello from HHS-OIG stated: “These three former executives deliberately concealed a known defect in medical devices used to detect lead poisoning—a condition with potentially irreversible consequences,” said Roberto Coviello, Special Agent in Charge at the U.S. Department of Health and Human Services, Office of Inspector General. “The criminal sentences announced today mark an important step toward justice for the thousands of children and vulnerable patients who were put at risk by the corrupt actions of these defendants.”
The FDA ultimately determined that LeadCare devices could not accurately test venous samples due to this malfunction which led to recalls for those products as well as warnings advising against using them with venous samples.
Court documents referenced guidance from health authorities noting there is no safe level for lead exposure; even low amounts may result in lifelong physical or mental harm—particularly among young children or pregnant women living in older housing where contact with sources such as lead-based paint is more likely.
The case was prosecuted by Assistant U.S. Attorneys Leslie Wright and Mackenzie A. Queenin from the Health Care Fraud Unit.
