Opinion
Civ. No. 3:96-CV-699-H.
March 31, 2000.
MEMORANDUM OPINION
This is a pharmacy malpractice case. Plaintiffs have sued on theories of strict liability, failure to warn, negligence, breach of express warranty and breach of implied warranty. The pharmacy, Walgreen Company ("Walgreen"), has moved for summary judgment on all claims. The pharmacy argues that it has satisfied its limited duty to accurately fill Mrs. Allen's prescriptions. Moreover, Walgreen contends that Mrs. Allen's physician, as learned intermediary, had sole responsibility to warn her of any risks associated with the drug prescribed. Plaintiffs have not asserted a claim against the physician.
Plaintiffs argue that Walgreen had a duty to check Mrs. Allen's prescription history prior to filling her prescription. If Walgreen had consulted Mrs. Allen's patient profile, they say, it would have realized that Mrs. Allen was pregnant and should not take Altace. Plaintiffs also argue that Mrs. Allen received no warnings from Walgreen. The parties agree that the Court must determine the scope of a pharmacist's duty under Indiana law. Whether such a duty arises under our facts presents an interesting and difficult question, which the parties have argued with great skill.
Summary judgment is appropriate when there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. See Fed.R.Civ.Proc. 56(c). For purposes of summary judgment, any factual dispute must be resolved in favor of the non-moving party, in this case Plaintiffs, unless the evidence presented is so one-sided that reasonable people could not find for the non-moving party. See Betkerur v. Aultman Hosp. Ass'n, 78 F.3d 1079, 1087 — 88 (6th Cir. 1996) ; Street v. J.C. Bradford Co., 886 F.2d 1472, 1479-80 (6th Cir. 1989);. However, under Indiana law determining whether a relationship between the parties gives rise to a particular duty is for the courts to decide. See Miller v. Griesel, 308 N.E.2d 701, 706 (Ind. 1974).
I.
Janis Allen learned she was pregnant in April 1994. At that time, she was taking Altace, an ACE inhibitor, to treat hypertension. Dr. Marilyn Mahan, Mrs. Allen's obstetrician, continued prescribing Altace to Mrs. Allen during her pregnancy. Dr. Mahan now admits that this was a mistake and claims to have confused Altace with Aldomet, another hypertension drug. Women in their second or third trimester of pregnancy should avoid taking Altace because it can seriously damage or even kill a developing fetus. As Walgreen was aware, Altace carries a "black box warning" to alert of this risk.
Walgreen keeps track of its customer's prescriptions through a computerized database known as Intercom. Intercom stored Mrs. Allen's name, sex, address, phone number and prescription history. The system is designed to flash a red alert if any combination of the drugs the customer is taking might have a negative interaction. The Intercom system is not programmed to react when Altace is taken with prenatal drugs or given to a woman of child bearing age.
Both prior to and during her pregnancy, Mrs. Allen filled her prescription for Altace at Walgreen. At all times, the prescription was accurately filled in accordance with physician instructions, but the pharmacists who filled Mrs. Allen's prescription during her pregnancy cannot recall reviewing her prescription history before filling the prescription. It was not Walgreen's policy at the time to require such a review. If the pharmacists had reviewed Mrs. Allen's prescription history, they would have noticed that Walgreen had recently supplied Mrs. Allen with Natalins and Phenergan. Natalins are known as "prenatal vitamins," although they are also prescribed to people who are not pregnant. In fact, Mrs. Allen had taken them prior to becoming pregnant. Walgreen admits, however, that a prescription for Natalins provides reason to suspect a patient is pregnant. Phenergan also indicates possible pregnancy since it is sometimes, although not exclusively, used to treat morning sickness. Neither these prior prescriptions nor the fact that the prescribing physician was a well known obstetrician with offices two blocks away alerted the pharmacists that Mrs. Allen was pregnant.
During Mrs. Allen's second trimester, Walgreen's refilled her Altace prescription on June 27, July 27, and August 29. On September 30 when Mrs. Allen sought another refill, a pharmacist observed that she was visibly pregnant. Recognizing the risk of danger Altace poses for pregnant women, Walgreen refused to fill the prescription until consulting Mrs. Allen's prescribing doctor. When Walgreen spoke with Dr. Mahan, she changed the prescription to Aldomet.
Tests taken after Mrs. Allen discontinued use of Altace did not reveal any abnormality, but complications caused her to deliver by C-section in November, one month early. Her baby, David Allen, another Plaintiff, has renal problems and developmental delays which may be related to Mrs. Allen's ingestion of Altace during pregnancy.
It should be noted, however, that Mrs. Allen's pregnancy was considered high risk from the beginning due to her obesity and high blood pressure.
II.
Plaintiffs attempt to hold Walgreen liable under a theory of strict liability, arguing that Altace was unsafe for its intended use. Because Plaintiffs have failed to produce any expert testimony that Altace is defective and unreasonably dangerous for controlling hypertension, Plaintiffs' strict liability claim must be dismissed.This same analysis also applies to Plaintiffs' claims for breach of express and implied warranty. These torts assume that Altace was not merchantable or not fit for its intended use. Walgreen supplied Mrs. Allen with unadulterated Altace. Plaintiffs have presented no evidence to establish that the Altace supplied was not a merchantable product. Similarly, the Altace was prescribed to fight hypertension, and there is no proof that Altace is not fit for this purpose.
Underlying these claims, Plaintiffs imply that Altace was unsafe or unmerchantable because the pharmacist failed to warn her of Altace's risk to pregnant women. Plaintiffs make these arguments directly in their failure-to-warn negligence claim. Such a claim necessarily assumes that pharmacists must warn customers of the risks associated with the drugs they supply. However, Indiana is among the "overwhelming" majority of states that has specifically rejected such a duty. See Hooks SuperX v. McLaughlin, 642 N.E.2d 514, 518 (Ind. 1994); Ingram v. Hook's Drugs, Inc., 476 N.E.2d 881, 885-887 (Ind.Ct.App. 1985);. In Ingram, the Indiana Court of Appeals held that a pharmacist has no duty to warn unless the physician includes warnings in the prescription. See id. at 887. In this case, Dr. Mahan did not include any warnings. Therefore, Walgreen had no duty to warn Mrs. Allen under Indiana law. Plaintiff's failure to warn claim must be dismissed.
III.
This leaves Plaintiffs' more general negligence claim. Plaintiffs argue that by filling a prescription that was contraindicated based on the customer's prescription history and prescribing physician, the pharmacy failed to exercise reasonable care. Most states limit a pharmacist's duty to accurately filling the customer's prescription and being alert for clear errors on the face of the prescription, like a lethal dose. However, Indiana courts impose at least some additional duties. As held in Hooks SuperX v. McLaughlin, 642 N.E.2d 514 (Ind. 1994), pharmacists have a duty to stop a prescription or not to refill it when it is refilled at an unreasonably fast rate. This Court must now predict whether Indiana courts would extend a pharmacist's duty to the facts of this case.
Plaintiffs cite several sources to justify that the pharmacist owes the customer a duty in this case. First, Plaintiffs cite Indiana Code § 25-26-13-16 for the proposition that the pharmacist has a duty to exercise professional judgment in the best interest of a patient's health. Plaintiffs reference the same code provision to support the argument that the pharmacist has a duty to refuse to honor a prescription when a patient's medical condition contraindicates the drug for use by that patient.
Section 25-26-13-16 as written in 1994 and today:
(a) A pharmacist shall exercise his professional judgment in the best interest of the patient's health when engaging in the practice of pharmacy.
(b) A pharmacist has a duty to honor all prescriptions from a practitioner or from a physician, podiatrist, dentist, or veterinarian licensed under the laws of another state. Before honoring a prescription, the pharmacist shall take reasonable steps to determine whether the prescription has been issued in compliance with the laws of the state where it originated. The pharmacist is immune from criminal prosecution or civil liability if he, in good faith, refuses to honor a prescription because, in his professional judgment, the honoring of the prescription would:
(1) Be contrary to law;
(2) Be against the best interest of the patient;
(3) Aid or abet an addiction or habit; or
(4) Be contrary to the health and safety of the patient.
Plaintiffs also cite 856 Ind. Admin. Code tit. 1-33-2(a). This administrative provision addresses patient counseling requirements and mentions reviewing a patient's prescription profile prior to offering counseling. At most, this provision indicates that a pharmacist should review a patient's profile before filling a prescription. It does not address whether pharmacists have a duty to draw conclusions on a patient's medical condition from that profile. This Court finds that they do not.
Indiana's Code does require the pharmacist to exercise professional judgment when filling a prescription. However, the Code does not by itself create a duty to refuse to honor a prescription even if the prescription appears to be contraindicated. See McLaughlin, 642 N.E.2d at 518. On its face, it merely protects from liability pharmacists who refuse to honor prescriptions for valid reasons. Nevertheless, as the Indiana Supreme Court noted, by empowering pharmacists to exercise professional judgment, the statute does indicate that public policy is sometimes served by pharmacists questioning the prescriptions presented. See id.
While recognizing that the pharmacist has a duty under certain circumstances to refrain from dispensing a prescription as written, the court seems to have intentionally limited its holding. The McLaughlin court expressly reaffirmed Ingram, an Indiana Court of Appeals case that recognized the learned intermediary doctrine and refused to impose a duty to warn of a drug's side effects on pharmacists. See McLaughlin, 642 N.E.2d at 518. The Indiana Supreme Court distinguished the duty to monitor rate of consumption from the duty to warn of possible side effects. Reflecting upon these holdings, it seems that Indiana courts have declined to make the pharmacist a guarantor of the prescription drugs he or she fills, while at the same time making the pharmacist something more than a neutral conduit.
Indiana courts have articulated several strong justifications for recognizing a duty to monitor rate of consumption. First, the pharmacist may have personal knowledge of the prescription refill frequency. See id. Physicians usually do not know a patient's rate of use when the patient seeks to hide it. After all, physicians frequently prescribe several refills to last a patient until his next visit several months down the road. During this time, the physician is often unaware how quickly the patient consumes the prescribed drugs. Pharmacists are able to monitor consumption more easily.
Of course, the patient could also obscure his rate of consumption from the pharmacist by using different pharmacies, but imposing a duty on the pharmacist to monitor consumption creates an additional check without costing much money or infringing on the physician-patient relationship.
Second, monitoring rate of consumption does not interfere with the physician-patient relationship. See id. When a pharmacist refuses to fill a prescription that is being refilled at an unreasonably fast rate, the pharmacist is not challenging the physician's judgment. Rather he is enforcing the physician's instructions for use. Thus, the pharmacist's duty compliments the physician's duties by only interfering when the patient is not following the physician's orders. Finally, imposing the duty satisfies the public policy of preventing drug addiction and illegal resale of drugs.
The duty to analyze a customer's prescription history and warn of potential conflicts is quite a bit more significant than the duty to monitor usage. It is more analogous to the duty to warn, which Indiana courts have rejected. Indiana recognizes that the physicians are better positioned to warn of conflicts with other drugs or ongoing treatment. The duty to warn of side effects is different from the duty to monitor consumption because the duty to warn requires knowledge of the patient's medical condition and history. Without this information, a pharmacist cannot easily assess the risks and benefits of a particular drug. Physicians have this information; pharmacists do not. Even if both parties had the same information, physicians have significantly more training than pharmacists. For these reasons, Indiana courts have retained the principle that the physician, not the pharmacist, ought to stand as gatekeeper of prescription drugs.
Simply because the pharmacist may have access to historical data about the customer does not mean that he should have a duty to analyze that data as would a physician. In McLaughlin, only the pharmacist had the relevant data. To evaluate it required merely a pharmacological assessment, not one also involving a medical judgment. These distinctions, it seems to this Court, separate the duty Plaintiffs seek to impose here from the duty the Indiana Supreme Court imposed in McLaughlin.
In this Court's view, the discussion in McLaughlin about the contractual relationship between the pharmacist and its customer does not change the doctor-patient relationship nor does it necessarily impose a duty upon the pharmacist to make the kind of analyses and judgments that doctors should make themselves.
The Court concludes that Indiana courts would view our case as more similar to Ingram than to McLaughlin. Only the physician is fully aware of the patient's medical condition and history. The physician alone must be responsible for the appropriate treatment. Indiana courts have not yet imposed a legal duty on pharmacists to discern the patient's condition from the prescription history or prescribing physician's specialty or to second-guess the physician's treatment instructions based on this limited knowledge. To extend the pharmacist's duty in this manner would seem contrary to the policy considerations underlying McLaughlin and Ingram. This Court predicts that Indiana courts would not do so.
Naturally, this discussion leaves many questions unanswered. It does not decide whether a pharmacy could be liable for filling a prescription for a lethal dose. That information is available on the face of the prescription without need of knowledge of the patient's medical condition. Whether a pharmacist could be liable for filling a prescription known to have a negative interaction with another drug prescribed at the same time remains undecided. The Court narrowly decides that the pharmacist is not required to ascertain the patient's medical condition based on his or her prescription history or the prescribing physician's specialty and to refuse to honor prescriptions that might harm a patient in that medical condition.
The Court acknowledges that in many cases imposing such a duty could have benefits. Requiring pharmacists to serve as a second check on physicians' prescriptions might avoid some prescription errors. However, a pharmacist can, in the exercise of professional discretion, still question the physician about any prescription even without the threat of liability. Pharmacists should not have to defend suits when they correctly fill a prescription that a physician improperly prescribed. Requiring them to do so would only complicate and interfere with the physician-patient relationship. A plaintiff has ample opportunity to recover from the physician for any prescription mistakes.
The Court will enter an order consistent with this Memorandum Opinion.
cc: Counsel of Record UNITED STATES DISTRICT COURT WESTERN DISTRICT OF KENTUCKY AT LOUISVILLE CIVIL ACTION NO. 3:96-CV-699-H
ORDER
Having read Defendant's motion for summary judgment and Plaintiffs' response, and being otherwise sufficiently advised,
IT IS HEREBY ORDERED that Defendant's motion for summary judgment is SUSTAINED, and Plaintiffs' complaint is DISMISSED WITH PREJUDICE.
This is a final and appealable order.
This ___ day of March, 2000.