Pharmacy Law: May Regulations Be Used to Support a Negligence Claim?

APRIL 01, 2008
Joseph L. Fink III, BSPharm, JD

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

A civil lawsuit was filed alleging personal injuries and wrongful death resulting from negligent treatment and care of a patient in a nursing home in a Southern state. The defendants had moved for summary judgment based on an argument that the plaintiffs had not established a sufficient case for the matter to go to a jury. The plaintiffs had based much, if not all, of their case on the argument that the nursing home had a legal duty of care based on guidelines applicable to such institutions in state regulations. May such regulations be introduced at trial to establish the legal standard of care?

Facts of the Case

The basic claim was that the deceased patient was a victim of a pattern and practice of neglect while in the extended-care facility. The patient had suffered a litany of injuries while in the care of the nursing home—pneumonia, falls, unexplained injuries, bone fractures, urinary and kidney infections, weight loss, pressure sores, poor hygiene, sepsis, and, ultimately, death. At the trial court level, it was alleged that the owner and administrator of the facility had breached the duty of reasonable care by failing to provide adequate staffing and supervision of staff, had failed to develop and implement an appropriate residential care plan, had failed to maintain adequate records, and had otherwise been negligent in the operation of the nursing home.

The Court's Ruling

The motion for a summary judgment by the defendant operators of the facility had been granted at the trial court level, dismissing the claim even before a trial was held. The plaintiffs appealed to the state court of appeals, claiming that the trial court judge's decision was erroneous. The appellate court agreed with the trial court judge, and the dismissal of the case was affirmed. Upon further appeal to the state supreme court, the ruling at the 2 lower levels was affirmed as well.

The Court's Reasoning

The legal rule applicable to such situations in that state was that alleged violations of regulations do not alone support a civil lawsuit for negligence. The fact that the regulations had been violated may serve as evidence of negligence to be weighed by the jury, but that breach does not in and of itself dictate that negligence occurred.

It should be emphasized that the focus in this case was on regulations adopted by an administrative or regulatory agency. Pharmacy has no shortage of those at both the state and federal levels—boards of pharmacy, state controlled- substances offices, the FDA, the US Drug Enforcement Administration, the US Consumer Product Safety Commission, and other agencies.

The rule in this case should be contrasted with a doctrine in the law known as negligence per se. Under this rule, if 4 conditions exist, a statute may be introduced at trial to, on its own, establish the legal duty expected of the pharmacist. These 4 elements are required for negligence per se:

  1. The standard of behavior must be stated in a statute from the legislature—not a regulation from an administrative or regulatory agency.
  2. The statute must impose an affirmative duty on the defendant (ie, something that must be done to conform to the statute).
  3. The statute must be designed to protect an identifiable group of individuals.
  4. That protection in (3) must be from an identifiable harm.

Perhaps this would best be illustrated by applying those criteria to something community pharmacists deal with every day—the use of child-resistant closures on containers bearing oral dosage forms.

  1. The mandates for the pharmacist's behavior come from the Poison Prevention Packaging Act of 1970, a statute.
  2. This legislation mandates that such closures be used unless the patient or prescriber requests otherwise.
  3. The statute is designed to protect children under the age of 5...
  4. ...from gaining access to oral dosage forms that could harm them when consumed without adult supervision.

If negligence per se exists, the burden of proof for the plaintiff will be greatly reduced, and the defendant will have greater difficulty mounting a successful defense. Think of all the statutes that apply to pharmacists in their professional activities on a daily basis. Add to that the myriad of regulations from the smorgasbord of administrative and regulatory agencies that apply to the decisions and acts of pharmacists. For this reason, along with many others, it is important for pharmacists to be thoroughly familiar with the expectations for them set forth in the law.