Patent Issue: Supplier Liability in Medical Implants and Devices: The "Biomaterials Access Assurance Act"

Abstract

As we begin this new millennium, we are confronted with emerging technologies in the field of biomedical engineering that broaden the horizon of medical treatment by implantation. For example, research scientists are currently developing a neural arm prosthesis that will stimulate sensations corresponding to the amounts of pressure that a person would normally feel in their hand when doing various tasks.1 In another example, other inventors have developed a process by which a patient’s own cartilage can be used to create new tissue that can be surgically implanted to replace the damaged tissue.2 Each year millions of people depend on the availability of such life-saving or life-enhancing medical implantation devices. In turn, many of the designers, manufacturers, and sellers of these life-saving or life-enhancing medical implantation devices depend on a continued supply of raw materials and component parts for the development, improvement, and maintenance of these devices. What would happen if the supply of raw materials and component parts used in these medical implantation devices suddenly stopped? The medical device industry has been threatened with just such a possibility. The raw materials and components suppliers were being subjected to huge litigation expenses in defending a vast amount of, and often frivolous, lawsuits from plaintiffs who alleged that the suppliers’ materials harmed them in some way. Such allegations included the inadequate design and testing or inadequate warning of medical implantation devices manufactured with the materials or parts provided by the suppliers. Although it was very rare for a supplier to actually be held liable in these actions, the economic costs involved in defending such lawsuits created a lack of economic incentive for the suppliers to continue to sell their products to medical device companies for implantable purposes. As a result of these lawsuits, the medical industry was faced with the very real possibility that the production of these life-saving or lifeenhancing devices would have to cease. In an effort to address the concerns facing both the medical industry and the raw materials and component parts industry, President Clinton, on August 13, 1998, signed into law a bill entitled the “Biomaterials Access Assurance Act.”3 This law provides for expeditious procedures to dispose of unwarranted lawsuits against the raw materials and component parts suppliers in a manner as to minimize litigation costs. Examples of such expeditious procedures include allowing suppliers to move for motions to dismiss or motions for summary judgments. However, what if there is a situation where the raw materials and component parts supplier is truly at fault? Don’t fret, this law does not automatically dispose of all lawsuits brought by plaintiffs against the supplier, just those that are without merit. Those lawsuits with merit include actions for harm to a claimant caused by an implant if the supplier is also the manufacturer of the implant; actions for harm to a claimant caused by an implant if the supplier is also the seller of the implant; actions