Magellan Diagnostics Agrees to Plead Guilty and Pay $42 Million to Resolve Criminal Charges

BOSTON – Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., has agreed to resolve criminal charges relating to its concealment of a device malfunction that produced inaccurately low lead test results for potentially tens of thousands of children and other patients. 

As part of the criminal resolution, Magellan will plead guilty to violations of the federal Food, Drug and Cosmetics Act and pay a $21.8 million fine, $10.9 million in forfeiture and a minimum of $9.3 million to compensate patient victims. Today’s resolution also includes a deferred prosecution agreement to resolve felony conspiracy fraud charges against the company.  

Magellan’s devices – LeadCare Ultra, LeadCare II and LeadCare Plus – 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 Plus and LeadCare Ultra were predominantly used to test venous samples.

Magellan has admitted that it misled its customers and the FDA about a serious malfunction that affected Magellan’s LeadCare devices when they were used to test venous blood samples. By hiding the malfunction and later deceiving customers and the FDA about when the company discovered the malfunction, the nature, extent and frequency of the malfunction, and the risks associated with the malfunction, Magellan caused an estimated tens of thousands of children and other patients to receive inaccurately low lead test results.

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 December 2013 without informing customers or the FDA of the malfunction. Several months after the release, LeadCare Ultra customers independently discovered the malfunction and complained about inaccurate results. In response, Magellan told its customers that it had only recently identified the malfunction and had not observed the malfunction in its clinical trials prior to product release. Magellan, in fact, had known about the malfunction for over a year, including before the product release. 

Magellan’s testing in 2013 also indicated that the same malfunction affected the LeadCare II device, which was by far Magellan’s highest-revenue product. Magellan, however, did not notify its customers and the FDA about the LeadCare II malfunction until November 2016. 

In 2017, the FDA contacted Magellan and asked when the company first discovered the malfunction. 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 had discovered the malfunction in 2013. Magellan then sent a false timeline to the FDA, which omitted the company’s internal 2013 studies about the malfunction.

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 and LeadCare Plus for venous blood samples because of the malfunction.

According to the Centers for Disease Control and Prevention, 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 today’s 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 Jamie Herbert, Kelly Lawrence, Elysa Wan and Leslie Wright of the Criminal Division are prosecuting the case.