2024 DOJ Settlement
On May 21, 2024, Magellan Diagnostics, Inc. (Magellan), entered into an Agreement with the U.S. Department of Justice (DOJ) that resolved the DOJ’s investigation of Magellan that began in 2018. The DOJ investigation primarily involved conduct by former Magellan employees that occurred between 2013 and 2017 concerning the malfunction of Magellan’s LeadCare® line of products when testing blood lead levels using venous blood samples, as outlined in the Statement of Facts (Attachment A to the Agreement). As a result of the malfunction, patients who were tested with a LeadCare® device during that time period may have received results that were falsely low. In other words, a LeadCare® device may have indicated a blood lead level below the CDC-recommended initial threshold of concern even though a patient’s actual blood lead level was above that threshold. The use of venous blood samples was discontinued in 2018, and the product-related issues involved in the investigation were fully remediated at that time. As part of the resolution, Magellan agreed to pay $42 million over time in accordance with the negotiated terms of the settlement. Magellan also agreed to make the settlement documents available to the public on its website, and links to that information can be found below.
As part of the settlement, Magellan agreed to create and fund a Victim Compensation Fund to compensate patients who were demonstrably harmed for the pecuniary damages they suffered as a result of the delayed detection of lead poisoning or lead exposure due to the malfunction in Magellan’s LeadCare® devices. “Pecuniary” damages mean a patient’s losses that can be measured in terms of monetary value, including for example, lost wages due to attending a doctor’s appointment, or a medical bill related to delayed treatment for lead poisoning. Other types of damages – like pain and suffering or diminished quality of life – and attorneys’ fees are not compensable under the settlement.
All claims for damages will be reviewed by an Independent Compliance Monitor (the “Monitor”), Andrew O’Connell of Guidepost Solutions. The Monitor will, among other things, evaluate victim compensation claims and recommend payment for valid claims. If you believe you are entitled to compensation you must make a claim to the Monitor before January 6, 2027. A link to the Monitor’s website and more information about the claims process can be found here.