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Former Magellan Diagnostics Execs Charged with Covering up Lead Testing Defect

Three former Magellan Diagnostics executives are facing criminal charges for attempting to cover up a glitch in their lead-testing devices. This glitch caused the amount of lead detected in the blood of patients to be greatly underestimated. 


 


The malfunctioned devices - LeadCare Ultra, LeadCare II, and LeadCare Plus - are designed to detect lead levels and lead poisoning in the blood.


 


Amy Winslow, former CEO (Chief Executive Officer), Hossein Maleknia, former COO (Chief Operating Officer), and Reba Daoust, former Director of Quality and Regulatory Affairs, learned of the malfunction during an FDA clearance process in June 2013. However, the devices were released to the market in December 2013 with no mention of the defect. 


 


When customer complaints flooded in over inaccurate results, the company produced press releases commenting that no malfunction had been detected in their clinical trials. Rather than attempting to correct the glitch, Winslow allegedly told a Magellan employee to stop studying the malfunction so the company could maintain “plausible deniability.”


 


The former executives repeatedly downplayed the problem, the extent and frequency of the problem, and the associated risks over the years. As a result, it is estimated that tens of thousands of children and adults received inaccurately low lead test results.  


 


According to the court documents, the company only filed an FDA report after an outside consultant told Magellan that if they did not notify the FDA about the problem, they would. 


 


When the FDA contacted the company and asked when the problem was discovered, they allegedly falsely told the FDA they learned of the issue just a few months earlier. 


 


The former executives 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,” according to the United States Attorney Office, District of Massachusetts press release. 


 


Winslow, Maleknia, and Daoust could face up to 20 years in prison for the charges of wire fraud and wire fraud conspiracy, five years in prison for the charges of conspiracy to defraud an agency of the United States, and three years in prison for the charges of misbranded medical devices. 


 


“Concealing the fact that a device is producing inaccurate lead test results to boost profits while knowing there is no safe level of lead in the blood, as alleged in this case, is brazen disregard to the health and safety of our program beneficiaries,” said Philip M. Coyne, Special Agent in Charge for the U.S. Department of Health and Human Services, Office of Inspector General. “Today’s arrest should serve as a strong reminder that we will never tolerate such behavior that puts patients at risk”


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Tags: FDA and LeadCare Plus LeadCare Ultra Hossein Maleknia lead LeadCare II Reba Daoust Magellan Diagnostics Amy Winslow recall



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