Conor here: While the after-the-fact advice from the following piece might be helpful, it sure would be better if our government could prevent this from happening in the first place.
How is it possible that Magellan devices used for more than half of all blood lead tests in the US over a four year period were defective and the FDA didn’t know? The first sentence of the FDA Mission:
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Maybe I’m missing something, but it’s hard to see how the agency can perform those tasks if the safety system relies on companies whose profits are dependent on the success of their products to swiftly disclose problems. Maybe the FDA system should be on trial as well. While that isn’t happening, the FDA is instead “exploring the use of AI technologies to facilitate our internal operations and regulatory processes, which could benefit both agency experts and the public by streamlining workflows and facilitating high quality, novel medical products more quickly reaching the patients who need them. “ So there’s that.
One piece of good news from the Magellan case, the “settlement does not affect the DOJ’s ongoing prosecution of three former Magellan employees who no longer work for the company.”
Those three employees are the former CEO, COO and director of quality assurance and regulatory affairs who are charged with wire fraud, conspiracy to commit wire fraud, conspiracy to defraud an agency of the U.S. and introduction of misbranded medical devices into interstate commerce with intent to defraud and mislead.
Each of the charges carries a potential fine of up to $250,000, and those for wire fraud and conspiracy to commit wire fraud, could result in jail sentences of up to 20 years.
By senior correspondent Julie Appleby. Originally published at KFF Health News.
A company that makes tests for lead poisoning has agreed to resolve criminal charges that it concealed for years a malfunction that resulted in inaccurately low results.
It’s the latest in a long-running saga involving Massachusetts-based Magellan Diagnostics, which will pay $42 million in penalties, according to the Department of Justice.
While many of the fault-prone devices were used from 2013 to 2017, some were being recalled as late as 2021. The Justice Department said the malfunction produced inaccurate results for “potentially tens of thousands” of children and other patients.
Doctors don’t consider any level of lead in the blood to be safe, especially for children. Several U.S. cities, including Washington, D.C., and Flint, Michigan, have struggled with widespread lead contamination of their water supplies in the last two decades, making accurate tests critical for public health.
It’s possible faulty Magellan kits were used to test children for lead exposure into the early 2020s, based on the recall in 2021. Here’s what parents should know.
What Tests Were Affected?
The inaccurate results came from three Magellan devices: LeadCare Ultra, LeadCare II, and LeadCare Plus. One, the LeadCare II, uses finger-stick samples primarily and accounted for more than half of all blood lead tests conducted in the U.S. from 2013 to 2017, according to the Justice Department. It was often used in physician offices to check children’s lead levels.
The other two could also be used with blood drawn from a vein and may have been more common in labs than doctor’s offices. The company “first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results – specifically, lead test results that were falsely low” in June 2013 while seeking regulatory clearance to sell the product, the DOJ said. But it did not disclose that information and went on to market the tests, according to the settlement.
The agency said 2013 testing indicated the same flaw affected the LeadCare II device. A 2021 recall included most of all three types of test kits distributed since October 27, 2020.
The company said in a press release announcing the resolution that “the underlying issues that affected the results of some of Magellan’s products from 2013 to 2018 have been fully and effectively remediated,” and that the tests it currently sells are safe.
What Does a Falsely Low Result Mean?
Children are often tested during pediatrician visits at age 1 and again at age 2. Elevated lead levels can put kids at risk of developmental delay, lower IQ, and other problems. And symptoms, such as stomachache, poor appetite, or irritability, may not appear until high levels are reached.
Falsely low test results could mean parents and physicians were unaware of the problem.
That’s a concern because treatment for lead poisoning is, initially, mainly preventive. Results showing elevated levels should prompt parents and health officials to determine the sources of lead and take steps to prevent continued lead intake, said Janine Kerr, health educator with the Virginia Department of Health’s Childhood Lead Poisoning Prevention Program.
Children can be exposed to lead in a variety of ways, including by drinking water contaminated with lead from old pipes, such as in Flint and Washington; ingesting lead-based paint flakes often found in older homes; or, as reported recently, eating some brands of cinnamon-flavored applesauce.
What Should Parents Do Now?
“Parents can contact their child’s pediatrician to determine if their child had a blood lead test with a LeadCare device” and discuss whether a repeat blood lead test is needed, said Maida Galvez, a pediatrician and professor at the Icahn School of Medicine at Mount Sinai in New York.
During an earlier recall of some Magellan devices, in 2017, the Centers for Disease Control and Prevention recommended that patients be retested if they were pregnant, nursing, or children younger than 6 and had a blood lead level of less than 10 micrograms per deciliter as determined by a Magellan device from a venous blood draw.
The 2021 recall of Magellan devices recommended retesting children whose results were less than the current CDC reference level of 3.5 micrograms per deciliter. Many of those tests were of the finger-stick variety.
Kerr, at the Virginia health department, said her agency has not had many calls about that recall.
The finger-stick tests “are not that widely used in Virginia,” said Kerr, adding that “we did get a lot of questions about the applesauce recall.”
In any case, she said, the “best course of action for parents is to talk with a health care provider.”
4 comments
Comments are closed.
Magellan had better get themselves ready for a tsunami of lawsuits coming their way. How many families did not receive help because the Magellan device gave a low reading and how many were denied medical help, again based on dodgy readings. I can see a desire to throw those three former employees under a bus by both Magellan and the Government (“bad apples’ – nothing to see) but it cannot have been all on their shoulders for what was going on.
I hope any criminal trial turns over the whole rock and isn’t satisfied with a few scapegoats. Where was the pressure coming to release faulty tests? Interesting if there was money coming in from corporations who could be facing huge clean-up bills.
FFS, Magellan obtained a deferred prosecution action from the bribed ones. The penalty will be deemed a business expense, those two factors mean business as usual. The regulatory agencies are presented to the public as corporate watchdogs. The agencies are actually industry captured as corporate lap dogs.
How amazing that the devices had a fault that reduced the pressure on corporations and governments to undertake costly cleanups and allowed them to dodge lawsuits for lead contamination.
Reminds me of all of the wage theft cases over the past 10 years where employees were paid the wrong wages due to ‘software faults’, where, amazingly, the “faults” always resulted in employees being underpaid, sometimes being substantially underpaid.