by Richard C. Alvarez

Page 53

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 health-care 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 compound the drug prescribed; 2) he has used due and proper care in filling the prescription . . .; 3) the proper methods were used in the compounding process; [and] 4) the drug has not been infected with some adulterating foreign substance.”7

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.8 The courts also made clear that a pharmacist’s failure to warn about the risks of a prescription was wholly irrelevant and not actionable.9 Until recently, it was the consensus among Florida’s courts that the discretionary 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.10

This consensus began to erode, however, when the courts considered the voluntary undertaking doctrine in the context of a pharmacist’s liability for breach of warranty.11 Under the voluntary undertaking doctrine, “one who undertakes to act, even when under no obligation to do so, thereby becomes obligated to act with reasonable care.”12 In Sanderson v. Eckerd Corp., 780 So. 2d 930 (Fla. 5th DCA 2001), 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.13

The notion of a voluntary undertaking was more recently replaced by a traditional notion of professional negligence.14 In this context, a pharmacist’s liability has extended to the possibilities of 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.15

Not all Florida courts have agreed with this movement toward pharmaceutical malpractice and the recognition of discretionary errors or a failure to warn as a possible basis of liability.16 But, considering the recognition of a duty to warn elsewhere in the common law and under the statutes regulating pharmacies, any disagreement about this duty and its breach seems more the product of judicial policy than good sense.17

In today’s environment, a patient depends 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
Of course, good sense also suggests that if a physician’s conventional duty to advise the patient is now placed upon a pharmacist, the pharmacist should likewise 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.”18 In reality, however, 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 F.S. Ch. 766. In all actions for medical negligence or “the negligence of a healthcare provider,” for example, the claimant has the burden of proving a breach in the prevailing professional standard of care which proximately caused injury.19 Such proof must be made by an expert who is a licensed healthcare provider, a specialist in the same area as the defendant-physician, and an active practitioner or instructor in the specialized area.20 Furthermore, claims of medical malpractice must be preceded by a formal investigation and discovery among the prospective parties.21 The formal investigation requires the claimant to secure a favorable report from a qualified expert.22 This written report must then be delivered to the defendant-physician along with formal notice of the claimant’s intent to initiate litigation.23 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.24 In addition to these protections under Ch. 766, a physician’s exposure to noneconomic damages is curtailed greatly by arbitrary limits or caps.25 Regardless of the number of medical defendants, no more than $500,000 can be awarded to an individual claimant and no more than $1 million can be awarded per occurrence.26 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.27

It would seem sensible that these protections under Ch. 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.28 In Sheils v. Eckerd Corp., 560 So. 2d 361 (Fla. 2d DCA 1990), the court effectively abandoned the notion of products liability from which pharmaceutical liability originated and refused to apply the four-year statute of limitations applicable to products.29

Other courts have resisted importing such protections, even as pharmaceutical liability expands. At least two have expressly ruled that pharmacists do not share the protections and implicit deference routinely given to physicians.30 In Sova Drugs, Inc. v. Barnes, 661 So. 2d 393 (Fla. 5th DCA 1995), the court held that the restrictions of Ch. 766 did not apply to a pharmacist who allegedly misfilled a prescription.31 In Layton v. SmithKline Beecham, 2006 WL 2194498 (M.D. Fla. 2006), a separate court held that the restrictions of Ch. 766 did not apply to a pharmacist who failed to warn a patient.32 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 for failing to include pharmacists as “healthcare providers” enjoying the protections of Ch. 766.33

It is true that pharmacists are not specifically included in the definition of “healthcare providers” who enjoy the benefits of presuit notice, informal discovery, and the arbitrary limits on damages under Ch. 766.34 Under Ch. 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[.]”35 Ch. 465, under which pharmacists are licensed, is conspicuously absent from this list.

The exclusion of pharmacists makes little sense, specifically in regard to claims for a failure to warn or to exercise professional judgment. Pharmacists are included in the definition of “healthcare providers” or “healthcare practitioners” elsewhere under Florida law. For example, when the issue is public health or business regulation, pharmacists are “healthcare practitioners.”36 When the issue is state employment, pharmacists are “professional healthcare providers.”37 Finally, and with the utmost contradiction and irony, when the issue is medical malpractice insurance, pharmacists are “healthcare providers.”38

Conclusion
Legislative change may be necessary as pharmaceutical liability continues to evolve and expand to 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 healthcare 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. At the same time, if pharmacists now bear physicians’ conventional burden of advising or warning patients about medications, they also should be entitled to the same protections and implicit deference when claims of negligence arise due to the alleged failure to perform these discretionary acts. q

1 See Powers v. Thobhani, 903 So. 2d 275, 279 (Fla. 4th D.C.A. 2005); Estate of Sharp v. OmniCare, Inc., 879 So. 2d 34, 36 (Fla. 5th D.C.A. 2004); Johnson v. Walgreen Co., 675 So. 2d 1036, 1038 (Fla. 1st D.C.A. 1996).
2 Fla. Stat. §465.003(6).
3 Id.
4 McLeod, 174 So. 2d at 737.
5 Id. at 738.
6 Id. at 739.
7 Id.
8 E.g., Albertson’s, Inc. v. Adams, 473 So. 2d 231, 232 (Fla. 2d D.C.A. 1985).
9 See Johnson v. Walgreen Co., 675 So. 2d 1036, 1038 (Fla. 1st D.C.A. 1996); Pysz v. Henry’s Drug Store, 457 So. 2d 561, 562 (Fla. 4th D.C.A. 1984).
10 Pysz, 457 So. 2d at 562.
11 Sanderson v. Eckerd Corp., 780 So. 2d 930 (Fla. 5th D.C.A. 2001); see also Dent v. Dennis Pharmacy, Inc., 924 So. 2d 927, 929 (Fla. 3d D.C.A. 2006).
12 Union Park Memorial Chapel v. Hutt, 670 So. 2d 64, 67 (Fla. 1996).
13 Sanderson, 780 So. 2d at 933.
14 Dee v. Wal-Mart Stores, Inc., 878 So. 2d 426 (Fla. 1st D.C.A. 2004); Powers v. Thobhani, 903 So. 2d 275 (Fla. 4th D.C.A. 2005).
15 Dee, 878 So. 2d at 428.
16 See Estate of Sharp v. OmniCare, Inc., 879 So. 2d 34, 36 (Fla. 5th D.C.A. 2004); Layton v. SmithKline Beecham Corp., 2006 WL 2194498 *2 (M.D. Fla. 2006).
17 Cf. Johnson v. Walgreen Co., 675 So. 2d 1036, 1038 n. 3 (Fla. 1st D.C.A. 1996).
18 Fla. Stat. §465.002.
19 Fla. Stat. §§766.102(1) and (3).
20 Fla. Stat. §766.102(5)(a).
21 Fla. Stat. §§766.106 and 766.203.
22 Fla. Stat. §766.203(2).
23 Fla. Stat. §766.106(2).
24 Fla. Stat. §766.106(6).
25 Fla. Stat. §766.118.
26 Fla. Stat. §766.118(2).
27 Fla. Stat. §766.209(4).
28 See Sheils v. Eckerd Corp., 560 So. 2d 361, 362 (Fla. 2d D.C.A. 1990).
29 Id.
30 Sova Drugs, Inc. v. Barnes, 661 So. 2d 393 (Fla. 5th D.C.A. 1995); Layton v. SmithKline Beecham Corp., 2006 WL 2194498 (M.D. Fla. 2006).
31 Sova Drugs, 661 So. 2d at 395.
32 Layton, 2006 WL 2194498 at *2.
33 Id.; Sova Drugs, 661 So. 2d at 395.
34 See Fla. Stat. §766.202(4)(previously Fla. Stat. §768.50(2)(b) when Sova Drugs and Layton decided).
35 Id.
36 See Fla. Stat. §381.00593(3); Fla. Stat. §456.001(4).
37 See Fla. Stat. §110.107(28).
38 See Fla. Stat. §627.357(1)(b)(11).

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 in the areas of personal injury and commercial disputes.

This column is submitted on behalf of the Trial Lawyers Section, Bradley E. Powers, chair, and D. Matthew Allen, editor.