A “Medical Device” is defined by the FDA as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals,
- and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
This broad definition means that medical devices can include items ranging from pacemakers to tongue depressors. Medical devices are regulated by the FDA and grouped into three different classes. Class I devices are subject to the fewest regulations because they pose the lowest risk to patients. Class III devices, on the other hand, are subject to the strictest regulations because they pose the highest risk of harm.
Manufacturers of medical devices can defraud the federal government in a number of ways. For instance, medical device manufacturers may pay kickbacks to doctors to induce them to prescribe their products, or they may market their products for uses that have not been approved. Further, manufactures of medical devices may fail to use current good manufacturing practices in making their products. These and other activities by manufacturers of medical devices can form the basis for claims under the False Claims Act.
Real World Examples of Recent Medical Device False Claims Act Cases:
- 2012: Orthofix agreed to pay the government over $34 million to resolve allegations that the company engaged in a number of schemes to defraud the government, including waiving patient co-payments thereby causing the government to overpay, giving kickbacks to physicians to induce them to use the company's devices, and failing to advise patients of their right to rent devices rather than purchase them. The whistleblower received over $9 million as a result of the settlement.
- 2011: Medtronic paid over $23 million to settle two False Claims Act lawsuits alleging that the company improperly used fees in post-market studies and device registries as a means of providing kickbacks to doctors to induce them to implant the company's pacemakers and defibrillators. The two whistleblowers shared in an award of nearly $4 million.