Magellan Diagnostics’ former CEO Amy Winslow pleaded guilty on 11 March to concealing device malfunctions in the company’s LeadCare lead detection tests that led to inaccurately low blood lead level (BLL) test results for thousands of US patients.
The Massachusetts-based company’s LeadCare II and LeadCare Ultra devices detected lead levels and lead poisoning in the blood of children and adults, with LeadCare II accounting for more than half of all blood lead tests conducted in the US between 2013 and 2017.
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The US Attorney’s Office for the District of Massachusetts prosecuting documents stated that Winslow, along with Magellan’s former chief operating officer Hossein Maleknia and former director of quality assurance and regulatory affairs Reba Daoust, first became aware that a malfunction in its LeadCare Ultra device could cause inaccurate test results in 2013. Both Maleknia and Daoust have since also pled guilty.
However, the company released LeadCare Ultra to the market in late 2013 without informing customers or the US Food and Drug Administration (FDA) of the issue. In November 2014, Magellan sent a letter to its LeadCare Ultra customers advising them of the malfunction and recommending that they wait 24 hours before running their tests, a missive that contradicted the instructions for use approved by the FDA. Magellan eventually reported the LeadCare Ultra malfunction to the FDA and advised the agency of the change it made to the device’s instructions in April 2015.
In 2013, Magellan also became aware that the same malfunction affected its LeadCare II device when it was used to test venous samples, but did not notify the FDA about this issue until after Ohio-based Meridian Bioscience’s $66m acquisition of the company in 2016.
The FDA ultimately found that all four of Magellan’s LeadCare devices could not accurately measure patients’ BLL and issued a full recall in May 2017.
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By GlobalDataJodi Cohen, lead special agent in charge of the FBI’s Boston division, described the executives’ actions as “downright deceitful and dangerous”.
Cohen said: “They concealed a medical device malfunction that resulted in inaccurate lead test results for thousands of children and other vulnerable patients 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,” she added.
In May 2024, Magellan agreed to pay around $42m to resolve its criminal charges; comprising a $21.8m fine, $10.9m in forfeiture, and a minimum of $9.3m to compensate patient victims.
The introduction of misbranded medical devices can carry a jail sentence of up to three years, or up to one year of supervised release and a fine of up to $250,000. All three executives will be sentenced on 23 July, 26 June, and 24 June respectively.
