A medical device company in Massachusetts has agreed to pay $42 million to resolve criminal charges over a malfunctioning device that produced inaccurate lead test results in potentially thousands of patients, including children, authorities said.
Magellan Diagnostics, Inc., headquartered in Billerica, agreed to plead guilty on Wednesday, May 22, to violations of the federal Food, Drug and Cosmetics Act, the U.S. Attorney's Office for the District of Massachusetts announced.
As part of the criminal resolution, Magellan will pay $21.8 million fine, $10.9 million in forfeiture and a minimum of $9.3 million to compensate patient victims. The resolution includes a deferred prosecution agreement to resolve felony conspiracy fraud charges against the company.
According to prosecutors, Magellan's LeadCare Ultra, LeadCare II and LeadCare Plus devices were used to detect lead levels and lead poisoning through either blood draws from the arm, known as venous samples, or fingerstick blood samples. LeadCare II, which primarily used fingerstick samples, was used for more than half of all blood lead tests in the U.S. from 2013 through 2017. LeadCare Ultra and LeadCare Plus primarily tested venous samples.
Magellan admitted it misled customers and the U.S. Food and Drug Administration about a "serious malfunction" that affected LeadCare devices when they were used to test venous samples, producing inaccurately low lead results.
The company first learned of the malfunction in its LeadCare Ultra device in June 2013 during the FDA clearance process, but said nothing and released the device to the market in December 2013. Months later, LeadCare Ultra customers discovered the malfunction on their own and reported the inaccurate results.
The company also discovered the same malfunction in its LeadCare II device, its highest-revenue product, in 2013. Magellan did not notify customers or the FDA about the malfunction until 2016.
After additional FDA testing revealed inaccurate results for venous samples, all LeadCare devices were recalled, and the agency warned consumers not to use them.
According to the Centers for Disease Control and Prevention, there is no safe level of lead in the blood, and exposure can cause lifelong health problems, particularly in children and pregnant women.
Patients who believe they or a family member were demonstrably harmed by the faulty devices can complete a questionnaire on the FBI’s website at www.fbi.gov/MagellanCaseInquiry to potentially receive compensation as part of the settlement.
—TMX contributed to this report.
