Pharmacy Law: Is a Pharmacy a "Health Care Provider"?

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

Were the protections put in place when a state legislature enacted a statute known as the Medical Professional Liability Act in an attempt to place limits on damage awards in malpractice lawsuits against "health care providers" available to pharmacies?

Facts of the Case

A patient experiencing pain and swelling in his foot visited a physician, who arrived at a diagnosis of gouty arthritis and prescribed colchicine tablets. The patient presented the prescription at a pharmacy, where the pharmacist accurately recorded the prescriber's instructions on the label of the medication container—"Take 1 tablet every hour until pain stops or diarrhea starts or nausea." Neither the physician's instructions nor the printed patient information sheet provided by the pharmacy indicated an upper limit to the number of dosage units that should be consumed in a given period of time.

Two months later, the patient again began to have the symptoms of acute gouty arthritis, and for 3 days, he consumed the medication as directed on the label of the container. Later he experienced stroke-like symptoms and was hospitalized. The diagnosis then was colchicine poisoning and toxicity that had led to severe and permanent damage to the patient's kidneys, resulting in a requirement of routine kidney dialysis for the remainder of the patient's life.

The patient and his spouse filed suit against the prescriber who had recommended use of the pharmaceutical and the pharmacy that had provided it. The core allegations were that the prescriber had failed to specify a limit on the amount to be consumed and that the pharmacy had negligently dispensed the drug without clarifying the usage instructions by specifying a maximum daily dosage. A further allegation for the pharmacy was that it had failed to recognize the potential toxicity of the prescribed dosage. The physician settled the claim out-of-court, and the case against the pharmacy went forward.

During the pretrial discovery process, the attorney representing the pharmacy continually asserted that the case should proceed in a fashion consistent with the statutory requirements of the West Virginia Medical Professional Liability Act. The patient and his spouse filed a motion with the trial court to prevent the defendant pharmacy from invoking the liability limits of that statute. Following a hearing on the motion, the trial court judge ruled in favor of the pharmacy, concluding that pharmacies were included within the definition of "health care provider" in the statute. The trial court judge delayed further proceedings in the case while the plaintiffs appealed this decision to the state Supreme Court, with the question presented to the appellate court couched in these terms: "In a civil action filed against a defendant licensed pharmacy for allegedly having negligently dispensed medication, is the pharmacy a ?health care provider,' as defined by the relevant statute?"

The Court's Ruling

The court ruled that the answer to the question is "No."

The Court's Reasoning

In the process of deciding the case, the state's highest court looked at a number of factors. First, it turned its attention to the issue of whether it could even consider affidavits submitted by members of the legislature when the bill was enacted. The notion was that these present and former legislators could shed some light on what had been the legislative intent at the time of enactment. The trial court had declined to use that source of information, and the Supreme Court agreed. Next, the court examined the specific wording of the statute in question. The statute had been enacted "to encourage and facilitate provision of the best medical care and facilities to the citizens" of the state. It included changes creating unique procedural guidelines for handling cases alleging negligence by a health care provider, limiting the damages that may be awarded and how those damages may be collected.

The definition of health care provider in the statute is "a person, partnership, corporation, facility, or institution licensed by, or certified in, this state or another state, to provide health care or professional health care services, including, but not limited to, a physician, osteopathic physicians, hospital, dentist, registered or licensed practical nurse, optometrist, podiatrist, chiropractor, physical therapist, or psychologist, or an officer, employee, or agent thereof acting in the course and scope of such officer's, employee's, or agent's employment." The defendant pharmacy argued that, although the phrase "including, but not limited to" did not include pharmacies, the statute should be given a broad interpretation to include any person or business entity licensed to "provide health care or professional health care services." Pointing out that enactment of the statute represented a major shift from common law principles, the court felt constrained to use a narrow interpretation of the wording enacted by the legislature.