U.S. Department
of Justice
United States v. Amy Winslow, Hossein Maleknia, and Reba Daoust
Docket Number: 23-CR-10094-PBS
Case Description
On April 5, 2023, the former CEO, COO, and Director of Quality Assurance and Regulatory Affairs for Magellan Diagnostics, Inc. (Magellan), a medical device company headquartered in Billerica, Massachusetts, were charged in connection with concealing a device malfunction that allegedly produced inaccurately low lead test results for tens of thousands of children and other patients.
The defendants Amy Winslow, 51, of Needham Heights, Mass., Mohammad Hossein Maleknia, 64, of Bonita Springs, Fla.; and Reba Daoust, 66, of Amesbury, Mass., 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.
Magellan’s devices – LeadCare Ultra, LeadCare II and LeadCare Plus – detected lead levels and lead poisoning in the blood of children and adults using either venous (i.e., blood draws through the arm) or fingerstick samples. LeadCare II, which was predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States from 2013 through 2017. LeadCare Plus and LeadCare Ultra were predominantly used to test venous samples.
According to the federal indictment, Winslow, Maleknia and Daoust – Magellan’s former CEO, COO, and Director of Quality Assurance and Regulatory Affairs, respectively – repeatedly misled Magellan customers and the FDA about a serious malfunction that affected Magellan’s LeadCare devices when they were used to test venous blood samples. By allegedly hiding the malfunction and later deceiving customers and the FDA about when they discovered the malfunction, the nature, extent and frequency of the malfunction, and the risks associated with the malfunction, the defendants caused an estimated tens of thousands of children and other patients to receive inaccurately low lead test results.
Please see the indictment and the U.S. Attorney’s Office press release for further information. This case is assigned to U.S. District Court Judge Patti B. Saris, and for pretrial proceedings it is assigned to Magistrate Judge Judith G. Dein. If you or a family member believe you received an inaccurate blood lead test result from a LeadCare device between 2013-2017, please complete the questionnaire located on the FBI’s website at www.fbi.gov/MagellanCaseInquiry.
Case Status
Court Dates
- 4/5/2023 - Amy Winslow and Reba Daoust will have their Initial Appearance in federal court on 4/5/2023 at 2:30 PM in Courtroom 15 (In person only) before Magistrate Judge Judith G. Dein.
- 8/8/2024 - Final Pretrial Conference scheduled for Amy Winslow, Mohammad Hossein Maleknia, and Reba Daoust at 2:30 PM in Courtroom 19 (In Person Only) before District Court Judge Patti B. Saris.
- 9/16/2024 - Jury Trial scheduled for Amy Winslow, Mohammad Hossein Maleknia, and Reba Daoustat at 8:30 AM in Courtroom 19 (In Person Only) before District Court Judge Patti B. Saris.
Documents
Potential Victims
If you or a family member believe you received an inaccurate blood lead test result from a LeadCare device between 2013-2017, please complete the on-line questionnaire located on the FBI website at www.fbi.gov/MagellanCaseInquiry. Also please read the Frequently Asked Questions document for additional information.