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.
Magellan Diagnostics devices that may have been defective include:
- LeadCare Ultra
- LeadCare II
- LeadCare Plus
Magellan LeadCare testing devices were purchased or used in doctors’ offices, medical clinics, hospitals, and testing laboratories all over the U.S. Businesses and organizations who purchased the machines may have been placed at risk of financial loss, harm or other damages and may be eligible for compensation.
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. Named officials include 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 thousands 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. The three Magellan officials individually profited hundreds of thousands of dollars 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.
It may also have placed financial and ethical burdens on clinics, hospitals, laboratories and medical groups who paid for a machine that did not work and put their patients in danger.
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 caused medical professionals not to recommend 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. They also may not receive appropriate information or instructions of what to do when lead test results are inaccurate. This may have left them unaware of the dangers of lead poisoning and the dangers of continued exposure and without medical treatment.
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.
Parents and caregivers of children or 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 and may be eligible for compensation.
Purchases of Magellan LeadCare Testing Devices May Also Have Suffered Losses
Magellan LeadCare testing devices were purchased and used in Hospitals, Laboratories, Medical Clinics and Physicians’ Offices. Businesses and organizations who purchased the devices were expecting that the machines would provide accurate results to patients.
Lead testing results may be used to diagnose developmental or medical conditions and formulate a plan of treatment. When lead testing results showed blood concentration levels that were falsely low, diagnosis and treatment may have been delayed or even prevented.
Under reporting blood concentrations may have led to failures for both the patient and the businesses who used the machines. Medical businesses and organizations may have suffered losses in both the cost of the machines and a financial and ethical risk of failing to treat patients effectively.
Hospitals, laboratories, medical clinics and doctors’ offices who purchased Magellan LeadCare lead testing device may be eligible for compensation.