Reading the Rx right is not enough: millions of Americans rely on prescribed drugs to stay healthy--and on their pharmacists to protect them from medication errors. Some courts are beginning to recognize that pharmacists must do more than fill prescriptions accurately.

Medication-related errors are a serious problem in the U.S. health care delivery system. A recent Institute of Medicine (IOM) report recognized today's "extensive use of drugs" in hospitals and in outpatient settings. It found that in 1998, nearly 2.5 billion prescriptions were dispensed in U.S. pharmacies at an estimated cost of about $92 billion. About 3.75 billion drugs were administered to hospital patients. (1)

The institute noted that 7,391 people died in 1993 from medication errors. (2) This number was significantly higher than the 1983 figure, with the largest rise taking place outside hospitals. (3) Another study suggested that the rise is due to a shift to outpatient treatment that requires patients, rather than health care providers, to exercise quality control over the medications they are taking. (4)

Many of the errors made when drugs are prescribed on an outpatient basis may involve pharmacists' mistakes. The IOM report cited a Massachusetts study finding that 2.4 million prescriptions are improperly filled each year; in 88 percent of the errors, the wrong drug or the wrong strength is dispensed. (5)

The large number of prescription drug injuries resulting from medical professionals' mistakes has challenged the courts to respond with rulings that appropriately allocate the risks and costs of these injuries. The courts are faced with a fundamental question: Who should bear the costs--consumers, drug manufacturers, physicians, hospitals, managed care companies, or the community as a whole?

Recent appellate decisions reveal emerging trends in lawsuits seeking to hold pharmacists responsible for drug-induced injuries. These breach-of-duty claims include a pharmacist's failure to properly fill a prescription, to warn or counsel, to protect a consumer's privacy, and to avoid false communications about the consumer to third parties such as police. Many of these claims have been dismissed. (6) Courts have been most receptive when the claim has involved an improperly filled prescription. (7)

The trend toward viewing pharmacists as independent and knowledgeable professionals who are responsible for failing to warn or counsel consumers about the benefits and risks of prescribed drugs began only recently. Until the past decade, the courts' guiding principle was that the physician should bear sole responsibility for communicating this information to patients, and the pharmacist's duty is to fill the prescription accurately, unless it contains an obvious error.

The 1990 Omnibus Budget Reconciliation Act (OBRA) expanded pharmacists' role in reducing the risks of prescribed drugs by requiring that they counsel Medicaid recipients. OBRA and state laws enacted to enforce its requirements locally have altered the pharmacist standard of care in some jurisdictions to include counseling and "a review of drug therapy before each prescription is filled or delivered" to these patients. (8)

However, some appellate court decisions were issued before state statutes expressly imposed a duty to warn on pharmacists, and these should raise a red flag for plaintiffs in pharmacist liability cases. If a claim against a pharmacist involves more than the duty to properly fill a prescription, the attorney must understand the law under OBRA, and related public policy concerns, in order to persuade the court that the claim presents an issue of fact for the jury, not a question of law for the court. (9)

If the plaintiff asserts that a pharmacist had a duty to go beyond accurately filling the prescription or correcting an obvious error in it, some courts may still respond with skepticism. Three approaches appear promising for plaintiffs who make this argument.

First, they can recast the claim to assert that a reasonable pharmacist concerned about the safety and efficacy of the prescribed drug has a duty to communicate with the prescribing doctor. This approach addresses court concerns that imposing a duty to warn on pharmacists would unduly interfere with the doctor-patient relationship.

Second, if the state has passed a statute or regulation specifically imposing a duty on pharmacists to warn or counsel, plaintiffs can invoke that law as defining a new standard of care for pharmacists. (10) Attorneys can argue that precedent predating the statute does not apply to current cases.

Third, plaintiffs can argue that these earlier decisions rejecting expanded pharmacist liability incorrectly characterized the issue: They construed the cases as presenting a question of duty--an issue for the court--when they should have viewed them as presenting a standard-of-care question for the jury, one that turns on the facts of particular cases.

While theories such as strict liability, breach of warranty, and violation of privacy rights may warrant consideration because of unusual facts or particular state statutes, negligence based on the standard of care will be the important theory in most cases. (11) But proof of causation remains a significant hurdle: Because the plaintiff was taking the drug to treat an existing illness, proving the precise nature and extent of harm caused by the medication error may be especially difficult. (12)

Accepted duty

Although case law regarding the appropriate standard of care for a pharmacist is evolving, courts widely agree that a pharmacist has a duty to accurately fill a prescription. (13) In Walter v. Wal-Mart Stores, Inc., the court affirmed a jury award to an 80-year-old woman whose pharmacist gave her the wrong chemotherapy drug. (14) The pharmacist mistook chlorambucil, the generic drug prescribed by her physician, for alkeran, the generic name for Melphalen--a substantially more powerful prescription drug that requires more careful monitoring.

As a result, the plaintiffs cancer did not go into remission, and she required several hospitalizations and numerous blood transfusions. On appeal, the court affirmed the verdict--even though the plaintiff did not present expert testimony--observing that no matter how the standard of care was phrased, the jury could find negligence based on the pharmacist's admission that he made a mistake, did not follow the standard four-step process to check for errors, and did not counsel her.

A more egregious case of an inaccurately filled prescription is Harco Drugs, Inc. v. Holloway, which resulted in compensatory and punitive damages against a pharmacy that filled a patient's cancer-medication prescription with heart medication. (15) The court implied a duty to warn in explaining why the evidence supported punitive damages:

   [W]e believe that a prescription from an oncologist that a pharmacist
   believes to call for Tambocor, a heart medication used by cardiologists to
   treat arrhythmias or serious heart ailments, should cause [the pharmacist]
   grave concern and necessarily prompt further inquiry. The extreme
   unusualness of a prescription from a cancer specialist supposedly calling
   for a dangerous heart medication, combined with the alleged illegibility of
   the prescription, is sufficient evidence of a reckless disregard of the
   safety of others to create a jury question as to whether Harco acted
   wantonly. (16)

Unaccepted duty

Some courts have recently rejected the argument that a pharmacist has a duty to warn or counsel patients about drug risks. For example, in Morgan v. Wal-Mart Stores, Inc., two pharmacies had filled a doctor's prescriptions to treat a 12-year-old boy's attention deficit hyperactivity disorder. (17) The boy died because the drug caused a blood disorder. The child's mother testified that when she filled the prescription, the Wal-Mart pharmacist gave her no warnings.

The court held that the pharmacist had no general duty to warn the patient of the potential adverse effects of the drug, absent special circumstances or neglect, despite known indications that the patient should not take it. The court wrote, "We do not dispute that a pharmacist may be held liable for negligently filling a prescription in such situations, but we cannot discern from the relevant case law a trend towards imposing a more general duty to warn." (18) In the court's view, without these special circumstances, the law places the duty to warn on the prescribing physician as the learned intermediary. (19)

Courts also applied a narrow interpretation of the pharmacist's duty to warn in Kasin v. Osco Drug, Inc., and Silves v. King. The Kasin court found that the pharmacist did not assume a duty to warn the customer of all possible side effects of the prescription drug by voluntarily warning about particular risks, (20) and Silves found no duty to warn of the risk of drug interactions or to consult with the doctor. (21) Like the Morgan court, these courts relied on the concept that the physician, as the learned intermediary, is responsible for patient counseling.

An important case that has influenced courts to allow pharmacists to use the learned-intermediary defense is McKee v. American Home Products Corp. (22) A majority of the Washington Supreme Court rejected the plaintiff's argument that pharmacists who, over a 10-year period, filled prescriptions for the appetite suppressant Plegine should have warned her that the drug was addictive. The court reasoned that imposing such a duty on pharmacists would disrupt the doctor-patient relationship:

   The pharmacist still has a duty to accurately fill a prescription ... and
   to be alert for clear errors or mistakes in the prescription. The
   pharmacist does not, however, have a duty to question a judgment made by
   the physician as to the propriety of a prescription or to warn customers of
   the hazardous side effects associated with a drug, either orally or by way
   of the manufacturer's package insert. (23)

Supportive case law

Despite these decisions, a 1999 Missouri case may map a path to an area of expanded liability that courts may be able to accept. The ruling provides support for the first of the three promising approaches for plaintiffs described earlier: asserting a pharmacist's duty to communicate with the prescribing doctor.

Horner v. Spalitto involved a claim that a pharmacist was negligent in filling a prescription for Placidyl, a strong hypnotic drug, to be used at a rate of three times the normal dose. (24) The pharmacist noticed the high dosage prescribed, called the doctor's office, and was told by someone that it was OK because the patient needed to be sedated the entire day. The pharmacist filled the prescription, and the patient died after taking the drug.

In reversing a trial court's grant of summary judgment for the pharmacist, the appellate court took the view that whether the pharmacist acted reasonably in these circumstances presented a question of fact for the jury:

   Pharmacists have the training and skills to recognize when a prescription
   dose is outside a normal range. They are in the best position to contact
   the prescribing physician, to alert the physician about the dose and any
   contraindications relating to other prescriptions the customer may be
   taking as identified by the pharmacy records, and to verify that the
   physician intended such a dose for a particular patient. We do not perceive
   that this type of risk management unduly interferes with the
   physician-patient relationship. Instead, it should increase the overall
   quality of health care. (25)

The shift in emphasis from a duty to warn the consumer to a duty to consult with the prescribing doctor is subtle but important. Courts have become comfortable with a drug manufacturer's duty to provide an adequate warning to the physician and the physician's duty to obtain informed consent from the patient. Arguably, the pharmacist, as a medical professional involved in providing drugs to patients, should bear more responsibility for doing so safely. The common goal for doctors, pharmacists, and drug manufacturers should be to effectively communicate with each other to enhance the safe prescribing and dispensing of drugs, and to do so in a manner that protects patient privacy and trust.

The second theory that holds promise for plaintiffs rests on OBRA. A clear trend in post-OBRA decisions recognizing a pharmacist's duty to warn has yet to emerge. One court has rejected the argument outright, reasoning that the state statute enforcing OBRA does not create a cause of action. (26) A few courts, however, have found that an OBRA-implementing statute creates a duty to warn. (27)

If a failure-to-warn theory relies on a state statute, the court must understand that the statute defines or provides evidence as to the standard of care. It does not create a new cause of action. The cause of action already exists under the common law, as does the pharmacist's duty to exercise reasonable care in filling a prescription. The important question is whether the standard of care includes communicating with the prescribing physician or warning the patient in particular circumstances.

The court must decide whether the statute establishes the standard of care or merely serves as evidence of it. (28) Because a goal of OBRA is to protect consumers from the risks of improperly prescribed drugs, the court may adopt the statute as defining the standard of care in the state. (29)

The third theory--the potentially persuasive effect of reformulating the issue from duty to standard of care--has appeared in at least two cases. In Dooley v. Everett, expert opinion supported the claim that the pharmacist had a duty to warn the customer or physician of an adverse interaction between two drugs prescribed by the same doctor and filled by the same pharmacist on different days. (30) In Lasley v. Shrake's Country Club Pharmacy, Inc., the plaintiff offered as evidence parts of the American Pharmaceutical Association Standards of Practice for the Profession of Pharmacy, which notes that a pharmacist has a duty to advise a customer of highly addictive properties of a drug and of its potentially hazardous interaction with other drugs. (31)

Both courts adopted the view that whether a pharmacist owes a duty to warn is a question of what a reasonable professional would do in the same or similar circumstances.

Each court found that because the plaintiff proffered expert testimony as to the standard of care--in which the expert concluded that in the particular circumstances the pharmacist should have warned the patient about the drug's dangers--the plaintiff's negligence claim presented a question that should be decided by a jury.

Emerging trends

Several economic and social trends in health care may affect how courts assess the appropriate extent of pharmacist liability. These trends include the growing number of elderly patients who regularly take prescription drugs, doctors' greater reliance on outpatient care, and pharmaceutical companies' increasingly aggressive marketing campaigns.

As courts begin to appreciate these forces, they may see a need to reshape tort doctrine to recognize a more active role for pharmacists in ensuring safe drug use. Some courts have already done so, and lawyers who represent plaintiffs harmed by pharmacist negligence can build on that foundation.

Notes

(1.) INSTITUTE OF MEDICINE, TO ERR IS HUMAN: BUILDING A SAFER HEALTH SYSTEM 32 (Linda T. Kohn et al. eds., 2000).

(2.) Id.

(3.) Id. at 32-33.

(4.) David P. Phillips et al., Increase in U.S. Medication-Error Deaths Between 1983 and 1993, 351 LANCET 9103 (1998).

(5.) INSTITUTE OF MEDICINE, supra note 1, at 27n.16.

(6.) See Evans v. Rite Aid Corp., 478 S.E.2d 846 (S.C. 1996) (no cause of action against pharmacy for employee's falsely telling third party that customer had a venereal disease; pharmacy did not owe customer duty of confidentiality); Smith v. Sneed, 938 S.W.2d 181 (Tex. App. Ct. 1997) (trial court properly dismissed false prosecution claim against physician who erroneously told pharmacist that patient's prescription was for 36 pills rather than 360, leading to the patient's arrest for attempting to obtain drugs by fraud).

(7.) For an overview of claims with extensive case citations, see Jonathon M. Purver, Druggist Liability for Improperly Filling Prescription, 34 AM. JUR. POF. 2d 199 (2001); Laura W. Smalley, Causes of Action Against Pharmacist for Injury or Death Caused by Prescription Drugs, 13 CAUSES OF ACTION 2d 91 (1999).

(8.) 42 U.S.C.A. [section] 1369r-8 (2000).

(9.) See, e.g., Lauren Fleischer, Note, From Pill Counting to Patient Care: Pharmacists' Standard of Care in Negligence Law, 66 FORDHAM L. REV. 165 (1999) (arguing that treating pharmacists as professionals for purposes of negligence suits would better serve the interests of plaintiffs and the pharmaceutical industry).

(10.) See, e.g., ILL. STAT. Ch. 225 [section] 85/3 (2001); FLA. ADMIN. CODE R. [section] 21s-1.035 (1990); KAN. ADMIN. REGS [section] 68-2-20; UTAH ADMIN. R. 58-17-2(26)f (1990).

(11.) See Smalley, supra note 7.

(12.) See, e.g., Hatten v. Price, 663 So. 2d 351 (La. Ct. App. 1995) (appellate court reversed and reduced a pain-and-suffering award, reasoning that the evidence showed the erroneous medication caused two hospitalizations but did not worsen the plaintiff's heart condition).

(13.) See S. Craig Smith & Thomas William Arbon, Prescription for Error, TRIAL, Oct. 1999, at 66.

(14.) 748A.2d 961 (Me. 2000).

(15.) 669 So. 2d 878 (Ala. 1995).

(16.) Id. at 880. The court also ruled that it was proper to admit evidence of incident reports prepared by the defendant's employees that noted prior prescription-filling errors as well as complaints filed with the Alabama State Board of Pharmacy. Id. at 881.

(17.) 30 S.W.3d 455 (Tex. App. Ct. 2000).

(18.) Id. at 466.

(19.) See, e.g., Stone v. Smith, Kline & French Lab., 447 So. 2d 1301 (Ala. 1984) (noting that a prescribing physician acts as the learned intermediary between the drug company and the patient); Martin ex rel. Martin v. Ortho Pharm. Corp., 661 N.E.2d 352 (Ill. 1996); McKee v. Am. Home Prod. Corp. 782 P.2d 1045 (Wash. 1989) (finding that although a pharmacist has a duty to accurately fill a prescription, a pharmacist does not have a duty to warn customers of the hazardous side effects associated with a drug).

(20.) 728 N.E.2d 77 (Ill. App. Ct. 2000).

(21.) 970 P.2d 790 (Wash. Ct. App. 1999).

(22.) 782 P.2d 1045 (Wash. 1989).

(23.) Id. at 1055-56.

(24.) 1 S.W.3d 519 (Mo. Ct. App. 1999).

(25.) Id. at 523 (emphasis added).

(26.) Johnson v. Walgreen Co., 675 So. 2d 1036, 1038 (Fla. Dist. Ct. App. 1996) ("the legislative history in the instant case is devoid of any indication that the legislature intended to create a private cause of action under these circumstances, and the language of [section] 465.003(5) was adopted within the regulatory scheme for pharmacists"); see also Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455 (Tex. App. Ct. 2000) (dealing with the implication of the Texas statute creating a duty for pharmacists to counsel patients about the benefits and risks of prescribed drugs).

(27.) Pittman v. Upjohn Co., 890 S.W.2d 425, 435 (Tenn. 1994) ("significant factor affecting [a] pharmacy's duty [is] the knowledge that no warning had been given by the physician. Under these circumstances it [is] reasonably foreseeable that [the patient is] at risk of injury. Consequently, the pharmacy, as well as the physician, owe [the patient] the duty to warn"); see also Lasley v. Shrake's Country Club Pharm., Inc., 880 P.2d 1129 (Ariz. Ct. App. 1994).

(28.) For an analysis of whether the purpose of OBRA includes adopting it as defining the standard of care, see David B. Brushwood, The Pharmacist's Duty Under OBRA-90 Standards, 18 J. LEG. MED. 475, 501 (1997) (noting that OBRA's express purposes include patient safety).

(29.) See RESTATEMENT (SECOND) OF TORTS [section] 286, setting forth the criteria for when a court should adopt a statute as defining the standard of care.

(30.) 805 S.W.2d 380 (Tenn. Ct. App. 1990).

(31.) 880 P.2d 1129 (Ariz. Ct. App. 1994).

Frank M. McClellan is a professor at Temple University School of Law in Philadelphia.