Defective Magellan Lead Testing Devices
Magellan LeadCare devices are machines used to detect levels of lead in a person’s blood, most commonly in children. Between 2006 and 2017, LeadCare devices may have understated lead blood concentration levels. This alleged defect may have prevented children and others from receiving prompt treatment for elevated lead levels. In 2017, these defective Magellan devices were used to conduct at least 2.5 million tests, or more than half of all lead tests conducted in the United States.
Magellan Diagnostics devices that may have been defective include:
- LeadCare Ultra
- LeadCare II
- LeadCare Plus
Magellan LeadCare testing devices were used in doctors’ offices, medical clinics, hospitals, and testing laboratories all over the U.S. Children and others whose lead testing results were inaccurate may have been placed at continued risk.
Parents and caregivers of children and other people who were tested with a Magellan lead testing device may be eligible for compensation.
Magellan Executives Face Criminal Charges
Three former Magellan officers and employees have been charged with conspiracy, wire fraud and FDA violations by the U.S. Attorney’s Office for the District of Massachusetts. The officials are the Chief Executive Officer (CEO), Chief Operating Officer (COO) and Director of Quality Assurance and Regulatory Affairs for Magellan Diagnostics, Inc.
Magellan LeadCare testing devices were introduced in 2006 and have been used in millions of children and adults. Company officials are accused of discovering the inaccuracy of the testing devices in 2013 but covering up the problems in order to protect the company, boost profits and maintain company stock values in preparation for a sale to Meridian Bioscience. Magellan’s CEO and COO received bonuses of almost $2.5 million after the sale of the company.
Once the defects were discovered within Magellan, company employees were ordered to stop studying the defects so that they would remain hidden. After Magellan was acquired in a completed sale, the defects were disclosed to the FDA. The Agency then issued a recall for affected devices in 2017. This delay may have placed tens of thousands of children and other patients at continuing risk.
Lead Exposure in Children and Adults
The U.S. Centers for Disease Control and Prevention have stated that no concentration level of lead in the blood is safe. Toxicities that occur as a result of lead poisoning may be irreversible and will worsen with further exposure.
Lead poisoning often occurs in children and adults when items containing or food contaminated with lead are ingested, when lead-contaminated dust is inhaled or when lead-contaminated water is consumed. Childhood lead poisoning may result in intellectual disability and behavioral disorders. High levels of lead may affect the brain and central nervous system, result in coma, convulsions, or death.
Children are particularly vulnerable as lead may affect a developing brain and neurological systems more severely. Pregnant women may also be more affected by lead poisoning which results in developmental disorders, low birth weight, and premature birth of the infant.
Children and others tested for lead with the LeadCare devices may have received inaccurate results which understated lead concentrations in their bodies, and which may have caused medical professionals not to undertake treatment that would otherwise have been pursued. It may have prevented further investigation or avoidance of the origins of any lead exposure, such as continued consumption of contaminated drinking water.
Magellan LeadCare Victims May Be Unaware of Risk
Many parents or caregivers of children or others who are tested for lead blood concentration levels are not told what methods or devices have been used to perform testing, and may not realize that their lead exposure was higher than what they and their physician were led to believe. This deception may have caused those tested to forego treatment and/or steps to reduce ongoing lead exposure.
Because many parents and other patients may not know of past testing inaccuracies, the Federal Bureau of Investigation (FBI) has launched an investigation intending to identify potential victims of this criminal fraud.
Children and others who were tested for levels of lead in the blood between 2006 and 2017, may have been placed at risk of serious health effects if the device used for testing was made by Magellan. Those tested and their parents or caregivers may be eligible for compensation.