Medical Device Company Fined $21.8M for Concealing Faulty Lead Test Results

Magellan Diagnostics was fined $21.8 million and ordered to compensate patients for concealing faulty lead test results.Photo byNational Cancer InstituteonUnsplash

Magellan Diagnostics, Inc. has been ordered to pay a $21.8 million fine, $10.9 million in forfeiture, and at least $9.3 million to compensate affected patients after concealing a malfunction in its blood lead testing devices that produced inaccurately low lead test results, the U.S. Attorney's Office for the District of Massachusetts announced today.

The company, based in Billerica, Mass., pleaded guilty to two counts of introducing a misbranded medical device into interstate commerce, the department says.

According to the department, the charges stem from Magellan’s failure to notify the U.S. Food and Drug Administration (FDA) of a malfunction in its LeadCare Ultra and LeadCare II devices.

These devices, used to detect lead poisoning in children and adults, produced inaccurate results when testing venous blood samples.

Despite being aware of the malfunction as early as June 2013, Magellan released the devices to the market without informing the FDA or its customers, the department stated.

In August 2014, customers discovered the malfunction and reported inaccurate results. Magellan, however, delayed notifying the FDA until April 2015, far beyond the required 30-day reporting window.

The department also noted that Magellan altered the devices’ user instructions without prior FDA approval. By 2016, the FDA determined the LeadCare devices were unreliable for venous blood testing, leading to a recall.

According to the department, the malfunction potentially impacted thousands of patients, particularly children, who are most vulnerable to lead exposure.

“Medical device makers have an obligation to provide truthful information to protect patients. By deliberately concealing and consistently misleading consumers and the FDA about device malfunctions, Magellan acted with gross disregard for its responsibility to comply with FDA requirements and put patients at risk,” said Fernando McMillian, Special Agent in Charge, FDA Office of Criminal Investigations, New York Field Office.

“We will continue to thoroughly investigate those whose actions undermine the integrity of the FDA regulatory process which exists to protect consumer health.”

The department states that those who believe they received an inaccurate lead test between 2013 and 2017 can submit information via a questionnaire on the FBI’s website.