False Claims Prompt Recall of Magnetic Resonance DeviceOct 6, 2008 | Parker Waichman LLP
A magnetic resonance device made by Nebion, LLC of California is subject to a Class I recall. According to the Food & Drug Administration (FDA), the Nebion HLX-8 Magnetic Resonance Device was not approved by the agency, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.
The Nebion HLX-8 Magnetic Resonance Device affected by this recall was manufactured between December 25, 2006 through June 11, 2008, and distributed from June 1, 2007 through June 11, 2008. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
According to the FDA, the labeling of the Nebion HLX-8 Magnetic Resonance Device made claims that the device could treat a variety of ailments, including cancer (pancreatic, lung, bone and breast), migraines, rheumatoid arthritis and premenstrual syndrome. The FDA said Nebion has not provided any evidence to back its claims.
In June, Nebion called each customer who purchased the device. Customers were also mailed a recall letter with a response form, and were requested to either mail or FAX it back to the company. The company said it would pick up the device at its own expense. Customers were also instructed to stop using the Nebion HLX-8 Magnetic Resonance Device immediately.
Unapproved medical devices that make false claims similar to the Nebion HLX-8 Magnetic Resonance Device are not rare. In February, at a hearing of the House Energy and Commerce subcommittee, FDA Commissioner Andrew von Eschenbach said that the agency is taking steps to stop manufacturers who import fraudulent, and often, dangerous medical devices into the United States. The hearing was prompted by a 2007 Seattle Times series entitled, “Miracle Machines,” which revealed how manufacturers and operators use unproven devices—some illegal and some, often, dangerous—to misdiagnose diseases, divert critically ill patients from legitimate care, and divest people of their savings.