Medicolegal Risks and Outcomes of Sedation

Abstract

Most children who receive sedation outside the operating room have good outcomes and benefit from efforts to reduce pain and anxiety during a procedure. However, administration of sedative and analgesic agents to children in the outpatient setting always carries some risk to the patient. If a child has an adverse outcome after sedation, and there is evidence of substandard care then there is the potential for a professional liability (“malpractice”) claim against the providers and/or the facility. It is difficult to track with any reliability the actual results of all such claims throughout the USA, in part because there is no uniform national system to report jury verdicts and judgments in state courts that are not appealed. Further, if a malpractice case is settled prior to a jury verdict, the details of those settlements are often kept confidential by the agreement of parties, typically at the request of the medical providers or their insurance carriers. A review of publicly available reports has identified several pediatric sedation claims of alleged negligence. In each of these malpractice cases, the allegations were that the care provided by the professionals (and/or institution) was below an established standard of care, that there was a breach of that standard and that the breach caused injury to the patient. Standard of care is defined as that care which a reasonable physician in a particular specialty would have given to a similar patient, under similar circumstances. Because most clinicians have similar access to information and knowledge, they are usually held to a national standard of care regardless of how remotely the individual may practice.

Glossary

The following are general lay definitions of terms common to the practice of criminal and civil law. Some of the precise definitions vary from state to state according to that state’s laws and practice.

Breach 

The violation of an obligation, engagement, or duty.

Certificate of merit 

A certificate filed in a medical malpractice action. Under court rules, it is filed by the plaintiff’s attorney with the complaint (the document that begins the lawsuit and contains the plaintiff’s allegations). In a certificate of merit, the plaintiff’s attorney certifies that he/she has reviewed the facts of the case, and has consulted with a medical expert and concluded that the plaintiff’s action has merits.

Civil lawsuit 

A legal case brought on behalf of an individual (plaintiff) against another individual or entity (defendant) who acted negligently (below some standard of care) and thereby caused them harm. This case is brought for a monetary recovery for damages sustained by the plaintiff. The plaintiff’s burden of proof in a civil lawsuit is typically by a preponderance of the evidence, a lesser burden of proof than in a criminal prosecution ¹². A successful civil lawsuit usually results in the payment of money for the losses sustained by the plaintiff.

Criminal Negligence 

Acting in a grossly negligent manner. Typically this involves the conscious disregard of a known risk of death or serious injury.

Defense 

Those responsible for representing a defendant in a criminal case or a civil lawsuit ¹³. The defense does not have the burden of proving innocence or lack of fault.

Homicide 

The unlawful taking of another’s life. Homicide ranges from first degree murder, the taking of a life with specific intent to kill and with malice, to involuntary manslaughter ¹⁴, an accidental killing where the defendant acts unintentionally and without malice but with criminal negligence ¹⁵.

Indemnity 

A contractual insurance agreement whereby the insurer agrees to pay for the insured’s loss or claims arising from some contemplated act, such as professional negligence.

Informed consent 

The consent given by a patient to a doctor that allows the doctor to perform a certain procedure or render particular treatment. The consent is “informed” because the doctor has explained the specifics of the procedure or treatment to the patient, including the risks and alternatives, who has then made a knowing, informed decision about whether they want to proceed.

Involuntary manslaughter 

The unlawful taking of another’s life without intent to kill or to harm and without malice, but the act is committed with criminal negligence.

Jury verdict 

The definitive answer(s) given by the Jury to the court concerning the issues or questions of fact committed to the jury for their deliberation and determination. Depending on the jurisdiction, verdicts in civil lawsuits may not require unanimity.

Malpractice 

Professional negligence. This is an act of negligence committed by a professional such as a doctor, a lawyer, an engineer, etc., while acting within their profession. The negligent conduct is measured by the standard of care in that profession and in that specialty in which the professional practices. A doctor who commits malpractice is said to have breached the standard of care in their area of specialty.

Negligence 

Failing to act in a reasonably prudent manner.

Prosecution 

Charging an individual (defendant) with a violation of criminal law, marshaling the evidence against that individual, presenting the evidence to a court or jury and, if a conviction is obtained, proceeding to sentencing against the individual. The prosecutor represents the people of the state where the crime occurred and technically not the victim of the crime, although the prosecutor often speaks on behalf of the victim. The prosecutor bears the burden of proving guilt beyond a reasonable doubt. If a conviction is obtained, the defendant faces incarceration.

Standard of care 

The standard according to which negligence in a particular situation is determined. The care that an ordinary prudent person would exercise under similar circumstances.