Three former executives of Massachusetts-based medical device company Magellan Diagnostics are facing the music after pleading guilty to charges related to misleading customers and the FDA about a serious malfunction in their lead testing products. The company's former CEO, COO, and Director of Quality Assurance and Regulatory Affairs admitted to their roles in a scheme that resulted in countless inaccurately low blood lead test results between 2013 and 2017, affecting particularly children and pregnant women who are most vulnerable to lead exposure.
According to an announcement by the U.S. Attorney's Office, Amy Winslow, 53, Hossein Maleknia, 66, and Reba Daoust, 68, now await sentencing for their actions. While Winslow and Daoust provided guilty pleas to one felony count each, it is Maleknia who admitted to two felony counts, awaiting his sentencing amidst this fallout of justice.
Magellan's lead testing devices, predominantly the LeadCare II and LeadCare Ultra, were used for blood lead tests throughout the United States. The malfunction, hidden from the public, significantly underreported blood lead levels when used with venous blood samples. This deceit not only betrayed customer trust but potentially caused lifelong health issues for those affected – as no level of lead in the blood is considered safe, posing irreversible physical and mental damage, as noted by the CDC.
Authorities are taking the case very seriously, with Leah B. Foley, the United States Attorney, stating, "These defendants eroded that trust by misleading regulators and customers about devices they knew could provide inaccurate results, and thereby knowingly endangered the health of children and other patients across the country." In a clear warning, she emphasized that those who choose deception in healthcare will not escape justice. Echoing her sentiment, several other agencies, including the FBI and HHS-OIG, voiced their commitment to holding such fraudulent practices accountable. All obtained these comments via the same announcement.
As a response to the findings, the FDA necessitated a recall of all LeadCare devices for venous samples and issued a warning against their usage for such. The repercussions of these actions weigh heavily, with possible sentences spanning up to five years in prison and hefty fines reaching $250,000 or twice the gross gain from the offense, dependent on the specific charge and case adjudication guidelines. Those who believe they have received inaccurate blood lead test results from a LeadCare device can fill out a questionnaire on the FBI's website, while updated information regarding the case status remains accessible on the U.S. Attorney's Office website.
