Can federal regulations on hospital-acquired conditions create liability?

Plaintiff’s attorneys are substituting regulations for standard of care.

Standard of care is a concept used in determining whether an individual was negligent and potentially liable for an injury. Although the standard of care may vary in specificity, it often revolves around the concept of what a reasonable individual would have done under similar circumstances. If an individual breaches the standard that applies and their actions cause harm to another individual, they will be liable for negligence.

This concept is carried over to the medical field. However, medical professionals are not asked to meet the standard of a reasonable individual; instead, the medical standard of care refers to the type of care that a reasonably skilled and competent medical provider would have provided to a patient under the same treatment circumstances. These standards are set by medical professionals and are based on scientific evidence. When medical professionals breach the applicable standard and their actions cause harm to a patient, they may be liable for medical malpractice.

How federal regulations could affect the standard of care

The establishment of a set standard of care is a topic of great debate in the medical community. As technology and medical science evolves, so do the standards to which physicians are held. One recognized standard may suggest that a doctor do X, whereas another may state they should do Y. As you can imagine, a plaintiff’s lawyer will always argue for the standard that imposes liability on the doctor. However, in recent years, a new technique has emerged: substituting federal regulations or guidelines for the standard of care. The most common way this is done is by citing federal regulations regarding never events and hospital-acquired conditions.

The meanings of never event and hospital-acquired conditions are derived from federal sources. Hospital-acquired conditions are the subject of federal law enacted in October 2008, which, in order to provide an incentive for hospitals to reduce hospital-acquired conditions, provides for a reduction in the amount of governmental medical benefits payable for inpatient hospital services related to such conditions. The term never event comes from proposed guidelines issued by the Centers for Medicare & Medicaid Services regarding the payment of benefits. However, the “never event” language was eventually omitted from the rule and the term is no longer used for purposes of Medicare and Medicaid payment policies.

This issue was considered by an Ohio court in a case involving a patient who underwent surgery for recurrence of renal cell carcinoma. The patient remained at the hospital in the days following the surgery and he developed at least 1 pressure ulcer in the area of his buttocks and coccyx. The patient alleged that, as a result of malpractice, he required additional treatment for years after the surgery. The patient alleged that the development and delayed healing of his ulcers was attributable at least in part to a sponge that was left inside his body and caused a chronic infection. In his complaint against the hospital and urologist, the patient alleged that the occurrence of a never event and/or hospital-acquired condition constituted proof that the standard of care was breached.

In this case, the Ohio court ultimately held that nothing in the statutes or the regulations suggests an intent to establish a new standard of care applicable to private lawsuits. Generally, the occurrence of a never event or a hospital-acquired condition standing alone should not satisfy a medical negligence plaintiff's obligation to demonstrate the applicable standard of care or a breach of that standard.

However, it is worth noting that this a rapidly developing area of the law. Regulatory rules are often used as evidence in other areas of law. As such, it is reasonable to anticipate more and more plaintiffs’ lawyers in the years to come will attempt this bait-and-switch to persuade a jury that since a federal regulation was violated, the hospital/physicians must have breached the standard of care.