Three former top executives for a Billerica, Massachusetts-based medical device company have pleaded guilty to federal charges for parts in concealing a malfunction in a lead testing device that gave inaccurately low results for tens of thousands patients, including children, prosecutors said.
Magellan Diagnostics' devices — LeadCare Ultra, LeadCare II and LeadCare Plus — test blood for lead levels and lead poisoning, but the three former executives misled customers and the Food and Drug Administration about a malfunction that affected devices that tested blood drawn from the arm, according to the U.S. Attorney's Office for Massachusetts. The FDA eventually found that LeadCare devices can't accurately test blood drawn from the arm, leading to a recall and a warning to the public about the devices being used for that purpose.
Former CEO Amy Winslow, 53, of Needham Heights, Massachusetts, pleaded guilty to a count of introducing misbranded medical devices into interstate commerce, prosecutors said. Former Chief Operating Officer Hossein Maleknia, 66, of Bonita Springs, Florida, pleaded guilty to two counts of introducing misbranded medical devices into interstate commerce, while former Director of Quality Assurance and Regulatory Affairs Reba Daoust, 68, of Amesbury, Massachusetts, pleaded guilty to a count of making false statements. All three are due for sentencing this summer.
"We trust that medical devices provide accurate results. We trust that when doctors give us information, it’s based on reliable science. These defendants eroded that trust by misleading regulators and customers about devices they knew could provide inaccurate results, and thereby knowingly endangered the health of children and other patients across the country," U.S. Attorney Leah Foley said in a statement.
Prosecutors said the three executives "repeatedly misled Magellan customers and the FDA about a serious malfunction" that affected their LeadCare devices when they were used to test blood drawn from patients.
Boston's top FBI agent, Jodi Cohen, called their actions "downright deceitful and dangerous" in a statement.
Anyone who believes they or a family member got an inaccurate blood lead test from a LeadCare device, between the years 2013 and 2017, was urged to fill out an FBI questionnaire at fbi.gov/MagellanCaseInquiry, where more information about the case is available.
Last year, Magellan settled with the Justice Department over the blood draw sample inaccuracy, agreeing to pat $42 million while also creating a victim compensation fund — more details on the settlement here.
According to the Food and Drug Administration, Magellan Diagnostics issued a voluntary Class I recall, the most serious type, in May 2021 for several of its blood lead testing products because the FDA had "significant concerns" that the performance of the test might provide falsely low results and could lead to health risks in young children and pregnant women. The recall was expanded several times.
The company remediated the issues with the products and was able to return them to market starting in February 2022.
"Obtaining falsely low results may lead to patient harm including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children," the FDA said in its report.
In a 2016 interview with NECN, Winslow talked about how Magellan sent lead testing kits and equipment for use in doctors offices in Flint, Michigan, in the wake of the city's drinking water crisis.
"We have the only system available that can be used to test for lead exposure in doctors offices," Winslow said. "It's very small, portable, easy to use, and it just takes two drops of blood from a fingerstick and a doctor can then deliver an immediate result. So if you have a worried parent, the doctor can say 'Your child's OK,' or 'Here's what we have to do to take action,' and our system is the only one who can do that. So we really wanted to make sure that it was easily available in Flint to help all these families that are so concerned."
In this Feb. 17, 2016, interview on NECN, Magellan Diagnostics' then president and CEO, Amy Winslow, discusses the water crisis in Flint, Michigan, and says that lead exposure happens more than people may realize.
Prosecutors previously said the former Magellan executives first learned that a malfunction in their LeadCare Ultra device could cause inaccurate lead test results during the FDA clearance process back in June 2013. But they released the product to the market six months later without informing customers or the FDA about the malfunction. Several months after the product's release, customers discovered the malfunction on their own and complained about the inaccurate results. But the defendants continued to deny the malfunction, even though they had allegedly known about it for over a year, even before the product's release.
The indictment said Magellan discovered the same malfunction in 2013 in its LeadCare II device, by far its highest-revenue product. But Winslow and Maleknia were positioning the company for sale at the time, which prosecutors said would have been put in jeopardy if there was a malfunction affecting LeadCare II.
"It is alleged that Winslow told a Magellan employee to stop studying the malfunction in LeadCare II devices because Magellan needed to maintain 'plausible deniability,'" prosecutors said. "Only after Magellan was acquired by Meridian Bioscience, Inc. for $66 million in March 2016, did the defendants notify customers and the FDA about the LeadCare II malfunction. Magellan’s report to the FDA about LeadCare II allegedly made materially false and misleading statements and concealed material facts about Magellan’s discovery of the malfunction in LeadCare II."
After Meridian acquired Magellan, prosecutors said Winslow received a $2 million bonus and Maleknia a $448,000 bonus.
According to court documents, the defendants delayed notifying the FDA and then misled the FDA about the malfunction. The defendants only filed an FDA report for LeadCare Ultra after an outside consultant told Magellan that if they did not notify the FDA about the malfunction, the consultant would. In 2017, prosecutors said the FDA contacted Magellan and asked when the company first discovered the malfunction.
It was alleged that, at Daoust and Maleknia’s instruction, Magellan’s representative falsely told the FDA that Magellan first discovered the problem after receiving customer complaints in late 2014 and shortly before Magellan notified the FDA in 2015 – even though Magellan actually discovered the malfunction almost four years earlier, in 2013. Winslow also caused Magellan to send a false timeline to the FDA, which omitted the company’s internal 2013 studies about the malfunction.