Product liability and perioperative nurses - OR Nursing Law

AORN Journal, Feb, 2004 by Ellen K. Murphy

Perioperative nurses use myriad devices, supplies, and equipment when caring for patients. Many of these items are inherently dangerous and have the potential to injure patients if used improperly. Every perioperative nurse also knows that devices must be used according to manufacturers' instructions and warnings. This column reviews the legal implications for facilities and their employee nurses related to device use and concludes with a discussion of several examples of popular devices that have been misused occasionally.

REVIEW OF PRODUCT LIABILITY

Product liability refers to the liability of a manufacturer, seller, or supplier of a product for injuries caused by a defect in the design or manufacture of that product. This area of the law encompasses three legal theories: strict liability, breach of warranty, and negligence.

Strict liability sometimes is referred to as liability without fault. Unlike negligence, which requires a lack of care or failure to behave or make decisions reasonably, a manufacturer or seller of a product can be sued successfully, even if care was used in a product's design or manufacture. The injured party only needs to prove that the product was defective or that the manufacturer failed to issue adequate warnings about proper use of an inherently dangerous product.

Breach of express or implied warranty is a theory in contract law. Essentially, a manufacturer or seller can be held liable if a product does not perform as promised or as described in its literature and injury results.

Negligence incorporates the same well-known theory that applies to nursing practice. Manufacturers must be reasonable and prudent in the design, manufacture, and distribution of their products. This includes a legal duty to provide safety instructions and warnings. In short, manufacturers and sellers of products have substantial exposure for injuries sustained during use of their products.

Product liability theories do not apply to users of a product unless they also are sellers. Facilities and nurses usually are considered users and not sellers or suppliers of products; however, facilities and nurses can assume a manufacturer's liability exposure if they modify a product, engage in off-label use, or otherwise fail to follow manufacturers' instructions or warnings. Facilities and nurses are advised to avoid unnecessarily assuming product liability exposure because the liability can be substantial.

PROVISION OF A PRODUCT OR SERVICE

During the past 30 years, numerous cases have examined whether a hospital or clinic is a seller of products used and charged for during procedures or whether these products merely are a part of the hospital's provision of a service. The difference is critical. If a hospital or clinic were deemed a seller of a product, it would have product liability exposure under the strict liability, breach of warranty, and negligence theories. Strict liability and breach of warranty theories, however, do not apply to the provision of services. The general trend has been to conclude that hospitals and clinics do not sell products, even when the products used are billed at a marked up price. Instead, products used are considered incidental to a hospital's primary business or service, and neither strict liability nor breach of warranty applies.

Courts and legislatures have been reluctant to apply breach of warranty or strict liability to hospitals providing blood or blood products, implants, clips, or staples, even when the hospitals charged separately for those supplies and, thus arguably, could have been considered sellers. When an Illinois court did find that a blood transfusion was a product and not a service and allowed a strict liability claim (Cunningham v MacNeal Memorial Hospital, 47 Ill 2d 443 266 NE2 897 [1970]), the state legislature enacted a statute to clarify that no breach of warranty on strict liability claims could be brought for blood products or other transplanted tissue.

Courts examine medical records, billing records, and the patient's purpose in seeking treatment when deciding if providing an implant constitutes providing a product or a service. Typically, they conclude that patients come to facilities seeking services and not to buy products. For example, a patient sought care to treat her incontinence, she did not come to buy a sling (Brandt v Boston Scientific, 204 Ill 2d 640, 792 NE2d 296 [2003]), or a patient sought to have a spinal problem corrected and not to purchase a cervical plate (McCombs v Southern Regional Medical Center, 233 GA App 676. 504 SE2d 747 [1998]). In these cases, the courts concluded that the patient came to the facility seeking a service, and the facility provided a service, even when products were implanted and billed for.

IMPLICATIONS FOR PERIOPERATIVE NURSES

There is nothing a perioperative nurse can do proactively to make it more likely that a court will treat a particular procedure more like a service than selling a product and thereby prevent the patient from suing trader strict liability or breach of warranty claims. There are major implications for perioperative nurses under negligence theory, however. During the same time period when courts were deciding blood and implants were part of services provided rather than the sale of products, they were consistent in determining that negligent use of a product by a health care facility or its staff members can and does result in liability for the user (eg, Monk v Doctor's Hospital, 403 F2d 580 [DC Cir 1968]).