Source: US Food and Drug Administration
Department of Justice
U.S. Attorney’s Office
District of Massachusetts
FOR IMMEDIATE RELEASE
Thursday, October 10, 2024
Company failed to notify FDA about serious malfunction in lead testing devices that resulted in inaccurately low blood level results in children and adults
BOSTON –Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., was sentenced yesterday in federal court in Boston for criminal charges related to the concealment of a device malfunction that produced inaccurately low lead test results for tens of thousands of children and other patients.
Magellan has been ordered to pay a $21.8 million fine, $10.9 million in forfeiture and a minimum of $9.3 million to compensate patient victims. Magellan pleaded guilty to two counts of introducing a misbranded medical device into interstate commerce. Magellan was charged criminally on May 21, 2024
“Keeping the people of Massachusetts safe takes a variety of forms. In the case of Magellan Diagnostics, it means protecting children who may have been exposed to dangerous levels of lead that can lead to serious health consequences. This company has admitted that it left lead blood level monitoring devices in pediatricians’ offices that it knew were providing inaccurately low readings, putting thousands of kids at risk of not having their elevated lead levels accurately diagnosed. In addition to holding the company accountable, this criminal sentence requires the company to undertake an extensive effort to identify and compensate victims.”
“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.”
“It’s absolutely appalling that Magellan Diagnostics was more concerned about its bottom line than it was about coming clean to their customers and the FDA about a serious malfunction in its lead testing devices that we believe unnecessarily endangered the health of incredibly vulnerable victims,” said Jodi Cohen, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. “When you’re not feeling well, and you’re trying to find out why, the last thing you should have to worry about is whether the diagnostic test you’re relying on lives up to its manufacturer’s claims. The FBI is grateful to see that the victims affected by Magellan’s actions in this case are one step closer to being compensated.”
“Magellan concealed a serious flaw in its lead testing devices while ignoring the well-being of patients and knowingly providing inaccurate results of lead levels in the blood,” said Roberto Coviello, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of Inspector General. “This type of egregious conduct, which only sought to benefit the corporate bottom line, can erode the public’s trust in our nation’s health care system. Today’s sentencing should send a clear message that any company engaging in such dangerous activity will be held accountable.”
Magellan’s LeadCare Ultra and LeadCare II devices detected lead levels and lead poisoning in the blood of children and adults using either venous (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 Ultra was predominantly used to test venous samples.
According to court documents, Magellan failed to timely notify the FDA about a serious malfunction that caused the company’s LeadCare devices to produce inaccurate blood lead level results when used to test venous blood samples. Magellan also changed the user instructions for the LeadCare devices without prior FDA notice or approval.
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 late 2013 without informing customers or the FDA of the malfunction. In August 2014, LeadCare Ultra customers independently discovered the malfunction and complained about inaccurate results. FDA regulations required the company to file a medical device report about the malfunction within 30 days, but Magellan did not do so.
In November 2014, Magellan sent a letter to its LeadCare Ultra customers advising them of the malfunction and recommending that they wait 24 hours before running their tests. This contradicted the instructions for use approved by the FDA. Magellan did not, however, report the malfunction to the FDA or advise the FDA of its change to the instructions until April 2015, nearly 21 months after Magellan discovered the malfunction and almost 8 months after customers discovered the malfunction on their own. In August 2015, Magellan changed the label instructions for the LeadCare Ultra device to require users to wait 24 hours before using the device to test blood samples, rather than testing the samples immediately. FDA regulations required the company to provide advance notice of the label change and file necessary reports of device correction, but Magellan did neither.
Magellan’s testing in 2013 also indicated that the same malfunction affected the LeadCare II device when it was used to test venous samples. Magellan, however, did not notify the FDA about the LeadCare II malfunction until November 2016.
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 or LeadCare Plus for testing venous blood samples because of the malfunction and a recommendation that doctors retest certain patients.
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.
As part of the criminal resolution, Magellan has agreed to compensate patients who were demonstrably harmed for the economic damages they suffered as a result of the malfunction in Magellan’s blood lead testing devices. If you or a family member believe you received an inaccurate blood lead test result from a LeadCare device between 2013–2017, please complete the questionnaire located on the FBI’s website at www.fbi.gov/MagellanCaseInquiry. Information about the status of the case is located on the U.S. Attorney’s Office website: https://www.justice.gov/usao-ma/victim-and-witness-assistance-program/magellan-diagnostics-inc.
Acting U.S. Attorney Levy; FDA SAC McMillan; FBI SAC Cohen; and HHS-OIG SAC Coviello made the announcement today. Assistant U.S. Attorneys James Herbert, Kelly Lawrence and Leslie Wright of the Health Care Fraud Unit prosecuted the case.
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