Dive Brief:

• The former CEO, chief operating officer, and director of quality assurance and regulatory affairs for Magellan Diagnostics have been charged with concealing a device malfunction that allegedly produced inaccurately low lead test results for tens of thousands of patients, including children.
• The company’s LeadCare II test, used mainly for fingerstick samples, 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.
• The executives are accused of failing to report the test malfunction to customers and the Food and Drug Administration despite knowing about it for years, in order to boost the company’s bottom line, federal officials said. Magellan was acquired by Meridian Bioscience for $66 million in March 2016.

Dive Insight:

Magellan’s tests, called LeadCare Ultra, LeadCare II and LeadCare Plus, were used to detect lead levels and lead poisoning in the blood of children and adults using either blood draws through the arm or fingerstick samples.

According to the indictment, defendants Amy Winslow, Magellan’s former CEO; Hossein Maleknia, the former COO; and Reba Daoust, the former director of quality assurance and regulatory affairs, repeatedly misled customers and the FDA about a serious malfunction in the LeadCare devices when they were used to test venous blood samples.

The executives first learned that a malfunction in the LeadCare Ultra test could produce falsely low results during the FDA clearance process around June 2013, but the test was marketed in December 2013 without informing customers or the FDA of the flaw, the indictment alleges.

When customers independently discovered the problem and complained about inaccurate results, the defendants falsely stated that they “recently identified cases” of the malfunction and had not observed the issue in clinical trials before the product’s release, the indictment said.

Magellan’s testing in 2013 allegedly also indicated that the same malfunction affected the LeadCare II device, which was the company’s highest-revenue product.

Only after Magellan was acquired by Meridian Bioscience three years later did the defendants notify customers and the FDA about the LeadCare II malfunction, federal officials said, and Magellan’s report to the FDA about the test allegedly made false and misleading statements about how the issue was discovered.

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 the tests.

According to the Centers for Disease Control and Prevention, lead exposure may cause irreversible, lifelong physical and mental health problems. Young children and pregnant women are most vulnerable to lead exposure.

Winslow, Maleknia and Daous face charges of 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.

“We are extremely disappointed that the government chose to go forward with this misguided prosecution,” BJ Trach, Winslow’s attorney and a partner at law firm Latham & Watkins, said in an email to MedTech Dive. “Amy left Magellan amicably 5 years ago, and was a thoughtful, compassionate, and effective leader there through difficult times for the company. She did not commit any crimes, and this prosecution, inexplicably initiated so many years after the events at issue, should never have been brought. We look forward to Amy having her day in court, and we are confident she will be vindicated.”

Winslow and Daoust will make an initial appearance in federal court in Boston on Wednesday. Maleknia is also expected to make an initial appearance in federal court in Tampa on Wednesday.

This story has been updated to add a statement from Amy Winslow’s attorney.