Medical-legal issue: healthcare provider liability related to defective implants

Orthopaedic surgeons must be aware of the legal liabilities that can arise when the implants they use to help patients turn out to be defective and are recalled by the manufacturer. Product liability laws have evolved over the past 100 years; from almost never holding the manufacturer liable, they now favor a strict liability standard to discourage the manufacture and sale of a defective product. The legal doctrines of strict liability and breach of warranty now govern most cases of a defective product. The party faced with a product liability lawsuit has two kinds of legal defenses; those that avoid liability, and those that decrease the extent of liability. In general, hospitals and physicians have not been held liable when a defective medical device is implanted in a patient; the rationale being that such parties are not engaged in the sale or distribution of the product. However, it is uncertain how courts will interpret the activities of surgeons who have close consulting ties to industry and who vigorously promote a medical device that subsequently turns out to be a defective product. In this article, we examine the legal principles governing product liability laws, and the relevant risk management principles that orthopaedic surgeons should be mindful of while using implants.