Company Execs Endangered ‘Tens of Thousands’ of Vulnerable Kids by Knowingly Selling Flawed Lead-Testing Devices

Three former executives of a Massachusetts-based health diagnostics company deliberately concealed a problem with the company’s lead-testing devices that produced inaccurately low results for tens of thousands of children, according to federal prosecutors.

Amy Winslow, Reba Daoust and Mohammad Hossein Maleknia — all former executives at Magellan Diagnostics — “deceived customers and the FDA [U.S. Food and Drug Administration] about the reliability of medical tests that detected lead levels [and] endangered the health and lives of incredibly vulnerable victims,” U.S. Attorney Rachael S. Rollins said in a press release.

Winslow, 51, is the former CEO; Maleknia, 64, is the former chief operating officer; and Daoust, 66, is the former director of Quality Assurance and Regulatory Affairs.

All three were indicted April 4 by the U.S. Attorney’s Office for the District of Massachusetts, and charged with conspiracy to commit wire fraud, wire fraud, conspiracy to defraud an agency of the U.S. and introduction of misbranded medical devices into interstate commerce with intent to defraud and mislead.

The charges can carry prison sentences of up to 20 years and fines of $250,000, the U.S. Attorney’s Office said.

Commenting on the lawsuit, Dr. Elizabeth Mumper, a pediatrician and former medical director of the Autism Research Institute, told The Defender:

“If the allegations are correct, it reveals corruption at high levels and an abhorrent disregard for the well-being of innocent children who rely on adults to keep them safe.

“Unfortunately, even a massive fine would not be able to reverse the damage already done to children’s bodies and brains.”

The Magellan Diagnostics products — marketed under the names LeadCare Ultra, LeadCare II and LeadCare Plus — tested lead levels through blood draws or fingersticks.

The three products accounted for more than half of all blood lead tests conducted in the U.S. from 2013 through 2017, according to the U.S. Attorney’s Office for the District of Massachusetts.

Joseph R. Bonavolonta, a special agent who heads the FBI’s Boston Division, said the executives knew about a “serious flaw” in the company’s devices as early as June 2013 when they sought FDA clearance for the products.

But they “failed to come clean to their customers and the FDA about it in order to boost their company’s bottom line,” Bonavolonta said.

Winslow told a Magellan employee to stop studying the malfunction in LeadCare II devices because Magellan needed to maintain “plausible deniability,” the prosecutors alleged…