The former CEO of Magellan Diagnostics was sentenced in Massachusetts federal court Monday to a year of home confinement for failing to alert regulators to a problem in the company's lead-testing devices that resulted in inaccurately low lead levels being detected in blood samples.

Magellan Diagnostics' former CEO Amy Winslow pled guilty last March to allowing mislabeled LeadCare Ultra devices to be used and sold without notifying the FDA about the problem and a change to its use instructions. (iStock.com/jarun011) Amy Winslow, who pled guilty last March to a charge of allowing mislabeled LeadCare Ultra devices to continue to be used and sold without notifying the U.S. Food and Drug Administration about the problem and a change to its use instructions, was also ordered by U.S. District Judge Patti B. Saris to pay a $10,000 fine.

Judge Saris, pointing to millions of dollars Winslow earned in her role as CEO, said she would have imposed a higher fine but for the statutory maximum.

"I do agree this is a serious offense because it involves a device used to test levels of lead in children," and because Winslow and other executives waited for months before alerting customers, then failed to notify the FDA for several years, the judge said.

Prosecutors had requested a year in prison, the maximum sentence contemplated under Winslow's plea agreement.

Winslow and two other Magellan executives, operations chief Mohammad Hossein Maleknia and quality assurance director Reba Daoust, were accused of an intentional scheme to hide the issue with its LeadCare products while the Massachusetts-based company was in the process of being acquired by Meridian Bioscience in 2016.

Winslow pled guilty to the single count ahead of a trial that had been set for April 2025 on a series of fraud counts. Her lawyers urged the court to impose a year of supervised release, framing the case as a failure to fulfill a regulatory requirement but not an intentional fraud.

Judge Saris rejected that suggestion Monday.

"I do believe that Ms. Winslow was involved in the decision-making process with the other two co-defendants and that she deliberately misled the FDA," the judge said.

"On the other hand, maybe it was months late, but she eventually did send a letter" to customers alerting them of the issue and what she believed to be a fix, adding a 24-hour incubation period for the tests, Judge Saris also noted. "It wasn't as if she completely ignored the problem."

Winslow told the court she is "deeply sorry for failing to ensure Magellan filed the appropriate documents when it was a requirement to do so," but that she "did not believe that any patient was or would be harmed by any actions I took under my leadership."

Since she pled guilty, Winslow said, the government "has continued to assert publicly that I engaged in conduct that I just didn't commit."

She also told the court she had already paid a high price for the lapse, which "forever changed my life," ending "a career I worked hard to develop," and limiting her ability to take part in community service work.

The government, meanwhile, requested a year in prison to send a message to other executives who may be calculating their own cost-benefit analysis of disclosing a defective product.

Assistant U.S. Attorney Leslie Wright told the judge that Winslow casts herself as "the victim," blaming everyone, including her employees, customers, the FDA, the U.S. attorney's office, and supplier Becton Dickinson, which she said changed the formula of a component in test tubes.

"The blame game the defendant insists on playing is indicative of her entitlement," Wright argued, at one point comparing Winslow's alleged lack of remorse to the defendants in the "Varsity Blues" college admissions bribery scandal.

Wright also pointed to Winslow's Brown University and Harvard University education and prior experience at other life sciences firms, including C.R. Bard and Genzyme — factors the judge had also noted during the hearing.

"She knew sales should not be prioritized over patient safety," Wright told the judge.

The sentencing followed several months of wrangling over the factors the court should consider in calculating an advisory sentencing guidelines range, something the judge is legally required to do even in a case in which there was a plea agreement calling for Winslow to receive a sentence of no more than a year.

"I've been a judge for 30 years and this is the most complicated, labor-intensive sentencing I've ever had," Judge Saris said at the outset of Monday's sentencing hearing, the first of two scheduled for this week in the case. "Everything is disputed."

Winslow's attorney, William J. Trach of Latham & Watkins LLP, objected to the probation department's reliance on a statement of the case, alleging the statement was based on the original charges, not what Winslow had admitted to in March.

Meanwhile, the judge repeatedly pressed prosecutors for the basis of some of the assertions in the statement.

"I feel like a broken record, if one can still use that metaphor," Judge Saris said during one such disagreement over the number of people Winslow allegedly oversaw in connection with the failure to report. "I don't have evidence in this record," she told Wright in rejecting the government's position that Winslow directed more than five people in the scheme.

Maleknia, who also pled guilty last spring, is due in court Thursday. The government is seeking a nine-month prison term for him, while Maleknia is requesting two years of probation.

Daoust's sentencing is scheduled for Nov. 21.

The government is represented by Leslie Wright and Mackenzie A. Queenin of the U.S. Attorney's Office for the District of Massachusetts.

Winslow is represented by William J. Trach, Terra Reynolds, Nathan A. Sandals and Patricia Amselem of Latham & Watkins LLP.

The case is U.S. v. Winslow et al., case number 1:23-cr-10094, in the U.S. District Court for the District of Massachusetts.