FBI seeks families of children impacted by bad lead tests; executives face charges

Three former executives from a Massachusetts-based medical device company face charges in connection with an alleged conspiracy to conceal a malfunction with equipment that tested for dangerous lead poisoning in the blood of tens of thousands of children and adults. Amy Winslow, 51, of Needham Heights, Massachusetts; Reba Daoust, 66, of Amesbury, Massachusetts; and Hossein Maleknia, 64, of Bonita Springs, Florida, face charges including 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 was the CEO, Malkenia was the COO and Daoust was the director of quality assurance and regulatory affairs for Magellan Diagnostics, Inc., which is headquartered in Billerica. Winslow, Maleknia and Daoust are all accused of misleading customers and the Food and Drug Administration about a serious malfunction that caused inaccurately low lead test results, according to an announcement from the office of U.S. attorney for Massachusetts, Rachael Rollins. Three Magellan products detected lead levels and lead poisoning in the blood of children and adults using either blood drawn through a vein in the arm or fingerstick samples. One of those products, LeadCare II, accounted for more than half of all blood lead tests conducted in the United States from 2013 through 2017. The lead testing products have been subject to recalls, which cited a problem stemming from the paperboard material used to package parts of the test.Rollins' office said Winslow, Maleknia and Daoust learned their products could deliver inaccurately low lead test results during an FDA clearance process in 2013 but released the product without informing customers or the FDA about the malfunction. Winslow allegedly told an employee to stop studying the issue to maintain "plausible deniability," Rollins' office said, and the FDA wasn't informed about the issue until after the company was acquired in 2016 by Meridian Bioscience for $66 million. "We believe these executives knew about this malfunction for years but failed to come clean to their customers and the FDA about it in order to boost their company’s bottom line," said Joseph R. Bonavolonta, special agent in charge of the Federal Bureau of Investigation, Boston Division. Distribution of the products resumed in 2022, according to the company's website. "According to the CDC, there is no safe level of lead in the blood. Additionally, young children and pregnant mothers from low-income households living in public housing are the most vulnerable to lead exposure. We allege that these defendants deceived customers and the FDA about the reliability of medical tests that detected lead levels. By doing so, we assert that they endangered the health and lives of incredibly vulnerable victims," Rollins said in a statement. Parents who believe that their children received an inaccurate lead test or who has information that may be pertinent to the investigation are being asked to contact the FBI. "As previously disclosed, Meridian and Magellan have cooperated extensively with federal authorities in the investigation that led to these charges, and we have been and will continue to engage in resolution discussions with the Department of Justice," Meridian Bioscience wrote in a statement published Wednesday. Winslow and Daoust are scheduled to appear in federal court in Boston on Wednesday and Maleknia is scheduled to make an appearance in federal court in Tampa.