|David W. Bibeau, as Personal
Representative of the Estate
of Katherine Ann Kurtz-Bibeau,
James Michael Shortt, M.D.;
||C/A No. 3:04-22306-10
MEMORANDUM IN SUPPORT
I. NATURE OF THE CASE
This is a wrongful death medical malpractice and professional negligence case arising out of the intravenous administration of .03% hydrogen peroxide solution to Plaintiff. The hydrogen peroxide compound solution was allegedly administered by Dr. James Michael Shortt. The compound was allegedly provided to Dr. Shortt by Congaree Pharmacy, Inc., George Dawn, R.Ph. and J.H. “Buster” Phillips (referred to hereafter collectively as “Congaree”). Plaintiff alleges that the administering of the compound and other medications by Shortt was improper and that it was improper for Congaree to provide the compound to Shortt. All Defendants deny liability. The Congaree Defendants move for Summary Judgment because the Plaintiffs’ claims against them proceed upon a mistaken understanding of the role and duties of a compounding pharmacist.
II. STATEMENT OF THE FACTS
In 2001, Katherine Ann Kurtz-Bibeau, a medical technician with the Veterans Administration Hospital in St. Paul, Minnesota, was diagnosed with multiple sclerosis. (Complaint ¶ 8). As her health deteriorated and she had exhausted the available resources in mainstream medicine, she began investigating alternative treatments for her disease. Id. In her search for alternative treatments she discovered Dr. Shortt. Id. Dr. Shortt offered various alternative treatments for Kurtz-Bibeau, including a type of oxidative therapy wherein low dose hydrogen peroxide is administered intravenously into the patient. Id. Shortt saw Kurtz-Bibeau initially on October 21, 2003. (Complaint ¶ 11). She returned to Columbia, South Carolina and received an intravenous injection of hydrogen peroxide on March 9, 2004. (Complaint ¶ 14). She returned for a second treatment on March 11, 2004, but received an intravenously administered treatment other than hydrogen peroxide. Kurtz Bibeau was hospitalized on March 12, 2004 and died March 14, 2004. (Complaint ¶ 16).
Kurtz-Bibeau’s death certificate provides the cause of death to be cardiac arrest, systemic shock and DIC, (disseminated intravascular coagulation) and Iatrogenic Infusion of Hydrogen Peroxide per Coroner Gary Watts 9-9-04. (Death Certificate, Exhibit A).
It is alleged that Congaree provided sterile 3% hydrogen peroxide compound to Dr. Shortt, which Dr. Shortt then diluted to one one-hundredth concentration and administered to Kurtz-Bibeau. (Complaint ¶ 13).
In or about 1999, Phillips of Congaree first agreed at Dr. Shortt’s request to produce and provide to him a 3% hydrogen peroxide that he could dilute to .03% and administer in his office. (James Horace Phillips, Jr., Deposition p. 20, l. 19–p. 21, l. 9; Exhibit B).1 Hydrogen peroxide 3% is available commercially. (Phillips’ Dep., p. 21, ll. 10-25, p. 54, ll. 4-6; Exhibit B). Congaree produced the 3% hydrogen peroxide by adding water to 35% commercially available hydrogen peroxide and then sterilizing the product by filtering it through a .22 micron filter. (Phillips’ Dep., p. 111, ll. 2-12, Exhibit B). Over the course of five years, Congaree provided the sterile 3% hydrogen peroxide to Dr. Shortt at his request on a few occasions for use by Dr. Shortt in his clinic. On or about March 9, 2004, Congaree provided Dr. Shortt compounded sterile 3% hydrogen peroxide. (Phillips’ Dep., p.189, ll. 13-16, p.190, l1.14-15, Exhibit B). It was Congaree’s understanding that Dr. Shortt would further dilute the compound to .03% before administration. (Phillips Dep., p. 21, ll. 5-7; Exhibit B). It is unknown whether the hydrogen peroxide Congaree provided to Dr. Shortt on March 9, 2004, was the hydrogen peroxide administered to Kurtz-Bibeau. Notably, Dr. Shortt did not write a prescription for the hydrogen peroxide and Congaree never dispensed hydrogen peroxide to Mrs. Bibeau.
Footnote 1: Hereinafter referred to as “Phillips’ Dep. ; Exhibit B”.
III. STANDARD OF REVIEW
In ruling on a motion for summary judgment, the Court must determine whether under the governing law there can be but one reasonable conclusion as to the verdict. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 106 S. Ct. 2505, 2512 (1986). The party seeking summary judgment always bears the initial responsibility of informing the Court of the basis of its motion, and demonstrating that there is an absence of any dispute as to a material fact. Adickes v. S.H. Kress & Co., 398 U.S. 144, 157, 90 S. Ct. 1598, 1608 (1970). Rule 56(c) of the Federal Rules of Civil Procedure requires the Court to grant judgment in favor of the moving party when the nonmoving party fails to present evidence to dispute an issue of material fact. A court must render summary judgment in favor of the moving party “if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and the moving party is entitled to a judgment as a matter of law.” Fed. R. Civ. P. 56(c).
The moving party’s burden of proof is “discharged by ‘showing’ – that is, pointing out to the district court – that there is an absence of evidence to support the nonmoving party’s case.” Celotex Corp. v. Catrett, 477 U.S. 317, 325, 106 S. Ct. 2548, 2554 (1986). “When the moving party has carried its burden . . . its opponent must do more than simply show that there is some metaphysical doubt as to the material facts.” Matsushita Electric Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986)(citations omitted). “[T]he nonmoving party must come forward with specific facts showing that there is a genuine issue for trial . . . [and] [w]here the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no genuine issue for trial.” Id. at 587 (citations omitted). The burden upon the nonmoving party to establish a genuine issue of material fact is not insubstantial. “[T]here is no issue for trial unless there is sufficient evidence favoring the nonmoving party for a jury to return a verdict for that party. If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted.” Anderson, 477 U.S. at 249-50, 106 S. Ct. at 2511 (citations omitted).
No genuine issue of material fact exists in the case because as a compounding pharmacy, Congaree fully discharged its legal duties to Mrs. Kurtz-Bibeau by providing the exact formula requested by Dr. Shortt to him – a licensed physician – for his use in his office.
IV. LEGAL ARGUMENT
I. There is no evidence establishing that the Congaree Defendants were negligent, grossly negligent, negligent per se, willful, wanton, or reckless in the particulars alleged in the Plaintiffs’ Amended Complaint.
In their Amended Complaint, Plaintiffs allege these Defendants were negligent, grossly negligent, negligent per se, willful, wanton, and reckless in the following particulars:
a. filling and dispensing a prescription for 3% hydrogen peroxide for intravenous ingestion;
b. failing to warn Mrs. Kurtz-Bibeau of the risk of severe and potential fatal complications associated with hydrogen peroxide ingestion;
c. failing to provide a drug regimen review;
d. failing to provide pharmacy care to Plaintiff;
e. failing to make a determination of therapeutic appropriateness;
f. failing to interpret and assess the prescription order for potential adverse reactions or side effects;
g. dispensing hydrogen peroxide for human ingestion when the government approved label provided for “external use only” and
h. failing to exercise due care in the professional practice as a pharmacist.
The balance of this memorandum will address each allegation of wrongful conduct allegedly committed by these Defendants and explain why the allegations fail.
A. The Congaree Defendants did not fill and dispense pursuant to a prescription drug order 3% hydrogen peroxide for intravenous ingestion.
The South Carolina Pharmacy Practice Act establishes two very distinct types of pharmacy practice: the dispensing pharmacist, who fills prescriptions for individual patients, and the compounding pharmacist, who prepares compounds at a licensed physician’s request, for the physician’s use in an office or hospital setting.
There is no evidence that Congaree dispensed 3% hydrogen peroxide pursuant to a prescription drug order. The South Carolina Pharmacy Practice Act, which governs the acts of Congaree, defines “prescription drug order” as:
“A lawful order from a practitioner for a drug or device for a specific patient, issued for a legitimate medical purpose within the prescriber’s course of legitimate practice and including orders derived from collaborative pharmacy practice.”
S.C. Code Ann. § 40-43-30(47)(emphasis added).
The Act further defines “dispense” as:
“The transfer of possession of one or more doses of a drug or device by a licensed pharmacist or person permitted by law, to the ultimate consumer or his agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.”
S.C. Code Ann. § 40-43-30(14).
Congaree provided the sterile hydrogen peroxide compound to Dr. Shortt for use in his clinic at the order of Dr. Shortt. (Phillips’ Dep., Exhibit 3, Exhibit C). There was no prescription drug order as that phrase is defined in the Act because the hydrogen peroxide was not ordered for a “specific patient”. Moreover, the hydrogen peroxide was not “dispensed” as that term is defined in the Act because it was not provided directly to the “ultimate consumer or his agent.”
Rather than dispensing a drug to a specific patient, Congaree, in this instance, provided a compound to a physician for clinic use treating a patient, as is specifically allowed by the Practice Act. The Practice Act defines “compounding” as, among other things:
“the preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extracting from substances of natural origin or independently by means of chemical or biological synthesis.”
S.C. Code Ann. § 40-43-30(7).
The Practice Act further specifically allows a pharmacist to “compound products based on an order from a practitioner for use by practitioners for patient use in institutional or office settings.” S.C. Code Ann. § 40-43-85(CC)(2)(e). Here, Dr. Shortt ordered 3% hydrogen peroxide for use in his office. The Practice Act clearly allows Congaree to provide the product in such a manner.
Congaree cannot be liable for “filling and dispensing a prescription for 3% hydrogen peroxide” because these Defendants did not provide the hydrogen peroxide pursuant to a prescription drug order as that term is defined in the Practice Act. Congaree properly, under the terms of the Practice Act, provided the hydrogen peroxide to Dr. Shortt to use in his office.
B. Congaree had no duty to warn Ms. Bibeau of the risks of the hydrogen peroxide provided to Dr. Shortt for office use.
The South Carolina Pharmacy Practice Act does not impose a duty on a pharmacist to counsel a patient concerning the risks or side effects of a drug unless the patient presents a prescription drug order for a new medication:
“Upon receipt of a prescription drug order for a new medication and following review of the patient’s pharmacy record, the pharmacist shall personally offer counseling to the patient or the patient’s agent. Using his best professional judgment, the pharmacist’s counseling shall 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 shall include appropriate elements of patient counseling…”
S.C. Code Ann. § 40-43-86(L)(1)(emphasis added). As outlined above, Congaree did not provide the hydrogen peroxide to Ms. Bibeau at all, much less in response to a prescription drug order.
The Practice Act imposes no duty on a compounding pharmacist to counsel a patient concerning risks of a drug. It is obvious, in a circumstance such as we have here where the medication was provided to the physician for administration, and only the physician has direct contact with the patient, the physician would be expected to provide any counseling concerning risks of the drug, and that is the reason the legislature chose not to impose a duty on the pharmacist to counsel when the medication is provided to the doctor for clinic use.
C. Congaree had no duty to provide a drug regimen review.
The Congaree Defendants had no opportunity, let alone a duty, to review Mrs. Bibeau’s pharmacy patient record. The Pharmacy Practice Act §§ 40-43-86(K) and (L) require a pharmacy patient record review only upon the presentation by the patient of a prescription drug order. See S.C. Code Ann. §§ 40-43-86(K)and (L) (emphasis added). Because the hydrogen peroxide was provided to Dr. Shortt at his order for clinic use and not pursuant to a prescription, a drug regimen review was not required. In fact, because the hydrogen peroxide was provided to Dr. Shortt for him to administer in his practice of medicine at his clinic, there were no pharmacy patient records to review.
D. The Congaree Defendants had no duty to provide pharmacy care to Mrs. Bibeau.
The Pharmacy Practice Act defines “pharmacy care” as:
“The direct provision of drug therapy and other pharmacy patient care services through which pharmacists, in cooperation with patient and other health care providers, design, implement, monitor, and manage therapeutic plans for the purpose of improving a patient’s quality of life.”
S.C. Code Ann. § 40-43-30(38). No provision in the Pharmacy Act imposes a duty on Congaree to provide pharmacy care. Mrs. Bibeau was not a Congaree pharmacy patient. There is no evidence that Congaree was involved with Dr. Shortt in a collaborative effort in designing, implementing, or managing Mrs. Bibeau’s care. Neither was Congaree ever asked by Shortt or Bibeau to be involved in Mrs. Bibeau’s care. (David Bibeau’s Dep., p. 64, l. 9 – p. 66, l. 25, Exhibit D). The Practice Act does not impose a duty upon Congaree to assume the provision of pharmacy care to Mrs. Bibeau, and Congaree did not undertake to provide such care. In order to have a duty to provide pharmacy care, Congaree would have had to have assumed that duty by agreement or actions and it did neither.
E. The Congaree Defendants had no duty to make a determination of the therapeutic appropriateness of hydrogen peroxide.
The Pharmacy Practice Act requires a pharmacist to make a determination of the therapeutic appropriateness of a drug only when the pharmacist is presented with a prescription drug order by a patient:
“A pharmacist shall review the pharmacy patient record and each prescription drug order presented for dispensing for purposes of promoting therapeutic appropriateness by identifying:
(1) over-utilization or under-utilization;
(2) therapeutic duplication;
(3) drug-disease contraindications;
(4) drug-drug interactions;
(5) incorrect drug dosage or duration of drug treatment;
(6) drug-allergy interactions;
(7) clinical abuse/misuse.
Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem which shall, as appropriate, include consultation with the practitioner.”
S.C. Code Ann. § 40-43-86(K)(emphasis added). When a pharmacist provides a drug to a physician for office use, it is not required nor is it even possible for a pharmacist to determine the therapeutic appropriateness of a drug. Indeed, when a compounding pharmacist provides a drug to a physician for office use, the pharmacist might not even know how or why the physician intends to use it. Congaree provided the hydrogen peroxide on the order of Dr. Shortt to use in his office; therefore, there was no statutory or common law duty to determine the therapeutic appropriateness of the hydrogen peroxide.
F. The Congaree Defendants had no duty to Mrs. Bibeau to assess a prescription order for potential adverse reactions or side effects.
The Pharmacy Act requires a pharmacist to counsel a patient concerning potentially serious side effects of interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur, when a prescription drug order for a new medication is presented by the patient. S.C. Code Ann. § 40-43-86(L)(1)(e). As explained above, there was no prescription drug order in this circumstance. The hydrogen peroxide was provided to Dr. Shortt for use in his office as allowed under section 40-43-86(CC)(2)(e) of the Practice Act. Therefore, the Congaree Defendants had no duty to Mrs. Bibeau to assess a prescription drug order for therapeutic appropriateness.
G. The Congaree Defendants owed no duty to Mrs. Bibeau to refrain from providing Dr. Shortt hydrogen peroxide to use intravenously.
No duty existed in Congaree to refrain from providing to a licensed physician a medication that the doctor intends to put to an “off-label” use in his practice of medicine. As we have stated in response to every other allegation, the Practice Act places no duties on a pharmacist to determine risks, side effects, indications, contraindications, or therapeutic appropriateness or counsel patients in any way when the medication is being provided for office use to a licensed physician. See S.C. Code Ann. § 40-43-86(CC). All duties imposed by the Practice Act which Plaintiffs cite in their Complaint are triggered only upon the presentation of a prescription drug order by the patient to the pharmacist. When the drug is provided to the physician and not the patient, there is a licensed medical professional directly involved in the administration of the medication. The involvement of the physician negates the necessity and the ability of a pharmacist to provide counseling or pharmacy care, consider drug contraindications, evaluate off-label uses, or carry out other duties under by the Practice Act, because the physician is tasked with carrying out those duties. The Congaree Defendants had no duty to do any investigation into the appropriateness of the hydrogen peroxide for injection into a patient under the normal course of practice or the Practice Act.
The U.S. Food and Drug Administration has also recognized that it is the physician’s responsibility to make certain that when he uses a drug in a manner not indicated on a label, he makes certain the use is safe and rationally indicated. In its 1998 information sheet, the USFDA provides “[g]ood medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If the physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects. Use of a marketed product in this manner, when the intent is the ‘practice of medicine,’ does not require the submission of an Investigational New Drug Application, Investigational Device Exemption or review by an Institutional Review Board.” (U.S. Food and Drug Administration “Guidance for Institutional Review Boards and Clinical Investigators” 1998 Update, Exhibit E). The duty to make medical judgments is vested in the physician, not the pharmacist, when the physician is administering the medication himself.
There simply is no duty imposed by law on the Congaree Defendants to refrain from providing Dr. Shortt hydrogen peroxide. It is Dr. Shortt’s responsibility to use the product in accordance with generally accepted standards of medical care.
H. The Congaree Defendants did not fail to exercise due care in the practice of pharmacy.
An essential element in a cause of action for negligence is the existence of a legal duty of care owed by the Defendant to the Plaintiff. Bishop v. South Carolina Dept, of Mental Health, 331 S.C. 79, 502 S.E.2d 78 (1998). An affirmative legal duty only exists if created by statute, contract, relationship, status, property interest, or some other special circumstance. Miller v. City of Camden, 317 S.C. 28, 451 S.E.2d 401, rehearing den. aff’d as mod. 329 S.C. 310 (Ct.App. 1994). Congaree owed no duty to Mrs. Bibeau because she was not a pharmacy patient, therefore no special relationship existed, and there were no statutorily imposed duties owed to Mrs. Kurtz-Bibeau. S.C. Code Ann. § 40-43-10 et seq.
The purchaser of the hydrogen peroxide was Dr. Shortt. Mr. Phillips had discussed the hydrogen peroxide therapy with Dr. Shortt; Phillips had read literature on the therapy; and Phillips had undergone the therapy himself on several occasions. (Phillips’ Dep., p. 31, l.11 – p. 32, l. 13, and p. 218, ll. 4-8, Exhibit B). Dr. Shortt was a “learned intermediary” between the Congaree Defendants and the patients Dr. Shortt treated. See infra. As the learned intermediary between Congaree and the patients to whom he administered the hydrogen peroxide, Dr. Shortt possessed the ability and the duty to evaluate the patient’s needs, asses the risks and benefits of the drug, and supervise the drugs use. See infra. Further, because the use was an “off-label” use, Dr. Shortt had the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects. The Congaree Defendants express no opinion as to whether Dr. Shortt complied with accepted standards of medical practice. (See U.S. Food and Drug Administration “Guidance for Institutional Review Boards and Clinical Investigators” 1998 Update, supra, Exhibit E).
Because the Practice Act imposes no duties upon a pharmacist to a patient in a situation where a compounded product is provided to a physician for use in the physician’s clinic, the only potential duty would be that imposed by common law. In a professional negligence case, the standard of care that a plaintiff must prove is that the professional failed to conform to generally recognized and accepted practices of his profession; if the plaintiff is unable to demonstrate such failure to conform the professional cannot be found liable as a matter of law. Doe v. American Red Cross Blood Services, 297 S.C. 430, 377, S.E.2d 323, 326 (SC 1989); Evans v. Rite Aid Corporation, 324 S.C. 269, 478 S.E.2d 846 848 (SC 1996). There are no South Carolina cases establishing the standard of care for a pharmacist who provides a compound directly to a physician for use in that physicians clinic pursuant to S.C Code Ann. § 40-43-86(CC)(2)(e).
The purchaser in this case was Dr. Shortt. To the extent any warnings were required to be given concerning the hydrogen peroxide to Ms. Bibeau, they were to be given by Dr. Shortt. Dr. Shortt was a learned intermediary. A learned intermediary is one who exercises individualized medical judgment based on knowledge of the patient and the treatment for the illness, and generally only a physician can be a learned intermediary. Odom v. G.D. Searle & Company, 979 F.2d 1001 (4th Cir. (S.C.) 1992); Brooks v. Medtronic, Inc., 750 F.2d 1227 (4th Cir. (S.C.) 1984); Mazur v. Merck & Co., 767 F. Supp. 697 (E.D.Pa. 1991) aff’d 964 F.2d 1348 (3rd Cir. 1992) cert. den. 506 U.S. 974, 121 L. Ed.2d 371, 113 S.Ct. 463 (1992).
Although there are no cases in this jurisdiction directly on point,2 the South Carolina Courts have dealt with pharmacists’ duties with regard to the sale of drugs and the related issue of a manufacturer’s duty to warn. The learned intermediary doctrine places the duty to warn of the risks associated with a drug on the physician and not the pharmacists. Madison v. American Products Corp. and Aiken Drug Co., 358 S.C. 449, 595 S.E.2d 493, 496 ( 2004); also see Mazur. Although the Madison case dealt with a strict liability cause of action rather than negligence, the rationale is applicable here because there is no duty imposed by the Practice Act, and the Practice Act specifically allows a pharmacist to provide a compound directly to a physician to use in his office; a circumstance in which the drafters of the Practice Act would have foreseen that no direct relationship between the pharmacist and patient would exist. The Madison Court held that “[c]ompounding pharmacies provide a unique and valuable service in our health care system, one which we have no reason to deter at this point. Nor do we believe that pharmacies are in a good position to insure against, or take steps to reduce the risks of harm done by the drugs used in their compounded products through additional warnings.” Id. citing favorably In re New York Diet Drug Litig., 262 A.D.2d 132, 133, 691 N.Y.S.2d 501, 502 (1st Dept.1999) (absent an allegation pharmacist failed to fill prescriptions as directed, there was no basis to hold pharmacists liable under theories of negligence, breach of warranty, or strict liability).
Footnote 2: The Court of Appeals in Indiana faced somewhat similar issues in a case of first impression in which the plaintiff alleged a pharmacist was liable in negligence for a failure to warn the plaintiff of the risks of a drug. In arriving at their holding that pharmacists had no duty to warn patients being treated by physicians with prescription drugs, the Indiana Court relied heavily on cases in the jurisdiction that held manufacturers had no duty to warn patients concerning the risks of a drug. Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881 (Ind.Ct.App. 1985).
Similarly, the Fourth Circuit Court of Appeals applying South Carolina law has held that manufacturers of drugs generally have no duty to warn patients of risks. In Odom v. G.D. Searle & Co., 979 F.2d 1001 (4th Cir. (S.C.) 1992), the Fourth Circuit held that under the learned intermediary doctrine, the manufacturer’s duty to warn extends only to prescribing physicians, who then assume the responsibility for advising the individual patient of risks associated with the drug or device. Moreover, the manufacturer cannot be said to have caused the injury if the doctor already knew the medical risks. 979 F.2d at 1003. In Brooks v. Medtronic, Inc., 750 F.2d 1227 (4th Cir. (S.C.) 1984), the Fourth Circuit, applying South Carolina law, held that prescription drugs are an exception to the usual rule that warnings must be given to the ultimate user of a product. “It is settled in a substantial majority of the jurisdictions that the duty a manufacturer owes to the consumer is to warn only the physician of any risks associated with the drug.” Brooks, 750 F.2d at 1230, citing Stanback v. Parke, Davis and Co., 657 F.2d 642, 644 (4th Cir. 1981). In its opinion, the Fourth Circuit stated the following policy for the rule, which is equally applicable in determining that a pharmacist has no duty to warn the patient when the drug is provided to the physician:
“Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, in an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then who must warn ultimate purchasers of danger inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.” Brooks at 1231 citing Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276, cert. den., 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974).
Where no duty to warn is created by statute, many jurisdictions have found no common law duty in the pharmacist to warn the patient of risks of a drug because such a duty would require pharmacists to substitute their judgment for that of the prescribing physician. See Ramirez v. Richardson-Merrell, Inc., 628 F. Supp. 85 (E.D.Pa. 1986) (to impose a duty to warn on the pharmacist, however, 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); Raynor v. Richardson-Merrell, Inc., 643 F. Supp. 238 (D.C.Dist.Col. 1986) (patients rely on their physicians, not pharmacists, for warnings of the risks associated with prescription drugs, and requiring a pharmacist to warn would, in effect, require a pharmacy to substitute its judgment for that of the physician); Jones v. Irvin, 602 F. Supp. 399 (S.D.Ill. 1985); also see Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881 (Ind.Ct.App. 1985). (pharmacist had no duty under Indiana statute to warn, therefore duty rests on physician to warn the patient, particularly if pharmacist had no knowledge of patient’s medical history or conditions); Hofherr v. Dart Industries, Inc., 853 F.2d 259 (4th Cir. 1988) (the injection of a third party in the form of a pharmacist into the physician/patient relationship could undercut the effectiveness of the ongoing medical treatment by the physician); McLeod v. W.S. Merrell Co., Div. of Richardson Merrell, Inc., 174 So.2d 736 (1965) (Court held the pharmacists had no duty to warn patient who obtained a drug not available to the general public but, rather only available through a physician); Batiste v. American Home Products Corp., 32 N.C.App. 1, 231 S.E.2d 269 (1977), (Court held pharmacist had no duty to warn where pharmacist filled the prescription as directed, there was no allegation the product was other than it was supposed to be, there was no allegation that the druggist did any compounding or added to or took away from the product as prepared or the druggist did anything to change the prescription given); Bichler v. Willing, 397 N.Y.S.2d 57, 58 A.D.2d 331 (1977) (when a consumer asks a druggist to fill a prescription, thus enabling him to obtain a drug which is not otherwise available to the public, he does not rely on the druggist’s judgment as to whether that particular drug is inherently fit for its use but rather he places that confidence and reliance in the physician who prescribed the remedy).
When Mrs. Kurtz-Bibeau began looking for alternatives to her current treatment for multiple sclerosis, she researched the hydrogen peroxide therapy and contacted Dr. Shortt to administer the treatment; Congaree was not consulted nor involved in that decision. (Plaintiffs’ Complaint ¶ 8; Bibeau’s Dep., supra, Exhibit D). In fact, there is no allegation that the Congaree Defendants ever met Mrs. Kurtz-Bibeau prior to her death. The Congaree Defendants were not informed of Mrs. Kurtz-Bibeau’s medical condition, they were not told what medications she was on, and they were not aware what other medical treatments she was undergoing. As is inherently the case with compounding pharmacists, these Defendants were without any information about Mrs. Kurtz-Bibeau sufficient to allow them to provide any valuable input into her treatment, much less warn her about a treatment recommended by her treating physician, who possessed all of the information Congaree did not.
The South Carolina Practice Act imposes no duties upon a pharmacist to a patient when the patient is not a pharmacy patient who has presented a prescription drug order to be filled. The Practice Act allows a pharmacist to provide a drug to a physician without a prescription drug order when the drug is to be used by the physician for the medical treatment of patients in his office. It is not alleged that Congaree failed to provide the exact compound that Dr. Shortt ordered. Congaree owed no duty to Mrs. Kurtz-Bibeau other than to correctly prepare the compound that her doctor ordered. Based on the forgoing, the Congaree Defendants’ Motion for Summary Judgment should be granted.
Barnwell Whaley Patterson & Helms, LLC
James H. Elliott, Jr.
M. Dawes Cooke, Jr., Fed Id No.: 288
James H. Elliott, Jr., Fed Id. No: 7043
Jay Jones, Fed Id No.: 9479
P.O. Drawer H
Charleston, SC 29402
Attorneys For Defendants
Congaree Pharmacy, Inc.
George Dawn, R.Ph.
J. H. “Buster” Phillips, Jr., R.Ph.
Charleston, South Carolina
This page was posted on May 24, 2006.