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Three former executives of a Massachusetts-based health diagnostics company deliberately concealed a problem with the company’s lead-testing devices that produced inaccurately low results for tens of thousands of children, according to federal prosecutors.
Amy Winslow, Reba Daoust and Mohammad Hossein Maleknia — all former executives at Magellan Diagnostics — “deceived customers and the FDA [U.S. Food and Drug Administration] about the reliability of medical tests that detected lead levels [and] endangered the health and lives of incredibly vulnerable victims,” U.S. Attorney Rachael S. Rollins said in a press release.
Winslow, 51, is the former CEO; Maleknia, 64, is the former chief operating officer; and Daoust, 66, is the former director of Quality Assurance and Regulatory Affairs.
All three were indicted April 4 by the U.S. Attorney’s Office for the District of Massachusetts, and charged with conspiracy to commit wire fraud, wire fraud, conspiracy to defraud an agency of the U.S. and introduction of misbranded medical devices into interstate commerce with intent to defraud and mislead.
The charges can carry prison sentences of up to 20 years and fines of $250,000, the U.S. Attorney’s Office said.
Commenting on the lawsuit, Dr. Elizabeth Mumper, a pediatrician and former medical director of the Autism Research Institute, told The Defender:
“If the allegations are correct, it reveals corruption at high levels and an abhorrent disregard for the well-being of innocent children who rely on adults to keep them safe.
“Unfortunately, even a massive fine would not be able to reverse the damage already done to children’s bodies and brains.”
The Magellan Diagnostics products — marketed under the names LeadCare Ultra, LeadCare II and LeadCare Plus — tested lead levels through blood draws or fingersticks.
The three products accounted for more than half of all blood lead tests conducted in the U.S. from 2013 through 2017, according to the U.S. Attorney’s Office for the District of Massachusetts.
Joseph R. Bonavolonta, a special agent who heads the FBI’s Boston Division, said the executives knew about a “serious flaw” in the company’s devices as early as June 2013 when they sought FDA clearance for the products.
But they “failed to come clean to their customers and the FDA about it in order to boost their company’s bottom line,” Bonavolonta said.
Winslow told a Magellan employee to stop studying the malfunction in LeadCare II devices because Magellan needed to maintain “plausible deniability,” the prosecutors alleged.
Federal prosecutors said the defendants suppressed knowledge of the flaw to not jeopardize the sale of the company — from which they personally benefitted.
Meridian Bioscience acquired Magellan in 2016 for $66 million — and only then did the defendants tell customers and the FDA about the problem, prosecutors said. Even then, the defendants misled the FDA about the malfunction.
As a result of the sale, Winslow received a bonus of roughly $2 million and Maleknia received $448,000, according to the U.S. Attorney’s Office.
The FBI is asking individuals who believe they received an inaccurate blood lead test result from a LeadCare device between 2013-2017 to complete a questionnaire.
‘Devastating effects on children’s ability to learn and their mental health’
According to the Centers for Disease Control and Prevention, there is no safe level of lead for children.
Mumper told The Defender:
“As evidence has accumulated over the years, it has become clear that even small amounts of lead can have devastating effects on children’s ability to learn and their mental health.
“Kids may experience gastrointestinal symptoms like abdominal pain, vomiting and constipation. They may have headaches, seizures or developmental delays.”
Lead exposure in childhood also can cause permanent and irreversible neurologic damage, she said.
A 2021 article in the Journal of the American Heart Association concluded that the burden of proof had been unequivocally met that lead is a risk factor for cardiovascular disease based on the “clinical, toxicological, and experimental evidence.”
And a 2018 study published in The Lancet Public Health estimated that each year in the U.S., more than 400,000 deaths can be attributed to environmental lead exposure.
The problem of lead exposure in children persists despite the removal of leaded gasoline and regulations to remove lead from paint, Mumper said.
Children’s clothing sets sold by Amazon, TJMaxx and other retailers were recalled in December 2022 for containing lead paint, CBS News reported.
The FDA in January proposed new guidance limits on lead in processed baby food and on foods — including dry cereals, mashed fruits and root vegetables — intended for children under age 2.
However, nutritional experts questioned the FDA’s proposals, arguing that no level of lead in foods is safe and that the rules do not cover other heavy metals or foods for the general population.
Pedram Esfandiary, a Los Angeles-based attorney who previously litigated cases involving heavy metal content in baby foods and their potential connection to autism spectrum disorder and attention-deficit/hyperactivity disorder, called the proposed guidelines “an overdue step in the right direction.”
A report by the Environment America Research & Policy Center released Feb. 23 showed that most states fall short in providing oversight for lead in the water supplies of U.S. public schools.
Mumper pointed out that during the 2015 drinking water crisis of Flint, Michigan — in which the city’s water was not properly treated and contained lead — “government officials denied the existence of a problem and tried to discredit pediatrician Mona Hanna-Attisha for blowing the whistle on using data from her patients.”
Mumper called the Flint lead contamination crisis a “tragedy” and said, “If it is indeed true that lab values [obtained through Magellan’s products] falsely reassured doctors about lead levels, this is another tragedy affecting huge numbers of children.”