Court: Washington Supreme Court; November 30, 1989; Washington; State Supreme Court
Elaine McKee appeals a summary judgment dismissing her claims against pharmacists Gerald Sidran and Leonard Mezistrano, who filled her prescriptions for Plegine, an appetite suppressant, from 1974 to 1984. The trial court determined that the pharmacists had no duty to warn McKee about the drug's long-term adverse side effects. Plegine, an amphetamine classified as a class III drug, requires a prescription for each fill and is indicated for short-term use in weight management. The Physicians' Desk Reference warns of potential abuse and various side effects from prolonged use, including psychological dependence and severe dysfunction.
McKee filled nearly all her prescriptions at Sidran's pharmacy until he sold it to Mezistrano in 1981. Both pharmacists filled the prescriptions accurately and complied with labeling laws by removing the manufacturer's insert, which contained information about side effects. McKee did not receive warnings about the risks associated with long-term use, nor was she given the manufacturer's insert. In 1985, she initiated a lawsuit against the pharmacists, the prescribing physician, and the drug manufacturer, seeking damages for injuries attributed to her addiction to Plegine. Only her claims against the pharmacists are relevant to this appeal, alleging negligence for failing to warn her and for not providing the manufacturer's insert, as well as claims of strict liability and breach of warranties. The court ultimately affirmed the dismissal of her claims against the pharmacists.
Pharmacists sought summary judgment to dismiss all claims against them, arguing they had no duty to warn customers about prescription drug hazards. The trial court granted this motion, dismissing McKee's claims. McKee did not contest the dismissal of her strict liability and breach of warranty claims per RAP 10.3, failing to provide necessary legal arguments or authority to support them. Consequently, the court focused solely on her negligence claim. Under CR 56(c), summary judgment is appropriate only when there are no genuine issues of material fact, and the moving party is entitled to judgment as a matter of law. The court must view facts in the light most favorable to the nonmoving party. For an affidavit under CR 56(e) to be valid, it must be based on personal knowledge, present admissible facts, and demonstrate the affiant's competence. McKee's evidence regarding the standard of care relied on an affidavit from an Arizona physician, who was neither licensed in Washington nor a pharmacist, failing to meet the requirement for establishing the standard of care in Washington. As a result, the affidavit was deemed insufficient, leading the trial court to find no genuine issues of material fact. The appellate court affirmed the summary judgment granted by the trial court.
McKee argues that pharmacists had a duty to warn her about the harmful side effects of long-term Plegine use, seeking recovery under RCW 7.70.030(1), which allows for recovery when a healthcare provider fails to meet the accepted standard of care. Under RCW 7.70.020, pharmacists are classified as healthcare providers, and RCW 7.70.030 stipulates that the plaintiff must prove essential facts for recovery by a preponderance of the evidence. The requirements for proving a failure to adhere to the standard of care are outlined in RCW 7.70.040.
The court notes that the issue of a pharmacist's duty to warn is novel in Washington but aligns with the majority view in similar jurisdictions, which hold that pharmacists do not have a duty to warn. Citing a Florida case with similar facts, the court affirmed that pharmacists are not obligated to warn customers about the dangers of a prescribed drug or to inform physicians about a customer’s dependency. The responsibility lies with the physician to understand the drug and monitor the patient.
The Michigan Court of Appeals also supported this view, stating that while pharmacists must accurately fill lawful prescriptions, they are not required to warn patients of potential side effects when the prescription is valid and no warnings are mandated by the physician or manufacturer. The court referred to the "learned intermediary" doctrine established in Terhune v. A.H. Robins Co., which asserts that the duty to warn about prescription drug dangers lies with the physician, who is expected to inform patients based on their professional judgment. Thus, the patient relies on the physician's expertise regarding the medication's risks and benefits.
If a product is appropriately labeled with necessary instructions and warnings, manufacturers can reasonably expect physicians to use their informed judgment, based on the provided information and their own knowledge, to act in the patient's best interest. The learned intermediary doctrine, recognized by Illinois courts, establishes that physicians, as learned intermediaries, determine the appropriate drug for patients and decide which warnings to communicate. This doctrine was expanded to pharmacies in *Leesley v. West*. In *Kirk v. Michael Reese Hosp. Med. Ctr.*, it was affirmed that physicians decide how to inform patients about risks and benefits of drug therapy, relying on their medical judgment. Manufacturers are only required to warn physicians, not hospital personnel, as the latter do not prescribe medications. The foreseeability of injury without specific warnings varies based on individual patient conditions, which pharmacists cannot be expected to know. The physician-patient relationship is foundational to the delivery of medical services, and only the physician understands the complexities involved in choosing and prescribing medication. Pharmacists are obligated to fill prescriptions as directed and are not liable for negligence if the product is as intended. The relationship between physicians, patients, and manufacturers mirrors that of physicians and pharmacists, emphasizing the physician's role in assessing drug suitability and communicating relevant risks. The judgment of what constitutes a material risk lies with the physician, who is not required to disclose all potential risks, particularly when circumstances might justify nondisclosure. Pharmacists lack the medical training necessary to make these determinations.
Requiring pharmacists to warn patients about potential drug risks would disrupt the physician-patient relationship and ongoing treatment, with liability being more appropriately assigned to physicians. Most jurisdictions have similarly rejected imposing a duty to warn on pharmacists, as demonstrated in cases like Jones v. Irvin and Ramirez v. Richardson-Merrell, which highlight the potential harm of involving pharmacists in direct patient care decisions that should remain with physicians knowledgeable about the patient's medical history.
The court in Batiste v. American Home Products Corp. further established that a pharmacy cannot be held liable for failing to warn patients about side effects of medications, reinforcing that pharmacists are not qualified to advise on medical appropriateness.
While RCW 18.64.011(11) outlines the practice of pharmacy, including responsibilities such as monitoring drug therapy and providing drug information, it does not establish a mandatory duty for pharmacists to warn patients about drug dangers. The statute is definitional and does not impose specific duties, and WAC 360-12-150 clarifies that "monitoring drug therapy" pertains to institutional settings rather than community pharmacies. McKee argues for a duty to warn based on pharmacists' knowledge of the drug's risks; however, this duty is not universally applicable and is contingent upon the pharmacist's authority to prescribe, which is not the case here.
McKee cites Hand v. Krakowski and Riff v. Morgan Pharmacy to support her argument regarding pharmacist liability for prescription errors. In Hand, a pharmacy dispensed drugs contraindicated for an alcoholic patient, leading to the patient's death, establishing a potential duty to warn and question the prescribing physician due to the pharmacist's knowledge of the patient's condition. Riff involved a pharmacy's failure to address a prescription missing maximum dosage, resulting in an overdose, with expert testimony highlighting the pharmacy's negligence. Both cases emphasized the pharmacist's obligation to identify clear prescription errors.
However, McKee's case differs as the alleged negligence pertains to the physician's judgment about the appropriateness of Plegine for her condition. It is acknowledged that McKee's physician actively monitored her health during her treatment. Imposing the duty McKee suggests would require pharmacists to challenge physicians' judgments on prescriptions, a role outside their expertise and potentially infringing on the doctor-patient relationship. As noted by an Illinois court, the appropriateness of a prescription is contingent on both the drug's properties and the patient's specific condition. This duty would burden pharmacists and could create conflicts with physicians, undermining collaborative care. The prescribing physician is ultimately responsible for understanding the drug's characteristics, dosage, and monitoring the patient's treatment and safety.
Patients are responsible for informing their physicians about all medications they are taking. Drug manufacturers have an obligation to inform physicians about any adverse effects or necessary precautions related to their drugs. Assigning warning duties to pharmacists could lead to them second-guessing physicians’ prescriptions, potentially damaging the physician-patient relationship and causing unnecessary patient anxiety. Under RCW 7.70.020, pharmacists are recognized as health care providers, and the standards for proving deviations from accepted care are outlined in RCW 7.70.040. However, it is inappropriate to interpret these statutes as permitting testimony on pharmacy practices as a standard of care.
RCW 18.64 details pharmacists' responsibilities, including interpreting prescriptions and providing information about drugs, but does not mandate that pharmacists disclose all relevant information when filling prescriptions. While pharmacists may communicate therapeutic values and hazards, they are not legally required to provide complete contraindications or warnings. McKee, who had a prescription for each refill, was under continuous physician supervision.
Regarding the provision of manufacturer's package inserts, prescription drugs are exempt from over-the-counter labeling requirements under 21 U.S.C. 353(b)(2). The FDA mandates that inserts, which contain essential drug information, be directed to health care providers rather than consumers. There is no legal obligation for pharmacists to distribute these inserts, and imposing such a duty would create logistical challenges and potential liability issues for pharmacists, particularly since inserts are often only included in large drug packages.
Package inserts intended for physicians often contain technical details that may confuse patients. In response, the FDA mandated patient package inserts (PPIs) in 1980 to provide consumer-friendly information, but this requirement was rescinded in 1982, except for oral contraceptives and a few other drugs. There are concerns that direct consumer warnings could undermine the learned intermediary doctrine, which holds that physicians serve as the primary source of drug information for patients. Critics argue that even benign medications can have serious side effects, and providing detailed risks post-prescription could lead patients to reconsider their treatment decisions, potentially complicating the healthcare process. Additionally, mandating consumer access to manufacturer inserts could shift liability from physicians to pharmacists and manufacturers. The document suggests that any requirement for written warnings should be legislated, as the legislative process can evaluate the implications for all stakeholders involved.
In the case at hand, the court found that the pharmacists did not have a duty to warn the plaintiff, Elaine McKee, about the risks of Plegine, a drug prescribed by her doctor for ten years. The court upheld that pharmacists are responsible for accurately filling prescriptions and identifying clear errors but are not obligated to challenge a physician's judgment or provide warnings about side effects. The court affirmed the trial court's ruling that the defendants owed no duty to the plaintiff and were entitled to summary judgment, concluding that there was no genuine issue of material fact. Justice Dore dissented on the matter.
The plaintiff, during her deposition, asserted that she felt the amphetamines she was prescribed were crucial for her well-being despite being within her target weight range. The defendant pharmacists, Sidran and Mezistrano, chose to omit the manufacturer's warnings from the medication Plegine, which is an amphetamine associated with weight control but carries risks of addiction and severe side effects. Mezistrano admitted to removing the warning labels, claiming they were too complex for customers, despite the possibility of placing his label alongside the manufacturer's warnings. The warnings included critical information about the drug's limited usage for weight management and the potential for drug dependence, indicating that Plegine should only be used short-term. The pharmacists failed to inform the plaintiff about the necessity to discontinue use after a few weeks and the associated side effects, a negligence that persisted for ten years. Although the court acknowledges the pharmacists' potential negligence, the main issue is whether the plaintiff provided sufficient evidence for a jury to consider the negligence claim. The evidence suggests that the pharmacists did not meet the standard of care expected of healthcare providers, leading to the conclusion that the defendants' motion for summary judgment should have been denied, prompting the need to reverse the trial court's decision and remand for trial. It is established that pharmacists have a statutory duty of due care as defined in RCW 7.70.020.
RCW 7.70.040 establishes essential elements for proving that a health care provider's failure to adhere to the accepted standard of care resulted in injury. Key points include:
1. **Standard of Care**: The health care provider must demonstrate a degree of care, skill, and learning expected of a reasonably prudent provider in similar circumstances in Washington. This "reasonably prudent practitioner" standard is higher than the common law "average practitioner" standard, focusing on public expectations rather than peer expectations.
2. **Role of Expert Testimony**: Establishing the standard of care and causation typically requires expert testimony, as these medical facts are generally beyond the understanding of a layperson. Exceptions exist where laypersons can observe and describe certain facts without medical expertise.
3. **Jury's Role**: The determination of a pharmacist's duty of due care is a factual question for the jury, not a legal question for the court. The existence of a statutory duty under RCW 7.70.040 supersedes common law considerations regarding duty.
4. **Statutory Duty**: Under RCW 7.70.040, whether a duty exists is clearly established by the statute, leaving only the specifics of its application to be determined by a jury.
5. **Disagreement with Majority View**: The majority opinion incorrectly asserts that the standard of care for pharmacists is defined by RCW 18.64.011(11), which discusses pharmacy practice responsibilities. The majority interprets the language to suggest that providing warnings on dangerous drugs is optional, which the dissent contests as an incorrect application of the law.
In summary, RCW 7.70.040 defines a higher standard of care for health care providers, necessitates expert testimony for establishing medical facts, assigns the determination of duty to juries, and clarifies that statutory provisions govern this area rather than common law.
The argument presented lacks merit due to the misinterpretation of the statute, which has been taken out of context. RCW 18.64.011(11) defines the "practice of pharmacy" but does not address the standard of care for pharmacists. Specifically, RCW 18.64.020 prohibits practicing pharmacy without a license, implying that advising on drug therapeutic values without a license may be illegal. The Legislature's intent in drafting RCW 18.64.011(11) was unrelated to due care, and the majority's interpretation imposes meanings not supported by the statute. Furthermore, the determination of due care for health care providers, as established in Harris, is a factual matter for jury consideration with expert testimony, not a statutory definition.
The majority ruling that pharmacists owed no duty to warn McKee about Plegine's adverse effects affirms summary judgment, yet fails to clarify whether it addresses a legal duty distinct from due care or whether the failure to warn constituted a breach of due care. The only relevant issue is whether sufficient evidence exists for a jury to infer that the pharmacists breached their duty of due care. The distinction between a separate duty to warn and the general duty of due care is illustrated by Gates v. Jensen, where a distinct duty to inform patients was recognized. McKee does not assert this separate duty but contends there is evidence of a breach of due care under RCW 7.70.040.
The majority also ambiguously discusses whether the pharmacist's actions breached the standard of due care as a matter of law, referencing Helling v. Carey, which established that certain failures in care are clear violations of due care. In that case, the court mandated timely glaucoma tests for patients under 40, emphasizing the judiciary's role in establishing patient protection standards.
The court determined that the defendants were negligent for not conducting a harmless pressure test on the plaintiff, which should have been done based on the undisputed facts. In the case of Helling, the issue of negligence was raised due to a jury verdict favoring the defendants, and it was noted that a plaintiff can bring up negligence in a motion for summary judgment, while a defendant must demonstrate no issue of fact exists for the jury. McKee's case established that there was indeed a factual issue regarding the pharmacist's adherence to the standard of ordinary care.
Washington law mandates that pharmacists have a duty to advise customers about prescribed medications, as evidenced by two 1986 pharmacological literature sources. The definition of "Practice of pharmacy" under RCW 18.64.011(11) indicates pharmacists are responsible for interpreting prescriptions, dispensing medications, and providing drug information, confirming that these responsibilities imply affirmative duties. Additionally, RCW 18.64.005(11) grants the Washington State Board of Pharmacy authority to create regulations that support public health, with violations potentially leading to disciplinary actions against pharmacists.
The court ruled that summary judgment should have been denied, emphasizing the need to evaluate evidence favorably for the nonmoving party to identify genuine material facts for the jury. McKee presented adequate evidence, including depositions, to challenge the defendants' motion for summary judgment, demonstrating factual disputes that required jury resolution. Notably, one deposition indicated that the medication Plegine comes with a warning label, highlighting the pharmacist's obligation to communicate important information to customers.
The warning regarding Plegine was derived from its entry in the Physicians' Desk Reference (PDR), which included specific warnings. Mezistrano, a pharmacist, filled prescriptions for Plegine for McKee from 1981 to 1984, believing at that time that the drug was not potentially addictive. He dispensed the medication in the manufacturer's bottles but removed the attached warnings to avoid causing consumer misunderstanding. Sidran, another pharmacist, filled prescriptions for McKee from 1977 to 1981 and acknowledged her long-term use of Plegine. He noted that it was common for pharmacies to fill repeated prescriptions for drugs that literature advises against using long-term, though this practice does not meet the standard of due care as established in RCW 7.70.040, which requires reasonable prudence. McKee's weight history indicates she never exceeded 138 pounds and dropped to 105 pounds during 1982-1983. An expert affidavit from Dr. Andrew Weil criticized the defendants' actions and outlined his qualifications, which include teaching drug abuse topics to pharmacy students and organizations. Despite his credentials, defendants argue that Dr. Weil's affidavit does not sufficiently qualify him as an expert in the case.
Dr. Weil’s lack of a medical license in Washington does not disqualify him as an expert witness, as the law allows for experts to testify based on qualifications rather than licensure. The case Walker v. Bangs establishes that a specialist can provide relevant testimony even if not licensed in the jurisdiction, as long as they possess specialized knowledge. Brotsky’s experience in federal maritime cases satisfies the qualifications for expert testimony in this instance, and excluding his testimony was deemed an error.
The standard of care in this context is defined by public expectations rather than peer actions, as per Harris. Expert testimony is encouraged to assist juries in assessing the prudence of medical procedures. Dr. Weil’s affidavit asserts that the drug plegine should not be prescribed for over a month and should never be given to individuals who are not overweight. He criticizes the pharmacists for dispensing plegine to Elaine McKee for approximately ten years, deeming it grossly substandard and harmful, resulting in serious physical and emotional issues, including two suicide attempts. The pharmacists failed to inform Ms. McKee of the risks associated with long-term use of plegine and neglected their duty to understand the drug’s dangers, which included risks of addiction and toxicity.
Pharmacists are obligated to inform patients about the risks associated with medications and to question physicians regarding the appropriateness of their prescriptions when concerns arise. In this case, the pharmacists failed to adequately inform themselves about the dangers of the drug Plegine, including risks of addiction and long-term toxicity, and did not advise patient Elaine McKee of these risks or provide her with the manufacturer's warnings. Plegine is contraindicated for individuals who are not overweight and should not be used for more than a few weeks, as clearly stated by the manufacturer and in the PDR, which the pharmacists were aware of. Despite McKee not being overweight, the pharmacists dispensed Plegine to her for at least ten years. A jury could find that a reasonably prudent pharmacist would have either refrained from dispensing an inappropriate drug, warned the consumer, or discussed the contraindication with the prescribing physician.
Furthermore, the pharmacists violated their duty of due care by removing warnings from consumer bottles, which were intended for patients. The argument that some manufacturers' warnings are not included with individual units is irrelevant here, as the warnings were present on the bottles dispensed to McKee. The majority's position suggesting that warnings might disturb patients is criticized as paternalistic, asserting that patients have a right to be informed of medication dangers. The issue of whether pharmacists should pass on such warnings is a factual matter for juries, as established by RCW 7.70.040. McKee provided enough evidence to warrant a jury evaluation on whether the pharmacists should have warned her about the drug's discontinuation after several weeks. Additionally, the destruction of the manufacturer's warning raises a factual question for the jury, which might conclude that this act constituted negligence.
The druggist's intervention prevented the plaintiff from receiving crucial warnings about the medication Plegine, which should only be taken for a limited duration. The drug was dispensed directly to the consumer in a small container, and the druggist had the capability to label the container with necessary warnings without altering the manufacturer's label. The majority opinion erroneously characterized the physician as a "learned intermediary," failing to recognize the druggist's obligation to inform the consumer about the drug's safe usage duration. The court highlights the responsibility of pharmacists to identify obvious errors in prescriptions, such as lethal dosages and inadequate instructions, which include the understanding that Plegine, an amphetamine, should not be prescribed for extended periods.
Evidence presented by McKee indicates that pharmacists Sidran and Mezistrano neglected to maintain the necessary warnings regarding Plegine for a decade, failing to inform her verbally about potential side effects or the advisability of discontinuing the medication after a few weeks. Their repeated negligence over ten years constitutes a breach of their duty of care under RCW 7.70.040, warranting a jury's consideration of their actions. The trial court's grant of summary judgment in favor of the pharmacists was deemed erroneous, leading to a recommendation for reversal and remand for trial. Additionally, relevant statutes and definitions regarding pharmacist responsibilities and the standard of care are referenced, underscoring the legal obligations that were not met in this case.
Renumbered as 766.102 in 1988, the statute outlines standards of recovery in medical negligence cases, indicating that claimants must prove, by a preponderance of evidence, that a health care provider breached the prevailing professional standard of care. This standard is defined as the level of care, skill, and treatment recognized as acceptable by reasonably prudent similar health care providers under relevant circumstances.
In the Batiste case, it was established that the plaintiff received a prescription from her physician, which the defendant druggist filled. It was noted that the drug was not available for general public purchase, as it required a prescription, thus the plaintiff did not rely on the druggist’s judgment regarding the drug's fitness for use, but rather on her physician's guidance. Consequently, claims based on implied warranties of fitness and merchantability were dismissed.
Additionally, WAC 360-12-150 defines "monitoring of drug therapy" by pharmacists as a review of patients' drug regimens to advise prescribing practitioners on necessary adjustments. This includes collecting drug use histories, measuring vital signs, and evaluating laboratory test results, although such practices could raise privacy concerns.
WAC 360-16-250 mandates that pharmacists provide oral instructions for the proper use of medications, encompassing nonjudgmental information such as dietary considerations and warnings against operating heavy machinery. The document does not determine if a failure to provide this information constitutes an actionable claim.
Pharmacies in Washington are mandated to maintain comprehensive patient medication records, including details on allergies, idiosyncrasies, and chronic conditions relevant to drug use, as specified in WAC 360-19-030(1)(i) and WAC 360-19-040(1)(g). However, pharmacists may not have access to a patient's complete medical history, which could lead to unawareness of potential drug contraindications. According to WAC 360-19-050, pharmacists must review patient medication records when receiving prescriptions to identify possible drug interactions or duplications, and they are required to consult with the prescriber if issues arise. Additionally, WAC 360-19-080(2) grants dispensers the authority to inform prescribers of any concerns regarding potentially harmful drug interactions stemming from previous prescriptions. Lastly, the amendment of RCW 18.64.005 in 1989 did not alter its text but modified its citation to RCW 18.64.005(7).
