A Billerica company is set to plead guilty to violations of federal law and pay out $42 million to resolve criminal charges tied to its coverup of a malfunction in a lead testing device it produced that produced inaccurate results for countless patients, including children, according to acting U.S. Attorney for Massachusetts Joshua S. Levy’s office.
Magellan Diagnostics, a medical device company headquartered in Massachusetts, will plead guilty to violating the federal Food, Drug and Cosmetics Act and will pay a $21.8 million fire, forfeit $10.9 million, and at least $9.3 million to compensate patient victims. The resolution reached Tuesday also includes an agreement to resolve felony conspiracy fraud charges against Magellan, according to federal prosecutors.
The company manufactures three devices, known as LeadCare Ultra, LeadCare II and LeadCare Plus, which detect lead levels and lead poisoning in patients’ blood through either venous or fingerstick tests. LeadCare II, which was primarily used to test fingerstick samples, accounted for more than 50% of all blood lead tests in the U.S. between 2013 and 2017. The other devices, LeadCare Plus and LeadCare Ultra, were mostly used to test venous samples, according to a statement from Levy’s office.
The company has since admitted that it misled both customers and the FDA about a “serious malfunction” affecting LeadCare devices used to test venous blood samples. By hiding the malfunction, the company caused an estimated tens of thousands of children and other patients to receive inaccurate results showing lead levels lower than they actually were, prosecutors said.
Magellan first learned that a malfunction in its LeadCare Ultra device may produce incorrect test results during the FDA clearance process in June 2013. Despite knowing of the flaw, the company released the device to market in December of that year without notifying customers or the FDA of the malfunction, Levy’s office said.
Months after the device was released, customers discovered the malfunction and began complaining about inaccurate results, according to Levy’s office. In response to the customer complaints, Magellan said it had only recently identified the malfunction and had not seen it during clinical trials prior to release. But, prosecutors say the company had known about the malfunction for more than a year at that point.
The company’s testing in 2013 also revealed the same malfunction affected its LeadCare II device — its highest-revenue product. But, the company did not tell customers or the FDA about the malfunction until November 2016, according to the statement.
The Food and Drug Administration reached out to Magellan in 2017 and asked when it first discovered the issue with the devices. Representatives for the company told the FDA they first discovered the problem in later 2014, shortly before they notified federal officials. Magellan then provided the FDA with a timeline, which omitted its internal studies about the malfunctioning devices in 2013.
Federal officials later learned the devices could not accurately test venous blood samples, and recalled all LeadCare Devices using those samples, warning the public not to use the company’s devices for venous tests due to the malfunction.
Citing the Centers for Disease Control and Prevention, Levy’s office noted “there is no safe level of lead in the blood.”
“Lead exposure may cause irreversible lifelong physical and mental health problems,” Levy’s office said.
Prosecutors encouraged anyone who believes they received an inaccurate blood test result to complete a questionnaire on the FBI’s website.
