By: Christopher A. Parrella, Esq., CPC, CHC, CPCO
Parrella Health Law, Boston, Ma.
A Health Law Defense and Compliance Firm

Magellan Diagnostics, a Massachusetts-based medical device company, has pleaded guilty to criminal charges for concealing malfunctions in its lead testing devices, LeadCare Ultra and LeadCare II. The faulty devices provided inaccurately low lead test results for tens of thousands of patients, including children. This led to serious health risks, as there is no safe level of lead in blood, especially for young children and pregnant women.

Magellan admitted to two counts of introducing a misbranded medical device into interstate commerce, violating the Food, Drug and Cosmetic Act (FDCA). The company failed to inform the FDA and its customers about the malfunction discovered during the FDA clearance process in 2013. Despite knowing about the issue, Magellan released the device to the market, and did not report the malfunction to the FDA until 2015.

Magellan has agreed to a $28.1 million fine, $10.9 million in forfeiture, and a minimum of $9.3 million to compensate affected patients. The devices, primarily used from 2013 to 2017, were eventually recalled after the FDA found them unable to accurately test venous blood samples.

This case highlights the critical importance of compliance with FDA regulations to ensure patient safety. At Parrella Health Law, we assist healthcare providers in navigating complex regulatory environments such as the FDA to avoid such costly and dangerous pitfalls. If you have any questions about compliance or need assistance, please contact Parrella Health Law at 857.328.0382 or email Chris directly at cparrella@parrellahealthlaw.com.

Christopher Parrella, ESQ, CPC, CHC, CPCO, is the founding partner of Parrella Health Law in Boston, Mass. The firm focuses exclusively on healthcare defense and compliance matters. Chris also travels the country on behalf of a wide range of healthcare organizations, lecturing on a variety of health care enforcement and compliance topics. Chris is one of a handful of health care attorney’s that are also Certified Professional Coders (CPC) and is a member of the AAPC’s National Legal Advisory Board and Ethics Committee.  He is also a Certified Professional Compliance Officer (CPCO) and Certified in Health Care Compliance (CHC.)