Medical Device Company Executives Convicted for Hiding Defects

Most fraudulent schemes are used to misappropriate money in one way or another based on false representations. Deception involving Medicare and Medicaid can be especially harmful because funds that go to the parties perpetrating fraud cannot be used to assist deserving beneficiaries. In some cases, the effects can even pose a danger to unknowing patients. 

A recent case involving Magellan Diagnostics, Inc., a Massachusetts-based medical device company, highlights the potentially devastating consequences of such misconduct. Three former executives of Magellan—its CEO, COO, and Director of Quality Assurance and Regulatory Affairs—have pleaded guilty to concealing a malfunction in their lead testing devices, which resulted in thousands of dangerously inaccurate results. 

Magellan’s LeadCare II and LeadCare Ultra devices were widely used to detect lead levels in the blood of children and adults. From 2013 to 2017, LeadCare II accounted for a majority of all blood lead tests conducted nationwide. In most LeadCare II cases, fingerstick samples were taken for these analyses. LeadCare Ultra, on the other hand, was used predominantly when venous blood samples were drawn through a patient’s arm.

The malfunction in question affected the accuracy of LeadCare devices when testing venous blood samples, leading to inaccurately low lead level readings. This issue was particularly alarming given the severe health risks associated with lead poisoning, especially in children. Elevated lead levels can cause developmental delays, learning difficulties and other long-term health problems.

Rather than addressing the malfunction transparently, Magellan’s former executives misled both their customers and the FDA. They concealed the malfunction, misrepresented when they discovered it and downplayed its nature, extent and associated risks. As a result, thousands of children and other patients received inaccurate test results, potentially delaying critical medical interventions. Eventually, the FDA issued a recall of LeadCare products used in the collection and analysis of venous samples.

This case underscores the importance of accountability in the medical device industry and the potential danger when no one comes forward with the truth. Regulatory agencies like the FDA rely on honest reporting from employees and others to safeguard public health. Should you have any knowledge regarding problems with diagnostic equipment or any other medical devices, it is imperative to speak up.   

At Kardell Law Group, we have extensive experience defending the rights of whistleblowers and representing them in cases where they can obtain a share of any financial recovery secured by the government as a result of healthcare fraud. Contact us today if you are aware of serious misconduct in the medical industry.