Prescription for harm: pharmacist liability.

Pharmacists are riding high in the public's opinion. Recent polls show them to be the most trusted professionals in the United States--garnering higher marks for honesty and ethical standards than the clergy.(1) Yet a recent article in the trade magazine Drug Topics discusses the "breaking of the trust" between pharmacists and their customers. The reasons: Pharmacists are misfilling prescriptions at alarming rates and are failing to warn of drug interactions and side effects.

A recent survey shows that 92 percent of pharmacists employed by large chain pharmacies were aware of dispensing errors made by their pharmacy during the last three years. While up to 50 percent of these errors were caught before the drug was ingested, many customers took either the wrong drug or the wrong dose of a drug.(2)

The number of potential victims is immense. More than half of all Americans over 45 regularly take prescription drugs, a total of about 1.6 billion prescriptions a year.(3) As our population ages and cost-containment pressures increase the pace of a pharmacist's work, the number of errors in filling prescriptions will only increase. The potential for harm is enormous because pharmacists "hold the life of another human being in their hands every minute of the workday."(4)

Pharmacists are held to a heightened standard of care in filling prescriptions:

In the discharge of their functions,

druggists and apothecaries, persons

dealing in drugs and medicines, should

be required not only to be skilful, but

also exceedingly cautious and prudent,

in view of the terrific consequences

which may attend, as they have not unfrequently

in the past....(5)

But while pharmacists can be liable for failing to properly fill prescriptions, they generally have not been found strictly liable in tort for the injuries caused by the defective nature of the pharmaceuticals they dispense. Normally, retailers of defective products share strict liability with the products, manufacturer.(6) However, in Murphy v. E.R. Squibb & Sons, Inc., the California Supreme Court concluded that retail strict liability does not apply to pharmacists.(7)

While the court grounded its decision on the technicality that the California legislature views a pharmacist's practice as a service rather than a product's sale, it cited other policy reasons for its decision. The court found that pharmacists, if subject to strict liability, might restrict availability of drugs by refusing to dispense those that posed the greatest risk of harm. Furthermore, a pharmacist w ho had a choice of several brands of the same drugs might select the more expensive, established product.(8)

One court has held that a pharmacist may be held strictly liable for a drug's defects. In Heredia v. Johnson, the court found that prescription ear drops were defective because they carried no warning regarding their danger when used by a patient with a ruptured ear membrane.(9) Finding that Nevada applies strict liability to a product seller in several circumstances, the federal court denied the pharmacist's claim that it could not be held strictly liable for the product's lack of warnings.

A pharmacist's liability for failure to warn is less clear. A number of courts have held that a pharmacist has no duty to warn of potential harmful side effects of medicines dispensed. In McKee v. American Home Products Corp., the defendant pharmacists filed a person's prescriptions for an addictive appetite suppressant for nearly 10 years.(10) Before dispensing the pills, the pharmacists removed the manufacturer's label with warnings about addiction and the manufacturer's recommendation that the drug be used for only a few weeks. No similar warnings were given by the pharmacists.

Despite these egregious facts, the court found that the pharmacists could not be liable because they had no duty to either warn of the potential side effects of the dispensed drug or monitor the plaintiff's drug use.(11) The McKee court found that imposing these duties would place the pharmacist between the physician, who has presumably superior knowledge about drug side effects, and the patient. Rather, the pharmacists, duties were limited to accurately filling prescriptions and being alert for mistakes in prescriptions.

Courts, relying on the learned intermediary doctrine, have also found that a pharmacist should not be liable for failure to warn of a drug's harmful effects. The learned intermediary rule provides that drug manufacturers, duty to warn extends only to prescribing physicians. The manufacturer has no duty to warn the ultimate consumer of the drug of its harmful propensities as it is up to the prescribing physician to determine what facts should be told to the patient.(12)

The cases extending the learned intermediary doctrine to pharmacists reason that imposing a duty to warn on the pharmacist could intrude on the doctor-patient relationship or even force the pharmacist to practice medicine without a license.(13)

Other courts have not always expressed sound rationales for similar holdings. In Leesley v. West, for example, the court found that a pharmacist had no duty to warn a customer about a drug's potential side effects. The court reasoned in part that it would be unreasonable to require pharmacists to copy package inserts they received from the drug manufacturers and provide them to each customer.(14)

Some courts have viewed the duty-to-warn issue differently. In Riff v. Morgan Pharmacy, a pharmacy, allegedly on the advice of a physician, repeatedly refilled prescriptions for the painkiller suppository Cafergot.(15) After consuming many of the refills, the customer suffered permanent nerve damage.

She and her husband filed suit, alleging that the pharmacist had failed to warn that nerve damage is a side effect of prolonged use of the drug. The pharmacist argued that his duty was limited to correctly supplying the medication. The court rejected this argument, finding that "appellant would seem to argue that a pharmacy is no more than a warehouse for drugs and that a pharmacist has no more responsibility than a shipping clerk who must dutifully and unquestionably obey the written orders of omniscient physicians."(16)

The pharmacist further argued that he had relied on the express instructions of the doctor. The court, however, held that the pharmacist had a duty to warn a patient of the obvious inadequacies appearing on the face of the prescription and to notify the prescribing physician that the prescription did not include limitations regarding the minimum dosage.(17)

There have also been cases that have found that a pharmacist has a duty to warn of possible drug interactions. In Hand v. Krakowski, the plaintiff, who the pharmacist knew was an alcoholic, was sold over 700 doses of a psychotropic drug known to be contraindicated with alcohol.(18) The court stated that where a pharmacist knows that a customer is an alcoholic, and also knows or should know that a prescribed drug is contraindicated with alcohol, the druggist may

have a duty to warn the customer of the grave danger involved. The court also concluded that the pharmacist may have a duty to ask the prescribing physicians if the drug use should be discontinued.(19)

Many commentators have criticized holdings that a pharmacist has no duty to warn about a drug's side effects, because the holdings conflict with present-day pharmaceutical practice.(20) The day when pharmacists answered all customers, questions by referring them back to physicians is over. According to a 1987 survey, 87 percent of pharmacists surveyed reported telling their patients about drug interactions or side effects.(21)

A pharmacist's duty to counsel a customer on prescription use has been addressed legislatively. Recent federal guidelines require participating states to ensure that pharmacists discuss with anyone who has a Medicaid-paid prescription all common side effects and adverse drug interactions posed by the prescribed drug.(22) These practice standards could well create new standards of liability covering pharmacist counseling activities.(23) Also, the refusal of courts to recognize a pharmacist's duty to warn may change as plaintiffs point out that, in practice, pharmacists have assumed that duty.

Indeed, in Frye v. Medicare-Glaser Corp., the court found that a pharmacist, by warning that a particular drug could cause drowsiness, assumed the duty to provide a complete warning. Since the pharmacist did not tell the patient that the drug also interacted adversely with alcohol, the pharmacist was liable for the patient's death caused by that interaction.(24)

Many pharmacy chains now advertise computerized drug interaction services. If a patient uses and relies on one of these services, a cause of action for fraud or one arising under state consumer protection statutes could arise.(25)

Practice Considerations

The most common case against a pharmacist is for negligently failing to provide either the correct drug or a correct dosage of a drug. Given a pharmacist's heightened duty to fill prescriptions correctly, negligence can often be easily established

The plaintiff's lawyer should first determine whether the client still has any of the medicine or the prescription package In failure-to-warn cases, the package may contain partial warnings that can be used to argue that the pharmacist assumed a duty to warn In misfilling cases, analysis of the medication should be done to determine what it is

Even with the misfilled medication in hand, however, trial attorneys may find some pitfalls waiting for them First, attorneys must be aware that actions against pharmacists are usually governed by the special procedural requirements that apply in medical negligence cases For example, the statute of limitations in these actions is often shorter than for other negligence claims Also, there are o*en requirements that expert affidavits be submitted early in the litigation.(26)

Copies of Prescription

Copies of the prescription must be obtained both from the physician and the pharmacy To escape liability for misfilling prescriptions, pharmacists may claim they could not read the poor handwriting of physicians Juries may be sympathetic to this strategy, as they undoubtedly share the almost mythical belief that doctors scribble their prescriptions

Therefore, it is important to establish through discovery that pharmacists are supposed to call physicians to verify any questions concerning prescriptions Walgreen Co, for example, has a written policy requiring its pharmacists to contact a prescribing physician whenever the pharmacist has a doubt about a drug or dosage prescribed.(27) Also, many states have regulations requiring pharmacists to verify all in-doubt prescriptions.(28) To find out whether a state has a regulation like this, lawyers should contact the state board that oversees pharmacies

Pharmacists may also argue that they are not at fault because the prescribed drug was a "look-alike, sound-alike" drug, and it was not negligence to mistake it for the prescribed drug (for example, if Oxsoralen was used to fill a prescription for Oxacholin) A pharmacy expert can testify that some pharmacies either break up the alphabetical shelving of drugs with similar names to lower the odds of picking up the wrong bottle or use special precaution labels for seldom-dispensed drugs or drugs that are of unusual doses.(29)

A lawyer handling a pharmaceutical case should also check the Physician's Desk Reference to compare the recommended doses of both the prescribed and given drugs.(30) At the pharmacist's deposition, the lawyer should be prepared to compare the dosages, sizes, and colors of the prescribed and given drugs If at all possible, the pharmacist should be made to admit that these differences should have alerted him or her to the prescribing error

It is important to discover early in the case how many prescriptions have been improperly filled by the defendant pharmacist or chain pharmacy In a recent case, it was discovered that Walgreen Co had filled more than 1,000 prescriptions with either the wrong drug or the incorrect dosage.(31) Since the pharmacy may try to contest that it is liable for the acts of its employee, it is necessary to discover how many times the pharmacist at issue had made similar mistakes This information can then be used to show the pharmacy w as directly negligent for hiring, or retaining, the pharmacist

Where evidence shows more than an isolated mistake and a pattern of misconduct, punitive damages may be justified, particularly if the defendant did not try to prevent similar mistakes from occurring.(32) According to a survey of chain pharmacists, pharmacists who discover that major mistakes have been made in filling prescriptions often do nothing to prevent future errors.(33)

Comparative Negligence 

Another potential defense in these cases is the plaintiff's comparative negligence The pharmacist may assert that a customer has a duty to check the label before consuming a drug But where a plaintiff took a drug with a label showing it was meant for someone else, it is a question of fact whether this constitutes negligence by the plaintiff

For example, in Davis v. Katz & Besthoff, a pharmacy argued that even though it had given a customer the wrong drug, the customer should have recognized the mistake because another person's name was typed on the label The court, while conceding that a purchaser should inspect a label, found that the customer was not contributorily negligent because the customer had been on the medicine for three days and was probably too drowsy to read the label.(34)

Also, if a patient is given a prescription for one drug and gets another, jurors may think that the plaintiff naturally assumed that the drug was a generic substitute An argument can then be made that the plaintiff should not be punished for relying on the pharmacist's expertise

In summation, the lawyer should remind the jurors that it is up to them to ensure that the plaintiff gets what he or she deserves Drugs can cause devastating injuries or death Victims of pharmacy negligence deserve to be compensated for their injuries, and jurors must realize that they are entrusted with the responsibility of ensuring that justice is done.

Notes

(1) Rx'ers Get Top Ranks Again in Gallup Poll, DRUG STORE NEWS, July 15, 1991, at B 3; Kathi Gannon, I Recommend . . . What R.Ph.s Suggest in OTC's, DRUG TOPICS, Aug. 16, 1993, at 30. (2) Carol Ukens, Breaking the Trust, DRUG TOPICS, Nov 23, 1992, at 58. (3) Viveca Novak, The other Drug Lords When the Pharmaceutical Industry Comes Calling, Congress Listens, COMMON CAUSE, July Sept. 1992. (4) Ukens, supra note 2, at 58 59. (5) Cases v. Raisinger, 430 So. 2d 104, 107 (La. Ct. App. 1983) (quoting Trumbaturi v. Katz & Resthott; 158 So. 16 (La. 1934)). See also Adkins v. Mong, 425 N.W.2d 151, 152 (Mich Ct. App. 1988) (holding pharmacist to "very high standard" in filling prescriptions); Timothy E. Travers, Annotation, Druggist's Civil Liability for Injuries Sustained as Result of Negligence in Incorrectly Filling Drug Prescriptions, 3 A.L.R. 4th 270, 277 (1981). (6) See Vandermark v. Ford Motor Co., 391 P.2d 168, 171-72 (Cal. 1964). (7) 710 P2d 247, 251-53 (Cal. 1985). (8) Id. at 253. (9) 827 F. Supp. 1522 (D. Nev. 1993). (10) 782 P.2d 1045, 1048 54 (Wash. 1989). (11) Id. See also Ramirez v Richardson Merrell, Inc., 628 F. Supp. 85, 88 (E.D. Pa. 1986); Jones v Irvin, 602 F. Supp. 399 (S.D. Ill 1985); Ullman v. Grant, 450 N.Y.S.2d 955, 956 (Sup. Ct. 1982). (12) Nichols v. Central Merchandise, Inc., 817 P.2d 1131, 1133 (Kan. Ct. App. 1991); Fakhouri v. Taylor, 618 N.Y.S.2d 518, 521 (Ill. App. Ct. 1993) . (13) Nichols, 817 P2d 1131, 1133. (14) 518 N,.E.2d 758, 762 (Ill. App. Ct. 1988). (15) 508 A.2d 1247 (Pa. Super. Ct. 1986). (16) Id. at 1251. (17) Id. at 1252. (18) 453 N.Y.S.2d 121 (N.Y. App. Div. 1982). (19) See also Speer v. United States, 512 F. Supp. 670, 679 (N.D. Tex. 1981), aff'd on other grounds, 675 F.2d 100 (5th Cir. 1982) (finding that under Texas law a pharmacist has a duty to monitor a prescription refill and ensure that excessive quantities of dangerous drugs are not dispensed); Krueger v. Knutson, 111 N.W.2d 526, 532 (Minn. 1961) (affirming finding that where druggist knows that a product is to be mixed with another, which would have a harmful effect, druggist must advise customer). But see Kinney v Hutchinson, 449 So. 2d 696, 697 (La. C t. App. 1984) (holding pharmacist has no duty to warn of drug interactions); Jones v Irvin, 602 F. Supp. 399, 402 (S.D. Ill. 1985) (holding pharmacist has no duty to warn that dangerous amount of drug u as prescribed). (20) See David Brushwood, The Pharmacist's Drug Information Responsibility After McKee v. America Home Products, 48 FOOD & DRUG L.J. 377 (1993) [hereinafter Brushwood, The Pharmacist's Drug Information]; David Brushwood & Larry M. Simonsmeier, Drug Information for Patients, 7 J. LEGAL MED. 279, 300 ( 1986). (21) Valentine Cardinale, Reach Out and Change Someone, DRUG TOPICS, Dec. 14,1987, at 8. Indeed, the 1992 White Paper published by The American Pharmaceutical Association recognized that pharmacists are not bystanders in drug treatment, but are active participants in drug therapy and must accept responsibility for promoting therapeutic outcomes and reducing medication-related problems. AMERICAN PHARMACEUTICAL ASS'N, THE ROLE OF THE PHARMACIST IN COMPREHENSIVE MEDICATION USE MANAGEMENT (1992), cited in Brushwood, The Pharmacist's Drug Information, supra note 20, at 385, n.36. (22) 42 U.S.C.A. [sections]1396r-8(g)(2)(A) (West 1990). (23) Pharmacists who assume a duty to counsel patients must do so with reasonable care. See Kaspirowitz v Schering Corp., 175 A.2d 65X (N.J. Super. Ct. App. Div. 1961 ) (pharmacist settled case alleging that he told customer that adverse effects were nothing to worry about and that treatment should continue); Brush wood & Simonsmeier, supra note 20, at 308; Frank A. Duckworth, The Potential Liability of Pharmacists Arising from Announcements of New Standards and Codes of Practice, 43 FOOD, DRUG COSMETIC L.J. 1 (1988). (24) 579 N.E.2d 1255 (Ill. App. Ct. 1991). (25) See, e,g., MINN. STAT. ANN. [sections] 325F.69 (1981) and MINN. STAT. ANN. [sections]8.31, subd. 3a (West Supp. 1994) (creating private cause of action against anyone who uses a misleading statement or deceptive practice in connection with the sale of any merchandise). (26) See, e.g., Becker v. Meyer Rexall Drug, 367 N.W.2d 424 (Mich. Ct. App. 1985) (applying two-year professional malpractice statute of limitations to bar action against pharmacist); Sparks v. Kroger Co., 407 S.E.2d 105 (Ga. Ct. App. 1991) (requiring that an initial affidavit of expert review be filed with complaint in case). A federal court has held that the statute of limitations in a misfilling case starts to run after the patient discovers that he or she has received the wrong medicine when the pharmacist knew that the prescription was misfilled and did not tell the patient. Griffin v Phar-Mor, Inc., 790 F. Supp. 1115 (S.D Ala. 1992). (27) Walgreen's policy manual (on file with authors). (28) See MINN. R. 6800.3100(c) (1991). (29) Ukens, supra note 2, at 64. (30) PHYSICIAN'S DESK REFERENCE (48th ed. 1994). (31) Discovery documents from D.O. v Walgreen, No. 90 006637 (Minn., Hennepin County Dist. Ct. Feb. 9, 1993) (on file with authors). (32) See, e.,g., Bradbury v. Phillips Petroleum Co., 815 F.2d 1356,1364 65 (10th Cir. 1987) (discussing the admission into evidence of similar wrongful acts to show absence of mistake or accident in support of plaintiff's claim for punitive damages). (33) Ukens, supra note 2, at 60. (34) 333 So. 2d 698 (La. Ct. App. 1976). See also Jacobs Pharmacy Co. v Gipson, 159 S.E.2d 171 (Ga. Ct. App. 1967).