Three former executives of Magellan Diagnostics, Inc. (Magellan) were recently charged in connection with concealing a device malfunction for one of their medical devices that allegedly produced inaccurately low lead test results for tens of thousands of children and other patients. Lead poisoning can be very difficult to detect as signs and symptoms do not typically appear until “dangerously high” levels of lead have accumulated in the body and blood testing is the best way to detect lead poisoning.
According to the indictment, Amy Winslow, Mohammad Hossein Maleknia, and Reba Daoust were charged with conspiracy to commit wire fraud, wire fraud, conspiracy to defraud an agency of the United States, and introduction of misbranded medical devices into interstate commerce with intent to defraud and mislead. Winslow, Maleknia, and Daoust – Magellan’s former President/Chief Executive Officer, Chief Operating Officer/Vice President of Operations, and Director of Quality Assurance and Regulatory Affairs, respectively – repeatedly mislead Magellan customers and the Food and Drug Administration (FDA) about a serious malfunction that impacted Magellan’s LeadCare devices when they were used to test venous blood samples.
The LeadCare Ultra, LeadCare II, and LeadCare Plus were used to detect lead levels and lead poisoning via venous or fingerstick samples in children and adults. LeadCare II, predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States from 2013 to 2017. LeadCare Ultra and LeadCare Plus were mostly used to test venous samples.
By allegedly hiding the malfunction of low lead test results – and then deceiving customers and the FDA about the timing of discovering the malfunction, as well as the nature of the malfunction, the extent and frequency of the malfunction, and the risks associated with the malfunction – Winslow, Maleknia, and Daoust “caused an estimated tens of thousands of children and other patients to receive inaccurately low lead test results.”
The defendants allegedly learned of the malfunction in the LeadCare Ultra device around June 2013, during the FDA clearance process. However, they did not stop – or mediate – this problem, but instead released LeadCare Ultra to the market in December 2013 without making any mention of the malfunction. It was only a few months after the release of LeadCare Ultra that customers discovered the malfunction and started to complain about inaccurate results. Instead of making things right in that moment, the defendants allegedly doubled down on the devices and caused Magellan to provide “false and misleading statements to customers that they ‘recently identified cases’ of the malfunction and they did not observe the malfunction ‘in our clinical trials prior to the product release.’”
In fact, it wasn’t until an outside consultant told Magellan that if they did not notify the FDA about the LeadCare Ultra malfunction, the consultant would, that the company told the FDA about the malfunction. Additionally, at the alleged direction of Daoust and Maleknia, when the FDA asked Magellan when the company first discovered the malfunction, Magellan falsely told the FDA that the problem was first discovered after receiving customer complaints in late 2014. Winslow also caused the company to submit a false timeline to the FDA, omitting the company’s internal 2013 studies about the malfunction.
Testing performed by Magellan in 2013 also found that the LeadCare II device had the same malfunction. At that time, LeadCare II was Magellan’s highest-revenue product, and Winslow and Maleknia were working to position Magellan for a sale. Winslow allegedly told a Magellan employee to stop studying the malfunction because the company needed to “maintain ‘plausible deniability.’” Once Magellan was acquired by Meridian Bioscience, Inc. in March 2016, the executives finally notified customers and the FDA about the LeadCare II malfunction. In that report, Magellan allegedly made materially false and misleading statements and concealed material facts about the discovery of the malfunction in LeadCare II.
Ultimately, Magellan issued a voluntary Class I recall in May 2021 for several of its blood lead testing products due to “significant concerns” about the performance of the tests. In February 2022, the company was able to return LeadCare II to market after remediating the issues, and in October 2022, was able to return LeadCare Plus and LeadCare Ultra to market.
This is a problem because as noted by United States Attorney Rachael S. Rollins, “there is no safe level of lead in the blood,” and as such these inaccurately low lead tests “endangered the health and lives of incredibly vulnerable victims,” including young children and pregnant mothers in low-income households and/or those living in public housing.