Pharmacy Malpractice: A Prescription for the Problem
Pharmacy Malpractice: A Prescription for the Problem by Thomas A. Cifarelli
Reprinted from the Consumer Attorneys Association of California's Forum Magazine (2002)
I. INTRODUCTION
Pharmacists and pharmacies enjoy a level of trust unparalleled in the healthcare field. Patients who question their medical care, often seeking two or three opinions from physicians or hospitals, routinely accept the medications dispensed by their pharmacists without a second thought. This enormous trust is understandable, since pharmacists are not asked to diagnose illness, but are simply expected to accurately dispense the medications prescribed by physicians. Nonetheless, thousands of pharmacy errors occur each year, sometimes with devastating effects. The recent growth of national corporate pharmacy chains must be examined when assessing the possible causes of pharmacy errors. This article is designed to identify the most common types of prescription errors, assess the methods available to impose liability for such errors, and explore the damages which may be appropriate in such cases.
II. TYPES OF PHARMACY ERRORS
Any instance where a pharmacy patient does not receive precisely the medication and dosage ordered by their doctor should be considered as a potential malpractice case. In fact, prescription errors can come in many forms.
One of the most common misfilling errors involves dispensing medication different from the one ordered by the doctor. This is perhaps the clearest example of pharmacy negligence. At their most fundamental, the pharmacist's duties include inspecting the doctor's prescription, the medication dispensed for it, and the medication label before giving it to the patient. Pharmacists have a duty to ensure that the drug prescribed is exactly the one dispensed. Two factors that may influence such errors are the growing trend of large pharmacies to place undue influence on sales volume and the fact that many entirely different medications have very similar names. It is easy to see how an environment where pharmacists are sometimes expected to fill upwards of 40 or 50 prescriptions per hour to meet sales expectations can result in cases where incorrect medications with similar sounding names are erroneously dispensed, with disastrous results. I will address the growing emphasis on pharmacy sales and profit below.
Another type of misfilling can occur when the correct medication is dispensed in an incorrect dosage. For example, the doctor prescribes 5.0 mg pills, but the pharmacist dispenses 50 mg pills. An over- or under-dosage of the correct medication can cause as much harm as taking the wrong medication.
Mislabeling is yet another variety of misfilling. This sort of error involves dispensing the proper medication with a label containing improper use instructions. Another mislabeling error involves inadequate or erroneous warnings. Attorneys presented with a prescription error case should compare the label instructions with the doctor's written prescription. The prescription itself can be obtained from the pharmacy, which is required to maintain the script as part of its patient medication records. (Cal. Code of Regs. § 1707.1.)
Another type of pharmacy error which may trigger liability involves a pharmacy dispensing a drug contraindicated for a medication the pharmacy knows the patient is concurrently taking, with no physician order approving the simultaneous use of both substances.
In any pharmacy error case, several steps should be taken to secure all the prescribed, there are several other responsibilities inspired by a broad array of federal and state legislation. All such statutes should be considered when prosecuting a pharmacy malpractice case.
A. Omnibus Budget Reconciliation Act
One of the most important recent developments in the area of pharmacy services was the Omnibus Budget Reconciliation Act of 1990 (OBRA), Pub. L.No. 101-508, 104 Stat. 1388 (1990). This federal legislation mandates certain pharmacy services for Medicaid recipients. One of the most important of OBRA's provisions relates to drug use review (DUR). These provisions of the legislation are specifically designed to improve quality of patient care through specific pharmacist responsibilities. The DUR provisions require the pharmacist to maintain a patient profile to identify all of the medications a particular patient is taking, regardless of the prescribing doctors. It is not uncommon for patients to have several prescriptions dispensed from different physicians at the same time. Under such circumstances, the pharmacist may often be the only health care provider with complete information regarding that patient's medications. Recognizing the pharmacist's unique knowledge and ability to protect against possible harmful interaction from multiple medications, OBRA requires pharmacists to review the patient's profile for harmful interactions and to counsel patients about the prescribed drug therapy and its potential side effects. At the very least, a pharmacist must offer counseling services regarding the medication.
While OBRA technically applies only to Medicaid patients, nearly all 50 states have enacted OBRA-inspired regulations which cover the dispensing of prescriptions to outpatients. California is no exception, with several statutes enacted regarding the pharmacist's responsibilities.
B. California Law
California common law recognizes that a pharmacy error such as dispensing a medication with a label containing improper use instructions will trigger a breach of duty claim for negligence. (See Huggins v. Longs Drug Stores Cal. Inc. (1993) 6 Cal.4th 124.)1 No doubt inspired by OBRA, over the last several years California's Legislature has passed a number of statutes imposing additional pharmacist responsibilities.
For example, Business & Professions Code § 4076 addresses a pharmacist's duty regarding prescription containers and labeling. The statute mandates that a pharmacist "shall not" dispense any prescription in an incorrectly labeled container. (See § 4076 (a).) More specifically, the statute requires that labels include use directions, the patient's name and the prescriber's name, the date of issue, the pharmacy location, the strength, quantity and expiration date of the medication, as well as additional information depending upon the type of prescription dispensed.
Similarly, California Code of Regulations, Title 16, Article 2 outlines a host of pharmacist duties. For example, section 1707.1 requires that a pharmacy maintain medication profiles, with specific information regarding treatment and related conditions, on all patients who have prescriptions filled at that pharmacy. Furthermore, section 1707.2 requires pharmacists to provide oral consultation to patients upon request or whenever the pharmacist deems it warranted in the exercise of judgement and section 1707.3 requires pharmacists to review a patient's drug therapy and to screen for drug therapy problems. Provisions of the Health & Safety Code also address prescription labeling requirements.2
These statutory provisions provide a checklist for evaluating a pharmacist's conduct in a prescription error case. The pharmacist must comply with each requirement every time a new prescription is filled. Violations of any of these provisions should always be considered when evaluating a pharmacy error case. If a breach of any statutory duty can be established, a negligence per se jury instruction should always be considered at trial.
C. Another Statutory Remedy
The Consumer Legal Remedies Act, codified as Civil Code § 1750 et seq., has received a great deal of attention in recent years. The Act has been invoked in deceptive advertising claims ranging from credit card fraud to medical malpractice in the HMO field. (See e.g., Broughton v. Cigna Health Plans of California (1999) 21 Cal.4th 1066.)3 This statute provides a powerful tool to prosecute pharmacy error cases. More and more often, pharmacies, particularly national pharmacy chains, rely upon smoothly packaged advertising campaigns to lure customers away from their neighborhood stores to new, larger pharmacy chain outlets popping up all over. Invariably, these chains utilize advertisements touting their safety programs, promising abundant safety checks, high tech computer safety programs and caring pharmacists purportedly available 24 hours a day for their customers. Not surprisingly, these promises of superior care are often effective, luring customers to switch from their small local pharmacies to the chain store. If these promises are not kept, then a separate claim for false and deceptive advertising should be considered. Indeed, safety checks in whatever form would likely eliminate a huge percentage of pharmacy mis-fills. If a pharmacy advertises goods and services which are not actually delivered, the injured consumer should have more remedies than solely pursuing an action for simple negligence.
The Consumer Legal Remedies Act was designed to prevent precisely such misleading and deceptive advertising. The statute applies to the sale or lease of goods or services to any consumer and is to be "liberally construed." (See Civ. Code § 1770.) The statute makes a number of unfair methods of competition or unfair or deceptive acts or practices involving consumers unlawful. Some of the unlawful acts or practices which may be applicable in a pharmacy malpractice case include:
Representing that goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities which they do not have....
Representing that goods or services are of a particular standard, quality, or grade, or that goods are of a particular style or model, if they are of another.
Advertising goods or services with intent not to sell them as advertised.
Representing that a transaction confers or involves rights, remedies, or obligations which is does not have or involve. (Civ. Code § 1770 subds. (5)(7)(9)(14).)
When considered in the context of the advertisements regularly used by many pharmacies, particularly large national chains, to promote their services, these provisions seem well-suited. Moreover, it appears from the language of the statute that a non-intentional act may trigger liability. Specifically, the Act allows a defense if an alleged violation was "not intentional and resulted from a bona fide error notwithstanding the use of reasonable procedures adopted to avoid any such error." (Civil Code § 1784 (a), emphasis added.) By implication, therefore, the absence of such procedures should also support liability under the Act.
One of the most compelling reasons for the use of the Act in a pharmacy error case is the extensive remedies allowed under the statute. Indeed, one who suffers any damage as a result of any of the unlawful acts or practices is entitled to actual damages, injunctive relief and punitive damages, among other things. (§ 1780.) Further, an order of costs and attorney's fees is mandatory for a prevailing plaintiff. (§ 1780 subd. (c).) In addition, the Act is non-exclusive and may be pursued in addition to any other claim under law such as negligence. Finally, the statute of limitations for a claim under the Act is three years. (§ 1783.)
If the facts support it, the trial attorney should always consider the Act as an additional possible basis upon which liability may be imposed in a pharmacy error case.
IV. AN ARGUMENT FOR EXEMPLARY DAMAGES
Pharmacies are unusual malpractice defendants in that they bear little resemblance to most health care providers. Most often pharmacies function as part of larger stores where one can purchase everything from toys to school supplies, groceries and even small electronics and household appliances. Further, pharmacies are marketed not as traditional healthcare entities but as retail outlets meeting nearly all consumer needs. Newspapers regularly carry coupons for the larger chains and television advertisements are common for pharmacies. It is not surprising then that pharmacies are generally run as any other large corporation, with a strong overriding emphasis on sales, volume and profit. When such motivations interfere with the delivery of healthcare services, an argument for punitive damages should be zealously pursued.
A pharmacy's corporate philosophy and training may provide evidence to support the imposition of punitive damages. Although every business may understandably be motivated by profit and growth, the healthcare field demands that primary concerns be toward the health and well-being of patients. These interests are in direct conflict in the healthcare field. If you can prove that the pharmacy had a policy of putting profits and sales above patient care, then a good argument can be made that the pharmacy acted with a conscious disregard for the patient's safety sufficient to support punitive damages.
The method by which pharmacies evaluate pharmacists may also provide evidence to support punitive damages. If a pharmacist's salary or/and promotion is dependent upon sales, with no regard for patient care or safety, then an argument can be made that the pharmacy promotes a disregard for patient safety in favor of sales and profits. Similarly, if the pharmacist involved in a given error case has a history of past errors and the pharmacy has done nothing to correct or even address the problem with the pharmacist in question, then certainly one should consider a claim for punitive damages under the theory that the pharmacy was aware of an ongoing safety problem but disregarded it in favor of profits and sales.
Finding a good pharmacist expert will be an important part of arguing for punitive damages in a pharmacy error case. An expert will be particularly helpful in exposing the conflict between emphasizing pharmacy sales and profit over the pharmacist's professional responsibilities and ethical code of conduct to put patient care first. When looking for a pharmacy expert, I recommend searching pharmacy schools and hospital pharmacies to ensure that your expert is not him or herself subject to cross examination that they too were once aligned with the same corporate pharmacy mentality they have been retained to criticize. When selecting an expert you should also be mindful of his or her own history of dispensing errors. Although mistakes can happen to anyone, an expert with a long history of errors including any resulting in serious injury might be vulnerable to severe cross-examination on this issue. Since information on certain errors is generally publicly available through the State Board of Pharmacy, it is better to do your homework and uncover your expert's history rather than hope that the defendant does not unearth a potentially embarrassing track record.
As long as pharmacies continue to operate under a corporate philosophy of emphasizing sales and profits over patient care there will be arguments for the imposition of punitive damages. But remember, while pharmacies operate in a corporate culture, they still enjoy the benefits and protections of health care providers, including CCP § 425.13. Accordingly, any claim for punitive damages must be first established by motion showing specific evidence sufficient to convince a judge of the existence of a prima facie case of malice, oppression or fraud. (Looney v. Superior Court (1993) 16 Cal.App.4th 521.) In this regard, even if the evidence is in conflict, if the plaintiff has presented a sufficient pleading and evidence showing that a prima facie case will be established at trial, the court must grant the motion. (College Hospital v. Superior Court (1993) 13 Cal.App.4th 1193.)
V. CONCLUSION
Pharmacies are in a unique position, benefitting from the protections available under the MICRA statute while operating in a corporate setting driven by ever-increasing sales and profits. This combination can create a number of hurdles in the litigation context. Consequently, you must be prepared to address defenses made under the MICRA statute. However, a pharmacy's health care provider status should be used against it offensively. Pharmacies must be held to the same professional standards of other healthcare providers and should not be allowed to blatantly put profits ahead of patient care. Cases involving pharmacy errors should be zealously prosecuted to determine the type of error at issue, the statutes implicated by the error and the full measure of responsibility to be imposed on the pharmacy. Moreover, as health care providers, pharmacies should be held accountable for the full measure of damages resulting from operating in a manner that puts business interests above patient safety. As has been the case in many areas of our society improved through litigation, the "prescription" to cure much pharmacy malpractice will likely be aggressive and wise litigation.
1. The Huggins decision held that parents who administered prescribed medication according to erroneous instructions directing five times the dosage ordered by the doctor could not recover for emotional distress as direct victims.
2. See Health & Safety Code §§ 26630 and 26643.
3. Although the Broughton decision held that CLRA claims were subject to arbitration, with the trial court retaining jurisdiction only for purposes of issuing orders for injunctive relief, the holding impliedly establishes that healthcare services fall within the Act's protections.
