Three former executives of Magellan Diagnostics, Inc., a medical device company based in Billerica, Massachusetts, have been sentenced for their roles in concealing a malfunction in the company’s lead testing devices. The devices produced inaccurately low results for thousands of children and other patients.
Amy Winslow, 54, who served as CEO, received a sentence of one year of home detention and was fined $10,000. She pleaded guilty to one felony count related to introducing misbranded medical devices into interstate commerce. Hossein Maleknia, 66, the former COO, was sentenced to nine months of home detention and ordered to pay a $20,000 fine after pleading guilty to two felony counts for similar violations. Reba Daoust, 69, the Director of Quality Assurance and Regulatory Affairs, was sentenced to one year of probation—with six months in home detention—and fined $600 following her guilty plea on one felony count of making false statements.
The company’s LeadCare II and LeadCare Ultra devices were used to detect lead levels in blood samples from both children and adults. LeadCare II accounted for more than half of all blood lead tests conducted in the United States between 2013 and 2017. The malfunction primarily affected tests using venous blood samples.
Federal authorities stated that Winslow, Maleknia, and Daoust misled both customers and the Food and Drug Administration (FDA) about the nature and extent of the malfunction with LeadCare devices when testing venous samples. This concealment led to thousands receiving inaccurate test results.
“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.”
“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 at FDA Office of Criminal Investigations in New York Field Office. “We will continue to pursue and bring to justice those who endanger public health and safety.”
“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 from FBI 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.”
“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 from U.S. Department of Health & 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.”
Following investigation by federal agencies including FDA-OCI and HHS-OIG, it was determined that LeadCare devices could not reliably test venous samples; this led to recalls affecting all such units using venous samples as well as public warnings against their use for those types.
According to court documents referencing guidance from Centers for Disease Control & Prevention (CDC), there is no safe level for lead exposure—especially among young children or pregnant women—since even minimal exposure can cause permanent physical or mental health problems.
The prosecution was handled by Assistant U.S. Attorneys Leslie Wright and Mackenzie A. Queenin from the Health Care Fraud Unit.
