Mislabeling the pharmacist who does more than just mislabel the prescription: pharmaceutical liability under Florida Law.

• Author: Alvarez, Richard C.

Like any prescription, the law of pharmaceutical liability is an amalgam. It is a blend of concepts, principals, and notions derived, in large part, from other sources. In most instances, it proves effective. But in others, supplementation may be necessary. All pharmaceutical liability law, however, is certainly subject to further research, refinement, and change.

Change may be necessary regarding claims of pharmaceutical liability, as its grounds have evolved from simple principals of products liability into more complex notions of medical malpractice. Claims asserting ministerial errors, such as the misfiling or mislabeling of a prescription, have been supplemented with independent claims asserting discretionary errors, such as a pharmacist's failure to warn a patient about a prescription. Discretionary errors are traditionally the subject of malpractice claims, yet pharmacists do not share the protections and implicit deference given to physicians under Florida law when these claims arise. This article suggests that the Florida Legislature should extend these same protections to pharmacists when subjected to claims for an alleged failure to warn.

In Florida, the liability of pharmacists is largely determined under the common law. While regulatory statutes are manifold, none create a private right of action. (1) The regulatory statutes are helpful, though, in describing the general duties of pharmacists.

A pharmacist's duties are both ministerial and discretionary in nature. Obviously, part of a pharmacist's job is to label and fill a prescription correctly. However, as part of dispensing a prescription, "the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription order for potential adverse reactions, interactions, and dosage regimen she or he deems appropriate in the exercise of her or his professional judgment...." (2) Under the statutory regimen, "[t]he pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of her or his professional judgment, counseling is necessary." (3)

Some of these duties are discretionary and, like the duties of a physician, require the exercise of professional judgment and due care. Nevertheless, unlike physicians or other healthcare providers, a pharmacist's breach of his or her discretionary duties does not constitute medical malpractice under Florida law.

Breach of the Pharmaceutical Duty of Care

A pharmacist's breach has been viewed historically as a breach of warranty in Florida. This notion of products liability was first applied by the Florida Supreme Court in McLeod v. W. S. Merrell Co., 174 So. 2d 736 (Fla. 1965).

In McLeod, the court was asked to decide whether a pharmacist who properly filled a prescription was liable for harm caused by the patient's subsequent use of the prescription. (4) The court concluded that no liability arose under the circumstances, but not without a thorough analysis of the law which would predicate such liability. First, the court dismissed any notion that a breach of an implied warranty of fitness or implied warranty of merchantability had occurred. (5) An implied warranty of fitness could arise only if the patient had relied upon the skill and judgment of the pharmacist. An implied warranty of merchantability could arise only if the medication were available generally to the public. Neither condition had arisen. The Florida Supreme Court in McLeod continued its analysis by rejecting the application of other notions of products liability, such as strict liability. (6) Instead, it opted for fashioning a pharmacist's liability based upon express warranty. The court explained: "[A] druggist who sells a prescription warrants that: 1) he will...