Magellan Diagnostics Penalized for Faulty Lead Tests

Magellan Diagnostics, a Massachusetts-based medical device company, pleaded guilty to charges of concealing a malfunction in its lead testing devices that resulted in inaccurately low lead levels reported for thousands of patients, including children. The company has been ordered to pay a total of $32.7 million, which includes a $21.8 million fine and $10.9 million forfeiture, as well as setting aside $9.3 million for compensation to affected patients. The faulty devices were sold between 2013 and 2017, despite the company being aware of their inaccurate results as early as 2013. Prosecutors allege that this deception endangered public health, particularly among vulnerable populations. Former executives of Magellan, including the ex-CEO, face trial for related charges, while the company continues to operate under the ownership of Meridian Bioscience. The FDA had ordered the devices off the market in 2017, after numerous complaints and investigations revealed the extent of the issue.