By: Christopher Parrella, Esq., CPC, CHC, CPCO
Parrella Health Law, Boston, MA.
A Health Care Provider Defense and Compliance Firm

Three former executives of Magellan Diagnostics have pleaded guilty to federal charges for concealing a malfunction in their lead testing devices—an act that jeopardized the health of thousands of children and other patients. The plea agreements come nearly two years after a federal grand jury indicted the executives for deceiving regulators and customers about the reliability of their LeadCare devices, which were widely used across the United States from 2013 to 2017.

A Fraud That Put Children at Risk

Magellan’s LeadCare II and LeadCare Ultra devices were designed to detect lead poisoning, a serious health threat that disproportionately affects young children and pregnant women. But the company’s leadership—former CEO Amy Winslow, COO Hossein Maleknia, and Director of Quality Assurance & Regulatory Affairs Reba Daoust—knowingly concealed a device defect that produced falsely low lead test results when using venous blood samples.

For years, they misled both customers and the FDA about the issue, delaying critical warnings that could have protected patients. As a result, thousands of children and adults may have unknowingly been exposed to dangerous lead levels, missing opportunities for early intervention and treatment.

Corporate Deception and the Fallout

Prosecutors revealed that Magellan executives:

• Knew about the malfunction but failed to report it.
• Misled the FDA about the scope and severity of the problem.
• Prioritized corporate profits over patient safety.

Ultimately, federal regulators determined that the LeadCare devices could not accurately test venous blood samples. The FDA issued a recall and warned the public not to use the devices for venous testing.

The consequences for the executives were severe:

• Winslow (CEO): Pleaded guilty to introducing misbranded medical devices into commerce. Sentencing is set for July 23, 2025.
• Maleknia (COO): Pleaded guilty to two counts of the same charge. Sentencing is scheduled for June 26, 2025.
• Daoust (Director of QA & Regulatory Affairs): Pleaded guilty to making false statements. She will be sentenced on June 24, 2025.

Each faces up to five years in prison and a $250,000 fine, underscoring the gravity of their actions.

A Wake-Up Call for Healthcare Leaders

This case serves as a stark warning for healthcare executives: misleading regulators and endangering patient health will carry serious consequences. Transparency, compliance, and patient safety must take precedence over financial incentives.

If your healthcare organization is navigating compliance risks, regulatory challenges, or government investigations, Parrella Health Law can help. Contact us at 857.328.0382 or reach out to Chris directly at cparrella@parrellahealthlaw.com.