Federal Preemption of Class III Medical Devices receiving premarket approval
Case in Review
Court rulings have held that the preemption clause included in the Medical devices act of 1976 protects class III medical devices which have been approved through the Food and Drug Administration’s (FDA) premarket approval process (PMA) from litigation. Injured parties have no means to seek relief from device manufacturers for injuries sustained due to the use of a class III medical device receiving PMA.
Overview of the FDA and Medical devices act of 1976:
Congress created the Food and Drug Administration in 1938 under a statute known as the Federal Food, Drug and Cosmetic Act. Under the 1938 act, the FDA could not prevent medical devices from entering the market but they could remove unsafe devices from the marketplace. The FDA believed that those same powers given to regulation of drugs should be extended to medical devices to ensure public safety. The Medical devices act of 1976 granted oversight and approval of medical devices to the FDA as a logical extension of duties already provided under previous legislation.
The act provided for three classes of medical devices, levels I, II and III. Devices classified under level III were given the most rigorous level of testing and review due to the fact that these devices could produce the greatest level of harm. Level III devices are the only class of devices that are subject to premarket approval which requires manufacturers to submit information related to the safety and effectiveness of their devices for FDA review and approval.
The Medical devices act of 1976 included a preemption clause over state law to ensure the federal statutes held supremacy over any state statutes or requirements. Section 360k of the MDA contains this specific preemption provision: “[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement Â– (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”
Consumer: Consumers using these medical devices are at best in ill health at the time of receipt of a class III medical device and realistically near death. Due to the severity of their illness, their focus is on survival not on what medical device will be used. These consumers must rely upon their doctors, hospitals, their insurance company (if any), the FDA and medical device manufacturers to provide a safe and proven device to improve and extend their quality of life. By the nature of this relationship, these parties are in a fiduciary position to the patients and their families.
Consumers receiving a device that has undergone the premarket approval process are assured that the product has...