Magellan Diagnostics, Inc., a medical device company based in Billerica, Massachusetts, has agreed to plead guilty and pay $42 million to settle criminal charges related to concealing a malfunction in its lead testing devices. The malfunction resulted in inaccurately low lead test results for potentially tens of thousands of patients, including children.
The company will plead guilty to violating the federal Food, Drug, and Cosmetics Act, incurring a $21.8 million fine, $10.9 million in forfeiture, and at least $9.3 million for compensating affected patients. Additionally, Magellan entered a deferred prosecution agreement to resolve felony conspiracy fraud charges.
Magellan’s devices — LeadCare Ultra, LeadCare II, and LeadCare Plus — are used to detect lead levels in blood using venous and fingerstick samples. LeadCare II accounted for over half of all blood lead tests in the U.S. from 2013 to 2017. LeadCare Plus and LeadCare Ultra primarily tested venous samples.
Magellan admitted to misleading its customers and the FDA about a malfunction in its LeadCare devices when used for venous samples. The company discovered the issue with LeadCare Ultra during the FDA clearance process in June 2013 but released the device in December 2013 without disclosing the malfunction. Customers later reported inaccuracies, which Magellan falsely claimed to have only recently identified.
Internal tests in 2013 also revealed the malfunction in LeadCare II, the company’s top revenue generator. Magellan did not inform customers or the FDA until November 2016. In 2017, when the FDA inquired about the malfunction’s discovery, a Magellan representative falsely stated it was found in late 2014. The FDA eventually recalled all LeadCare devices used for venous samples and issued a public warning.
The Centers for Disease Control and Prevention states that no level of lead in blood is safe, and exposure can cause irreversible health issues, particularly in young children and pregnant women.
As part of the resolution, Magellan will compensate patients demonstrably harmed by the malfunction. Those who believe they received inaccurate blood lead test results from 2013 to 2017 can complete a questionnaire on the FBI’s website.
