Mass company will pay $42 million in connection with the criminal cover-up of the medical device problem

Criminality

Magellan Diagnostics, Inc. pleads guilty to criminal charges for concealing lead-level testing device malfunction.

A Massachusetts-based health care company will plead guilty to criminal charges related to concealing the malfunction of a lead-detection device, according to the U.S. Attorney’s Office for the District of Massachusetts. The company agreed to pay $42 million in fines and damages.

Magellan Diagnostics is headquartered in Billerica. Their devices – LeadCare Ultra, LeadCare II and LeadCare Plus – are designed to detect lead levels in the blood of children and adults. The devices used a blood test or fingerstick sample to detect lead levels or poisoning.

According to the U.S. Attorney’s Office, the LeadCare II device accounted for more than half of all blood lead tests conducted in the U.S. between 2013 and 2017.

In 2014, the company began receiving customer complaints about incorrect test results, in particular falsely low results. The U.S. attorney’s office said the FDA contacted the company in 2017 and the company provided a false timeline.

The investigation found that Magellan knew about the 2013 failure and continued to release new devices without informing the public. The company had been aware of the malfunction for over a year and prior to the release of LeadCare II. Customers were not notified until November 2016.

The U.S. attorney’s office estimated that tens of thousands of children and adults received falsely low test scores. Lead exposure can be especially dangerous for children and pregnant women. People living in older homes (built before 1978) are also at risk of exposure to lead paint or fixtures.

Magellan agreed to pay patients a minimum of $9.3 million in damages, pay a $21.8 million fine to the FDA, and pay $10.1 million in forfeiture.

The FBI has released a questionnaire for anyone who thinks they may have received erroneous results from the Magellan device.