Magellan Diagnostics was sentenced last week in federal court in Boston for criminal charges related to concealing a device malfunction that caused inaccurately low lead test results for tens of thousands of children and other patients.
According to a release from the U.S. Department of Justice (DOJ), the Billerica, MA-based Magellan pleaded guilty to two counts of introducing a misbranded medical device into interstate commerce. Magellan was charged criminally on May 21, 2024.
Former executives of the company were charged in 2023 with conspiracy to commit wire fraud, wire fraud, conspiracy to defraud an agency of the U.S., and introducing misbranded medical devices into interstate commerce with the intent to defraud and mislead.
The firm was ordered to pay a $21.8 million fine, $10.9 million in forfeiture, and a minimum of $9.3 million to compensate patient victims, the DOJ said.
According to the court, Magellan failed to notify the U.S. Food and Drug Administration (FDA) promptly about a serious malfunction that caused the company's LeadCare devices to produce inaccurate blood lead level results when testing venous blood samples. Magellan also changed the user instructions for the LeadCare devices without prior FDA notice or approval, according to court documents.
The LeadCare Ultra and LeadCare II devices used blood from either venous or fingerstick samples for detecting lead levels. The LeadCare II device, which was predominantly used to test fingerstick samples, was used for more than half of all blood-based lead tests conducted in the U.S. between 2013 and 2017, according to the DOJ. LeadCare Ultra was predominantly used to test venous samples.
Magellan first learned that the LeadCare Ultra had a risk of producing falsely low lead test results during the FDA clearance process in June 2013 but released LeadCare Ultra to the market later that year without informing customers or the FDA of the findings. Subsequently, according to the DOJ, Magellan did not file a medical device report about customer malfunctions within 30 days, as required by FDA regulations.
Furthermore, according to the DOJ, Magellan sent a letter in 2014 to its LeadCare Ultra customers informing them of the malfunction and recommending that they wait 24 hours before running the test, but the company did not report the malfunction or the changed instructions until April 2015. In August 2015, Magellan changed the label instructions for the LeadCare Ultra device, again not providing notice of the label change or necessary reports of device correction, said the DOJ.
Magellan's testing in 2013 also indicated that the same malfunction affected the LeadCare II device when it was used to test venous samples. Magellan did not notify the FDA about the LeadCare II malfunction until November 2016, according to the DOJ. The FDA ultimately determined that the tests had a significant risk of inaccurately low results when used with venous samples, which resulted in recalls for the devices.
As part of the criminal resolution, Magellan will compensate patients who were demonstrably harmed for economic damages they have suffered as a result of the malfunctioning devices.
