Ex-Magellan Diagnostics execs charged with concealing lead-test defect
Reuters
Published Apr 05, 2023 12:59PM ET
Updated Apr 05, 2023 02:56PM ET
By Andrew Goudsward
(Reuters) - Three former executives of medical device company Magellan Diagnostics concealed a malfunction in the company’s lead-testing devices that caused tests to underestimate the level of lead in people's blood, U.S. prosecutors in Boston said in announcing criminal charges on Wednesday.
Amy Winslow, Hossein Maleknia and Reba Daoust misled Magellan customers and the Food and Drug Administration (FDA) about when they discovered the defect, the extent of the problem and the risks associated with it, prosecutors said.
Winslow, the company’s former CEO, Maleknia, the former chief operating officer, and Daoust, the former director of quality assurance and regulatory affairs, were indicted in U.S. district court in Massachusetts on charges including conspiracy to commit wire fraud and conspiracy to defraud a U.S. agency.
Attorneys for Winslow and Daoust did not immediately respond to requests for comment. Attorney information for Maleknia was not immediately available.
A spokesperson for Meridian BioScience Inc, which purchased Magellan in 2016, said the company has cooperated with the federal investigation that led to the indictment and it expects to pay a fine as part of a corporate resolution with the U.S. Justice Department. That agreement has not been finalized.
The company said all devices the malfunction affected have been cleared by the FDA “and will remain available for clinical use.”
Magellan Diagnostics ultimately recalled all three devices in 2021 and resumed distribution last year, according to the FDA.
The malfunction affected three of Magellan’s lead-testing devices, including one that accounted for more than half of all blood lead tests conducted in the U.S. between 2013 and 2017, according to prosecutors.
Rachael Rollins (NYSE:ROL), the U.S. attorney in Massachusetts, said the executives “endangered the health and lives of incredibly vulnerable victims,” including the poor and young children, who are at most at risk of lead exposure.
Get The News You Want
Written By: Reuters
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.