The outpatient procedure was supposed to be routine and uneventful. A simple tonsillectomy performed on a well sedated five-year-old was expected to result in a sore throat for two days, with the reward for good behaviour being all the chocolate ice-cream the child could consume. The surgeon, charge nurse, scrub tech, and certified registered nurse anesthetists were dumbfounded when the acrid odour of singed flesh suddenly emanated from beneath the drape covering the child’s left leg.
A pre-gelled grounding pad had been placed there, intended to distribute the energy evenly from the electrosurgery device which the surgeon was using, first to cut the tissue and then to coagulate the blood flow at that site. A quick assessment by the team revealed that the gel within the pad had hardened and thereby provided a focal point for the electricity that was supposed to have dissipated over a larger area of the child’s thigh.
A 25 cent-sized third-degree burn was discovered, which would eventually require three surgical scar revisions as the child grew into adulthood. Pursuant to hospital protocol, a member of the surgical team met with the parents of the child and—without placing blame—described the facts known to have occurred, referring them to the hospital’s risk manager for future updates and information.
"Remedial measures can be taken, if necessary, without fear that such actions will be construed as an admission of fault in a court of law."
This scenario constitutes a reportable event which then triggers an incident report, pursuant to hospital policies and procedures. The report typically identifies eye-witnesses to the incident and all equipment and medications utilised during the operation. It is intended to be a factual report, without the recording of any conclusions, recommendations, or remedial actions.
The report is not a part of the patient’s hospital chart; rather, it is a document generated for submission to the hospital’s risk manager or quality assurance department. It is at this point that we begin to weigh our concerns about how our investigation into the incident will allow us freely to determine how this unintended complication happened and how to avoid a similar occurrence in the future, without fear that any conclusions and remedial actions will be used against us in the likely event that a lawsuit alleging medical malpractice is filed against the hospital, and/or a products liability claim is brought against the manufacturer of the grounding pad.
Virtually every state government has enacted legislation which recognises the importance of providing protection for individuals who are members of peer review groups that evaluate the quality and efficiency of professional healthcare providers, and in doing so, they have created a vehicle by which a comprehensive investigation may be conducted without concern that the process will be open to discovery by litigants in a court of law.
Within that peer review process there may be a root cause analysis determination, which may lead to possible sanctions against a member of the hospital staff or suggestions for changes to a policy or procedure, as an attempt to reduce the risk of an event occurring again. The conclusions of the peer review committee and the subsequent remedial measures taken are usually not discoverable in a lawsuit, although the names of the persons who testified factually may be required to be given, which, in effect, allows the litigants to reconstruct and discover the facts that were disclosed in the peer review process.
An additional protection for the hospital and healthcare providers is afforded through early consultation with the hospital’s general counsel or other counsel whose services are often paid for by the healthcare provider’s insurer. Any investigation that is directed and supervised by counsel will provide another layer of protection through what most states refer to as actions ‘in anticipation of litigation’. The attorney will meet with the risk manager or quality assurance personnel and provide direction for the investigation, peer review, or root cause analysis.
Counsel’s guidance in these endeavours will give additional protection against the discovery of the content of conversations with staff members through the establishment of this attorney-client relationship. A plaintiff’s counsel would be prohibited from offering evidence of a remedial measure taken to decrease the likelihood that an incident would recur, since a jury would likely consider the measure to be an acknowledgement of fault.
If hospital personnel were fearful that the implementation of a remedial measure would result in a jury viewing the action this way, the measure would likely not be taken. A vast majority of states have also passed legislation similar to that enacted by Congress through Federal Rule of Evidence 407, which is titled Subsequent Remedial Measures. It states that when measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove:
• Culpable conduct;
• A defect in a product or its design; or
• A need for a warning or instruction.
As the reference to a product design or warning in Federal Rule of Evidence 407 would suggest, this same rule would apply to a claim against the manufacturer of the grounding pad, for example, if that company changed its policies in regard to product expiration dates or changed the manufacturing process itself to reduce the likelihood of a recurrence of the problem with the gel hardening. The public interest in having a company or healthcare facility address known problems and seek to improve the quality of their product or services outweighs the interest of the individual litigant in an isolated lawsuit.
Early recognition of the need for legal protections that allow a thorough investigation into the facts of an incident so that remedial measures can be taken, if necessary, without fear that such actions will be construed as an admission of fault in a court of law, would mean that the interests of both the public and the litigants would be protected. Legal counsel in the jurisdiction where an incident occurs is best positioned to afford the advice necessary to implement the legal protections that will allow a safer environment for the delivery of healthcare.
Michael Frick is a partner at Hall Booth Smith, and is writing on behalf of Pendulum. For more information on Pendulum visit: www.wearependulum.com