Amy Winslow, the former CEO of Magellan Diagnostics, has pleaded guilty to a serious charge related to faulty lead-testing devices. These devices reportedly gave inaccurately low results, affecting tens of thousands of patients. Winslow is the last of three former executives from the company to accept a plea deal in this case.
The indictment against Winslow accused her of violating the Food, Drug, and Cosmetic Act. Specifically, she was charged with introducing misbranded medical devices into the market with the intention to mislead. The issue came to light after Magellan discovered a malfunction in its devices in 2013. Despite knowing about the problem, the company sent out a misleading letter in 2014 that Winslow edited. This letter instructed customers to incubate blood samples for 24 hours before using the lead-testing devices, which contradicted the device’s label that promised immediate and accurate results.
Prosecutors stated that Winslow and her colleagues did not inform the U.S. Food and Drug Administration (FDA) about the malfunction until after the company was acquired by Meridian Bioscience in 2016. A recall of the affected devices was only initiated in 2017.
As part of her plea agreement, prosecutors will recommend a sentence of one year and one day in prison, along with a $10,000 fine. They also plan to drop several fraud charges against her. Winslow’s sentencing is scheduled for July 23.
Magellan Diagnostics, which is now owned by Meridian Bioscience, previously agreed to pay $42 million to settle related charges concerning the reliability of its lead-testing devices. These devices are crucial for detecting lead levels in the blood, especially in children.
Winslow’s case highlights serious concerns about accountability in the medical device industry, particularly when it comes to patient safety.