Federal prosecutors say they were made aware of the device malfunctions “over a year” before the products were released, but they “deceived” both customers and the FDA about the issues.
Three executives at a Massachusetts-based medical technology company have been hit with federal charges for allegedly hiding a major malfunction in lead-testing devices used by thousands of patients. The Department of Justice says executives at Magellan Diagnostics “endangered the health and lives” of patients by “concealing” a defect in its LeadCare devices that caused inaccurately low lead test results.
CEO Amy Winslow, COO Hossein Maleknia, and Director of Quality Assurance and Regulatory Affairs Reba Daoust have been charged by the U.S. Attorney’s Office with conspiracy to commit wire fraud, wire fraud, conspiracy to defraud an agency of the United States, and introduction of misbranded medical devices into interstate commerce with intent to defraud and mislead. U.S. Attorney Rachael S.
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