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November 13, 2006
MISLABELING THE PHARMACIST WHO DOES MORE THAN JUST MISLABEL THE PRESCRIPTION - A Study of Pharmaceutical Liability Under Florida Law
The Florida Bar Journal
January 2007
Trial Lawyers Forum
http://www.floridabar.org/DIVCOM/JN/JNJournal01.nsf
Richard C. Alvarez
Copyright 2007 by Florida Bar; Richard C. Alvarez
Like any prescription, the law of pharmaceutical liability is an amalgam or mixture of sorts. 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 is certainly subject to further research, refinement, and change.
Change may be necessary regarding claims of pharmaceutical liability as their grounds have evolved from simple principals of products liability into more complex notions of medical malpractice. Claims asserting ministerial errors, such as the misfilling 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 the traditional subject of malpractice claims, yet pharmacists do not share the protections and implicit deference given to physicians under Florida law when these claims arise.
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. See Powers v. Thobhani, 903 So.2d 275, 279 (Fla. 4th DCA 2005); Estate of Sharp v. OmniCare, Inc., 879 So.2d 34, 36 (Fla. 5th DCA 2004); Johnson v. Walgreen Co., 675 So.2d 1036, 1038 (Fla. 1st DCA 1996). The regulatory statutes are helpful though in their description of the general duties of pharmacists.
A pharmacist's duties are both ministerial and discretionary in nature. Obviously, he or she must 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[.]" Fla. Stat., Sec. 465.003(6). "The 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." Id.
Some of these duties are discretionary and, like the duties of any physician, require the exercise of professional judgment and due care. Nevertheless, unlike physicians or other health-care providers, a pharmacist's breach of his or her 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 the case of 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. Id. at 737. The Florida Supreme 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. Id. at 738. An implied warranty of fitness would arise only if the patient had relied upon the skill and judgment of the pharmacist. An implied warranty of merchantability would arise only if the medication were available generally to the public. Neither condition had arisen. The Florida Supreme Court continued its analysis with additional notions of products liability, including its rejection of the principles of strict liability. Id. at 739. Instead, the court opted for fashioning a pharmacist's liability based upon express warranty. More specifically, "a druggist who sells a prescription warrants that: (i) he will compound the drug prescribed; (ii) he has used due and proper care in filling the prescription . . .; (iii) the proper methods were used in the compounding process; and (iv) the drug has not been infected with some adulterating foreign substance." Id.
Subsequent decisions regarding a pharmacist's liability essentially remained true to the products-derived construct of McLeod. Liability was predicated exclusively on ministerial errors resulting in mislabeled or misfilled prescriptions. E.g. Albertson's, Inc. v. Adams, 473 So.2d 231, 232 (Fla. 2nd DCA 1985). A pharmacist's failure to warn about the risks of a prescription was wholly irrelevant and simply not actionable. See Johnson v. Walgreen Co., 675 So.2d 1036, 1038 (Fla. 1st DCA 1996); Pysz v. Henry's Drug Store, 457 So.2d 561, 562 (Fla. 4th 1984). It was the consensus among Florida's courts that the duty to warn was solely that of the prescribing physician and not the pharmacist who only received and filled the prescription in a ministerial manner. Pysz, 457 So.2d at 562.
It was not until the courts considered the voluntary undertaking doctrine that a duty to warn began to emerge and augment a pharmacist's liability for breach of warranty. Sanderson v. Eckerd Corp., 780 So.2d 930 (Fla. 5th DCA 2001); see also Dent v. Dennis Pharmacy, Inc., 924 So.2d 927, 929 (Fla. 3rd 2006). Under the doctrine, "one who undertakes to act, even when under no obligation to do so, thereby becomes obligated to act with reasonable care." Union Park Memorial Chapel v. Hutt, 670 So.2d 64, 67 (Fla. 1996). In the case of Sanderson v. Eckerd Corp., the appellate court recognized the voluntary undertaking doctrine in light of the pharmacy's advertised promise that its computer system would detect and warn patients of adverse reactions to prescriptions. 780 So.2d at 933.
The notion of a voluntary undertaking has since been substituted with a traditional notion of professional negligence. Dee v. Wal-Mart Stores, Inc., 878 So.2d 426 (Fla. 1st 2004); Powers v. Thobhani, 903 So.2d 275 (Fla. 4th DCA 2005). In this context, a pharmacist's liability has extended to both ministerial and discretionary errors. The ultimate question is not merely whether the prescription was filled or administered properly by the pharmacist. His or her failure to exercise discretion and to warn about the dangerous risks of the prescription can be independently negligent. Dee, 878 So.2d at 428.
Not all courts have agreed with this movement towards pharmaceutical malpractice and the recognition of discretionary errors or a failure to warn as a basis of liability. See Estate of Sharp v. OmniCare, Inc., 879 So.2d 34, 36 (Fla. 5th DCA 2004); Layton v. SmithKline Beecham Corp., 2006 WL 2194498, *2 (M.D. Fla. 2006). But, considering the recognition of a duty to warn elsewhere in the common law and under the statutes regulating pharmacy, any disagreement about this duty and its breach seems more the product of judicial policy than good sense. Cf. Johnson v. Walgreen Co., 675 So.2d 1036, 1038 n. 3 (Fla. 1st DCA 1996).
It takes little imagination, if any, to realize a patient's dependence on his or her pharmacy as a medical supplier, historian and adviser. The practice of medicine has become highly specialized and the role of a general practitioner is becoming obsolete. Most patients manage an assortment of visits to an assortment of doctors for an assortment of ailments. By comparison, their medicinal needs are most often consolidated and addressed at one pharmacy, if for no other reason than convenience. The potential hazards or risks of a medication or combination of medications are squarely within the purview of a qualified pharmacist. More importantly, the complete history of a patient's prescriptions is almost exclusively known by the pharmacist. A physician usually does not enjoy such organization or opportunity to advise the patient.
The Mislabeled Pharmacist
Good sense also suggests that, if a physician's conventional duty to advise the patient is now placed upon a pharmacist, the pharmacist should enjoy the same protections and implicit deference given to physicians when claims of negligence arise due to an alleged failure to warn. Like the practice of medicine, the practice of pharmacy is lauded as a "learned profession." Fla. Stat., Sec. 465.002. However, in reality, Florida law treats pharmacists and physicians quite differently.
Claims of negligence against physicians have garnered considerable attention from the Florida Legislature over the past few years and are now subject to a collection of rather complex and, at times, severe rules under Florida Statutes, Chapter 766. In all actions for medical negligence or "the negligence of a health-care provider," the claimant has the burden of proving a breach in the prevailing professional standard of care which proximately caused injury. Fla. Stat., Secs. 766.102(1) and (3). Such proof must be made by an expert who is a licensed health-care provider, a specialist in the same area as the defendant-physician, and an active practitioner or instructor in the specialized area. Fla. Stat., Sec. 766.102(5)(a). Furthermore, claims of medical malpractice must be preceded by a formal investigation and discovery among the prospective parties. Fla. Stat., Secs. 766.106 and 766.203. The formal investigation requires the claimant to secure a favorable report from a qualified expert. Fla. Stat., Sec. 766.203(2). This written report must then be delivered to the defendant-physician along with formal notice of the claimant's intent to initiate litigation. Fla. Stat., Sec. 766.106(2). The defendant-physician is thereafter given the opportunity to scrutinize the forthcoming claim and informally develop his or her defense through unsworn statements, written questions, the production of documents, and independent medical examinations. Fla. Stat., Sec. 766.106(6). In addition to these protections, a physician's exposure to noneconomic damages is curtailed greatly by arbitrary limits or caps. Fla. Stat., Sec. 766.118. Regardless of the number of medical defendants, no more than $500,000 can be awarded to an individual claimant and no more than $1,000,000 can be awarded per occurrence. Fla. Stat., Sec. 766.118(2). The total award of noneconomic damages is further reduced to only $350,000 in the event the claimant rejects the defendant-physician's admission of liability and offer to enter into binding arbitration. Fla. Stat., Sec. 766.209(4).
It would seem sensible that these protections under Chapter 766 should be extended to pharmacists when their discretionary acts of counseling and advising patients are challenged through a claim of negligence. One Florida court has even gone so far as to enforce the two-year statute of limitations for medical malpractice against claims involving only the ministerial error of mislabeling a prescription. See Sheils v. Eckerd Corp., 560 So.2d 361, 362 (Fla. 2nd DCA 1990). In Sheils, the court effectively disregarded the notion of products liability from which such claims originated and refused to apply the four-year statute of limitations applicable to products. Id.
Notwithstanding sensibility or reason, it is well-established in Florida that pharmacists do not share the protections and implicit deference routinely given to physicians. Sova Drugs, Inc. v. Barnes, 661 So.2d 393 (Fla. 5th DCA 1995); Layton v. SmithKline Beecham Corp., 2006 WL 2194498 (M.D. Fla. 2006). In Sova Drugs, Inc. v. Barnes, the court held that the restrictions of Chapter 766 did not apply to a pharmacist who allegedly misfilled a prescription. 661 So.2d at 395. In Layton, the court held that the restrictions of Chapter 766 did not apply to a pharmacist who failed to warn a patient. 2006 WL 2194498 at *2. No effort was made to differentiate between the ministerial error alleged in one case and the discretionary error alleged in the other. Instead, the courts opted for an easier explanation. They blamed the legislature. Id.; 661 So.2d at 395.
Pharmacists are not specifically included in the definition of "health-care providers" who enjoy the benefits of presuit notice, informal discovery, and the arbitrary limits on damages under Chapter 766. See Fla. Stat, Sec. 766.202(4)(previously Fla. Stat., Sec. 768.50(2)(b) when Sova Drugs, Inc. v. Barnes and Layton decided). Under Chapter 766, "health-care provider" means "any person licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, part I of chapter 464, chapter 466, chapter 467, or chapter 486[.]" Id. Chapter 465, under which pharmacists are licensed, is conspicuously absent from this list.
The exclusion of pharmacists surely makes little sense in regards to claims for a failure to warn or to exercise professional judgment. Pharmacists are included in the definition of "health-care providers" or "health-care practitioners" elsewhere under Florida law. For example, when the issue is public health or business regulation, pharmacists are "health-care practitioners." See Fla. Stat., Sec. 381.00593(3); Fla. Stat., Sec 456.001(4). When the issue is state employment, pharmacists are "professional health-care providers." See Fla. Stat., Sec. 110.107(28). Finally, and with the utmost contradiction and irony, when the issue is medical malpractice insurance, pharmacists are "health-care providers." See Fla. Stat., Sec. 627.357(1)(b)(11).
Conclusion
Legislative change may be necessary as pharmaceutical liability continues to evolve and include independent claims for the failure to counsel and advise patients. There can be little distinction between this discretionary duty and the duty of physicians and other health-care providers to exercise professional judgment and due care. A pharmacist's duty to warn patients of the risks of medications arises from his or her unique opportunity to do so. Unlike physicians, one pharmacy often serves a patient exclusively. If pharmacists now bear physicians' conventional burden of advising or warning patients about medications, they seem entitled to the same protections and implicit deference when claims of negligence arise due to the alleged failure to perform these discretionary acts.
Richard C. Alvarez is a founding member of Alvarez Garcia in Tampa and practices as a trial lawyer on behalf of both plaintiffs and defendants who have meritorious cases. These cases most often involve significant personal injury and commercial disputes.
Posted by alvarezgarcia at November 13, 2006 07:59 PM
