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Magellan Diagnostics Agrees to Plead Guilty and Pay $42 Million to Resolve Criminal Charges
BOSTON – In a stunning blow to the medical device industry, 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.
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.
Key Facts
- State: Massachusetts
- Agency: DOJ USAO
- Category: White Collar Crime
- Source: Official Source ↗
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