Magellan Diagnostics Pleads Guilty to Criminal FDCA Charges

BOSTON –Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., pleaded guilty today in federal court in Boston to criminal charges relating to its concealment of a device malfunction that produced inaccurately low lead test results for tens of thousands of children and other patients. 

Magellan pleaded guilty to two counts of introducing a misbranded medical device into interstate commerce, in violation of the federal Food, Drug and Cosmetic Act (FDCA). United States District Judge Patti B. Saris scheduled sentencing for Oct. 9, 2024. 

According to the plea agreement, Magellan also has agreed to pay a $28.1 million fine, $10.9 million in forfeiture, and a minimum of $9.3 million to compensate patient victims.   

Magellan’s LeadCare Ultra and LeadCare II devices detected lead levels and lead poisoning in the blood of children and adults using either venous (i.e., blood draws through the arm) or fingerstick samples. LeadCare II, which was predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States from 2013 through 2017. LeadCare Ultra was predominantly used to test venous samples.

Magellan admitted today that it failed to timely notify the FDA about a serious malfunction that caused the company’s LeadCare devices to produce inaccurate blood lead level results when used to test venous blood samples. Magellan also admitted that it changed the user instructions for the LeadCare devices without prior FDA notice or approval. 

Magellan first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results – specifically, lead test results that were falsely low – during the FDA clearance process in June 2013. Magellan, however, released LeadCare Ultra to the market in late 2013 without informing customers or the FDA of the malfunction. In August 2014, LeadCare Ultra customers independently discovered the malfunction and complained about inaccurate results. FDA regulations required the company to file a medical device report about the malfunction within 30 days, but Magellan did not do so. 

In November 2014, Magellan sent a letter to its LeadCare Ultra customers advising them of the malfunction and recommending that they wait 24 hours before running their tests. This contradicted the instructions for use approved by the FDA. Magellan did not, however, report the malfunction to the FDA or advise the FDA of its change to the instructions until April 2015, nearly 21 months after Magellan discovered the malfunction and almost 8 months after customers discovered the malfunction on their own. 

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, however, did not notify the FDA about the LeadCare II malfunction until November 2016. 

In August 2015, Magellan changed the label instructions for the LeadCare Ultra device to require users to wait 24 hours before using the device to test blood samples, rather than testing the samples immediately. FDA regulations required the company to provide advance notice of the label change and file necessary reports of device correction, but Magellan did neither.   

The FDA ultimately found that the LeadCare devices could not accurately test venous samples, leading to a recall of all LeadCare devices using venous samples and a warning to the public not to use LeadCare Ultra, LeadCare II or LeadCare Plus for testing venous blood samples because of the malfunction and a recommendation that doctors retest certain patients

According to the Centers for Disease Control and Prevention (CDC), there is no safe level of lead in the blood. Lead exposure may cause irreversible lifelong physical and mental health problems. Young children and pregnant women are most vulnerable to lead exposure, especially those from low-income households and those who live in housing built before 1978 because those homes are more likely to contain lead-based paint and have fixtures containing lead. 

As part of the criminal resolution, Magellan has agreed to compensate all patients who were demonstrably harmed for the pecuniary damages they suffered as a result of the malfunction in Magellan’s blood lead testing devices. If you or a family member believe you received an inaccurate blood lead test result from a LeadCare device between 2013–2017, please complete the questionnaire located on the FBI’s website at www.fbi.gov/MagellanCaseInquiry. Information about the status of the case is located on the U.S. Attorney’s Office website: https://www.justice.gov/usao-ma/victim-and-witness-assistance-program/magellan-diagnostics-inc. 

Acting U.S. Attorney Joshua S. Levy; Fernando McMillan, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office; Jodi Cohen, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division; and Roberto Coviello, Special Agent in Charge for the U.S. Department of Health and Human Services, Office of Inspector General made the announcement today. Assistant U.S. Attorneys James Herbert, Kelly Lawrence, and Leslie Wright of the Criminal Division are prosecuting the case.