BOSTON — The former CEO and two other high-ranking executives for Massachusetts-based Magellan Diagnostics have pleaded guilty to criminal charges related to the company’s lead-testing devices that produced inaccurately low results for tens of thousands of patients, the U.S. Attorney said Tuesday.
Amy Winslow, 53, of Needham Heights, Magellan’s former CEO, pleaded guilty to one felony count of introduction of misbranded medical devices into interstate commerce, U.S. Attorney Leah Foley said in a statement. U.S. District Court Judge Patti Saris scheduled her sentencing for July 23.
Hossein Maleknia, 66, of Bonita Springs, Florida, Magellan’s former chief operating officer, pleaded guilty to two felony counts of introduction of misbranded medical devices into interstate commerce. Saris scheduled his sentencing is scheduled for June 26.
Reba Daoust, 68, of Amesbury, Magellan’s former Director of Quality Assurance and Regulatory Affairs, pleaded guilty to one felony count of making false statements. She is scheduled to be sentenced on June 24.
Winslow, Maleknia and Daoust were indicted by a federal grand jury in April 2023.
Prosecutors said the three former executives misled regulators and customers about lead-testing devices manufactured by Magellan, a medical device company headquartered in Billerica.
The company’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.
By hiding the malfunction and later misleading customers and the FDA about when they discovered the malfunction, and the risks associated with the malfunction, Winslow, Maleknia and Daoust “caused an estimated thousands of children and other patients to receive inaccurately low lead test results,” Foley said.
“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,” 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,” Foley said.
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, Foley said.
“What these three senior executives did was downright deceitful and dangerous,” Jodi Cohen, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division, said in a statement. “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.”
According to court documents, as referenced by the Centers for Disease Control and Prevention, 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.
“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,” Special Agent in Charge Roberto Coviello of the U.S. Department of Health and Human Services Office of Inspector General, said in a statement. “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.”
If you or a family member believe you received an inaccurate blood lead test result from a LeadCare device between 2013-2017, federal officials are asking you to complete the questionnaire located on the FBI’s website. Information about the status of the case is located on the U.S. Attorney’s Office website.
For the charges of introduction of misbranded medical devices, Winslow and Maleknia face a sentence of up to three years in prison, up to one year of supervised release and a fine of up to $250,000.
For the charge of making false statements, Daoust faces 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.
This is a developing story. Check back for updates as more information becomes available.
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