Crime

Mass. company to pay $42 million in wake of criminal coverup of medical device issue

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

Reba Daoust, center, leaves The John Joseph Moakley United States Courthouse. She and two others were charged with knowingly selling defective lead test devices.
Reba Daoust, center, leaves The John Joseph Moakley United States Courthouse. She and two others were charged with knowingly selling defective lead test devices. Suzanne Kreiter/Boston Globe

By Adora Brown

2 minutes to read

A Massachusetts-based medical company will plead guilty to criminal charges of concealing a malfunction in a lead-detecting device, according to the District of Massachusetts U.S. Attorney’s Office. The company has agreed to pay $42 million in fines and compensation.

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

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

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In 2014, the company began to receive customer complaints that their test results were incorrect, specifically falsely low results. The FDA contacted the company in 2017 and the company provided a false timeline, the U.S. Attorney’s Office said.

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

The U.S. Attorney’s Office estimated that tens of thousand of children and adults received inaccurately low test results. Lead exposure can be particularly dangerous for children and pregnant women. Also, people living in older houses (built before 1978) are vulnerable to contact with lead paint or fixtures.

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According to Magellan, the three individuals accused of the cover-up no longer work for the organization. The settlement agreements do not impact the ongoing prosecution of the former employees.

Additionally, as of 2018, Magellan states that venous blood samples were discontinued and the product issues were resolved.

Magellan agreed to compensate patients $9.3 million (at minimum), pay a $21.8 million fine to the FDA, and pay a $10.1 million charge for forfeiture.

The president of Magellan Diagnostics, Tony Serafini-Lamanna, said in a written statement, “The underlying issues that affected the results of some of Magellan’s products from 2013 to 2018 have been fully and effectively remediated. Today, the devices and tests sold by Magellan are safe, FDA-cleared and are performing as intended.”

The FBI has provided a questionnaire for anyone who feels they might have received faulty results from a Magellan device.

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