Opinion
No. CV-03-0823651-S
November 15, 2004
MEMORANDUM OF DECISION ON DEFENDANT WALGREEN'S JUNE 15, 2004, MOTION TO STRIKE
Pursuant to a June 15, 2004, Motion to Strike, Walgreen moves to strike the First Count of the plaintiff's Fourth Revised Complaint dated April 26, 2004. For the reasons stated below, the motion is granted, with the exception of specifications of negligence (g) and (j).
Factual Background
The Fourth Revised Complaint alleges a wrongful death claim against Walgreen Company ("Walgreen"), Paul V. Edelen, M.D., East Hartford Family Practice, LLP, the State of Connecticut and CVS Pharmacy. The complaint alleges in relevant part that the decedent died on January 4, 2002, and further asserts that prior to her death, Walgreen had prescribed to her a number of prescription drugs.
The First Count is directed against Walgreen, alleging that Walgreen was negligent in failing to adequately review, record, warn and communicate to the decedent and her prescribers the potentially dangerous combination of medications she had been prescribed by her physicians. As Walgreen notes in its June 15, 2004 Memorandum of Law in Support of Motion to Strike, it is not alleged that Walgreen inaccurately filled the decedent's prescriptions.
The First Count specifically alleges that decedent's death was caused by Walgreen's negligence in the following ways:
a. In that Walgreen's failed to warn the decedent that the use of the medications would cause her serious harm;
b. In that Walgreen's had information as part of its computerized dispensing system that should have alerted the pharmacist of the dangers presented to the decedent due to the medication combination;
c. In that Walgreen's failed to communicate information to the prescribers of the unsafe and dangerous prescriptions;
d. In that Walgreen's failed to make appropriate records of any discussions or other communications with the prescribers;
e. In that Walgreen's prescribed medications in combinations that were unsafe;
f. In that Walgreen's had available to it information that would have indicated that a dangerous combination of medications were being given to the decedent, but failed to communicate this to the doctors, the prescribers or to the decedent;
g. In that Walgreen's knew or should have known that the combination of medications being supplied to the decedent would cause her harm and could have and should have taken measures to remedy or correct it, but that the decedent negligently and carelessly failed to do so;
h. In that Walgreen's failed to keep or maintain adequate records concerning prescriptions being received and filled for the decedent;
i. In that Walgreen's failed to properly review its prescriptions for the decedent to determine whether or not the medications being prescribed to her were safe or unsafe;
j. In that Walgreen's to fill prescriptions for medications it knew or should have known would cause harm and/or death to the decedent;
k. In that Walgreen's failed to comply with the requirements of C.G.S.A. Section 20-620 subsections (a) though (e).
Legal Analysis
The purpose of a motion to strike pursuant to Practice Book §§ 10-39 through 10-45 "is to contest the legal sufficiency of the allegations of any complaints to state a claim upon which relief can be granted." (Internal quotation marks omitted.) Peter-Michael, Inc. v. Sea Shell Associates, 244 Conn. 269, 270, 709 A.2d 558 (1998). "[F]or the purpose of a motion to strike, the moving party admits all facts well pleaded." RK Constructors, Inc. v. Fusco Corp., 231 Conn. 381, 383 n. 2, 650 A.2d 153 (1994). "The court must construe the facts in the complaint most favorably to the plaintiff." (Internal quotation marks omitted). Faulkner v. United Technologies Corp., 240 Conn. 576, 580, 693 A.2d 293 (1997). "[I]f facts provable in the complaint would support a cause of action, the motion to strike must be denied . . . [W]hat is necessarily implied [in an allegation] need not be expressly alleged." (Citation omitted; internal quotation marks omitted.) Lombard v. Edward J. Peters, Jr., P.C., 252 Conn. 623, 626, 749 A.2d 630 (2000). Negligence is a breach of duty. Urban v. Hartford Gas Co., 139 Conn. 301, 304 93 A.2d 292 (1952). The existence of a duty is a question of law. Petriello v. Kalman, 215 Conn. 377, 382-83, 576 A.2d 474 (1990). In considering whether public policy suggests the imposition of a duty, our Supreme Court has considered four factors: "(1) the normal expectations of the participants in the activity under review; (2) the public policy of encouraging participation in the activity, while weighing the safety of the participants; (3) the avoidance of increased litigation; and (4) the decisions of other jurisdictions." Murillo v. Seymour Ambulance Assn., Inc., 264 Conn. 474, 480, 823 A.2d 1202 (2003).
The Learned Intermediary Doctrine
Walgreen's principal argument is that as a matter of law, it does not owe a duty to plaintiff in connection with the allegations in the First Court and that all of the First Count should be stricken because of the learned intermediary doctrine. With respect to most — but not all — of the allegations in the First Count, this argument has merit.
"[T]he learned intermediary doctrine is part of our state law." Vitanza v. Upjohn Company, 257 Conn. 365, 373, 778 A.2d 829 (2001). Manufacturers in Connecticut are strictly liable for defective products under Section 402A of the Restatement (Second) of Torts. The absence of proper warnings may render a product defective and unreasonably dangerous. "The learned intermediary doctrine provides . . . in general terms, that adequate warnings to precribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly." (Internal quotation marks omitted). Id., 376. The doctrine "applies particularly to the medical field, and generally involves unavoidably unsafe products . . . which by law can go from the manufacturer to the ultimate user only by way of a prescribing physician." Id., 390. Because a prescribing physician — not a pharmacist — determines what medications should be taken by a patient, the physician "is in the best position to convey adequate warnings based upon the highly personal doctor-patient relationship." Id., 392. As the Vitanza court stated:
The learned intermediary doctrine is a rules of law stating a duty, i.e., that a drug manufacturer has a duty to warn prescribing physicians of the dangers associated with its product, and not the ultimate consumer . . . The learned intermediary doctrine stands for the proposition that, as a matter of law, the prescribing physician of a prescription drug is the person best able to take or recommend precautions against the harm.
Id., 382-84.
Walgreen readily concedes that while Connecticut law applies the learned intermediary doctrine in cases against pharmaceutical manufacturers, no Connecticut appellate court has yet extended its application to pharmacists. Only one Superior Court decision has been rendered on the issue. Carafeno v. Gordon, Superior Court, judicial district of New Haven, Docket No. CV 93-0343687 (May 6, 1993, Thompson, J.) ( 9 Conn. L. Rptr. 88) ("The court is inclined to agree with the argument of the pharmacy that absent special circumstances, it has no duty to warn as to possible side effects . . .") The issue presented by this case, therefore, is whether or not the doctrine should be extended to apply to pharmacists given the facts as alleged.
Walgreen argues that there is no persuasive reason not to extend the doctrine. It notes that in other jurisdictions where the learned intermediary doctrine has been accepted, it has been extended to pharmacists, citing numerous cases. See, e.g., Cottam v. CVS Pharmacy, 436 Mass. 316, 764 N.E.2d 814 (2002); Garside v. Osco Drug, 976 F.2d 77 (1st Cir. 1992); Brooks v. WalMart Stores, Inc., 139 N.C.App. 637, 535 S.E.2d 55 (2000), review denied, 353 N.C. 370, 547 S.E.2d 2 (2001). These decisions are premised on the proposition that it is the physician — not the pharmacist — who is in the best position to make judgments about prescriptions and dosages on an individual basis, taking into account the individual needs of each patient. It is not the pharmacist but the physician, Walgreen contends, who has a duty to be fully aware of the characteristics of drugs being prescribed, different medications the patient is taking, detrimental side effects, and potential dangers caused by interactions between medications.
As Walgreen notes, courts have held that the pharmacist is not privy to the doctor-patient relationship; has no particularized knowledge about the patient's medical history and proclivities; and that the pharmacist's duty is to fill prescriptions, not write them, or warn patients about potential side effects. The pharmacist's duty, Walgreen contends, is to accurately fill a prescription in accordance with a physician's instructions, not to question the propriety of the judgment made by the prescribing physician. McKee v. American Home Products Corp., 113 Wash.2d 701, 711, 782 P.2d 1045 (1989).
Walgreen acknowledges that the role of the pharmacists has changed from a simple dispenser of medicine to a trusted professional playing an essential part in medical treatment. See Morgan v. Wal-Mart Stores, 30 S.W.3d 455, 469 (Tex.App. 2000). But Walgreen asserts that courts have held that the learned intermediary doctrine applies to pharmacists because while they are not mere automotons, they do not have a doctor-patient relationship with the customer and because they do not prescribe the medication they sell:
Pharmacists, as suppliers, do not freely choose which `products' they will make available to consumers in any given instance, and patients, as consumers, do not freely choose which `product' to buy. Physicians exercising sound medical judgment act as intermediaries in the chain of distribution, preempting as it were, the exercise of discretion by the supplier-pharmacist, and, within limits, by the patient-consumer . . . While the patient is entitled to know, and a doctor has a duty to inform the patient, of any dangers or side effects associated with a drug recommended for treatment, we see no sound reason for imposing on pharmacists the duty to supply information about the risks of drugs that have already been prescribed. On the contrary, such a rule would have the effect of undermining the physician-patient relationship by engendering fear, doubt, and second-guessing.
Coyle v. Richardson-Merrell, Inc., 526 Pa. 208, 214-15, 584 A.2d 1383 (1991).
To impose a general duty on the pharmacist to question the prescribing physician's judgment would create an impediment in the physician-patient relationship, Walgreen contends, citing decisions that underline this concern. Ramirez v. Richardson-Merrell, Inc., 628 F.Sup. 85, 88 (E.D. Pa. 1986) ("To impose a duty to warn on the pharmacist . . . would be to place the pharmacist between the physician who, having prescribed the drug presumably knows the patient's present condition as well as his or her complete medical history, and the patient. Such interference in the patient-physician relationship can only do more harm than good."); Morgan v. Wal-Mart Stores, supra, 30 S.W.3d 467 ("The imposition of a generalized duty to warn would unnecessarily interfere with the relationship between physician and patient by compelling pharmacists seeking to escape liability to question the propriety of every prescription they fill.")
Finally, Walgreen argues that it is "illogical and unreasonable to impose a greater duty on the pharmacist who properly fills a prescription than is imposed on the drug's manufacturer." Fakhouri v. Taylor, 248 Ill.App.3d 328, 333, 618 N.E.2d 518, cert. denied, 152 Ill.2d 557, 622 N.E.2d 1204 (1993). (Internal quotation marks omitted). See also Coyle v. Richardson-Merrell, Inc., supra, at 211, 215.
Plaintiff notes in response that no Connecticut Appellate Court or Supreme Court decision has yet held that the learned intermediary doctrine should apply to pharmacists. To extend the protection of the doctrine to pharmacists, plaintiff argues, would relegate pharmacists to mere pill counters, likened to a shipping clerk who must dutifully and unquestionably obey the written order of omniscient physicians. Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 469, quoting Riff v. Morgan Pharmacy, 353 Pa.Super. 21, 28, 508 A.2d 1247 (1986). Moreover, even if the doctrine is extended to pharmacists, plaintiff argues that exceptions should apply when a pharmacist voluntarily assumes a duty to warn of adverse drug reactions. See, e.g., Sanderson v. Eckerd Corp., 780 So.2d 930 (Fla.Dist.Ct.App. 2001); Baker v. Arbor Drugs, Inc., 215 Mich.App. 198, 205-06, 544 N.W.2d 727 (1996) cert. denied, 454 Mich. 853, 558 N.W.2d 725 (1997) (holding that defendant voluntarily assumed a duty to warn when it advertised its computer system would monitor customers' medication and detect potential harmful drugs). Plaintiff further cites cases in which it has been held that where a pharmacy has knowledge that a medication is contraindicated for a specific customer, the pharmacy assumes a duty to take corrective measures. See, e.g., Happel v. Wal-Mart Stores, Inc., 199 Ill.2d 179, 766 N.E.2d 1118 (2002), Such a duty, plaintiff contends, in no way intrudes on the doctor-patient relationship. Additionally, there are a category of cases involving "obvious or known errors in the prescription." McKee v. American Home Products Corp., 113 Wash.2d 701, 715, 782 P.2d 1045 (1989). See, e.g., Homer v. Spalitto, 1 S.W.3d 519 (Mo.Ct.App. 1999) (where pharmacists prescribed prescription for what it knew to be a lethal dose); Riff v. Morgan Pharmacy, 353 Pa.Super. 21, 508 A.2d 1247 (1986), cert. denied, 514 Pa. 648, 524 A.2d 494 (1987) (the `reasonable pharmacist' has an affirmative duty to read prescription and be aware of patent inadequacies as to maximum safe dosage of known toxic drugs and medicines where pharmacy dispensed drugs which were contraindicated to patient it knew to be an alcoholic). As stated in Morgan v. Wal-Mart Stores, supra, 30 S.W.2d at 466:
CT Page 17349 In sum, courts holding that pharmacists owe their customers a duty beyond accurately filling prescriptions do so based on the presence of additional factors, such as known contraindications, that would alert a reasonably prudent pharmacist to a potential problem. 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.
The Court concludes that there is no logical reason why the learned intermediary doctrine should not be extended to pharmacies and pharmacists, subject to the exceptions mentioned above and delineated below. To impose a general duty on pharmacies and pharmacists to investigate and evaluate all medications prescribed by a physician or physician would be to create a redundant, time-consuming and costly burden outside the scope of their normal duties. Pharmacists are, for the most part, in the business of dispensing medications prescribed by physicians; they are not in the business of undertaking independent evaluation of medications prescribed by physicians who have active knowledge of the needs and proclivities of their patients. Viewed through the lens of the four Murillo criteria, the court concludes that (1) most participants in transactions with pharmacies do not normally expect the pharmacist to undertake a wholesale review of drug interactions and side effects; (2) the public will continue to transact business with pharmacies in the belief and expectation that physicians are monitoring prescribed medications; (3) imposition of the duty suggested by plaintiff would result in increased litigation; and (4) decisions in other jurisdictions support the proposition that no broad duty, such as that urged by plaintiff, should be imposed on pharmacists and pharmacies.
Courts considering the issue raised in this case have mentioned various policy issues underlying their decisions. In Leesley v. West, 165 Ill.App.3d 135, 518 N.E.2d 758, cert. denied, 119 Ill.2d 558, 522 N.E.2d 1246 (1988), it was noted that imposing a general duty to warn on pharmacists would place too heavy a burden on pharmacists by requiring them to "retai[n] and catalogu[e] every document received to be certain each is distributed with the appropriate drug." Id., 142. In Morgan v. Wal-Mart Stores, Inc., supra, 30 S.W.3d 455. The court expressed concern that requiring pharmacies to provide warnings could provide risk averse pharmacies to warn customers about all potential side effects, no matter how small, which could result in "a patient who is faced with an overwhelming number of warnings from his or her pharmacist deciding "not to take medications prescribed by a physician." Id., 467.
The Court also concludes that to free pharmacists from any duty under all circumstances would be unwise. In narrow circumstances, recognized by courts in other jurisdictions, and depending upon the facts, pharmacies and pharmacists may assume a duty to a customer in connection with dispensing medications prescribed by a physician or physicians. Specifically, such a duty may be assumed when (1) a pharmacy or pharmacist has specific knowledge of potential harm to specific persons in particular cases; or (2) the pharmacy or pharmacist makes a representation that they will engage in a process of evaluation of the possible effects caused by the administration of a drug or combination of drugs; or (3) there is something patently and unambiguously wrong with the prescription itself, e.g., it is or should be plain that the medication prescribed provides a fatal dose to the patient. In these instances, the pharmacist's duty to the patient is an outgrowth of the pharmacist's knowledge or the pharmacist's voluntary assumption of a duty through his or her own actions or representations. Recognition of these exceptions will neither impose unreasonable expectations on pharmacies nor interfere with the physician-patient relationship nor significantly increase litigation. As emphasized by the Supreme Judicial Court of Massachusetts in Cottam v. CVS Pharmacy, 436 Mass. at 326, "the scope of the duty voluntarily undertaken by a pharmacy is a fact-specific inquiry based on the totality of the pharmacy's communications with the patient and the patient's reasonable understanding, based on these communications, of what the pharmacy has undertaken to provide."
Allegations (g) and (j).
Assuming that the allegations in subsections (g) and (j) are true for purposes of deciding the pending motion, the motion to strike is granted as to all other specifications of negligence in the First Count, and denied as to these two allegations only. Each of these allegations, if proven true, might fall into the first exception to the learned intermediary doctrine listed above. All of the other specifications of negligence, by contrast, fall within the purview of the learned intermediary doctrine. Stated otherwise, the Court concludes that Walgreen owes plaintiff no duty with respect to subsections a, b, c, d, e, f, h, i, and k. Allegations (g) and (j) may be subject to a subsequent motion for summary judgment, but the Court concludes that they survive the pending motion to strike.
Allegation k
Allegation (k), premised on Gen. Stat. Section 20-620 subsections (a)-(e), deserves separate discussion.
Subsection 20-620 regulates a pharmacist's interaction with patients receiving Medicare benefits, as the decedent apparently was. The statute requires a pharmacist to undertake a drug utilization review of the patient's drug history and offer to counsel such patients on the usage of their medication.
However, plaintiff is unable to cite any case law or legislative history that this provision was intended to create a private cause of action for an alleged violation. Review of the legislative history does not disclose any basis to believe the legislature sought to create a private cause of action for violation of these provisions. Analogous provisions in other states have been held not to create a private cause of action. See, e.g., Johnson v. Walgreen Co., 675 So.2d 1036 (Fla.Dist.Ct.App. 1996) (Florida statute requiring pharmacist to provide counseling on proper drug usage did not create a private cause of action). See decisions cited in Walgreen's October 4, 2004, Reply to Plaintiff's Objection to Motion to Strike, at pages 3-5. As Judge Aurigemma stated in Schlicht v. Royer, Superior Court, complex litigation docket at New Britain, Docket No. X03 CV 99 0509270 (Dec. 3, 2002), courts are reluctant "to create a private cause of action when there is a reasonably adequate statutory remedy." In this case, the plaintiff has alleged a wrongful death action pursuant to General Statutes § 52-555. This court concludes that, absent contrary authority, Section 60-620 does not create a private cause of action.
Conclusion
For the reasons stated, due to the application of the learned intermediary doctrine, all of the specifications of negligence in the first count except (g) and (j) are stricken. Because these allegations as pleaded fall within exceptions to the application of the doctrine, as to them, the motion to strike is denied.
Douglas S. Lavine
Judge, Superior Court