BROOKLYN (CN) – A Quest Diagnostics subsidiary sold defective hormone tests that produced incorrectly elevated results, leading to thousands of unnecessary surgeries, a RICO class action claims in Federal Court. The class claims the inaccurate tests caused hundreds of millions of dollars in damages, including the price of tests, drugs to treat the “elevated hormones” and unnecessary surgeries for critically ill patients.
Delaware-based Quest bought Nichols Institute Diagnostics in the mid-1990s after the company created an automated test to measure parathyroid hormone levels in human blood or urine samples, according to the complaint.
Parathyroid hormone (PTH) regulates calcium levels and bone cells; parathyroid gland failure is a common complication of severe kidney disease. Doctors must monitor hormone levels to ensure that patients continue to experience burn turnover and a regulated metabolism.
Insufficient levels of vitamin D can cause bone pain, while too much calcium can cause nausea, vomiting, kidney stones and other side effects.
“If PTH levels are thought to be higher than they actually are, doctors will mistakenly prescribe too much of vitamin D drugs, which can lead to a painful calcification of blood vessels and other soft tissue, a condition arising from a dynamic low bone turnover disease that can be deadly,” according to the complaint.
“When patients thought to have high PTH levels do not respond to vitamin D drugs, they often will undergo surgery to remove their parathyroid glands.”
By 1999 approximately 90 percent of PTH tests performed on end-stage renal disease patients used the Nichols automated kits, the complaint states.
Nichols, a California company, claimed that the automated tests produced accurate and reliable results that were no different from an earlier test, which was more complicated and took 18 hours to perform, according to the complaint.
The class claims that between May 2000 and April 2006, many of the automated kits incorrectly found elevated levels of the hormone, which led to hundreds of millions of dollars in overtreatment and unnecessary surgeries.
The class claims that a competitor uncovered the trend toward “substantially higher” results in 2001, but Nichols and Quest misled the medical community by promoting the kits while concealing their defects. The defendants also introduced more tests that relied on the same system and produced elevated results, according to the complaint.
Another lab sued Quest and Nichols in 2004, spurring federal investigations. Nichols recalled all of its products in 2005 and shut down within the year, the complaint states, and Quest and Nichols paid $302 million to settle criminal and civil charges in April 2009.
The class seeks treble damages and reimbursement for the cost of buying defective kits and prescribing unnecessary treatments. It alleges fraud, RICO violations, deceptive business practices, breach of warranty and misrepresentation.
Lead plaintiff is the Teamsters Local 456. Its lead counsel is Michael London with Douglas & London of Manhattan.