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

Dr. Fink is professor ofpharmacy law and policy atthe University of KentuckyCollege of Pharmacy,Lexington.

Issue of the Case

A civil lawsuit was filed alleging personalinjuries and wrongful death resultingfrom negligent treatment and careof a patient in a nursing home in a Southernstate. The defendants had movedfor summary judgment based on anargument that the plaintiffs had notestablished a sufficient case for thematter to go to a jury. The plaintiffs hadbased much, if not all, of their case onthe argument that the nursing homehad a legal duty of care based on guidelinesapplicable to such institutions instate regulations. May such regulationsbe introduced at trial to establish thelegal standard of care?

Facts of the Case

The basic claim was that the deceasedpatient was a victim of a patternand practice of neglect while in theextended-care facility. The patient hadsuffered a litany of injuries while in thecare of the nursing home—pneumonia,falls, unexplained injuries, bone fractures,urinary and kidney infections,weight loss, pressure sores, poor hygiene,sepsis, and, ultimately, death. Atthe trial court level, it was alleged thatthe owner and administrator of thefacility had breached the duty of reasonablecare by failing to provide adequatestaffing and supervision of staff, hadfailed to develop and implement anappropriate residential care plan, hadfailed to maintain adequate records,and had otherwise been negligent in theoperation of the nursing home.

The Court's Ruling

The motion for a summary judgmentby the defendant operators of the facilityhad been granted at the trial courtlevel, dismissing the claim even before atrial was held. The plaintiffs appealed tothe state court of appeals, claiming thatthe trial court judge's decision was erroneous.The appellate court agreed withthe trial court judge, and the dismissalof the case was affirmed. Upon furtherappeal to the state supreme court, theruling at the 2 lower levels was affirmedas well.

The Court's Reasoning

The legal rule applicable to such situationsin that state was that alleged violationsof regulations do not alone supporta civil lawsuit for negligence. Thefact that the regulations had been violatedmay serve as evidence of negligenceto be weighed by the jury, butthat breach does not in and of itself dictatethat negligence occurred.

It should be emphasized that thefocus in this case was on regulationsadopted by an administrative or regulatoryagency. Pharmacy has no shortageof those at both the state and federallevels—boards of pharmacy, state controlled-substances offices, the FDA, theUS Drug Enforcement Administration,the US Consumer Product Safety Commission,and other agencies.

The rule in this case should be contrastedwith a doctrine in the law knownas negligence per se. Under this rule, if4 conditions exist, a statute may beintroduced at trial to, on its own, establishthe legal duty expected of the pharmacist.These 4 elements are requiredfor negligence per se:

• The standard of behavior mustbe stated in a statute from thelegislature—not a regulation froman administrative or regulatoryagency.
• The statute must impose an affirmativeduty on the defendant (ie,something that must be done toconform to the statute).
• The statute must be designed toprotect an identifiable group ofindividuals.
• That protection in (3) must be froman identifiable harm.

Perhaps this would best be illustratedby applying those criteria to somethingcommunity pharmacists deal with everyday—the use of child-resistant closureson containers bearing oral dosageforms.

• The mandates for the pharmacist'sbehavior come from the PoisonPrevention Packaging Act of 1970,a statute.
• This legislation mandates that suchclosures be used unless the patientor prescriber requests otherwise.
• The statute is designed to protectchildren under the age of 5...
• ...from gaining access to oraldosage forms that could harmthem when consumed withoutadult supervision.

If negligence per se exists, the burdenof proof for the plaintiff will begreatly reduced, and the defendant willhave greater difficulty mounting a successfuldefense. Think of all thestatutes that apply to pharmacists intheir professional activities on a dailybasis. Add to that the myriad of regulationsfrom the smorgasbord of administrativeand regulatory agencies thatapply to the decisions and acts of pharmacists.For this reason, along withmany others, it is important for pharmaciststo be thoroughly familiar withthe expectations for them set forth inthe law.