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Article Excerpt
A retrospective review of the cases brought by the Massachusetts U.S. Attorney's Office Health Care Fraud Unit between September 2008 and September 2009 reveals a high number of cases involving medical devices as compared to drugs or other medical products. Medical devices include a wide range of products, such as implants, stents, heart pacemakers, fetal monitors, x-ray equipment, and thermometers. They are used in patients for the purposes of diagnosis, therapy or surgery. By definition, medical devices do not achieve their primary intended purposes through "chemical action" and are not "dependent upon being mobilized" to achieve their primary intended purposes. Medical devices often require approval by the Food & Drug Administration ("FDA") before they may be legally distributed and marketed.
The gamut of products that may be considered medical devices are reflected in the cases brought by the Health Care Fraud Unit over this past year.
Bioelectrical Impedance Analysis ("BIA") Software Cases With the announcement of the sentencing of RJL Sciences, Inc. and its President, Rudolph J. Liedtke, on September 24, 2008, and the guilty plea and sentencing of Norma Muurahainen on October 30, 2008, the Health Care Fraud Unit in the District of Massachusetts appears to have concluded its prosecutions relating to the distribution of software used with Bioelectrical Impedance Analysis ("BIA") devices for the calculation of body cell mass and diagnosis of AIDS wasting. These...
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