Three former executives at a Massachusetts medical device company knowingly sold defective lead-testing machines between 2013 and 2017 that generated inaccurate results for tens of thousands of children across the country and for clients of at least one international relief organization, federal prosecutors said Wednesday.
The case raises the possibility that the presence of the toxic metal, which can cause multiple health problems, went undetected in many children. The Boston office of the FBI said it has launched a national campaign to locate people who used the devices between June 2013 and December 2017.
Amy Winslow, 51, of Needham; Reba Daoust, 66, of Amesbury; and Mohammad Hossein Maleknia,64, of Bonita Springs, Fla., are accused of knowing that devices made by Magellan Diagnostics had a manufacturing flaw that generated false negatives, giving parents the mistaken impression their children were safe, US Attorney Rachael Rollins’s office said.
One of the devices, the LeadCare II, accounted for 2.5 million tests in 2017 — half of all tests conducted in the United States that year, authorities said.
“We allege that these defendants deceived customers and the FDA about the reliability of medical tests that detected lead levels. By doing so, we assert that they endangered the health and lives of incredibly vulnerable victims,” Rollins said in a statement.
Winslow, the company’s former chief executive, and Daoust, the former director of quality assurance and regulatory affairs, made their initial appearance Wednesday in US District Court in Boston, where they were ordered to stay away from witnesses and released on personal recognizance. Both pleaded not guilty to all charges.
Winslow’s attorney, William Trach, faulted federal prosecutors for bringing the charges. According to her LinkedIn profile, Winslow was chief executive of Magellan from 2011 to 2018. She is now president of NanoImaging Services, according to the profile.
“We are extremely disappointed that the government chose to go forward with this misguided prosecution. Amy left Magellan amicably five years ago, and was a thoughtful, compassionate, and effective leader there through difficult times for the company,’’ Trach said in a statement. “She did not commit any crimes, and this prosecution, inexplicably initiated so many years after the events at issue, should never have been brought. We look forward to Amy having her day in court, and we are confident she will be vindicated.”
Daoust and her attorney declined to comment.
Maleknia, the former chief operating officer until 2021, was scheduled to appear in a Florida federal courtroom Wednesday, according to prosecutors. No information on the proceeding was available in federal court records Wednesday evening.
The three are charged 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.
In 2016, the Globe reported that Magellan, which was then located in Billerica, had marketed itself as “the most trusted name in lead testing,” and gained national media attention that year when it lent its devices to public health officials in Flint, Mich., where the city’s water supply had been contaminated by lead.
“We’re trying to put more of these analyzers in the hands of doctors,” Winslow told the Globe in 2016. “They’re small and portable and easy to use. They take a test that used to have to be done in a lab and now it can be done in a doctor’s office. And instead of waiting days or weeks, you can get the results in three minutes.”
But the Centers for Disease Control and Prevention and the Food and Drug Administration estimated that the malfunction of the Magellan device caused “tens of thousands of children and adults to receive false blood test results.”
The company’s line of LeadCare devices is used to test blood samples taken from a vein or samples drawn from a finger stick, according to the indictment. Its LeadCare II device was approved by the FDA for use in doctors’ offices and clinics. Its other LeadCare devices were designed for use at hospitals and reference labs.
Children can be exposed to lead through bits of old paint, contaminated dust, and — in some water systems — drinking water that passes through lead pipes.
Dr. Vandana Madhavan, a primary care pediatrician at Mass General for Children, said that over the last few decades, the threshold considered to be an elevated lead level in children has dropped, and today there is no level of lead in a child’s system that would be considered safe.
Children are typically screened for lead levels when they are 9 months, 2 years, and 3 years old, and also at 4 years if they live in higher risk areas, which includes much of Greater Boston and Massachusetts because of the state’s abundant old housing stock.
“Even though lead paint has not been used in the US after 1978, there is still a huge amount of lead in the environment,” Madhavan said. “It can be in soil, water, and products that may not undergo a strict regulatory process.”
The challenge with lead poisoning is that children often don’t show symptoms right away, as they would for something like carbon monoxide poisoning. The impact will show up later as developmental delays, such as in running, climbing, and jumping, or with fine motor skills, such as in eating, writing, or drawing, she said. There may also be language delays or problems concentrating.
If lead levels are extraordinarily high, she said, a child can be treated with chelation therapy — injections that bind with the offending substance and decrease its level in the body. But, she said, developmental delays from lead poisoning cannot be reversed.
Madhavan said the Mass General practice did not use the machines at issue in the case.
As for how families should react to the case, she said, “This is not like, ‘Bring your child to the emergency room right away.’ This is not an emergency, but families should be in the information-gathering phase to see if their child was affected. Hopefully practices will be reaching out to families proactively.”
Prosecutors allege that the three company executives discovered the flaw during internal testing on June 27, 2013, but instead of correcting the error started selling the devices to the public even after tests conducted in 2014 on workers at a battery factory who were exposed to lead found “an inherent risk for false negative blood test results,’' according to court papers.
When a hospital and a laboratory independently told the company they were receiving inaccurate results in 2014, the three executives met to discuss the problem, authorities allege.
“’ Please call a meeting together so we can discuss this,’' Daoust wrote in an e-mail, according to the indictment. “ ‘This is what we were afraid of.’ "
In 2017, an unidentified international relief organization that “provided humanitarian medical care” asked for guidance from the company on how to interpret test results. “The letter to AID Organization A contained materially false, misleading statements and concealed material facts,’' prosecutors wrote.
The three executives continued to hide the flaws to maintain the company’s profitability while it was being acquired for $66 million in March 2016 by Meridian Biosciences, which continues to operate the company under the Magellan name, prosecutors said.
In 2021, the FDA ordered a recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood lead tests made by Magellan “due to a significant risk of falsely low results.” The company resumed distribution of its LeadCare II test kits in February 2022, and LeadCare Plus and LeadCare Ultra test kits in October 2022, the FDA said.
In a statement about the criminal charges, Meridian said it has been “cooperating extensively” with federal law enforcement. The company, which was publicly traded until it was purchased by a South Korean company, is negotiating a payment with federal officials over the issue and has set aside funds for that purpose.
“Meridian and its subsidiaries are not defendants in the action,” the company said.
Globe correspondent Jeremy C. Fox contributed to this report.