Magellan Diagnostics Fined $42 Million for Distributing
Blood Lead Testing Devices That Gave False Low Readings:
Tens of Thousands of Children and Adults Affected
October 20-26, 2024 is International
Lead Poisoning Prevention Week, an excellent time to schedule blood lead level screening tests
especially for those who live in proximity to airports that service piston-engine aircraft. The
theme for this year's event - Bright Futures Begin Lead Free. Even small amounts of lead in a
child's blood can cause irreversible harms to the developing brain. For this reason it is paramount
that lead emissions are eliminated at the source by banning leaded aviation fuel once and for all.
Oregon law mandates that children on Medicaid/Oregon Health Plan have their blood lead levels checked at 12 and 24 months, or between 2 and 5 years if there is no record of a previous blood test. Unfortunately, Oregon, along with a number of other states, has long been out of compliance with this Medicaid requirement. According to a 2016 Washington County Public Health Department report, only 3% of children in this county have been tested for lead, even though the EPA has identified it as the most lead-polluted jurisdiction in the state.
But wait, it gets even worse. The few children and adults who were tested during a 4-year span between 2013 to 2017 may have received false low readings due to the use of flawed devices. The following excerpts are from a 10/10/2024 U.S. District of Massachusetts Attorney's Office press release:
Magellan Diagnostics Sentenced for Concealing Malfunction in Lead Testing Devices
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
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.
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. Information about the status of the case is located on the U.S. Attorney's Office website.
To read the release in full click here.
Below are the opening paragraphs of a 4/5/2023 CBS news report 3 Former Execs Arrested and Charged for Marketing Faulty Lead Testing Devices. As noted in the article, "If found guilty of wire fraud and wire fraud conspiracy, the defendants could face up to 20 years in prison and a possible fine of up to $250,000, prosecutors said. The separate charges for conspiracy to defraud a U.S. agency and misbranded medical devices entail possible jail time of up to 5 and 3 years respectively in addition to fines."
Three former executives of a company that makes machines that test lead levels in humans deliberately concealed a problem with the devices that produced falsely low results for tens of thousands of children, federal prosecutors alleged on Wednesday.
The children, as well as pregnant people and others, faced serious health risks because of the inaccurate test results, prosecutors said.
Amy Winslow, Reba Daoust, and Mohammad Hossein Maleknia—all former executives at Magellan Diagnostics—were charged with conspiracy to commit wire fraud, wire fraud, conspiracy to defraud an agency of the U.S., and introduction of misbranded medical devices into interstate commerce with intent to defraud and mislead, according to the U.S. attorney's office in Boston.
To view the full report click here.
Conclusion
The largest facility source of airborne lead pollution in Washington County and the state of Oregon is the Hillsboro Airport. Users of this facility release lead emissions, 1200 lbs each year, during the landing and take-off phase of flight. Additional lead is released during ground-up procedures, repetitive training activities, and the cruise phase. As a result area residents are often subjected to multiple doses of lead on a daily basis.
According to the Centers for Disease Control (CDC), "Children who live near airports may be exposed to lead in air and soil from aviation gas used in piston engine aircrafts." The Environmental Protection Agency estimates that nationwide 16 million people, including three million children, live within a kilometer of a lead emitting airport. Children and adults residing, working, attending school, and recreating in proximity to these facilities, beneath a touch-and-go pattern or under practice training area further from the airport should contact their doctors to request a blood test.
It is incumbent on public officials and health care providers to insure that people on the Oregon Health Plan as well as those covered by private insurance are tested and provided access to treatment if recommended.
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