Medical Product Analysis & Liability

The biomedical device and implant industry represents a complex and challenging environment for most attorneys.  Engineers and physicians are actively involved in the design, development and manufacture of materials and devices intended for a variety of life-sustaining applications and the science and technology involved is often cutting edge.

Because the functions of such devices and implants can have varying levels of impact on the well being of patients, the medical product liability is assessed in the analysis. The FDA has three levels of classification for regulatory purposes; Class I, Class II and Class III.  The increasing levels of regulation from Classes I through III represent, in effect, a quality control program to ensure that new devices undergo adequate and, if required, extensive testing and trials to establish their efficacy prior to formal release into the market place.  Understandably, the development cycle for a medical product can be quite complex, especially for medical products classified as either Class II or Class III.

When a case is brought alleging that a medical product was defective either by design or manufacture, it is absolutely critical to assemble a team of experts who understand the medical condition the device was intended to improve and the role of the device.  Furthermore, in some cases, the experts must possess a thorough understanding of medical product design and manufacture, as well as, material analysis.

AMFS can provide medical experts capable of analyzing these issues and providing counsel with the information necessary to properly analyze and, if appropriate, litigate their case.