Civil Liability

In most states, a basic case of liability can be made by showing that the regu­lations were violated and that the regulations were in place to protect the safety of the public. In some cases, the law explicitly creates a new statutory cause of action for liability.

The rules that apply to regulatory violations and their effect on liability vary from state to state. In some states, when that standard is violated and harm results, “normal” medical malpractice may be established without resort to experts to establish the standard of care. One such approach is called negligence per se. A violation of the law or regulations is proof of fail­ing to meet the appropriate standard of care. In a negligence per se claim, the plaintiff has to show that a law intended to prevent the type of injury that occurred was violated. A negligence per se claim may be made even if the defendant has not been convicted or administratively sanctioned under the law in question. In such cases, the plaintiff must prove that the defendant violated the law. Other states use a prima facie rule. In prima facie cases, it is presumed that the evidence is sufficient to establish the fact in question unless rebutted. The burden shifts to the defendant to prove that the viola­tion of the regulation was not negligence. In either case, however, there must be resulting harm to the patient for liability to exist.

Not every violation of the regulations, however, would result in liabil­ity. If vehicle maintenance regulations were violated, for example, it would not be grounds for a medical malpractice claim, but it might be grounds for liability for patient injuries incurred in a crash that resulted from improper maintenance. On the other hand, a violation that involved failure to restock mandated equipment and the lack of equipment made it impossible to prop­erly care for the patient would likely support a malpractice claim by a patient who was harmed by the lack of equipment. In the absence of explicit intent of the legislature or agency to create a safety standard or prior court rulings on the issue, it is up to the injured party to prove to a judge that the regula­tion is a safety standard that should be applied to create liability.