In a federal court in Boston, Magellan Diagnostics, a Massachusetts-based medical device company, faced legal consequences for hiding a critical malfunction in their lead testing devices that produced inaccurate low lead results for countless pediatric and adult patients. The judgment delivered yesterday has the firm shelling out a hefty $21.8 million fine, forfeiting another $10.9 million, and setting aside at least $9.3 million to patch up things with the patient victims, according to the U.S. Attorney’s Office.
By misbranding its LeadCare Ultra and LeadCare II devices, the company pleaded guilty to two counts of introducing misbranded medical products into the national market. These charges arose from an indictment released on May 21 of this year, as reported by documents from the FDA's New York Field Office. Although the devices were marketed for detecting lead poisoning in blood, their accuracy significantly declined when tested with venous blood samples. “It's absolutely appalling that Magellan Diagnostics was more concerned about its bottom line than it was about coming clean to their customers and the FDA about a serious malfunction in its lead testing devices that we believe unnecessarily endangered the health of incredibly vulnerable victims,” as stated by the FBI’s Boston Division in the press release.
The company became aware of the issue as early as 2013 when the FDA clearance process uncovered a malfunction that resulted in misleadingly low lead test results. However, instead of informing its customers or the regulatory agency, Magellan opted to launch the product by the end of the year, leaving offices and clinics unaware of the problem, this accord to the court documents cited by the U.S. Attorney’s Office. In fact, it wasn't until customer complaints in 2014, along with a series of delayed responses, evasion of FDA notification regulations, and label changes the following year—again without proper FDA notification—that the company began to partially address the issue.
As accountability measures are enforced, the healthcare industry is reminded that such reckless disregard for safety sets a concerning precedent. Special Agent in Charge of the U.S. Department of Health and Human Services, Office of Inspector General, who condemned actions that “can erode the public’s trust in our nation’s health care system,” as stated in the press release. Ultimately, Magellan's settlement includes compensatory measures for those who experienced economic harm due to the devices' inaccuracies. Information on eligibility for restitution can be found on the FBI’s case inquiry page or the U.S. Attorney’s victim and witness program website for those looking to seek compensation.
