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American Pharmacy Vol.NS18, No. 11, Oct. 1978/598
I
n February 1978 an article ap. pea red in the APhA Weekly under the following headline: "Rite Aid Loses $950,000 Negligence Case ."1 The Rite Aid Corporation, a chain of 524 pharmacies in and around Pennsylvania, and the pharmacist were found negligent in providing an occasional unauthorized refill of a prescription for prednisone over an 18-month period to Michael J. Eagen, son of the Pennsylvania Supreme Court chief justice. Eagen's claim was that he had developed cataracts and become almost blind as a result of using the drug. The case was filed against the physician also, but he is now dead and was not found negligent. Eagen's lawyer had originally asked for a $150,000 settlement. The judge awarded $700,000 compensatory damages to Eagen and his wife and $250,000 punitive damages to Eagen. The case is now on appeal to the Common Pleas Court of Pennsylvania. For the last decade, pharmacists have watched with growing concern the plight of their medical colleagues and the burgeoning malpractice claims and costs. Dr. Malcolm C. Todd, past president of the American Medical Association (AMA), recently said, "The cost of medical malpractice insurance is the biggest problem facing the young physician entering practice today."2 Many physicians in northern California refused to pay the skyrocketing premiums, which increased at the rate of 350 percent in some years. 3 For example, in 1975, annual rates for the lower risk group jumped from $1,032 to $4,644 and from $4,920 to $22,140 for the highest risk group. The number of claims, as well as settlement amounts, increased to the point where many insurance companies dropped physician professional liability lines. This
Don Newman, who writes on legal affairs, is director of the Washington office of the state of Indiana. This paper is intended by American Pharmacy as information only, not as legal, accounting or other professional service. If legal advice is required, the services of a competent professional should be sought. References may be obtained from the editor of American Pharmacy. American Pharmacy VoI.NS18, No. 11, Oct. 1978/599
lack of coverage compounds the problem. The issue of skyrocketing medical malpractice insurance costs and settlements has become so far reaching that today every state legislature is involved in an attempted resolution.
experiences of the last decade reflect what may be forecast for pharmacists? To answer this question, several areas of concern must be explored.
Balancing of Patients' and Pharmacists'Rights
Several reasons for the increased concern over medical malpractice have been identified recently. Deterioration of the professional relationship between patient and physician is one of the most frequently cited causes. Increased specialization, fragmentation of patient services and poor communications have strained these traditionally close relationships. As the medical care system has become increasingly complex, the delivery of such car~ has become impersonalized. In thIS atmosphere the patient has been less hesitant to file a suit against this impersonalized system and its providers.7 Costs must be weighed, in terms not only of awards, but also of the successful litigation. Being sued is an unpleasant and disruptive experience even when the suit is defended successfully. Both a practitioner's time and reputation usually are diminished in the process. 8 A practitioner's reputation cannot be evaluated, but the impact of premium costs can be. The total cost for medical malpractice premiums in the United States rose from $60 million in 1960 to $1 billion in 1975. 9
The basic reason for the difficulty in reaching a solution to the malpractice problem is the need for the balancing of rights. The patient has a right to treatment and care from the duly licensed health professional which meets an established standard of care, and a constitutionally protected right of redress in the event that standard of care is not provided. The health professional has a right to practice the established standard of care in an environment free of harassment and persecution. In his book, The Truth About Medical Malpractice, Ronald E. Gots states, "Proper solution must maintain the public right to legal redress at the same time as they deal with the most pressing excesses of bias against the medical community. The voluminous wave of nonmeritorious suits and the inordinately high awards in the successful ones must be brought under control, ... but in the final analysis, legal recourse should be reserved for those cases in which fundamental rights have been truly violated." One writer claims that the law in any field, when it has been derived mostly from the decisions of judges, as the law of malpractice has, is fundamentally distilled common sense. 5 Perhaps what is most difficult for legallaymen to focus on is the court's concern for legal balancing. Justice William O. Douglas expressed it succinctly when he said, " ... there are few areas of the law in black and white. The greys are dominant and even among them the shades are innumerable. For the eternal problem of the law is one of making accommodations between conflicting interests. This is why most legal problems end as questions of degree."6 In the meantime, pharmacists are growing more concerned about the future. Do the medical practitioner's
Concern Over Malpractice Claims
Increased Costs in Pharmaceutical Malpractice The incidence of malpractice claims against the pharmacist is relatively low compared to the number of medical malpractice claims. Obviously, the medical decision ma~er assumes a higher exposure and fIsk when involved in the practice of medicine than the pharmacist does in pharmacy as it is now practiced. ~ut recent pharmaceutical malpractIce insurance increases should heighten the pharmacist's awareness of the possibility of a trend. lo In 1967 the average rate for pharmaceutical malpractice insurance was $0.42/$1,000 of total store volume. (It varied from a low of $0.36/
15
$1,000 to a high of $0.48/$1,000 based on geographical location.) In 1977 a national rate of $0.60/$1,000 of total store volume was established.ll At the same time, base limits on pharmaceutical malpractice insurance were increased from $5,000/ $15,000 to $25,000/$75,000. Within that time frame the average total annual pharmacy sales increased from $198,917 in 1967 to $325,656 in 1977. 12 Since the cost of base coverage of this insurance is the product of the new rate times the yearly expanding total store volume, the impact is evident. However, there is an inherent danger in using statistics: supporters may find them superfluous, and critics may find them used like an inebriate around a lamp post-for support rather than illumination . But there can be little argument: the rate, the limits and the cost of pharmaceutical malpractice insurance have increased measurably in the last decade. Additionally, increased coverage is usually purchased. Currently, the most popular coverage appears to be $200,000/$600,000. 13 The customer (commonly the plaintiff in a malpractice suit) may base a claim on anyone of three theories of recovery: negligence, breach of warranty or strict tort liability.1 4 Negligence is the most common foundation for a malpractice suit, but pharmacists should not ignore the other two claims. Even though most breach of warranty suits in pharmacy involve the manufacturer, the pharmacist also is exposed to both express warranty, e.g ., in making an express statement about either a prescription or an OTC drug, and implied warranty as the seller of products. Express warranty is the older claim and fairly well understood, but implied warranty is a newer and more subtle basis for liability. The leading case in the field is Henningsen v. Bloomfield, decided in 1960. The court held both the manufacturer of an automobile and the dealer who sold it to the purchaser liable for injuries sustained by the purchaser's wife when a wheel broke. Is In a recent survey submitted by 23 insurance companies reporting on
16
product liability claims for July I, 1976, to March IS, 1977, successful suits on prescription drugs were brought by 92 parties. Prescription drugs had the highest average claim settlement of any product. The average drug product claim settlement of $171,173 was almost twice as high as the next category (tractors, trucks, mobile homes, etc.) at $92,405. 16 Further, the total number of product liability cases brought before federal courts increased 134 percent from 1,579 cases in FY 1974 to 3,696 cases in FY 1976, according to the administrative office of the United States Courts. I7 There is, however, relatively little case authority dealing with the liability in warranty of a pharmacist selling physician-prescribed drugs except when the product is sold under the pharmacist's own label or the pharmacist's own product is prescribed by the physician. I8 According to the surveys, the number of claims involving pharmacists' liability appears to be increasing gradually, while the amount per claim is rising at a more rapid rate.1 9
History of Pharmacy Malpractice The profession of pharmacy has been practiced in one form or another since human history has been recorded . An Egyptian papyrus of 3300 B.C. sets out a prescription formula. Over the span of centuries the physician and pharmacist were one. The development of our pharmacist of today did not occur until the early 1800s. A great reaction against the harsh medicines and the heavy dosages in which they were given produced contention among the sects in medicine and the factions in pharmacy. Gradually, pharmaceutical manufacturers took over the preparation of capsules, tablets and liquids . The mortar and pestle practically disappeared, and there emerged the pharmacist of today, who compounds fewer drugs but dispenses a great many more, both in kinds and in quantities, thus multiplying the opportunities for errors and the damage done by them.2o The basis of pharmacists' liability
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American Pharmacy Vol.NS18, No. 11, Oct. 1978/600
usually involves supplying the wrong drug, failing to give adequate warning, misrepresenting a substitute or making errors in filling a prescription. The overwhelming majority of cases predicate the pharmacist's liability on negligence, even though the first apparent case on the subject of pharmacists' liability was Fleet v. Hollenkamp,21 1852, which held that the pharmacist was an insurer of the wholesomeness of the article he supplied. Negligence is defined as omitting to do something that a reasonable person, guided by considerations that ordinarily regulate human affairs, would do, or doing something that a reasonable and prudent person would not do. 22 Since the degree of harm that may be done by a pharmacist's mistake is great, the standard of care imposed by the law is a high one: "People trust not merely their health but their lives to the knowledge, care and prudence of druggists, and in many cases a slight want of care is liable to prove fatal to someone."23 Not all courts speak of the pharmacist's duty in terms of the highest degree of care. Many use the term "ordinary care," but this is a distinction without a difference. To avoid negligence, one must use the care that a reasonable and prudent person would use under the circumstances. Whether it is described as "the highest," "ordinary" or "that commensurate with the risk," it can be measured only by the circumstances, which must include the risk to be guarded against. Any reasonable and prudent person would increase the care with the increased risk. Thus where the risk to be guarded against may be death, the highest care is in order, whether it is called "ordinary" or "highest." And when a person is self-represented to the public as having special competence, then the law imposes the duty of a reasonable and prudent person with that particular competence. 24 There are two possible standards against which a practitioner in the health field is measured: the local standard (commonly referred to as the "locality rule") and the general standard. If a pharmacist's practice is American Pharmacy VoI.NS18 , No. 11 , Oct. 1978/ 601
measured under the locality rule, "He is only required to have that reasonable degree of learning and skill which is ordinarily possessed by other druggists in good standing as to qualifications in similar communities ."2s Historically, there was an implication that medical practice in a small village differed from medical practice in a large city. However, in recent years the courts have been chipping
How to Select Malpractice Insurance Considerations in selecting a malpractice insurance policy include the following: • Consultation activities as well as product-dispensing activities should be covered. • Peer review coverage should be provided. • Coverage must be maintained for all locations in which a pharmacist practices. • Popular coverage is $200,000/ $600,000. • Court "costs" should be covered. • Legal costs should be borne by the insurance company. • Lost wages are a consideration. • It is desirable to require the pharmacist's agreement to any settlement. • Employee pharmacists should have an individual policy. • A relatively new approach to underwriting professional liability is the "claims-made basis." This is not as good as the "occurrence basis," which protects the insured against any occurrence during the term of the policy, even after it may have lapsed. 68 away at the strict application of this rule. For example, more recent opinions have held that physicians must maintain a standard of medical practice coexistent with medical centers readily accessible for medical trea tment which can be outside their locality. The implications of the erosion of the locality rule applicable to general practitioners should not be over-
looked by pharmacists . Medical specialists and nurses already are held to a general national standard of practice. 26 - 28 If this general standard is applied to pharmacists, does it mean that ultimately they may be obliged to maintain customer drug profiles, warn the physician and the patient of known contraindications, alert the patient to possible drug side reactions, inform the physician and the patient of new, superior drugs, warn the physician and patient of drug incompatibilities and perform a host of other pharmaceutical services now performed by some pharmacists but not others? In earlier cases, more often than not, the defendant pharmacist supplied poison by mistake in answer to an oral request by the customer for a named drug. In a frequently cited Michigan case, Brown v. Marshall, the defendant sold the plaintiff sulphate of zinc for epsom salts with the explanation it was a little dark from exposure. 29 Other cases in the early 1900s involved dispensing calomel for morphine,30 strychnine for morphine,31 acetanilid for phosphate of soda 32 and "roachsault" (roach poison) for "rochelle salts" (mild purgative).33 In a number of cases the defendant supplied a substitute for the drug requested by the plaintiff with assurances that it was the same thing or just as good. In the first case the defendant supplied calomel tablets for liquid cascara sagrada under his own label, and the court ruled that there was enough evidence of negligence to go to the jury.34 Negligence was found where the defendant substituted bichloride of mercury tablets for "Seiler's Antiseptic" tablets,3s defendant's own cold tablets for plaintiff's request,36 defendant's recommended laxative which killed plaintiff's dog,37 and defendant's own skin cure for plaintiff's pre scription. 38 The cases involving errors in filling prescriptions by pharmacists began in 1887 with Beckwith v. Oatman, in which the defendant supplied the wrong compound for the treatment of bronchi tis. 39 The leading case of Tremblay v. Kimball, decided in 1910, affirmed a judgment of $ 1,400 for 17
the plaintiff when corrosive sublimate containing bichloride of mercury and muriate of ammonia was accidentally substituted in a prescription calling for chlorodyne tablets. 40 Judgments for negligence have been awarded for mistakes in products, in strengths of the same product and in quantities of the same product, for mislabeling, for misdirecting, for other miscellaneous acts and for violation of statutes. Ordinarily, the plaintiff has the burden of proving the defendant guilty of negligence. But some courts have held that the proof of the delivery of a dangerous drug for a harmless one raises a presumption of negligence, thus throwing the burden on the pharmacist to explain how the mistake could happen without negligence. 41 Some courts say that it is a prima facie case of negligence. Other courts place the defendant in the same position by applying the doctrine of res ipsa [aquifer. 42 As generally stated today, conditions necessary for the application of res ipsa [aquifer are that (1) the injury does not occur in the absence of negligence, (2) the defendant had exclusive control of the event in which the plaintiff was injured and (3) the plaintiff was not contributorily negligent. 43 Pharmacists found guilty of a violation of a statute do well to accept the fact of their negligence and concen tra te their attack and the court's attention on the lack of proximate cause, the absence of damages, or the plaintiff's contributory negligence. 44 Proximate cause is most easily explained by the "but for" rule: The defendant's conduct is not the cause of the event, if the event would have occurred wi thou tit. At mos t this is a rule of exclusion. 45 In every action for negligence it must be established that the defendant's action was the proximate cause of plaintiff's injury. A necessary element of a cause of action for a negligent act is that the plaintiff must have suffered actual damages as a result of the negligence complained of. All too often, plaintiffs feel that they should be entitled to a reward for having discovered defendant's negligence. The law offers no such reward. No matter how 18
negligent the defendant's conduct may happen to be, the plaintiff's recovery rests on proof of damages. There may be recovery for punitive damages as well in a proper case. 46 The defendant may plead contributory negligence, comparative negligence and assumption of the risk by the plaintiff. Historically, contributory negligence of the plaintiff
apportioned between the plaintiff and the defendant . The assumption of the risk is the subject of much controversy. In its simplest sense, assumption of the risk means that the plaintiff, in advance, has consented to the defendant's action, thereby relieving the defendant of all legal duty. However, the plaintiff must know and understand the risk, and assume it voluntarily.4 7 Perhaps the most significant conclusion to be drawn from a historical study of the cases involving negligent liability of the pharmacist is that there are relatively few such cases. It is impossible to know whether this small number of lawsuits was due to the superb job being done by pharmacists in avoiding mistakes, the difficulty of tracing mistakes, other members of the health team receiving greater attention by litigants, an enhanced pharmacist/customer relationship, systematic enforcement of strong pharmacy laws or a combination of these factors. Status of Pharmacist Malpractice
'Ordinarily, the plaintiff has the burden of proving the defendant guilty of negligence. But some courts have held that the proof of the delivery of a dangerous drug for a harmless one raises a presumption of negligence ...' would bar recovery where the defendant's liability was predicated on negligence. But if the defendant's negligent conduct was willful or reckless, then the plaintiff's contributory negligence would not bar recovery. The hardship of the doctrine of contributory negligence is apparent: it places on the plaintiff the entire burden of the loss for which the defendant is also partially responsible. Many states have tempered this result by the promulgation of comparative negligence statutes, whereby damages are
A story is told about the mythical small town where there was one lawyer but not enough business to support him. Then another lawyer moved to town and there was enough business for both of them. This is indeed a "litigious society." And as part and parcel of this litigiousness, claims against professionals continue to multiply dramatically. There is no reason to expect tha t the frequency of these claims will return to former" normal" levels in the foreseeable future. Projections for 1978 indicate that 10 of every 100 practicing lawyers can be expected to be sued this year. 48 People are even exhorted to sue. An article on the subject in one magazine contained the introductory statement, "For many people, the only time in their lives when they have a chance to lay their hands on as much as $100,000 is when they are injured because of someone else's carelessness."49 A study of medical malpractice in the United States was published in 1973. Although the statistics on which this study was based are American Pharmacy VoI.NS18, No. 11, Oct. 1978/602
dated, the findings are provocative. There is at least the suggestion that as the patient educational level improves and the consumer movement builds up steam, the malpractice claim will be more effective as a control mechanism. The doctrine of res ipsa loquiter is being applied by an increasing number of jurisdictions at an increasingly frequent rate. The cost of health care is rising rapidly; this rate suggests that as hospital ex-
penses increase, malpractice cases will increase. 50 William J. Skinner in a recent article stated, "Pharmacists are now facing new problems in the malpractice field, especially now that clinical consulting, patient records, and pharmacy expertise are being used more and more ."58 Patient drug profiles are now amanda tory service of New Jersey pharmacists. Other pharmacists are taking patient drug histories
and advising patients on drug usage. When prescriptions call for a drug by generic name, the pharmacist usually chooses the brand to be dispensed. An important question regarding the emerging role of pharmacists is the compromise of the laws that prohibit the substitition of prescribed drugs. Most states have laws that prevent the filling of a prescription calling for one brand with another brand. This may be a trademark vio-
Do's and Don'ts of Pharmacy Practice A leading pharmacist/attorney practitioner, Arthur I. Goldberg, has developed eight simple rules based on his observations of the evolution over the past 10 years of malpractice cases involving pharmacy; 1. Do establish a clear set of procedures for receiving, compounding, dispensing and recording prescriptions . Keep these records up-to-date. Don't falsify records or go back to fill out an incomplete record to make the situation look better. An inconsequent impropriety can damage your credibility and destroy your defense . 2 . Do observe all laws, regulations and ethics governing the dispensing of drugs. These rules provide an independent standard of reasonable care which operates to your benefit . Don't break these rules. Not only does it increase your exposure in a malpractice case by making your position difficult to defend, but it also subjects you to disciplinary proceedings and a possible loss of insurance protection. Most insurance policies relieve the carrier from responsibility if the claim is caused by an illegal act. Thus an unauthorized and illegal substitution or an unauthorized dispensing or refilling of a prescription can hurt your defense, remove your insurance protection and expose you to disciplinary proceedings and state and federal criminal prosecution. 3. Do be candid and honest about a mistake if it occurs, keeping the patient's welfare uppermost in mind. An honest attempt to do your best under the circumstances has often prevented serious injury and has removed the personal antagonism that precipitates many such suits. Don't try to cover up a mistake and mislead the patient or physician. This impression invites further inquiry and action. More than one plaintiff has said, "I wouldn't have thought of suing if the mistake had been admitted and if everything possible had been done to help." 4. Do force others to inconvenience themselves, rather than have you break or bend the law. Don't rely on doctors, nurses and patients to back you up, even if your deviation from required procedure was for their convenience.
American Pharmacy Vol.NS18, No. 11, Oct. 1978/603
5. Do be particularly careful with patients who have" chronic conditions. Treat each refill as a new prescription-and check on the patient's condition, visits to the doctor and other medication. This is an area that requires greater inquiry, attention and responsibility. Don't assume that patients with chronic conditions have stable conditions, see their physicians regularly or are aware of the potency of their medications. Familiarity does breed indifference to both dispenser and patient. Too often, delicately balanced conditions are upset because patient and pharmacist become too · casual about refills and the continued taking of the same medication. 6. Do secure maximum insurance coverage with a carrier that specializes in this field. A broker, agent and insurance carrier-familiar with the problems of pharmacy-are important to you if a problem should occur. Don't assume that an association, employer or other party carries insurance that protects yo\,!. Get a representation in writing from the insurance company if this is the case. 7. Do report any incident immediately to your insurance carrier and attorney. Cooperation to make available all information promptly is essential. On hearing of an incident, sit down and write a chronological history of everything you know that occurred. Give it to your attorney to review and forward to your insurance company. Don't discuss this matter with anyone other than your attorney and insurance company representative (except as described above to aid in correcting the medical problem). Don't sign anything your attorney does not see. Don't divulge your records, except to your attorney and carrier. 8. Don't allow the threat of malpractice to make you practice pharmacy defensively and covertly. A compe.tent, careful pharmacist should practice the profession to the fullest extent possible and should not allow the specter of "malpractice" to inhibit the satisfaction and sense of accomplishment that result from the proper practice of pharmacy. 69
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'One of the toughest value judgments to give to a jury is whether the professional's performance met the required standard of care. What is a "competent" pharmacist? What should the minimum standards for the profession be?'
lation and evidence of unfair competition. But some states have a law that gives this authority to the pharmacists. 59 The U.S. Congress is considering bills that would override the states' antisubstitution laws by allowing pharmacists to substitute drugs and/or requiring that the product dispensed be the least expensive drug in the pharmacist's inventory (5.2179, H.R.1963). Unquestionably, as pharmacists assume the role of decision makers, they become greater risk takers.
Current Trends in Pharmacy The ability of new drugs is greater to do good-and greater to do harm.
Recent Malpractice Cases • A child became ill after a penicillin shot. The physician phoned a prescription for 2 gr aspirin suppositories in to the pharmacy. The employee who took the call and filled the prescription was not a registered pharmacist. He filled the prescription for 2 gr seconal suppositories. The child became worse and was hospitalized. In the subsequent suit the plaintiff received $22,000 actual damages and $2,500 punitive damages from the pharmacy and the employee. The case is of interest in that punitive damages were allowed even in the absence of Illalice and that the pharmacy was responsible as the employer. 51 • A man was informed that he should treat his family for worms. The pharmacist sold him "Jaynes Vermifuge" for children and adults. The children's package was labeled by the manufacturer, "CAUTION-Tablets must be swallowed whole-not chewed or crushed .... " The tablets contained hexylresorcinol, a drug which causes superficial erosion of the mucous membrane of the mouth and stomach. The three-year-old child chewed the tablets, contrary to her father's instructions, and became ill. The second day she was taken to the hospital, where she died on the third day of respiratory failure and convulsions. A toxicology report showed Darvon (propoxyphene hydrochloride) in her stomach and a trace of hexylresorcinol in her kidneys, but neither in sufficient quantities to be considered fatal. The father sued the pharmacist and manufacturer but received nothing, since the warning on the label was ignored. But this case does il-
20
lustrate the risk the pharmacist assumes in selling an OTC product. 52 • A 38-year-old housewife and mother had lung surgery followed by a prescription for Chloromycetin (chloramphenicol). She died the next year of aplastic anemia caused by the Chloromycetin. Negligence was claimed against the physician and the drug firm, and $400,000 in damages was awarded the plaintiff. Even though the manufacturer complied with all FDA rulings on the warning, the court concluded that the firm had overpromoted" the drug so as to induce physicians to prescribe it. The .decision implied that the manufacturer had complied with the letter of the law but not with the intent of the law. 53 • A customer who had undergone oral surgery had her prescription for Percodan (a combination product containing aspirin, caffeine, oxycodone hydrochloride and phenacetin) mixed up with another customer's prescription and took Meticorten (prednisone) for three days. At the trial she claimed weakness, nausea ahd hypertension as complications brought on by Meticorten. The trial court judge awarded plaintiff $4,500 over the claim of the pharmacist that the customer was contributorily'negligent in taking medication from a bottle with someone else's name on the label. The case was affirmed in favor of the plaintiff. 54 In some states, if proved, contributory negligence is a complete bar to plaintiff's recovery. • A situation arose whereby more than one person was negligent in this case, and the court spoke to the sharing 1/
of negligence damages by third part"ies. The court stated "that where a third party is found to have been responsible for a part, but not all of the negligence for which a defendant is cast in damages, the responsibility for that part is recoverable by the prime defendant against the third party defendant. To reach that end there must necessarily be an apportionment of responsibility in negligence between the parties."55 ' • A tranquilizer was dispensed instead of the prescribed oral contraceptive. The patient, who became pregnant and delivered a child, sued the pharmacist for damages. Damages were awarded which included child support until the child reached the age of majority. The pharmacist argued that having a child isa blessing and not the kind of "harm" that was compensable under tort law. The court disagreed. 56 • A plaintiff claimed that she suffered severe and permanent injuries because of the diethylstilbestrol prescribed by the defendant physician, supplied by the defendent manufacturer and dispensed by the defendant pharmacist to her mother while she was pregnant with the plaintiff. The entire action against ·the pharmacist was dismissed but over the dissent of the judge authoring the opinion. The judge, who was in the minority on appeal, thought the plaintiff's claim of strict liability against the pharmacist had merit in that the pharmacist had not demonstrated that he did not have or could not have attained the knowledge of the poten tial risks involved with diethylstilbestrol.
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Patient warnings take on added importance under these circumstances. Informed patient consent becomes critical to all concerned. Nowhere, at the moment, has this concern become more evident than with oral contraceptives. Patient package inserts (PPIs) imply informed consent on the assumption of three responsibilities: the manufacturer has the responsibility to supply the PPI; the pharmacist has the responsibility to dispense the PPI; and the patient has the responsibility to read the PPI. 60 The lis t of drugs that require dispensing with the PPI undoubtedly will grow in the near future. PPIs constitute the most direct way of informing the patient visibly about a particular medication . One of the direct considerations with the new drug product selection laws is the liability of the prescriber if the choice of manufacturer is given to the pharmacist. Only about onethird of the states that have such a law now exempt the physician from liability.61 Another trend is the publication of a manufacturer's policy covering pharmacist-dispensed generic drugs . The inference is that pharmacists are shopping for both quality protection and quality generic pharmaceuticals. A common clause in all such policies is the assumption of risk by the manufacturer only if there is a lack of negligence on the part of the pharmacist .66 The arguments for generic drug substitution laws are usually economic. The generic drug is generally less expensive than the trademark equivalent. If quality is comparable, the consumer could benefit. But if it is not, then the consumer risks losing both good health and good money. 62 The state of Washington promulgated a regulation requiring pharmacists to communicate prescription information to each patient. Subsequently, 1,200 questionnaires were mailed to physicians throughout the state soliciting their opinions on the regulation. Of the 482 returned questionnaires, 85 percent felt that the regulation was beneficial or of no harm to their patients and practice. 63 The most substantial attempt to redress the malpractice problem is
American Pharmacy VoI.NS18, No. 11, Oct. 1978/605
being made at the state legislative level. Many changes that will prove crucial are now affecting both the contributors and the consumers of health care. It is clear that they have a common goal: making the malpractice risk insurable at reasonable rates. 64 One of the toughest value judgments to give to a jury is whether the professional's performance met the required standard of care. What is a "competent" pharmacist? What should the minimum standards for the profession be? Independent of this question, a joint project by the American Pharmaceutical Association and the American Association of Colleges of Pharmacy launched a national survey of 5,000 pharmacists in an attempt to establish just such a model for national standards of practice for pharmacists. 65
Conclusion Pharmacy is the prime target on the horizon for malpractice suits. Clinical pharmacy with all of its attendant exposure and the increasing desire of young pharmacists to expand their area of responsibility will bring about a concomitant increase in this area of liability. The incidence of lawsuits filed against pharmacists appears to be increasing, although it is difficult to
collect reliable data. One underwriter stated that the claims involving pharmacists during the last six months of 1976 were three times the number it handled in the first six months of 1976. 67 Some commentators claim that malpractice cases or the threat of them has an adverse effect on quality standards . It is possible that a pharmacist could practice negative "defensive pharmacy" by choosing to forego any unrequired services rather than risk litigation. However, this policy penalizes the customer and is a poor answer to the malpractice problem. There is a proper way to practice positive defensive pharmacy by extending all of the pharmaceutical services available at that particular pharmacy to the customer. Many leading pharmacy practitioners have demonstrated that this approach is best, not only for the customer, but also for business. As a professional, the pharmacist is subject to two types of harm from a professional liability lawsuit: money damages and loss of esteem (reputation). Insurance against money damages is easily obtained, but the only way for the pharmacist to protect that fragile asset called reputation is through constant vigilance in daily practice and through maintaining the competency to practice. 0
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American Pharmacy Vol.NS18, No. 11, Oct. 1978/598
I
n February 1978 an article ap. pea red in the APhA Weekly under the following headline: "Rite Aid Loses $950,000 Negligence Case ."1 The Rite Aid Corporation, a chain of 524 pharmacies in and around Pennsylvania, and the pharmacist were found negligent in providing an occasional unauthorized refill of a prescription for prednisone over an 18-month period to Michael J. Eagen, son of the Pennsylvania Supreme Court chief justice. Eagen's claim was that he had developed cataracts and become almost blind as a result of using the drug. The case was filed against the physician also, but he is now dead and was not found negligent. Eagen's lawyer had originally asked for a $150,000 settlement. The judge awarded $700,000 compensatory damages to Eagen and his wife and $250,000 punitive damages to Eagen. The case is now on appeal to the Common Pleas Court of Pennsylvania. For the last decade, pharmacists have watched with growing concern the plight of their medical colleagues and the burgeoning malpractice claims and costs. Dr. Malcolm C. Todd, past president of the American Medical Association (AMA), recently said, "The cost of medical malpractice insurance is the biggest problem facing the young physician entering practice today."2 Many physicians in northern California refused to pay the skyrocketing premiums, which increased at the rate of 350 percent in some years. 3 For example, in 1975, annual rates for the lower risk group jumped from $1,032 to $4,644 and from $4,920 to $22,140 for the highest risk group. The number of claims, as well as settlement amounts, increased to the point where many insurance companies dropped physician professional liability lines. This
Don Newman, who writes on legal affairs, is director of the Washington office of the state of Indiana. This paper is intended by American Pharmacy as information only, not as legal, accounting or other professional service. If legal advice is required, the services of a competent professional should be sought. References may be obtained from the editor of American Pharmacy. American Pharmacy VoI.NS18, No. 11, Oct. 1978/599
lack of coverage compounds the problem. The issue of skyrocketing medical malpractice insurance costs and settlements has become so far reaching that today every state legislature is involved in an attempted resolution.
experiences of the last decade reflect what may be forecast for pharmacists? To answer this question, several areas of concern must be explored.
Balancing of Patients' and Pharmacists'Rights
Several reasons for the increased concern over medical malpractice have been identified recently. Deterioration of the professional relationship between patient and physician is one of the most frequently cited causes. Increased specialization, fragmentation of patient services and poor communications have strained these traditionally close relationships. As the medical care system has become increasingly complex, the delivery of such car~ has become impersonalized. In thIS atmosphere the patient has been less hesitant to file a suit against this impersonalized system and its providers.7 Costs must be weighed, in terms not only of awards, but also of the successful litigation. Being sued is an unpleasant and disruptive experience even when the suit is defended successfully. Both a practitioner's time and reputation usually are diminished in the process. 8 A practitioner's reputation cannot be evaluated, but the impact of premium costs can be. The total cost for medical malpractice premiums in the United States rose from $60 million in 1960 to $1 billion in 1975. 9
The basic reason for the difficulty in reaching a solution to the malpractice problem is the need for the balancing of rights. The patient has a right to treatment and care from the duly licensed health professional which meets an established standard of care, and a constitutionally protected right of redress in the event that standard of care is not provided. The health professional has a right to practice the established standard of care in an environment free of harassment and persecution. In his book, The Truth About Medical Malpractice, Ronald E. Gots states, "Proper solution must maintain the public right to legal redress at the same time as they deal with the most pressing excesses of bias against the medical community. The voluminous wave of nonmeritorious suits and the inordinately high awards in the successful ones must be brought under control, ... but in the final analysis, legal recourse should be reserved for those cases in which fundamental rights have been truly violated." One writer claims that the law in any field, when it has been derived mostly from the decisions of judges, as the law of malpractice has, is fundamentally distilled common sense. 5 Perhaps what is most difficult for legallaymen to focus on is the court's concern for legal balancing. Justice William O. Douglas expressed it succinctly when he said, " ... there are few areas of the law in black and white. The greys are dominant and even among them the shades are innumerable. For the eternal problem of the law is one of making accommodations between conflicting interests. This is why most legal problems end as questions of degree."6 In the meantime, pharmacists are growing more concerned about the future. Do the medical practitioner's
Concern Over Malpractice Claims
Increased Costs in Pharmaceutical Malpractice The incidence of malpractice claims against the pharmacist is relatively low compared to the number of medical malpractice claims. Obviously, the medical decision ma~er assumes a higher exposure and fIsk when involved in the practice of medicine than the pharmacist does in pharmacy as it is now practiced. ~ut recent pharmaceutical malpractIce insurance increases should heighten the pharmacist's awareness of the possibility of a trend. lo In 1967 the average rate for pharmaceutical malpractice insurance was $0.42/$1,000 of total store volume. (It varied from a low of $0.36/
15
$1,000 to a high of $0.48/$1,000 based on geographical location.) In 1977 a national rate of $0.60/$1,000 of total store volume was established.ll At the same time, base limits on pharmaceutical malpractice insurance were increased from $5,000/ $15,000 to $25,000/$75,000. Within that time frame the average total annual pharmacy sales increased from $198,917 in 1967 to $325,656 in 1977. 12 Since the cost of base coverage of this insurance is the product of the new rate times the yearly expanding total store volume, the impact is evident. However, there is an inherent danger in using statistics: supporters may find them superfluous, and critics may find them used like an inebriate around a lamp post-for support rather than illumination . But there can be little argument: the rate, the limits and the cost of pharmaceutical malpractice insurance have increased measurably in the last decade. Additionally, increased coverage is usually purchased. Currently, the most popular coverage appears to be $200,000/$600,000. 13 The customer (commonly the plaintiff in a malpractice suit) may base a claim on anyone of three theories of recovery: negligence, breach of warranty or strict tort liability.1 4 Negligence is the most common foundation for a malpractice suit, but pharmacists should not ignore the other two claims. Even though most breach of warranty suits in pharmacy involve the manufacturer, the pharmacist also is exposed to both express warranty, e.g ., in making an express statement about either a prescription or an OTC drug, and implied warranty as the seller of products. Express warranty is the older claim and fairly well understood, but implied warranty is a newer and more subtle basis for liability. The leading case in the field is Henningsen v. Bloomfield, decided in 1960. The court held both the manufacturer of an automobile and the dealer who sold it to the purchaser liable for injuries sustained by the purchaser's wife when a wheel broke. Is In a recent survey submitted by 23 insurance companies reporting on
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product liability claims for July I, 1976, to March IS, 1977, successful suits on prescription drugs were brought by 92 parties. Prescription drugs had the highest average claim settlement of any product. The average drug product claim settlement of $171,173 was almost twice as high as the next category (tractors, trucks, mobile homes, etc.) at $92,405. 16 Further, the total number of product liability cases brought before federal courts increased 134 percent from 1,579 cases in FY 1974 to 3,696 cases in FY 1976, according to the administrative office of the United States Courts. I7 There is, however, relatively little case authority dealing with the liability in warranty of a pharmacist selling physician-prescribed drugs except when the product is sold under the pharmacist's own label or the pharmacist's own product is prescribed by the physician. I8 According to the surveys, the number of claims involving pharmacists' liability appears to be increasing gradually, while the amount per claim is rising at a more rapid rate.1 9
History of Pharmacy Malpractice The profession of pharmacy has been practiced in one form or another since human history has been recorded . An Egyptian papyrus of 3300 B.C. sets out a prescription formula. Over the span of centuries the physician and pharmacist were one. The development of our pharmacist of today did not occur until the early 1800s. A great reaction against the harsh medicines and the heavy dosages in which they were given produced contention among the sects in medicine and the factions in pharmacy. Gradually, pharmaceutical manufacturers took over the preparation of capsules, tablets and liquids . The mortar and pestle practically disappeared, and there emerged the pharmacist of today, who compounds fewer drugs but dispenses a great many more, both in kinds and in quantities, thus multiplying the opportunities for errors and the damage done by them.2o The basis of pharmacists' liability
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usually involves supplying the wrong drug, failing to give adequate warning, misrepresenting a substitute or making errors in filling a prescription. The overwhelming majority of cases predicate the pharmacist's liability on negligence, even though the first apparent case on the subject of pharmacists' liability was Fleet v. Hollenkamp,21 1852, which held that the pharmacist was an insurer of the wholesomeness of the article he supplied. Negligence is defined as omitting to do something that a reasonable person, guided by considerations that ordinarily regulate human affairs, would do, or doing something that a reasonable and prudent person would not do. 22 Since the degree of harm that may be done by a pharmacist's mistake is great, the standard of care imposed by the law is a high one: "People trust not merely their health but their lives to the knowledge, care and prudence of druggists, and in many cases a slight want of care is liable to prove fatal to someone."23 Not all courts speak of the pharmacist's duty in terms of the highest degree of care. Many use the term "ordinary care," but this is a distinction without a difference. To avoid negligence, one must use the care that a reasonable and prudent person would use under the circumstances. Whether it is described as "the highest," "ordinary" or "that commensurate with the risk," it can be measured only by the circumstances, which must include the risk to be guarded against. Any reasonable and prudent person would increase the care with the increased risk. Thus where the risk to be guarded against may be death, the highest care is in order, whether it is called "ordinary" or "highest." And when a person is self-represented to the public as having special competence, then the law imposes the duty of a reasonable and prudent person with that particular competence. 24 There are two possible standards against which a practitioner in the health field is measured: the local standard (commonly referred to as the "locality rule") and the general standard. If a pharmacist's practice is American Pharmacy VoI.NS18 , No. 11 , Oct. 1978/ 601
measured under the locality rule, "He is only required to have that reasonable degree of learning and skill which is ordinarily possessed by other druggists in good standing as to qualifications in similar communities ."2s Historically, there was an implication that medical practice in a small village differed from medical practice in a large city. However, in recent years the courts have been chipping
How to Select Malpractice Insurance Considerations in selecting a malpractice insurance policy include the following: • Consultation activities as well as product-dispensing activities should be covered. • Peer review coverage should be provided. • Coverage must be maintained for all locations in which a pharmacist practices. • Popular coverage is $200,000/ $600,000. • Court "costs" should be covered. • Legal costs should be borne by the insurance company. • Lost wages are a consideration. • It is desirable to require the pharmacist's agreement to any settlement. • Employee pharmacists should have an individual policy. • A relatively new approach to underwriting professional liability is the "claims-made basis." This is not as good as the "occurrence basis," which protects the insured against any occurrence during the term of the policy, even after it may have lapsed. 68 away at the strict application of this rule. For example, more recent opinions have held that physicians must maintain a standard of medical practice coexistent with medical centers readily accessible for medical trea tment which can be outside their locality. The implications of the erosion of the locality rule applicable to general practitioners should not be over-
looked by pharmacists . Medical specialists and nurses already are held to a general national standard of practice. 26 - 28 If this general standard is applied to pharmacists, does it mean that ultimately they may be obliged to maintain customer drug profiles, warn the physician and the patient of known contraindications, alert the patient to possible drug side reactions, inform the physician and the patient of new, superior drugs, warn the physician and patient of drug incompatibilities and perform a host of other pharmaceutical services now performed by some pharmacists but not others? In earlier cases, more often than not, the defendant pharmacist supplied poison by mistake in answer to an oral request by the customer for a named drug. In a frequently cited Michigan case, Brown v. Marshall, the defendant sold the plaintiff sulphate of zinc for epsom salts with the explanation it was a little dark from exposure. 29 Other cases in the early 1900s involved dispensing calomel for morphine,30 strychnine for morphine,31 acetanilid for phosphate of soda 32 and "roachsault" (roach poison) for "rochelle salts" (mild purgative).33 In a number of cases the defendant supplied a substitute for the drug requested by the plaintiff with assurances that it was the same thing or just as good. In the first case the defendant supplied calomel tablets for liquid cascara sagrada under his own label, and the court ruled that there was enough evidence of negligence to go to the jury.34 Negligence was found where the defendant substituted bichloride of mercury tablets for "Seiler's Antiseptic" tablets,3s defendant's own cold tablets for plaintiff's request,36 defendant's recommended laxative which killed plaintiff's dog,37 and defendant's own skin cure for plaintiff's pre scription. 38 The cases involving errors in filling prescriptions by pharmacists began in 1887 with Beckwith v. Oatman, in which the defendant supplied the wrong compound for the treatment of bronchi tis. 39 The leading case of Tremblay v. Kimball, decided in 1910, affirmed a judgment of $ 1,400 for 17
the plaintiff when corrosive sublimate containing bichloride of mercury and muriate of ammonia was accidentally substituted in a prescription calling for chlorodyne tablets. 40 Judgments for negligence have been awarded for mistakes in products, in strengths of the same product and in quantities of the same product, for mislabeling, for misdirecting, for other miscellaneous acts and for violation of statutes. Ordinarily, the plaintiff has the burden of proving the defendant guilty of negligence. But some courts have held that the proof of the delivery of a dangerous drug for a harmless one raises a presumption of negligence, thus throwing the burden on the pharmacist to explain how the mistake could happen without negligence. 41 Some courts say that it is a prima facie case of negligence. Other courts place the defendant in the same position by applying the doctrine of res ipsa [aquifer. 42 As generally stated today, conditions necessary for the application of res ipsa [aquifer are that (1) the injury does not occur in the absence of negligence, (2) the defendant had exclusive control of the event in which the plaintiff was injured and (3) the plaintiff was not contributorily negligent. 43 Pharmacists found guilty of a violation of a statute do well to accept the fact of their negligence and concen tra te their attack and the court's attention on the lack of proximate cause, the absence of damages, or the plaintiff's contributory negligence. 44 Proximate cause is most easily explained by the "but for" rule: The defendant's conduct is not the cause of the event, if the event would have occurred wi thou tit. At mos t this is a rule of exclusion. 45 In every action for negligence it must be established that the defendant's action was the proximate cause of plaintiff's injury. A necessary element of a cause of action for a negligent act is that the plaintiff must have suffered actual damages as a result of the negligence complained of. All too often, plaintiffs feel that they should be entitled to a reward for having discovered defendant's negligence. The law offers no such reward. No matter how 18
negligent the defendant's conduct may happen to be, the plaintiff's recovery rests on proof of damages. There may be recovery for punitive damages as well in a proper case. 46 The defendant may plead contributory negligence, comparative negligence and assumption of the risk by the plaintiff. Historically, contributory negligence of the plaintiff
apportioned between the plaintiff and the defendant . The assumption of the risk is the subject of much controversy. In its simplest sense, assumption of the risk means that the plaintiff, in advance, has consented to the defendant's action, thereby relieving the defendant of all legal duty. However, the plaintiff must know and understand the risk, and assume it voluntarily.4 7 Perhaps the most significant conclusion to be drawn from a historical study of the cases involving negligent liability of the pharmacist is that there are relatively few such cases. It is impossible to know whether this small number of lawsuits was due to the superb job being done by pharmacists in avoiding mistakes, the difficulty of tracing mistakes, other members of the health team receiving greater attention by litigants, an enhanced pharmacist/customer relationship, systematic enforcement of strong pharmacy laws or a combination of these factors. Status of Pharmacist Malpractice
'Ordinarily, the plaintiff has the burden of proving the defendant guilty of negligence. But some courts have held that the proof of the delivery of a dangerous drug for a harmless one raises a presumption of negligence ...' would bar recovery where the defendant's liability was predicated on negligence. But if the defendant's negligent conduct was willful or reckless, then the plaintiff's contributory negligence would not bar recovery. The hardship of the doctrine of contributory negligence is apparent: it places on the plaintiff the entire burden of the loss for which the defendant is also partially responsible. Many states have tempered this result by the promulgation of comparative negligence statutes, whereby damages are
A story is told about the mythical small town where there was one lawyer but not enough business to support him. Then another lawyer moved to town and there was enough business for both of them. This is indeed a "litigious society." And as part and parcel of this litigiousness, claims against professionals continue to multiply dramatically. There is no reason to expect tha t the frequency of these claims will return to former" normal" levels in the foreseeable future. Projections for 1978 indicate that 10 of every 100 practicing lawyers can be expected to be sued this year. 48 People are even exhorted to sue. An article on the subject in one magazine contained the introductory statement, "For many people, the only time in their lives when they have a chance to lay their hands on as much as $100,000 is when they are injured because of someone else's carelessness."49 A study of medical malpractice in the United States was published in 1973. Although the statistics on which this study was based are American Pharmacy VoI.NS18, No. 11, Oct. 1978/602
dated, the findings are provocative. There is at least the suggestion that as the patient educational level improves and the consumer movement builds up steam, the malpractice claim will be more effective as a control mechanism. The doctrine of res ipsa loquiter is being applied by an increasing number of jurisdictions at an increasingly frequent rate. The cost of health care is rising rapidly; this rate suggests that as hospital ex-
penses increase, malpractice cases will increase. 50 William J. Skinner in a recent article stated, "Pharmacists are now facing new problems in the malpractice field, especially now that clinical consulting, patient records, and pharmacy expertise are being used more and more ."58 Patient drug profiles are now amanda tory service of New Jersey pharmacists. Other pharmacists are taking patient drug histories
and advising patients on drug usage. When prescriptions call for a drug by generic name, the pharmacist usually chooses the brand to be dispensed. An important question regarding the emerging role of pharmacists is the compromise of the laws that prohibit the substitition of prescribed drugs. Most states have laws that prevent the filling of a prescription calling for one brand with another brand. This may be a trademark vio-
Do's and Don'ts of Pharmacy Practice A leading pharmacist/attorney practitioner, Arthur I. Goldberg, has developed eight simple rules based on his observations of the evolution over the past 10 years of malpractice cases involving pharmacy; 1. Do establish a clear set of procedures for receiving, compounding, dispensing and recording prescriptions . Keep these records up-to-date. Don't falsify records or go back to fill out an incomplete record to make the situation look better. An inconsequent impropriety can damage your credibility and destroy your defense . 2 . Do observe all laws, regulations and ethics governing the dispensing of drugs. These rules provide an independent standard of reasonable care which operates to your benefit . Don't break these rules. Not only does it increase your exposure in a malpractice case by making your position difficult to defend, but it also subjects you to disciplinary proceedings and a possible loss of insurance protection. Most insurance policies relieve the carrier from responsibility if the claim is caused by an illegal act. Thus an unauthorized and illegal substitution or an unauthorized dispensing or refilling of a prescription can hurt your defense, remove your insurance protection and expose you to disciplinary proceedings and state and federal criminal prosecution. 3. Do be candid and honest about a mistake if it occurs, keeping the patient's welfare uppermost in mind. An honest attempt to do your best under the circumstances has often prevented serious injury and has removed the personal antagonism that precipitates many such suits. Don't try to cover up a mistake and mislead the patient or physician. This impression invites further inquiry and action. More than one plaintiff has said, "I wouldn't have thought of suing if the mistake had been admitted and if everything possible had been done to help." 4. Do force others to inconvenience themselves, rather than have you break or bend the law. Don't rely on doctors, nurses and patients to back you up, even if your deviation from required procedure was for their convenience.
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5. Do be particularly careful with patients who have" chronic conditions. Treat each refill as a new prescription-and check on the patient's condition, visits to the doctor and other medication. This is an area that requires greater inquiry, attention and responsibility. Don't assume that patients with chronic conditions have stable conditions, see their physicians regularly or are aware of the potency of their medications. Familiarity does breed indifference to both dispenser and patient. Too often, delicately balanced conditions are upset because patient and pharmacist become too · casual about refills and the continued taking of the same medication. 6. Do secure maximum insurance coverage with a carrier that specializes in this field. A broker, agent and insurance carrier-familiar with the problems of pharmacy-are important to you if a problem should occur. Don't assume that an association, employer or other party carries insurance that protects yo\,!. Get a representation in writing from the insurance company if this is the case. 7. Do report any incident immediately to your insurance carrier and attorney. Cooperation to make available all information promptly is essential. On hearing of an incident, sit down and write a chronological history of everything you know that occurred. Give it to your attorney to review and forward to your insurance company. Don't discuss this matter with anyone other than your attorney and insurance company representative (except as described above to aid in correcting the medical problem). Don't sign anything your attorney does not see. Don't divulge your records, except to your attorney and carrier. 8. Don't allow the threat of malpractice to make you practice pharmacy defensively and covertly. A compe.tent, careful pharmacist should practice the profession to the fullest extent possible and should not allow the specter of "malpractice" to inhibit the satisfaction and sense of accomplishment that result from the proper practice of pharmacy. 69
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'One of the toughest value judgments to give to a jury is whether the professional's performance met the required standard of care. What is a "competent" pharmacist? What should the minimum standards for the profession be?'
lation and evidence of unfair competition. But some states have a law that gives this authority to the pharmacists. 59 The U.S. Congress is considering bills that would override the states' antisubstitution laws by allowing pharmacists to substitute drugs and/or requiring that the product dispensed be the least expensive drug in the pharmacist's inventory (5.2179, H.R.1963). Unquestionably, as pharmacists assume the role of decision makers, they become greater risk takers.
Current Trends in Pharmacy The ability of new drugs is greater to do good-and greater to do harm.
Recent Malpractice Cases • A child became ill after a penicillin shot. The physician phoned a prescription for 2 gr aspirin suppositories in to the pharmacy. The employee who took the call and filled the prescription was not a registered pharmacist. He filled the prescription for 2 gr seconal suppositories. The child became worse and was hospitalized. In the subsequent suit the plaintiff received $22,000 actual damages and $2,500 punitive damages from the pharmacy and the employee. The case is of interest in that punitive damages were allowed even in the absence of Illalice and that the pharmacy was responsible as the employer. 51 • A man was informed that he should treat his family for worms. The pharmacist sold him "Jaynes Vermifuge" for children and adults. The children's package was labeled by the manufacturer, "CAUTION-Tablets must be swallowed whole-not chewed or crushed .... " The tablets contained hexylresorcinol, a drug which causes superficial erosion of the mucous membrane of the mouth and stomach. The three-year-old child chewed the tablets, contrary to her father's instructions, and became ill. The second day she was taken to the hospital, where she died on the third day of respiratory failure and convulsions. A toxicology report showed Darvon (propoxyphene hydrochloride) in her stomach and a trace of hexylresorcinol in her kidneys, but neither in sufficient quantities to be considered fatal. The father sued the pharmacist and manufacturer but received nothing, since the warning on the label was ignored. But this case does il-
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lustrate the risk the pharmacist assumes in selling an OTC product. 52 • A 38-year-old housewife and mother had lung surgery followed by a prescription for Chloromycetin (chloramphenicol). She died the next year of aplastic anemia caused by the Chloromycetin. Negligence was claimed against the physician and the drug firm, and $400,000 in damages was awarded the plaintiff. Even though the manufacturer complied with all FDA rulings on the warning, the court concluded that the firm had overpromoted" the drug so as to induce physicians to prescribe it. The .decision implied that the manufacturer had complied with the letter of the law but not with the intent of the law. 53 • A customer who had undergone oral surgery had her prescription for Percodan (a combination product containing aspirin, caffeine, oxycodone hydrochloride and phenacetin) mixed up with another customer's prescription and took Meticorten (prednisone) for three days. At the trial she claimed weakness, nausea ahd hypertension as complications brought on by Meticorten. The trial court judge awarded plaintiff $4,500 over the claim of the pharmacist that the customer was contributorily'negligent in taking medication from a bottle with someone else's name on the label. The case was affirmed in favor of the plaintiff. 54 In some states, if proved, contributory negligence is a complete bar to plaintiff's recovery. • A situation arose whereby more than one person was negligent in this case, and the court spoke to the sharing 1/
of negligence damages by third part"ies. The court stated "that where a third party is found to have been responsible for a part, but not all of the negligence for which a defendant is cast in damages, the responsibility for that part is recoverable by the prime defendant against the third party defendant. To reach that end there must necessarily be an apportionment of responsibility in negligence between the parties."55 ' • A tranquilizer was dispensed instead of the prescribed oral contraceptive. The patient, who became pregnant and delivered a child, sued the pharmacist for damages. Damages were awarded which included child support until the child reached the age of majority. The pharmacist argued that having a child isa blessing and not the kind of "harm" that was compensable under tort law. The court disagreed. 56 • A plaintiff claimed that she suffered severe and permanent injuries because of the diethylstilbestrol prescribed by the defendant physician, supplied by the defendent manufacturer and dispensed by the defendant pharmacist to her mother while she was pregnant with the plaintiff. The entire action against ·the pharmacist was dismissed but over the dissent of the judge authoring the opinion. The judge, who was in the minority on appeal, thought the plaintiff's claim of strict liability against the pharmacist had merit in that the pharmacist had not demonstrated that he did not have or could not have attained the knowledge of the poten tial risks involved with diethylstilbestrol.
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Patient warnings take on added importance under these circumstances. Informed patient consent becomes critical to all concerned. Nowhere, at the moment, has this concern become more evident than with oral contraceptives. Patient package inserts (PPIs) imply informed consent on the assumption of three responsibilities: the manufacturer has the responsibility to supply the PPI; the pharmacist has the responsibility to dispense the PPI; and the patient has the responsibility to read the PPI. 60 The lis t of drugs that require dispensing with the PPI undoubtedly will grow in the near future. PPIs constitute the most direct way of informing the patient visibly about a particular medication . One of the direct considerations with the new drug product selection laws is the liability of the prescriber if the choice of manufacturer is given to the pharmacist. Only about onethird of the states that have such a law now exempt the physician from liability.61 Another trend is the publication of a manufacturer's policy covering pharmacist-dispensed generic drugs . The inference is that pharmacists are shopping for both quality protection and quality generic pharmaceuticals. A common clause in all such policies is the assumption of risk by the manufacturer only if there is a lack of negligence on the part of the pharmacist .66 The arguments for generic drug substitution laws are usually economic. The generic drug is generally less expensive than the trademark equivalent. If quality is comparable, the consumer could benefit. But if it is not, then the consumer risks losing both good health and good money. 62 The state of Washington promulgated a regulation requiring pharmacists to communicate prescription information to each patient. Subsequently, 1,200 questionnaires were mailed to physicians throughout the state soliciting their opinions on the regulation. Of the 482 returned questionnaires, 85 percent felt that the regulation was beneficial or of no harm to their patients and practice. 63 The most substantial attempt to redress the malpractice problem is
American Pharmacy VoI.NS18, No. 11, Oct. 1978/605
being made at the state legislative level. Many changes that will prove crucial are now affecting both the contributors and the consumers of health care. It is clear that they have a common goal: making the malpractice risk insurable at reasonable rates. 64 One of the toughest value judgments to give to a jury is whether the professional's performance met the required standard of care. What is a "competent" pharmacist? What should the minimum standards for the profession be? Independent of this question, a joint project by the American Pharmaceutical Association and the American Association of Colleges of Pharmacy launched a national survey of 5,000 pharmacists in an attempt to establish just such a model for national standards of practice for pharmacists. 65
Conclusion Pharmacy is the prime target on the horizon for malpractice suits. Clinical pharmacy with all of its attendant exposure and the increasing desire of young pharmacists to expand their area of responsibility will bring about a concomitant increase in this area of liability. The incidence of lawsuits filed against pharmacists appears to be increasing, although it is difficult to
collect reliable data. One underwriter stated that the claims involving pharmacists during the last six months of 1976 were three times the number it handled in the first six months of 1976. 67 Some commentators claim that malpractice cases or the threat of them has an adverse effect on quality standards . It is possible that a pharmacist could practice negative "defensive pharmacy" by choosing to forego any unrequired services rather than risk litigation. However, this policy penalizes the customer and is a poor answer to the malpractice problem. There is a proper way to practice positive defensive pharmacy by extending all of the pharmaceutical services available at that particular pharmacy to the customer. Many leading pharmacy practitioners have demonstrated that this approach is best, not only for the customer, but also for business. As a professional, the pharmacist is subject to two types of harm from a professional liability lawsuit: money damages and loss of esteem (reputation). Insurance against money damages is easily obtained, but the only way for the pharmacist to protect that fragile asset called reputation is through constant vigilance in daily practice and through maintaining the competency to practice. 0
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