2.7 The Courts and Pharmacy Professionals
When a legal problem arises involving a pharmacy practice, the courts often become involved. The courts are separated between those established to resolve issues between the government and offending parties—criminal law cases—and those between citizens—civil law cases. In both criminal and civil courts, the party (person or group) filing the case is called the plaintiff, and the entity (person or group) being sued, or whom the case is against, is called the defendant.
Practice Tip
You can find access to many different state pharmacy boards by clicking on the map at https://PharmPractice7e.ParadigmEducation.com/PPMI assessment. You can also visit the websites of each state pharmacy board.
The plaintiff is responsible for providing sufficient evidence to prove their case, which is referred to as burden of proof. The standard, or level, of proof must eliminate reasonable doubt, which is a doubt about the guilt of a defendant that arises or remains after thorough consideration of the evidence or lack thereof. This means that the prosecutor or plaintiff must provide enough evidence that the party committed the offending act to convince a jury “beyond any reasonable doubt”. In civil cases, the burden of proof is not as high; it is that a “preponderance of evidence” points to a decision, or an accumulation of facts favors one side enough to decide upon the case.
The type of punishment in both kinds of court cases is dependent upon many factors, including the severity of the violation, the effects, and the type of case it is: criminal or civil. In the criminal case, the defendant might face monetary fines, probation, loss of professional license or ability to practice, or prison. The civil case might result in monetary awards to the plaintiff.
Criminal Violation of Pharmacy Laws and Regulations
When pharmacy violations occur under any level of law—federal, state, or local—a government prosecutor or public representative often brings a case against the suspected party. Such a case is filed using phrases like State v. Jessica Smith, PharmD. Examples of violations include providing controlled substances to people without prescriptions or for nonprescription purposes or substituting the wrong drug. It is the prosecutor’s duty to see that society is protected from practitioners who violate the law. For instance, in 2002, when a Missouri pharmacist was convicted of tampering, adulterating, and misbranding cancer chemotherapy drugs, he was convicted of 20 felony counts and sentenced to 17–30 years in jail without parole. In addition, 307 civil lawsuits were filed against him, including 100 wrongful death suits.
Before court, the state board of pharmacy reviews pharmacy cases, and lesser cases are generally settled out of court. The board applies varying levels of consequences based on the offenses (see Table 2.3 for examples). It determines whether the defendant’s license should be revoked, suspended (with voluntary surrender of license for the time period), not reissued, or the person be put on probation.
If evidence of alcohol or drug abuse is proven, the state board may require successful completion of a drug rehabilitation program or some other actions before the license can be reinstated, with random drug screening afterwards (see Table 2.3 for examples). As demonstrated in the Missouri case, if the severity of the offense and/or victim outcome merits it, the state board can ask for a criminal investigation, which can lead to indictment (formal criminal charge) and a trial, with criminal penalties of fines, probation, and/or jail time. Incarceration is rarely the punishment unless the acts in question were particularly deliberate and egregious, had an extreme outcome, or were clearly negligent (even an accident).
Table 2.3 Samples of California State Disciplinary Actions
Offense |
Action |
|---|---|
Personal misuse of drugs or alcohol; improper possession of controlled substances for sale; criminal offense with controlled substances; fraudulent acts, etc. |
Revocation of license, along with such options as a requirement for drug rehabilitation or mental health counseling prior to reinstatement Minimum 90 days suspension with 3 to 5 years probation and public reprimand; board fees paid by violator |
Emergency refill without prescriber authority; improper substitution of generic drug; or dispensing in incorrectly labeled container |
One year probation with optional terms that can be added |
Unlawful possession or disposal of needle or syringe; unprofessional conduct, etc. |
Three-year probation |
Civil Laws and Pharmacy Personnel
In cases where a criminal offense resulted in personal injury or damages, the victim or the victim’s family may also sue the party in civil court for monetary damages. The plaintiff is responsible for the burden of proof. If this situation occurs, the violator may be tried in two different courts, criminal and civil, as in the case of the Missouri pharmacist presented earlier. If there is not sufficient evidence to prove the criminal case beyond reasonable doubt, those who have been harmed may file a civil case. There are two main types of civil court actions pertinent to pharmacy: torts (which include negligence and malpractice) and contracts.
Torts and Personal Injuries
In civil law, a tort refers to personal injuries. Torts address wrongs that one citizen commits against another, with the injured party suing the party that caused the injury (e.g., Edgar Gonzales v. Dave’s Drug Store and Dave Jones, RPh). The most common tort in the medical/pharmacy arena is negligence, or carelessness, not acting as a reasonably prudent person would in the same situation. Malpractice, defined as improper, illegal, or neglectful professional activity, is a form of negligence. Other examples of torts include slander (using spoken words to speak falsely of another), libel (using written words to falsely represent another), assault (threatening another with bodily harm), and battery (causing bodily harm to another). For example, if a pharmacist or pharmacy technician speaks to a customer disparagingly about the professional competence of another healthcare professional, that pharmacist or technician may be found guilty of slander.
IN THE REAL WORLD
In February 2006 in Cleveland, Ohio, Emily Jerry, a bright-eyed two-year old, had just finished chemotherapy. Her tumor seemed gone, but her physician wanted one more round of chemotherapy to make sure. There was a backlog of hospital pharmacy orders, the computers were not working properly, and staffing was inadequate. A pharmacy technician, feeling rushed, made a chemotherapy compounding error (24 times the prescribed chemotherapy solution concentration). The technician told the pharmacist that she might have made an error. Pressured for time, the pharmacist did not check it carefully, and Emily Jerry died in great pain.
The state board revoked the pharmacist’s license, and he was indicted on charges of reckless homicide and involuntary manslaughter (unintentional death). He received six months in jail, six months under house arrest, 400 hours of community service, and thousands of dollars in court costs. The technician, who had no academic study or certification, was not prosecuted.
The bereaved family founded the Emily Jerry Foundation, dedicated to saving lives by reducing preventable medical errors. The foundation has pushed for greater education and certification for pharmacy technicians. In Ohio, they passed Emily’s Act in 2009, which requires that pharmacy technicians be at least 18 years of age, be certified and registered, and face disciplinary actions for errors. The foundation and the National Pharmacy Technician Association have been pushing for Emily’s Act to be integrated into every state and to become federal law.
Emily’s father, Christopher Jerry, told Pharmacy Times, “I believe in hindsight that my little Emily’s short life here on Earth was truly meant to save tens of thousands of lives going forward. I want to get technicians around the nation to continue to rally, and to let them know that I want to be their voice. If we all unite together on a national level, we will have a much more powerful voice to elevate the profession.” Visit the Emily Jerry Foundation website to learn more: https://PharmPractice7e.ParadigmEducation.com/EmilyJerry.
A patient may sue the healthcare provider for malpractice when a professional fails to offer the minimum standard of care that results in injury. The legal standard of care is the level of care or established practices commonly expected of a particular kind of healthcare provider in the local community. Standard of care is based on:
comparisons with the actions of other similarly educated healthcare professionals in the same situation and geographic area
compliance with existing written guidelines, protocols, or policies and procedures
expert testimony of healthcare professionals provided by the plaintiff or the defense
Only those healthcare providers who work in the same geographic area and have the same level of training would be compared for this specific standard of care. For example, a Denver pharmacist or technician would not be compared with those in Boston because local practices and protocols may differ. They would, however, be compared with other pharmacists or technicians working in the Denver area. Likewise, the job performance of a certified technician with advanced education and training practicing in Atlanta would be compared with other certified technicians in Atlanta. Because of the educational training, the technician would be held to a higher standard in a court of law than a noncertified technician.
Practice Tip
Generally technicians are not brought to court because of actions done within their job description since they are under a pharmacist’s approval. However, as technicians grow more educated, trained, are certified, and are given greater responsibilities, they are also growing more susceptible to litigation.
Negligence and Burden of Proof When a case of negligence or malpractice is brought, the burden is on the plaintiff to prove the four Ds of negligence: duty, dereliction, damages, and direct cause. The plaintiff must first prove that the defendant had a duty to provide care, or that there was a written or implied contract for care between the two parties. The plaintiff must then prove that the defendant was derelict or lacking in this duty, that this caused actual damages to the plaintiff, and that the damages were directly caused by the defendant’s derelict conduct. There must be a “preponderance of the evidence” that it is more likely that the defendant is guilty of the accused act than not.
If the defendant is found guilty, then they will be ordered to pay a monetary award to the plaintiff. It is not possible, however, for the defendant to be sent to prison through a civil court. Hospitals, residential facilities, pharmacies, most practicing pharmacists, and some pharmacy technicians carry professional liability insurance to protect their business and personal assets from civil lawsuits involving negligence or malpractice.
Legal Outcomes Several levels of negligence or malpractice may be determined during an investigation and subsequent trial. If two or more causes or circumstances add to the assessment of negligence and resulting personal injury to the patient, then a case of contributory negligence may be determined. For example, if the physician and pharmacist were both responsible for the patient’s injury, then each may be found guilty. The plaintiff’s award may be broken down proportionally according to the judge’s or jury’s assessment of comparative negligence.
In this instance, if the physician was found to be more responsible than the pharmacist, then the award may be broken down wherein the physician must pay 70% and the pharmacist 30% of the damages awarded. Cases even exist in which the patient is found to have contributed to his or her own injury (for example, not taking medication as directed) and is thus found to be comparatively negligent. In this type of case, the plaintiff’s total award may be reduced by a certain percentage depending on the judge’s or jury’s determination.
Law of Agency and Contracts
The law of agency and contracts is based on the Latin term respondeat superior, which translates to “let the master answer,” referring to the employee-employer relationship. An employee is, in effect, an “agent” for an employer and may enter into contracts on the employer’s behalf. This is an important agreement in the healthcare setting. For example, in a medical office, a nurse generally acts as a physician’s agent with patients; in the pharmacy, technicians act as agents for the pharmacist or pharmacy. This principle means not only that an implied contract exists in the healthcare setting, but also that the contract is just as valid as any verbal agreement or written contract drawn up by a physician or a pharmacist.
In a pharmacy, the exchange of a prescription between a patient and a pharmacy technician who agrees to fill the prescription is considered an implied contract. By accepting the prescription for filling, the pharmacy and its personnel are now obligated to provide the patient with a service. If a mistake is made, then the pharmacy and/or pharmacist may be held liable, even though the pharmacist was not specifically the one who accepted the prescription and entered into the contract to provide the service.
IN THE REAL WORLD
The following are real-life examples of preventable medication errors in the pharmacy. Training and experience are necessary to protect the public from these types of errors.
In 1997, a technician failed to dilute a dose of injectable enalapril that a doctor had prescribed to control the blood pressure of a premature infant. The child received a 750-mcg dose instead of a 6-mcg dose and suffered neurological damage at Boston Children’s Hospital. In the 2002 civil suit, the pharmacist, pharmacy supervisor, and technician were sued. They were covered under the hospital’s malpractice insurance.
In Florida, a teenage pharmacy technician, who was not formally trained or certified, typed in a dosage that was ten times the prescribed dose (by including an additional zero). This resulted in the death of a mother of three children. The state appeals court upheld a $26 million settlement against the chain pharmacy. The error could have been discovered by a routine check of the prescription by the pharmacist, but the prescription was not carefully checked; the pharmacy may also have been negligent in utilizing a young untrained technician.
In Maryland, a pharmacy technician inadvertently gave someone else’s medication to the wrong patient; the patient took the medication and died, and the pharmacy settled out of court. A similar case in Texas with the wrong drug being dispensed resulted in a costly hospitalization and a lawsuit against the pharmacy.
Therefore, the pharmacist (or pharmacy, in the case of a chain) must answer for all of the acts of their employees. However, a pharmacy technician can still be held liable if it can be proven that the technician overstepped the limitations of their position, such as by dispensing a prescription drug without a check by the supervising pharmacist.
Invasion of privacy is another pharmacy violation that may result in a civil lawsuit. Medical and prescription records, including those generated in the pharmacy, are considered the physical property of the facility that produced them. However, the information contained in them is the patient’s property. It may not be divulged without the patient’s consent to any nonmedical person, another provider, or an organization, unless by subpoena, a legal order.
If a member of the pharmacy staff violates patient privacy, the pharmacy is held responsible. Breaking HIPAA privacy laws is a federal criminal offense. HIPAA violations may carry heavy fines to the pharmacy and immediate termination of employment for the violator, including technicians. Confidentiality of medical information is further discussed in Chapter 15.