Quest Diagnostics Settles DOJ Charges Over Faulty TestsApr 16, 2009 | Parker Waichman LLP In January, we wrote that Quest Diagnostics, Inc. likely released wrong information on vitamin D test results. Those inaccurate results could have affected thousands of patients over the past two years according to a prior Reuters report. Now, the country’s largest diagnostic testing provider and its Nichols Institute Diagnostics (NID) unit have agreed to pay $302 million to resolve criminal and civil allegations, reported the Wall Street Journal.
The Journal, citing prosecutors, said that the allegations concern an array of faulty diagnostic test kits manufactured and sold until 2006. The arrangement involves Quest and the NID paying $262 million, plus interest, to resolve the federal False Claims Act allegations associated with the NID-manufactured diagnostic tests that are claimed to have given inaccurate and unreliable results, according to prosecutors, said the Journal.
A statement by the U.S. Attorney's Office in Brooklyn said that NID also pleaded guilty to felony misbranding linked to a test used by labs to measure parathyroid hormone levels, reported the Journal. NID agreed to pay a $40 million fine in that case. Also, Quest entered into a nonprosecution agreement, agreeing to cooperate with the government, reported the Journal.
The Journal said that the investigation into Quest originated out of a whistleblower lawsuit; the whistleblower received about $45 million of the recovery, one of the largest recoveries in a case involving a medical device, said prosecutors.
Meanwhile, in January, Newsday quoted Gary Samuels, a Quest spokesman as saying that problems in “a few of our laboratories” led to the testing errors that occurred on tests conducted from 2007 through the middle of 2008. It seems, said Samuels, that the majority of the mistakes involved exaggerating vitamin D levels in patients, according to Newsday, which explained that an error of this kind could result in patients not taking necessary vitamin D supplements. The elderly; the obese; exclusively breastfed babies; those who have limited sun exposure; people with fat malabsorption syndromes, such as cystic fibrosis; or those suffering from inflammatory bowel disease are at greatest risk for vitamin D deficiency.
Vitamin D maintains normal calcium and phosphorus blood levels; aids in the absorption of calcium, which helps develop and maintain strong bones; and protects against osteoporosis, high blood pressure, cancer, and some autoimmune diseases, explains the Mayo Clinic. Vitamin D deficiency could lead to rickets in children, which can cause skeletal deformities; in adults, vitamin D deficiency can cause osteomalacia, which results in muscular weakness and weak bones, says the Mayo Clinic.
Last June, doctors began calling the lab and questioning test results, said USA Today in a prior report; it was at that time that Quest opened its investigation of the problem. Newsday also reported that the editor of Dark Report, Robert Michel, the paper that broke that story, said, “The question most lab professionals would ask is why would it take 18 months to recognize the problems and begin to offer retests.” Michel pointed out that the Quest lab test recall is the largest such recall of its kind that he is aware of since he entered the field nearly 20 years ago.