Faulty Lead Tests Could Open Company Up to a Myriad of Personal Injury Claims
Lead poisoning has been in the news regularly since the crisis in Flint, Michigan, where communities in and outside of Flint suffered from the many effects regular exposure to lead can have, including learning disabilities, behavioral issues, anemia, hypertension, immunotoxicity, and toxicity to the organs.
Since the initial coverage of this health crisis, more and more communities have come forward with concerns over lead poisoning and test results showing elevated levels of lead in their communities. In fact, the New York Times recently highlighted the FDA’s announcement that some of the blood tests used to check for lead poisoning within the last three years may have incorrectly indicated that people—including children—were safe from lead exposure.
Lead is so toxic that really no level of it in the blood is safe. However, when healthcare providers come across levels of 5 micrograms per deciliter or more, they become “officially” concerned, and, at that point, efforts should be made to identify where and how the patient was exposed to lead and to take the proper steps to decrease that exposure for that patient and others. When a patient’s test results reveal a high level of lead in their blood, the patient should receive repeated blood tests at regular intervals (along with various treatments to address the negative effects of lead in the blood).
According to the Times article, Magellan knew that it had a problem with its tests as of three years ago, when it started receiving complaints. In late 2014, the company started notifying customers that the problem could be solved by incubating blood samples with the reagent mixture for 24 hours before running the test. The company also indicated that the issue was limited to a very small percentage of samples. However, the FDA itself was not alerted to the issue until almost a year later, and at that time, the company reiterated to the agency that the safety risk was very low. This is a serious issue, as the company arguably placed people’s lives at risk by not appropriately responding to indications that their product was defective.
The issue appears to be linked to a particular method used in conjunction with the tests: when blood used for the testing is drawn from the vein as opposed to capillary blood, it appears to yield inaccurate results. According to Meridian Biosciences (which now owns Magellan), approximately 10 percent (or close to $2 million) of all lead testing is done via venous blood testing. According to one pediatrician, most doctors draw blood from the vein only if blood drawn from the finger or heel shows an elevated blood test, and the doctor is seeking to confirm the result. Because of this, a number of people received a normal test result in error.
Although the FDA still has not released an official explanation as to why the tests are inaccurate if blood is taken from the vein, Magellan has indicated that it is supposedly due to a curing agent found in the rubber caps of the tubes that were used to collect the blood specifically from the vein. The company believes that the substance in the stoppers actually leached into the blood samples, thereby affecting the results.
With test results that may have underestimated blood lead levels, infants and young children around the country may have been affected, especially given how vulnerable they are when it comes to lead poisoning and the effects it has on cognitive deficits and other systems throughout the body. The tests produced by Magellan were evidently especially popular amongst healthcare professionals because they allowed them to conduct the blood tests more quickly and keep all associated follow-up in-house (as opposed to sending the samples off to a lab). The Magellan test is also the only FDA-approved device for rapid, in-office testing, which means it was used by thousands of pediatricians all over the country, at a minimum.
Outside of potential injury claims against government officials and others arguably responsible for lead poisoning in general, these tests—made by Magellan Diagnostics—may also give rise to product liability claims, as people relied on their test results (in believing their blood lead levels were fine) and therefore, did not obtain the treatment necessary to ensure that they were on their way to recovering from lead poisoning and its many negative effects. In addition, the company in being responsible for inaccurate, false negative tests, arguably interfered with actions that would have protected children from additional exposure.
The FDA has just started its investigation into this situation, but it has already warned health care professionals and labs not to use Magellan Diagnostics lead tests with blood drawn from a vein. Since the agency has issued this warning, any doctors who do not abide by it in practice and cease use of the tests in conjunction with testing blood from veins could be opening themselves up to malpractice claims as well. The agency has also urged that children under the age of six, and women who are pregnant or breastfeeding, who had blood drawn from a vein for a lead test and whose test results were less than 10 micrograms/deciliter, to be retested.
Magellan’s actions surrounding the discovery of this issue are very distributing. Not only did the company take its time in alerting the FDA to the various issues associated with its product, but the FDA found “red flags” in its review of the company’s actions and overall attitude concerning the issue, which has been described as “not a big deal” by the company. Amongst other concerning activities, the company dangerously underestimated the amount of risk to the public.
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