CHAPTER

1

CHAPTER OBJECTIVES

Upon completing this chapter, the reader will be able to:

▶  Identify the reasons why society regulates medications, as well as the limitations of this regulation.

▶  Distinguish the sources and types of laws in the United States.

▶  Describe the federal and state legislative processes.

▶  Describe the structure and function of the U.S. judicial system.

▶  List the responsibilities of administrative agencies.

▶  Distinguish among criminal, civil, and administrative liability.

▶  Describe the relationship between federal and state law.

Pharmacy laws describe for pharmacists the basic requirements of day-to-day practice. Pharmacy laws also define the relationship pharmacists have with the public they serve. As health professionals, pharmacists are highly regulated because the slightest misstep in drug distribution or pharmaceutical care could cost a life. As custodians of the nation’s drug supply, pharmacists are subjected to extensive regulation because the products pharmacists control are held to the most exacting standards of any consumer product. Pharmacists study the law, because through the law, society has described what is considered acceptable conduct for pharmacists, and pharmacists who fail to meet this level of acceptability will be held accountable for their failure.

In most pharmacy practice situations, the question of “What is legal?” can be addressed by answering the question “What is best for the patient?” Pharmacists may not always know the law, but they usually will know what is best for the patient, and this knowledge is ordinarily sufficient. However, sometimes situations are more complicated than this simplistic approach would suggest. Pharmacy laws have been drafted to describe the best general approach to specific pharmacy practice situations. They provide guidance for pharmacists by establishing rules that reflect societal value choices. It is essential for pharmacists to know these rules and how to use them.

Although pharmacy laws can describe basic practice requirements, they cannot substitute for good professional judgment. Sports metaphors are not always valuable in describing professional responsibilities, but it may be useful to think of pharmacists as being on an athletic team that follows the rules of a game as they are interpreted and applied by referees or umpires. Pharmacy law provides the rules, whereas government agencies interpret and apply them. Within this framework, pharmacists are free to develop various strategies and exercise good judgment, just as athletes do. Some strategies and judgments lead to success and others lead to failure. It is not the role of law to dictate strategy and professional judgment. The law merely establishes the overall framework within which the strategy is developed. Following the law is necessary, but not sufficient, for professional success, just as following the rules is necessary, but not sufficient, for athletic success. To succeed in pharmacy, as in athletics, an effective strategy must be used together with good judgment, and it is up to pharmacists themselves to determine this, just as it is up to athletes to determine how they can succeed within the rules. Pharmacists who look to the law for an effective practice strategy and professional judgment will be disappointed because they will not find anything beyond the basic rules for behavior and appointed officials whose job it is to enforce the rules.

THE NATURE AND ROLE OF LAW

Laws may generally be regarded as requirements for human conduct, applying to all persons within their jurisdiction, commanding what is right, prohibiting what is wrong, and imposing penalties for violations. The law, however, is much more than a collection of mandates and prohibitions. It is a framework through which people in a society resolve their disputes and problems in a way that does not involve force and consistently yields results that are acceptable to most of society. It is a socially prescribed process through which people declare their collective will and express their norms and values. This process of law accommodates the individual differences of every situation, but it recognizes as well the need to provide firm rules for people to follow. Therefore, the law attempts simultaneously to be flexible and also to maintain a reasonable degree of certainty. To achieve certainty, the law assumes the existence of a decision maker such as a legislature, an administrative agency, or a court that resolves disagreements by providing definitive, final answers reflective of society’s expectations.

Answers in law are not often easily derived, nor are they black and white in nature. Many times an attorney’s reply to a legal question is, “It depends.” Many laws are necessarily vague and variable because they deal with human relationships. It is impossible for lawmakers to foresee all of the countless, ever-changing human relationships that may occur. Courts often can reach decisions in law only after considerable reasoning based on several factors that may include the following:

•  Fundamental notions of fairness

•  The custom or history involved

•  The command of a political entity

•  The best balance between conflicting societal interests

Recognizing the flexibility inherent in the law is important to understanding and critiquing how and why certain laws, regulations, or judicial decisions have been written.

REASONS TO REGULATE MEDICINAL DRUGS

The government regulates medicinal drugs very heavily because of the potential risks to users. The concept of government regulation to protect people from harming themselves through risky choices conjures up images of an overbearing, paternalistic bureaucracy that forces people to behave in prescribed ways. If it can be assumed that people tend to act in their own self-interest by making decisions that will increase their personal happiness (e.g., higher income, more free time, improved health status), why does the government need to make decisions for people? Why not simply allow people to look out for themselves? One possible answer is that the free market does not always act efficiently to promote happiness-maximizing behavior. Such market inefficiency, often referred to as “market failure,” serves as justification for government regulation. The following four types of market failures are relevant to drug use:

1.  Public goods

2.  Externalities

3.  Natural monopolies

4.  Information asymmetry

Any legitimate government interference with a private choice to use medicinal drugs will be based on one or more of these identifiable market failures. In fact, government agencies should bear the burden of demonstrating that a market failure justifies interference with private choice. Government regulation need not occur in the absence of a specific reason to regulate.

Public goods are those necessary and beneficial commodities that private entities will not supply because there is no incentive for a private entity to provide them. National defense programs and lighthouses are classic examples of public goods; parks and intercity highways also fall within this category. Government must step in and regulate the market to provide these goods because an unregulated market will probably fail to provide them efficiently. Public goods in the drug industry include orphan drugs and vaccines. Orphan drugs are those drugs that are sufficiently safe and effective to be marketed, but the number of patients who need them is so small that it is not commercially feasible for a manufacturer to market them. Because the open market will not make these drugs available, government must step in to ensure availability for those who need them. The need to regulate vaccines, on the other hand, stems from the fact that they benefit society as a whole by preventing epidemics, but because of acute reactions to them they are viewed as too risky by many individuals. If every individual made a rational decision not to accept the risk of vaccines because their benefit is to all of society rather than to the individual, there would be no benefit to anyone, and epidemics would be unpreventable. Prevention of epidemics is a public good, and government must regulate by requiring vaccinations. At the same time, the government must ensure the availability of vaccines. Because of mass product liability actions, most manufacturers stopped producing childhood vaccines in the 1980s, and the country faced a crisis when less than six months of vaccine stores remained. The federal government stepped in to provide liability protection for vaccine manufacturers, and manufacturers not only resumed production but also developed new vaccines that were safer than the older ones.

An externality, another type of market failure, exists when the production or consumption of a good affects someone who does not fully consent to the effect and when the costs of a good are not fully incorporated into the consumer price. The parties who are directly involved in using the good may not consider the indirect impact of the production or consumption of the good for a party that is not involved in the use of that good. For example, people who purchase products manufactured in a factory that pollutes the air will probably not consider the costs associated with harm to the lungs of the people who live near the factory. In an unregulated market, where the manufacturer is not required to prevent air pollution, the purchase price of the product will not include the cost of the pollution. Because there is a market failure, government regulation is necessary. The overuse of antibiotics is an externality in drug therapy. A person who unnecessarily uses an antibiotic to treat a cold will probably not consider the cost to other people in terms of the increased resistance to the antibiotic within the general population. In part because of this externality, government must regulate the use of antibiotics by imposing a prescription requirement to ensure that unnecessary use by one person does not impose an indirect cost on other people.

A natural monopoly occurs when the fixed costs of providing a good are high relative to the variable costs, so the average cost declines over the time that the good is provided. Utilities that provide electricity, water, and natural gas are natural monopolies, for example, because the cost of establishing the infrastructure of supply lines vastly exceeds the cost of supplying the good once the infrastructure has been developed. Governments regulate these natural monopolies to promote efficiency. In drug therapy, the cost of demonstrating the safety and efficacy of a new drug is usually far greater than the cost of providing the new drug once it has been shown to be safe and effective. Government regulation ensures that there is an incentive to develop new drugs by initially providing an exclusive right to market them. After the period of exclusivity expires, regulation promotes efficiency by permitting competition by generic manufacturers.

Information asymmetry leads to market failures when the consumer is uninformed about the true value of a good. Some goods have characteristics that are obvious to a consumer before purchase (e.g., a chair, a tablet of paper). Consumers can evaluate other goods only after purchasing them (e.g., a used car, a meal at a restaurant). It is more difficult to evaluate medications because most consumers are unable to determine their value fully even after using them. Information about the benefits and detriments of medications does not flow freely within the lay public because it often is difficult for untrained individuals to understand these benefits and detriments. To minimize the possibility of market failure caused by information asymmetry, government regulation requires the provision of information and input by educated professionals into decisions about drug use. Without government regulation to promote the dissemination of information about drugs, patients and healthcare providers would find it more difficult to make good decisions about the benefits and detriments of drug therapy.

LIMITS OF THE LAW

Even though there may be good reasons for market regulations, there are limits on effective legal action. These limits originate not only in the constitutional parameters with which laws must harmonize but also in the human condition. Attempts to achieve overly broad objectives through the law will inevitably fail if they conflict with popular attitudes, habits, and ideals.

Human relationships, to the extent that they are well defined by society, are usually best left alone by legal institutions. In families, professions, and religious groups, for example, wholly internal disagreements are generally not amenable to legal resolution. Legal agencies lack the necessary expertise to deal with these problems, and the parties involved are not usually willing to abide by a legal pronouncement that fails to account for the peculiarities of a closely knit group. Excessively harsh enforcement of the law in the face of de minimis (very minor or trifling) violations counterproductively decreases respect for the law. No pharmacy can operate without occasional, very minor technical legal violations. If they have no real impact on the quality of drug therapy, such violations usually result only in warnings by law enforcers. This is not to say that the law will condone frequent or consistent minor violations. As a practical matter, however, there is little or nothing to be gained by pursuing occasional minor violations, obvious though they may be.

Avoidance of excessive punishment that does not “fit the crime” is usually a matter of enforcement discretion left to those who have legal authority at the “street level” to charge (or not charge) violators with infractions. However, in Young v. Board of Pharmacy, 462 P.2d 139 (N.M. 1969), the Supreme Court of New Mexico substituted its judgment for that of the enforcement authorities. The court reacted to what it believed was excessive punishment, ruling that charges made against a pharmacist were arbitrary, unlawful, and unsupported. The pharmacist had not kept accurate dispensing records and had been charged with “unprofessional conduct.” The court acknowledged the deficiencies of the pharmacist’s recordkeeping, but the court could not understand why accurate recordkeeping should be a test of a person’s professional character. This ruling in favor of the pharmacist does not mean that sloppy recordkeeping is acceptable, only that it should not be punished oppressively. Similarly, a Rhode Island court held that a pharmacist’s inadvertent dispensing error could not justify revocation of his license by the state department of health (Blais v. Rhode Island Department of Health, 2014 R.I. Super. 172 (2014)).

The fact that individuals in a free society are permitted to act in ways that they deem best for themselves—as long as their actions do not interfere with another individual’s right of action—also limits effective legal action. John Stuart Mill expressed this belief in his essay, “On Liberty,” when he said, “The only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others” (1986 (1859), p. 16). The law does not always accede to the Mill principle. Drug abuse and the use of unsafe medications (e.g., Laetrile) are legally restricted, for example, either because of the potential harm to others or because of a belief that some individuals are incapable of knowing what is in their own best interests. However, under most circumstances, individuals are free to make decisions for themselves without legal intervention.

Slogans such as “You can’t legislate morality” or its converse “There oughta be a law” oversimplify the role of the law in society. The law can influence behavior through its deterrent and educative role, but there are definite limits on that function. Society shapes the law, and the primary purpose of the legal system is to make the premises of society work.

TAKE-AWAY POINTS

  STUDY SCENARIOS AND QUESTIONS

SOURCES OF U.S. LAW

The U.S. government is a tripartite system consisting of the legislative, executive, and judicial branches. Each branch serves as a check to the power of the others, ensuring that no one branch can dominate and control the others. In general, the legislative branch of government makes the laws, whereas the executive branch enforces the laws, and the judicial branch interprets them. In theory this may be correct; in practice, however, all three branches make law together with what can be considered a fourth branch of government—administrative agencies.

THE CONSTITUTION OF THE UNITED STATES

The supreme law of the United States is the Constitution. Any federal or state statute or regulation that conflicts with the Constitution is invalid. The Federal Convention ratified the basic Constitution in 1787, and the Bill of Rights (i.e., the first 10 amendments) was added in 1791. In addition to the Bill of Rights, there have been 16 amendments to the Constitution since it was enacted. The passage of so few amendments to such a short document is quite remarkable and illustrates the timeless manner in which the Constitution was written.

The Bill of Rights includes rights generally recognized by everyone, such as freedom of speech, freedom of religion, freedom to be secure from unreasonable searches and seizures, protection against self-incrimination, and the right to due process. The Fourteenth Amendment, passed in 1870, applies the Bill of Rights to state governments.

LAW MADE BY LEGISLATURES: STATUTORY LAW

A legislature is an elected body of persons with the primary responsibility to enact laws, also called statutes. These statutes can be organized in a hierarchical order:

•  Federal statutes

•  State constitutions

•  State legislation

•  Ordinances

Article 1, section 1 of the U.S. Constitution provides that all legislative powers of the federal government shall be vested in a Congress, which shall be composed of a Senate and a House of Representatives. In addition to several specifically enumerated powers entrusted to Congress, article 1, section 8 provides that Congress shall have the power to make all laws “necessary and proper” for carrying out its responsibilities. The laws enacted by Congress apply nationwide.

Each state has its own constitution, which is usually much more detailed than the U.S. Constitution. Just as the U.S. Constitution is the supreme law over the whole country, a state constitution is the supreme law of the state.

Under the Tenth Amendment to the U.S. Constitution, states have the power to legislate in all areas except those prohibited or given to Congress by the U.S. Constitution. As a result, state legislatures have extremely broad powers to pass laws to protect the health, safety, and welfare of the public.

Each state government has the authority to create political subdivisions, such as municipalities and counties, to which the state can delegate certain functions. These political entities can enact ordinances that are enforceable as laws.

LAW MADE BY ADMINISTRATIVE AGENCIES

A legislature may create administrative agencies to implement desired changes in policies or to administer a body of substantive law when the legislature itself cannot perform these functions. It is impossible, for example, for state legislatures to monitor the activities of pharmacists and pharmacies on a regular basis. Therefore, the legislatures have created state boards of pharmacy to administer and enforce state pharmacy practice acts. Although the legislature creates them, such agencies are housed in the executive branch of government.

Several administrative agencies affect pharmacists at both the federal and state levels. Federal agencies include the following:

•  The Centers for Medicare & Medicaid Services, formerly the Health Care Financing Administration, which is housed in the Department of Health and Human Services (DHHS), is responsible for reimbursement policies and procedures for pharmacies and other healthcare providers participating in the Medicare and Medicaid programs.

•  The Food and Drug Administration (FDA), also housed in the DHHS, administers the federal Food, Drug, and Cosmetic Act (FDCA).

•  The Federal Trade Commission administers the Federal Trade Commission Act, enforcing unfair business practices and antitrust violations.

•  The Drug Enforcement Administration, under the jurisdiction of the U.S. Justice Department, administers the federal Controlled Substances Act.

Some state-level agencies of importance to pharmacists include the state board of pharmacy, which administers state pharmacy practice acts; the state department of health services; and state Medicaid agencies (usually under the department of health services), which determine state Medicaid policies and pharmacy reimbursement rates. Administrative agencies generally have considerable and broad authority, including the authority to perform legislative, judicial, and executive functions. Administrative agencies can be said to create law primarily through their authority to enact regulations and to render decisions at hearings.

Legislative Function

Administrative agencies accomplish their legislative function through the promulgation of regulations. Administrative regulations interpret and define statutes. For example, although the federal FDCA enacted by Congress requires compliance with “current good manufacturing practices,” it is really the regulations promulgated by the FDA that precisely and extensively define these practices. Similarly, for example, several states mandate that pharmacists complete a certain number of continuing education units over a specified period of time. Regulations promulgated by state pharmacy boards provide the necessary details, such as the types of continuing education units that are acceptable, the records that must be furnished to the state pharmacy board, and the requirements that continuing education providers must meet.

Because administrative agencies have a greater level of expertise than does Congress or a state legislature, it makes good sense for such agencies to determine how legislative policy will be implemented on a day-to-day basis. Recognizing the technical expertise of agencies, courts generally presume the actions of an agency to be valid.

Most administrative agencies promulgate regulations pursuant to a process known as “notice and comment rulemaking.” This process ensures that constituents whose interests are affected by the actions of the agency receive notice of any proposed regulation. Constituents then have an opportunity to comment on the proposed regulation. The agency considers all comments and may incorporate them into the regulation before its final promulgation. Although regulations are not statutes, they have the legal force of statutes and must be obeyed as such.

In order to be valid, a regulation must generally meet three legal tests. First, the regulation must be within the scope of the agency’s authority. For example, a state board of pharmacy is charged with administering pharmacy practice laws. Thus, it generally would not have the authority to regulate such issues as pharmacy investment practices or wage standards for pharmacy personnel.

Second, and often directly related to the first test, the regulation must be based on a statute that gives the agency the authority to promulgate the regulation. Generally, it is not legal for agencies to create new substantive law unless there is a statute enabling the agency to regulate in that area. For example, a state board regulation authorizing licensed pharmacy technicians to assist pharmacists with dispensing functions is likely to be invalidated unless there is a statute that recognizes the status of pharmacy technicians. Some courts have interpreted enabling legislation quite liberally. In Rite Aid of New Jersey, Inc. v. Board of Pharmacy, 304 A.2d 754 (N.J. Super. 1973), the court upheld a regulation passed by the New Jersey Board of Pharmacy to require that pharmacies maintain patient-profile record systems. The board cited as the enabling law a state law requiring pharmacists to keep prescription records on file. Although the law made no mention of patient medication records, the court found that the regulation was valid because it furthered the objective of the state law requiring pharmacists to keep records to protect the public. The court stated that the legislature could not be expected to anticipate every possible problem when it wrote the law.

As another example, the North Carolina Board of Pharmacy proposed a regulation limiting the number of continuous hours a pharmacist may work to 12 hours and requiring pharmacists be given one 30-minute and one 15-minute break if working longer than 6 continuous hours. Chain drug stores argued against the proposed regulation and the Rule Review Commission (RRC), which must approve state agency regulations, vetoed the rule on the basis that the Board lacked statutory authority to regulate pharmacists’ working conditions. The Board sued to force publication, but the trial court and state court of appeals, in a split decision, found for the RRC, concluding that the pharmacy board did not have the authority to regulate work conditions because it is a function of the North Carolina Department of Labor. The appellate court majority also concluded that setting limits on work hours and requiring breaks does not concern filling prescriptions. On appeal, the North Carolina Supreme Court reversed the court of appeals and sided with the dissenting appellate court judge that the Board did have the statutory authority to issue the regulation and that there is a relationship between continuous hours of work and accuracy in filling prescriptions (North Carolina Board of Pharmacy v. Rules Review Com’n., 620 S.E. 2d 893 (N.C. Ct. App. 2005); reversed 637 S.E. 2d 515 (N.C. 2006)).

The third legal requirement for a regulation is that it must bear a reasonable relationship to the public health, safety, and welfare. Thus, regulations that specify a dress code for pharmacists or that require the front door of a pharmacy to face the north or south side of a street are likely to be invalid.

Judicial Function

An administrative agency exercises its judicial function through its enforcement activities. The decision to institute proceedings is discretionary with the agency. Hearings conducted by administrative agencies resemble civil or criminal court proceedings; evidence is presented, arguments made, and a decision rendered. The results favor either the agency or the regulated party, perhaps creating new law by interpreting existing law. At one time, it was common to create new law through case-by-case enforcement (i.e., regulated parties discover that they have committed a violation only through an adjudicative proceeding), but notice and comment rulemaking has largely replaced that inefficient and unfair approach.

Agency decisions are usually subject to “judicial review” but only after the individual has availed him- or herself of every available administrative option, legally called “exhaustion of remedies.” On judicial review, a court usually examines the record of the administrative hearing. If the record shows that the agency’s decision was based on “substantial evidence,” the court often simply reviews the appropriateness of the decision in light of the evidence. If the court finds that the agency’s decision was not based on substantial evidence, it may decide to hear the case de novo, meaning that the court will pay no heed to the hearing findings but instead will conduct an entirely new trial.

The Federal Register and Code of Federal Regulations

Administrative agencies exercise considerable authority over pharmaceutical distribution and pharmacy practice, and pharmacists must be aware of the proposed and final regulations that affect their professional lives. Congress has prescribed that federal agency regulations be recorded in a specific manner so the public will have notice. This notice occurs primarily through two sources:

1.  The Federal Register

2.  The Code of Federal Regulations (CFR)

These two publications can be found at many public libraries, university and law school libraries, county courthouse libraries, and several government websites, including the U.S. Government Printing Office website (http://www.gpoaccess.gov).

The Federal Register is a daily publication that lists various federal actions, including proposed regulations, final regulations, and various government notices. The CFR is an annually revised compilation of final regulations divided and indexed by subject matter. There are 50 titles (i.e., divided subject areas) in the CFR, and each title is further divided into chapters, subchapters, parts, subparts, and sections.

To pass a regulation that would add a labeling requirement for prescription drugs, for example, the FDA would first publish in the Federal Register the proposed regulation, a notice of the intent to enact this regulation, and its reasons for proposing the regulation. A number would be included to identify exactly where the regulation, if enacted, would be placed in the CFR. (All FDA regulations are contained in Title 21 of the CFR.) The notice would invite public comment within a certain time frame. At the conclusion of the comment period, the FDA would review the comments, draft a final regulation, and publish this final regulation along with the agency’s comments and the effective date in the Federal Register. Simultaneously, this regulation would be inserted into its appropriate location within Title 21 of the CFR.

LAW MADE BY THE COURTS: COMMON LAW

When two or more parties cannot settle a dispute or controversy among themselves, they are likely to ask a court to settle the issue. The duty of the court is to apply the proper law to the facts before it and resolve the matter through judicial opinions (decisions). Whereas legislatures make law through statutes and administrative agencies make law through regulations and hearings, courts make law through judicial “opinions.” The word opinion is potentially misleading. When a court issues an opinion, the rules of law stated within it are not merely a point of view, subject to debate but with no general applicability. Rather, these rules are enforceable as law; they are binding on lower courts within the same jurisdiction and are persuasive in other jurisdictions. Judicial opinions establish enforceable legal principles either by expanding the common law (i.e., a body of judge-made law with its roots in centuries of resolved disputes) or by interpreting statutes and regulations.

The subject matter considered by a court varies a great deal from one day to the next. Thus, a court that is resolving a controversy relating to drug use today may have been presiding over a divorce yesterday and may be facing a dispute over securities tomorrow. Given the vast differences in subject matter, it is remarkable that courts are consistently able to resolve conflicts in a way that makes contextual sense, and it is inevitable that a court’s ruling will sometimes reflect a misunderstanding of the subject matter. There have been periodic calls for “science courts,” in which experts in both law and science work to resolve legal controversies relating to drug risks and other complex scientific issues. To date, however, no coordinated effort toward that end has materialized, and the judiciary continues to lack scientific expertise.

The term “common law” refers to law developed from judicial opinions. Much of the common law in the United States is based on law developed in England during the 200 to 300 years that followed the Norman conquest of England in 1066. Because the English kings in this period wanted to establish a uniform set of national laws, judges recorded and followed court decisions made previously. The result was a body of legal rules, many of which courts still follow today.

The English colonists retained the common law legal system when they came to North America. Each new state, except for Louisiana (whose law is based on French and Spanish law), then adopted common law into its system. Although many common law principles are uniformly applicable in all states, each state does have its own common law, and some common law principles differ from state to state. In some instances, common law principles have become so accepted and recognized that legislatures have codified them as statutes.

Stare Decisis

The essence of the common law system is the recording of judicial opinions and the reliance of courts on those previous opinions. This practice is called stare decisis, meaning “to abide by decided cases.” In practice, a court’s establishment of a certain rule of law based on a particular set of facts becomes a precedent that all lower courts in that jurisdiction must follow. Stare decisis serves two purposes:

1.  Establishing continuity of decisions

2.  Expediting judicial decision making

Stare decisis applies only to lower courts within the jurisdiction in which the precedent has been established. Thus, lower courts in one state need not follow a state supreme court ruling from another state. Similarly, a federal court of appeals in one circuit need not follow an opinion rendered in another circuit. Often, however, courts carefully consider opinions from other jurisdictions.

Stare decisis is not an inflexible principle. A court may vary from precedent primarily for two reasons. First, there may be factual distinctions between the case before the court and previous decisions on which the court relies. For example, a court may find that a pharmacist has a duty to warn patients of the drowsiness associated with an antihistamine drug but may later find that a pharmacist has no duty to warn patients of possible teratogenic effects associated with a sulfa drug. Lawyers commonly single out factual differences between cases in an attempt to convince a court that the present case is different from the precedent relied on by the other party in the lawsuit.

Second, courts may vary from a precedent because of changing times or circumstances since the precedent was established. A legal principle that was appropriate when the precedent was established may not be the best rule of law for society today. Thus, even if a court ruled in 1965 that pharmacists have no duty to warn a patient of adverse drug reactions, the court may be convinced to reverse that decision today, based in part on the different educational background of pharmacists in 1965 and today and the difference in societal expectations.

Relationship of Common Law to Statutory Law

Common law and statutory law merge when courts are required to interpret the meaning of statutes. It is virtually impossible for any legislature to write a law that is not ambiguous, vague, or confusing in some manner when applied to specific controversies. In fact, many statutes are deliberately written in very general language to provide flexibility. If a statute is too ambiguous or vague, however, courts may invalidate all or part of the statute as unconstitutional. For example, in an attempt to make it illegal to sell and possess devices for illicit drug use, some states in the late 1960s and early 1970s passed laws so broad and imprecise that even items like household teaspoons could have been considered illegal. In those states, the courts either invalidated all or parts of these laws. Courts do not commonly invalidate statutes unless they have no choice; they prefer to presume the constitutionality of a statute and make every attempt to interpret the statute in a way that results in a reasonable and fair application of the law to the facts of a case.

In numerous cases a court has had to interpret statutes and decide if the set of facts before it is subject to a particular law. What principles do courts apply when interpreting legislation? In conjunction with the rule of stare decisis, the most important approach that courts apply when interpreting statutes is to determine the legislative intent. In other words, the court attempts to put itself in the mind of the legislature and ask, “Did the legislature mean for the law to apply to the specific fact situation that the court is now considering?” Especially with respect to federal statutes, the court looks to legislative committee reports and any written legislative history to guide it in its interpretation. Often, the legislative history is of no assistance because the legislature never anticipated the type of situation that is the subject of litigation. In this event, the court looks to the overall intent and purpose of the legislation, asking, “Why did the legislature pass this law? What is the law attempting to accomplish? How does this particular situation apply to the law’s purpose?”

A state may pass a law, for example, that requires pharmacies to offer counseling to patients but does not require the pharmacist to actually provide the service if the patient refuses it. In one pharmacy, a clerk informs all patients that they may receive counseling from the pharmacist but will have to wait 30 to 60 minutes. As a result, nearly all patients refuse the counseling. The state board charges the pharmacist with violating the statute, but the pharmacy contends that it has complied with the law. If this case goes to court, the pharmacy’s actions may be ruled more an attempt to avoid the intent of the statute than an effort to accomplish the intent.

Although a determination of legislative intent generally prevails, courts often combine this analysis with other approaches to interpret a statute. One such other approach is to give the words in a statute their ordinary (commonly understood) meaning. Another is to support the position that best exemplifies current social policy. Yet another consideration that courts must heed is an individual’s constitutional right of due process. In this context, due process means that a reasonable person would be expected to know that this law applies or does not apply to the particular activity in question. It is unfair to hold someone accountable for a law that the person could not know was applicable.

DISTINGUISHING CRIMINAL, CIVIL, AND ADMINISTRATIVE LAW

A pharmacist’s wrongful act may subject the pharmacist to a criminal, civil, or administrative action, or perhaps all three at the same time. The government may initiate a criminal action if the pharmacist has violated a statute. For example, a pharmacist who sells a prescription-controlled substance without a prescription may be subject to a criminal action by the state or federal government. A person can be charged with a crime only if there is a statute prohibiting the conduct. The sanctions are usually a fine, a prison sentence, or both, depending on the severity of the crime and the penalties specified in the statute. The objectives of criminal statutes and prosecutions are to deter an undesirable activity as well as to punish and rehabilitate the wrongdoer.

A civil action is a lawsuit in which one private party sues another private party alleging an injury. If, for example, the pharmacist in the criminal case just discussed sold the controlled substance to a patient who was allergic to the drug and the pharmacist had knowledge of that allergy but simply forgot, the patient injured from ingesting the drug may sue the pharmacist for the injury. Civil actions may be based on common law, statutory law, or both. The objective of a civil action is to compensate the injured party for the damages caused by the wrongdoer.

An administrative action may occur when a pharmacist has violated a statute or regulation or has committed an act that, in the opinion of the agency, warrants an investigation. As discussed previously, such administrative actions are called “hearings.” Depending on the statutes and the nature of the violation, they may lead to sanctions including:

•  Warnings

•  Fines

•  License revocation

•  License suspension

•  Probation

The pharmacist in the situation discussed is likely to be subject to a state pharmacy board disciplinary hearing.

  TAKE-AWAY POINTS

  STUDY SCENARIOS AND QUESTIONS