United States v. Magellan Diagnostics, Inc.

Docket Numbers: 1:24-cr-10144-PBS and 1:24-cr-10146-PBS

Case Description

On May 21, 2024, Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., agreed to resolve criminal charges relating to its concealment of a device malfunction that produced inaccurately low lead test results for potentially tens of thousands of children and other patients. 

As part of the criminal resolution, Magellan will plead guilty to violations of the federal Food, Drug, and Cosmetics Act (FDCA) and pay a $28.1 million fine, $10.9 million in forfeiture, and a minimum of $9.3 million to compensate patient victims. This resolution also includes a deferred prosecution agreement to resolve felony conspiracy fraud charges against the company.  

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.

Magellan admitted that it misled its customers and the federal Food and Drug Administration (FDA) about a serious malfunction that affected its LeadCare Ultra and LeadCare II that could cause inaccurate test results – producing lead tests results that were falsely low. However, after learning about the malfunction, Magellan still released the devices to the market in 2013 without informing customers or the FDA of the malfunction.

By hiding the malfunction and later deceiving customers and the FDA about when the company discovered the malfunction, the nature, extent and frequency of the malfunction, and the risks associated with the malfunction, Magellan caused an estimated tens of thousands of children and other patients to receive inaccurately low lead test results.

The FDA ultimately found that the LeadCare Devices could not accurately test venous samples, leading to a recall of all LeadCare Devices using venous samples and a warning to the public not to use LeadCare Ultra, LeadCare II and LeadCare Plus for venous blood samples because of the malfunction.

Related Case

In April 2023, three former Executives for Magellan were charged with conspiracy, wire fraud and FDA violations in connection with concealing the device malfunction. Information about the status of this case is located here: https://www.justice.gov/usao-ma/victim-and-witness-assistance-program/united-states-v-amy-winslow-hossein-maleknia-and-reba-daoust.

Documents

• Press Release
• FDCA Information
• Felony Information
• Plea Agreement
• Deferred Prosecution Agreement
• Frequently Asked Questions & Contact Information

Potential Victims

As part of the criminal resolution, Magellan has agreed to compensate all patients who were demonstrably harmed for the pecuniary damages they suffered as a result of the malfunction in Magellan’s blood lead testing devices. 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.