As many as 7 million lead poisoning tests performed on children over the course of three years could have yielded the wrong results because they were defective. According to a USA Today news report, the U.S. Food and Drug Administration (FDA) recalled the faulty tests in May, and eight months later, it’s still uncertain what went wrong. The tests that are under scrutiny were made by Magellan Diganostics, which discovered as far back as 2014, that its three-minute test conducted in a doctor’s office could yield inaccurate results when used on blood drawn from a vein.
Most lead tests in children are taken by pricking the finger or heel to draw samples of blood from capillaries for testing. Health professionals and families are still dealing with the fallout, which have some worried that lack of trust in the screenings could result in fewer parents testing their children for lead poisoning.
Poor Handling of Product Defect Issue
Some also say doctors might stop doing the tests if they don’t believe they are accurate and send their patient elsewhere. If that happens, there is the fear that parents may not get their children tested. FDA also found that in addition to the devices being faulty, Magellan, the manufacturer, broke federal laws on how to handle product defect complaints. The complaints actually began in 2014. In 2015, the company filed a report with the FDA acknowledging the problem but stating that the problem had been resolved.
The FDA reviewed the matter and disagreed with Magellan. The agency also determined that Magellan had underestimated the number of people at risk. FDA then issued a Class I recall, the most serious type, in May 2017. In October, the FDA sent the company a letter scolding it for the manner in which it handled the situation. The FDA also warned the company that if it failed to fix the problems, the agency could take additional action including “seizure, injunction and civil money penalties.”
Lead Poisoning is Serious
According to the U.S. Centers for Disease Control and Prevention (CDC), at least 4 million households have children living in them that are being exposed to high levels of lead. There are approximately half a million U.S. children ages 1 to 5 with blood lead levels above 5 micrograms per deciliter, the reference level at which CDC recommends public health actions be initiated. There is simply no safe blood lead level in children. Because lead exposure often occurs with no obvious symptoms, it frequently goes unrecognized and untreated.
In children, lead poisoning could have serious consequences from stunted development and learning disabilities to irreversible brain damage. These defective products, by producing inaccurate results, put numerous children in harm’s way. As product defect lawyers who fight to uphold consumers’ rights, we hope this company is held accountable and that those who have suffered losses as a result of these product defects get the justice they deserve.