SC Lawyer, July 2004, #4. The evolving duty of pharmacists To warn or not to warn?.

• Author: By Lynn H.Gorod

South Carolina Lawyer

2004.

SC Lawyer, July 2004, #4.

The evolving duty of pharmacists To warn or not to warn?

South Carolina LawyerJuly 2004The evolving duty of pharmacists To warn or not to warn?By Lynn H.GorodA sound argument could be made that South Carolina's statute imposes a duty to warn on the pharmacist, and a violation of that duty constitutes negligence per se or, at least, evidence of negligence sufficient to send the claim to a jury.

A pregnant woman enters a South Carolina drug store to have her prescription filled by the pharmacist. The pharmacist fills the prescription accurately and dispenses it to the woman. Several months later the woman gives birth to a baby born with deformities attributable to the medication dispensed to her earlier in her pregnancy by the pharmacist. Did the pharmacist have a legal duty to warn the pregnant woman of hazards associated with taking that particular medication during pregnancy?

With drug therapy playing an increasingly important role in providing health care, courts are increasingly faced with the legal question of who in the health care community has a duty to counsel and warn consumers of potential problems that can occur when taking prescription drugs. While the liability of the prescribing physician for failure to warn has been fairly clear cut, the liability of the dispensing pharmacist has not been so clear. This article will look at the evolving role and potential liability in duty to warn cases of pharmacists in general and South Carolina pharmacists in particular.

The evolution of case law in pharmacist's duty to warn cases

Although the duty to warn consumers of unreasonably dangerous products is well established in product liability law, generally that duty has not extended to pharmacists in the context of prescription drugs. A number of jurisdictions have addressed the issue of whether a pharmacy has a duty to warn its customers of the risks and side effects of the drugs it dispenses, and the overwhelming majority have held that, in general, a pharmacy has no duty to warn its customers of side effects. Cottam v. CVS Pharmacy, 436 Mass. 316, 764 N.E.2d 814 (2002); Kintigh v. Abbott Pharmacy, 200 Mich. App. 92, 503 N.W.2d 657 (1988); Batiste v. Home Prods. Corp., 32 N.C. App. 1, 231 S.E.2d 269 (1977); Coyle v. Richardson-Merrill, Inc., 526 Pa. 208, 584 A.2d 1383 (1989). A pharmacist's duty of care has generally been held to entail providing the right drug in the correct dosage according to a valid and lawful prescription.

The basis for not extending this duty has widely been premised on the "learned intermediary doctrine."

This doctrine, which has been accepted in many jurisdictions, including South Carolina, provides that manufacturers of prescription drugs have a duty to warn prescribing physicians of a drug's known dangerous propensities. Physicians, in turn, using their medical judgment, have a duty to convey the warnings to their patients. The doctrine precludes the imposition of a duty upon drug manufacturers to warn patients directly. Brooks v. Medtronic, Inc., 750 F.2d 1227 (4th Cir. 1984); see also Tarallo v. Searle Pharm., Inc., 704 F. Supp. 653 (D.S.C. 1988).

Although not tested as of yet in South Carolina, in other jurisdictions the doctrine has been extended to also apply to pharmacists in exempting pharmacists and pharmacies from giving warnings. Kasin v. Osco Drug, Inc., 312 Ill. App. 3d 823, 728 N.E.2d 77 (2000); McKee v. Am. Home Prods. Corp., 113 Wn.2d 701, 782 P.2d 1045 (1989). In McKee, the Supreme Court of Washington concluded that the reasons for applying the learned intermediary doctrine to drug manufacturers apply with equal force to pharmacies. The court reasoned that the physician is in the best position to understand the patient's needs and to assess risks and benefits of a particular course of treatment and to make decisions regarding what the patient should be told regarding the prescribed medications. Id.

However, increasingly there have been exceptions to the learned intermediary doctrine creating responsibility, and consequentially liability, on the part of the pharmacist. A number of courts have found that "special circumstances" can alter the general rule that pharmacists do not have a duty to warn patients and/or contact prescribing physicians. A clear error on the face of the prescription has sufficed as special circumstances superseding the learned intermediary doctrine thereby requiring the pharmacist to warn of the potential danger. Nichols v. Cent. Merch., Inc., 16 Kan. App. 2d 65, 817 P.2d 1131 (1991). Prescriptions that clearly exceed the manufacturer's recommended dosage or are contraindicated with another drug the pharmacist knows the patient is taking or an allergy the pharmacist knows the patient has and create a substantial risk of serious harm have been held to impose a duty on the pharmacist to warn the patient or the prescribing physician of the potential danger. Lasley v. Shrake's Country Club Pharmacy, Inc., 179 Ariz. 583, 880 P.2d 1129 (Ct. App. 1994); Happel v. Wal-Mart Stores, Inc., 199 Ill. 2d 179, 766 N.E.2d 1118 (2002); Horner v. Spalitto, 1 S.W.3d 519 (Mo. Ct. App. 1999).

With the use of computer technology in today's pharmacies, actual knowledge of contraindications is much more likely than in the past, and the special circumstances that could impose a duty to warn on the pharmacist are much more likely to be present. In addition, even where a general duty does not exist, pharmacists can voluntarily assume such a duty. Cottam v. CVS Pharmacy, 436 Mass. 316, 764 N.E.2d 814, 819 (2002). In situations where a pharmacy has implemented and advertised a computer system to detect interactions for the benefit of its customers, the pharmacy has been held to have voluntarily assumed a duty that previously did not exist. Sanderson v. Eckerd Corp., 780 So.2d 930 (Fla. Dist. Ct. App. 2001).

However, the voluntary undertaking to warn is limited by the extent of the undertaking. Frye v. Medicare-Glaser Corp., 153 Ill. 2d 26, 605 N.E.2d 557 (1992). Warning of a particular side effect does not obligate the pharmacist to warn of all possible side effects that could result from taking a particular medication. In Frye, the pharmacist warned that a particular medication could cause drowsiness. The customer subsequently died from the combined use of alcohol and the medication. The court held that the drowsiness warning did not mean the pharmacist assumed the duty to warn the customer of other contraindications such as the danger of consuming alcohol when taking the medication.

In determining whether a pharmacist has a duty to warn, what other reasonably prudent pharmacists would do in the same or similar circumstances defines the duty owed and sets the standard of care. If particular warnings are generally given when dispensing a particular prescription, a pharmacist who fails to do so has opened himself up to possible liability if injuries result from the lack of disclosure. Pittman v. UpJohn Co., 890 S.W.2d 425 (Tenn.1994). While the case law shows a growing recognition of the pharmacist's changing role, nevertheless, many courts have continued to refuse to find a duty to warn.

The impact of a federal mandate on the pharmacist's duty to warn

In the 1980s, even though there were states that had enacted legislation recommending a duty to warn, courts were not persuaded that a statutory duty existed requiring pharmacists to warn of potential adverse effects from prescription drugs. Ramirez v. Richardson-Merrill, Inc., 628 F. Supp. 85 (E.D. Pa. 1986); Perkins v. Windsor Hosp. Corp., 142 Vt. 305, 455 A.2d 810 (1982). However, a federal statute was enacted in the early 1990s that mandated a standard of care for pharmacists in the form of guidelines to be followed in order to qualify for funding for prescription drugs through Medicaid. The Omnibus Budget Reconciliation Act of 1990 (OBRA '90), 42 U.S.C. § 1396r-8 (2000). OBRA '90 required pharmacists to perform a list of patient-oriented tasks that included screening for potential drug problems and also mandated the passage of applicable state law establishing standards for counseling of individuals receiving Medicaid. Id. § 1396r-8(g)(2)(A)(ii). OBRA '90 required states to adopt these provisions no later than January 1, 1993, and by early 1994, 40 states, including South Carolina, had extended the OBRA '90 mandates to all prescriptions, not just those funded by Medicaid. Kenneth R. Baker, The OBRA '90 Mandate and its Developing Impact on the Pharmacist's Standard of Care, 44 Drake L. Rev. 515 (1996). However, although this legislation sets a federal statutory standard of care, a failure to comply has not necessarily been held to constitute negligence. Morgan v. Wal-Mart, 30 S.W.3d 455 (Tex. Ct. App. 2000).

The impact of statutory law on the pharmacist's duty to warn in South Carolina

How would current South Carolina statutory law regarding the pharmacist's duties impact potential civil liability of the pharmacist? South Carolina is a state that has enacted detailed rules and regulations regarding the responsibilities of pharmacists to warn and counsel but with no case law as of yet to determine whether a private action could successfully be brought against a pharmacist who violates statutory law and thereby causes injury to a customer.

South Carolina statutory law's definition of "dispensing" includes assessing prescriptions for potential problems and counseling on proper drug usage. S.C. Code Ann. § 40-43-10(14) (Law. Co-op. 2001). The statute requires that a pharmacy patient record system be maintained by all pharmacies for patients for whom prescription drug orders are dispensed. Id. § 40-43-86(J)(1). The pharmacist is required to make a reasonable effort to obtain, record and maintain in the patient record system pertinent information regarding prior prescriptions and his comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug. Id. § 40-43-86(J)(1)(e)-(f). The pharmacist is also mandated to make a reasonable effort to obtain information from the patient or the patient's agent regarding any known allergies, drug reactions, idiosyncrasies and chronic conditions or disease states of the patient and the identity of any other drugs, including over-the-counter drugs or devices currently being used by the patient that may relate to prospective drug review. This information needs to then be recorded in the patient's record. Id. § 40-43-86(J)(2).

The pharmacist is required to review the pharmacy patient record and each prescription drug order presented for dispensing for purposes of promoting therapeutic appropriateness by identifying over-utilization or under-utilization, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions and clinical abuse/misuse. Upon recognizing any of these problems, the pharmacist needs to take appropriate steps to avoid or resolve the problem, as appropriate, which includes consultation with the physician. Id. § 40-43-86(K).

After a prescription is received and the patient's pharmacy record is reviewed, the pharmacist then is re-quired to personally offer counseling to the patient or the patient's agent. Using his best professional judgment, the pharmacist's counseling should include a discussion of those matters that the pharmacist considers appropriate for the patient or patient's agent in that particular situation. The discussion must be in person, whenever practicable, or by telephone and include appropriate elements of patient counseling. The counseling should include elements such as potentially serious side effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, the action required if they occur and the pharmacist's comments relevant to the patient's drug therapy, including any other information peculiar to the specific patient or drug. Id. § 40-43-86(L)(1). Alternate forms of patient information may be used to supplement patient counseling when appropriate including, but not limited to, written information leaflets, pictogram labels or video programs. Id. § 40-43-86(L)(2).

Where there are significant adverse drug reactions, they must be reported to the prescriber immediately upon discovery with appropriate entry also made in the patient's record. Id. § 40-43-86(M). Attempting to circumvent the patient counseling requirements or discouraging the patient from receiving patient counseling concerning their prescriptions is considered unprofessional conduct. Id. § 40-43-86(DD)(2). Willfully and knowingly failing to maintain complete and accurate records of all drugs dispensed in compliance with federal and state laws and regulations is also considered unprofessional conduct. Id. § 40-43-86(DD)(7). The statute's requirements regarding patient records and counseling apply equally to the growing number of out-of-state mail order facilities providing pharmaceutical services to residents in this state. Id. § 40-43-89(N)(5)(a)(ii) (Cum. Supp. 2003).

Violations of the provisions of this statute can lead to loss of one's license or permit to practice or operate a pharmacy as well as other disciplinary action and civil penalties. Id. §§ 40-43-140 to -160. While the statute imposes sanctions for its violation, it does not explicitly provide for a private cause of action on behalf of an individual who has suffered injury as the proximate result of a violation of the pharmacy practice statute.

While no cases have yet arisen in South Carolina to test the impact of the counseling provisions in South Carolina's pharmacy act on civil liability for failure to adequately warn and/or counsel, nearby jurisdictions have reached potentially conflicting outcomes. In 1986 before the federal mandates were enacted, the Florida legislature amended the definition of "dispense" in the Florida Pharmacy Act from one that dealt only with the physical transfer of prescription drugs from pharmacists to consumers or their agents to one similar to South Carolina's in that it includes the assessment of prescriptions for potential problems and counseling, if appropriate in the pharmacist's professional judgment. Fla. Stat. ch. 465.003(5) (Supp. 1986).

In 1996, the impact of this amendment was at issue when the Florida appellate court was presented with a case in which the plaintiff was suing a pharmacy for breaching its duty to her late husband by failing to warn him of potentially adverse drug interactions. Johnson v. Walgreen, 675 So.2d 1036 (Fla. Ct. App. 1996). In that case, the plaintiff's husband saw a number of physicians, each of whom prescribed different medications. The prescription drugs interacted fatally and caused the death of the plaintiff's husband from multiple drug toxicity. The lower courts granted the pharmacy's motion to dismiss, holding that no such duty to warn existed in Florida. Id.

In considering whether a duty to warn existed, the Florida Supreme Court had to consider how to interpret the language in the amendment that was one of first impression in Florida. Did the language in the pharmaceutical regulatory statute create a private cause of action? The court found that there was no intent on the part of the legislature to create a private remedy against pharmacists and declined to extend civil liability beyond that for not accurately filling prescriptions.

Nevertheless, the court did note that there were policy arguments in favor of doing so inasmuch as the pharmacist is often in the best position to identify potential danger when there is more than one doctor involved in the care and treatment of a patient. In addition, the court pointed to recent trends in federal and state administrative law that already required screening for potential drug interactions including the OBRA '90 mandates. However, the court felt that such policy arguments are best made in the legislative setting. Johnson, 675 So.2d at 1038. Using this analysis of the issue, the court found no civil liability despite a failure to meet standards mandated by statute.

On the other hand, Georgia has not yet had to address the impact of regulations of the Georgia State Board of Pharmacy requiring dispensing pharmacists to counsel customers concerning their medications "based on the professional judgment of the pharmacist." Ga. Comp. R.& Regs. r. 480-31-.01(c)(1) (1993). The case of Walker v. Jack Eckerd Corp., 209 Ga. App. 517, 434 S.E. 63 (1993), found that the pharmacist had no duty in August 1991 to give warnings regarding side effects associated with the discontinuation of an anti-psychotic drug. In a later case the Georgia court found Walker binding precedent for claims arising before January 1, 1993, and held that the pharmacist had no independent duty to give such a warning. Presto v. Sandoz, 226 Ga. App. 547, 487 S.E.2d 70 (1997). Whether the 1993 regulations create an independent duty remains unclear, but the Georgia court implied that the regulations could change the status quo and create civil liability for failure to warn.

When a similar case arises in South Carolina, a sound argument could be made that South Carolina's statute imposes a duty to warn on the pharmacist, and a violation of that duty constitutes negligence per se or, at least, evidence of negligence sufficient to send the claim to a jury. At the very least, the statute's detailed regulatory requirements for South Carolina pharmacists set a new and higher standard for what a reasonable pharmacist needs to do in the context of warnings and counseling regarding prescription drugs. It makes no sense for failure to meet that standard to potentially result in loss of a pharmacist's license, but to entail no corresponding malpractice liability for damages caused to the individual injured by that failure. Clearly, the legislature's intention in amending the law to require more of pharmacists than simply accurately filling lawful prescriptions was to provide added protection for all consumers of prescription medications.

Conclusion

New questions arise as society and the law evolve. As the Internet and drug advertising make the consumer more of an active player in drug selection/therapy decisions, how much new responsibility falls on the consumer for the consequences of drug therapy? Since drug companies will no longer be able to count on the learned intermediary doctrine as they increasingly advertise directly to the consumer, how will they attempt to protect themselves from failure to warn claims? What can be done about the growing number of online pharmacies, many originating overseas, that are not fulfilling the mandates of state and federal law? These questions need to be addressed. As far as the answer to the question of whether pharmacists now have a duty to warn, the answer is still evolving.

Were the woman at the beginning of this article who gave birth to a baby with deformities to include the pharmacist and pharmacy in a suit for damages, the pharmacist and pharmacy could no longer feel confident that the learned intermediary doctrine would protect them. The special circumstances exception and the voluntary assumption of a duty to warn as well as the language in the South Carolina Pharmacy Practice Act all gravitate toward a finding of a more substantial role and higher standard of care for pharmacists in counseling their customers. With this new standard comes a new likelihood of civil liability where there is a failure to meet that standard.

Lynn H. Gorod is a research attorney in Charleston and a registered pharmacist.

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