Product liability and perioperative nurses - OR Nursing Law

AORN Journal,  Feb, 2004  by Ellen K. Murphy

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Not only can the negligence of perioperative personnel result in liability for the facility, it also can relieve the manufacturer of liability. The author of a major textbook for health care administrators says, "The manufacturer of a product is not liable for injuries suffered by a patient if they are the result of negligence by the user." (1(p61))

Users of medical devices (eg, facilities, nurses, surgeons) can be and have been held liable to patients for injuries caused by medical devices and implants if the user does not or did not follow the manufacturer's instructions and warnings. Manufacturers have a duty to provide instructions and warnings, and failure to do so cam result in liability on the manufacturer's part. Users have a duty to follow those instructions and warnings, and failure to do so can result in liability on the user's part.

For example, a Texas appellate court reviewed the applicability of strict product liability, implied and express warranties, and negligence theories against a hospital in Cobb v Dallas Fort Worth Medical Center--Grand Prairie (48 SW3d 820 [Tex App 2002]). The plaintiff sued the hospital on each of these theories after pediatric pedicular screws were inserted during her surgery instead of screws appropriate to her weight and size. The patient also alleged the hardware used was not approved by the US Food and Drug Administration (FDA).

The Texas appellate court allowed the case to proceed under a negligence theory, but it concluded that the allegedly defective pedicular hardware and screws implanted in the plaintiff's back were inseparable from the services rendered by the hospital, and the plaintiff could not proceed on strict liability or breach and express warranty because under Texas law these were not applicable.

   To be held strictly liable,
   the law requires that one
   must sell a product in a
   defective condition and
   must be engaged in the
   business of selling such a
   product.... Generally,
   hospitals are not engaged
   in the business of selling
   the products or equipment
   used in the course of providing
   medical services....
   The products used are ...
   inseparably connected with
   the provision of medical
   services (Id at 826).

Even though the products may have been the wrong size and not FDA approved, the hospital could not be held liable under strict liability or breach of warranty claims. The court also concluded, however, that the hospital could be held liable under negligence theory. The affidavits of an expert witness and the manufacturer's representative and the deposition testimony of the surgical technologist supported a conclusion that the hospital had a duty to provide a complete set of orthopedic hardware that contained screws of different sizes, including the correct size for the patient. The surgical technologist's deposition and the surgeon's deposition showed that only part of the complete set was available during the plaintiff's surgery, and the screws provided were the incorrect size.