In 2006, as shown below, a federal court judge ruled that Congaree Pharmacy owner James H. Phillips, Jr., R.Ph. and an employee (George Dawn, R.Ph.) violated federal and state drug laws by compounding and dispending a hydrogen peroxide solution for intravenous use. The ruling came in response to a motion for summary judgment in the suit brought the survivors of Katherine Ann Kurtz-Bibeau, a 53-year-old Minnesota woman who died in March 2004 after undergoing intravenous hydrogen peroxide treatment for multiple sclerosis. The treatment was administered by co-defendant James M. Shortt, M.D., whose license was suspended in 2005 in connection with the woman’s death and his alleged mistreatment of two other patients. In granting the summary judgment, the judge concluded:
Reduced to its essential elements, Defendants’ conduct is no more or less than unauthorized drug selling. As the record establishes, Defendant Pharmacists did not provide Defendant Shortt an otherwise “commercially available” hydrogen peroxide drug for intravenous administration, did not have the required patient/practitioner/pharmacist relationship which is necessary to compound commercially available drugs, and did not have FDA approval to manufacture hydrogen peroxide for intravenous use. Finally, Defendant Pharmacists did not seek or obtain a prescription as a condition of providing hydrogen peroxide to Defendant Shortt for intravenous administration to his patients. These facts establish beyond dispute that Defendant Pharmacists were operating far outside the narrow scope of the authorized practice of pharmacy and are liable for the foreseeable injuries and death suffered by Ms. Bibeau.
A few months after the judge ruled, the suit against Phillips, Dawn, and the pharmacy was settled with payment of $1.2 million by their insurance company. Shortt settled separately for $200,000, which was the limit of his malpractice policy.
UNITED STATES DISTRICT COURT
DISTRICT OF SOUTH CAROLINA
|David W. Bibeau, as Personal
Representative of the Estate of
Katherine Ann Kurtz-Bibeau,
James Michael Shortt, M.D.; Health
Filed June 29, 2006.
This matter comes before me on motions for summary judgment filed by Defendants Phillips, Dawn and Congaree Pharmacy (hereafter referred to collectively as “Defendant Pharmacists”) on October 5, 2005 and by Plaintiff on October 19,2005. Having carefully considered the materials and arguments advanced by both parties, the Defendants’ motion is denied and Plaintiffs motion is granted.
SUMMARY OF FINDINGS
Defendant Pharmacists prepared and sold hydrogen peroxide for intravenous use upon the oral request of Defendant James Michael Shortt, an alternative medicine physician whose methods were known by Defendant Pharmacists to be outside routine and customary medical practices. As the direct and proximate result of the actions, Ms. Katherine Ann Kurtz-Bibeau received intravenously a hydrogen peroxide solution which compromised her body’s blood clotting functions and lead to her death. Richland County’s Coroner has declared Ms. Bibeau’s death by intravenous hydrogen peroxide to be a “homicide”. The death summary, autopsy report and certificate of death each confirm Ms. Bibeau’s death to be the direct and proximate result of receiving an injection of hydrogen peroxide into her bloodstream.l
lDefendant Pharmacists assert that there exist genuine issues of material fact as to the question of proximate cause. Having carefully considered Defendants’ arguments, there is no basis in the record to challenge the medical findings that Ms. Bibeau’s death was the direct and proximate result of the intravenous administration of hydrogen peroxide which Defendant Pharmacists provided to Defendant Shortt.
The approved label and Material Safety Data Sheets of commercially available hydrogen peroxide warn that ingestion ofthis product is toxic to blood and other living tissue. Additionally, Defendant Pharmacists knew that intravenous hydrogen peroxide was not approved by the FDA or commercially available in the marketplace. Nevertheless, without a lawful prescription from a physician, Defendant Pharmacists prepared and sold hydrogen peroxide with the knowledge that Defendant Shortt intended to infuse the drug into the veins of his patients.
The record establishes beyond dispute multiple violations offederal and state law regulating the conduct of pharmacists and designed to protect the public. Violations of these statutory legal standards and duties constitute multiple, independent acts of negligence per se under the common law of South Carolina. Defendant Pharmacists’ violations include:
1. Alteration or removal in whole or part of the label, or doing of any other act with respect to a drug held for sale after shipment in interstate commerce in violation of 21 U.S.C. § 331(k).
2. Compounding and delivering a drug requiring medical supervision without a written prescription, in violation of 21 U.S.C. § 353(b)(1);
3. Compounding, delivering and selling a drug not approved by the FDA, in violation of 21 U.S.C. § 355(i);
4. Compounding, delivering and selling a “misbranded” drug that fails to contain the requisite warnings, instructions and other label requirements, as required by 21 U.S.C. § 33l(a) and 21 U.S.C. § 352(f);
5. Adulteration or misbranding of a drug in interstate commerce in violation of 21 U.S.C. § 331(b);
6. The receipt in interstate commerce of a drug that is adulterated or misbranded and the delivery or proffered delivery thereof for pay in violation of 21 U.S.C. § 331(c);
7. Manufacture of a drug that is adulterated or misbranded in violation of 21 U.S.C. § 331(g);
8. Compounding a drug not commercially available in the marketplace, in violation of S.C. Code Ann. §§ 40-43-86(CC)(2)(b) and 40-43-30(7);
9. Compounding, delivering and selling a drug without a written prescription, in violation of S.C. Code Ann. §§ 40-43-86(CC)(2)(b) and 40-43-30(7);
10. Engaging in the unlicensed and unauthorized manufacturing of a drug, in violation of S.C. Code Ann. § 40-43-86(CC)(2)(f) and 21 U.S.C. § 355(i);
11. Issuing a prescription drug without a written order signed by the physician in violation of S.C. Code Ann. § 40-43-86(E)(7); and
12. Compounding, delivering and selling a drug without a prescription order for a legitimate medical purpose by a practitioner acting within the course of legitimate, professional practice. S.C. Code Ann. § 40-43-86(F);
STANDARD OF REVIEW
Rule 56( c) provides that summary judgment shall be rendered if the record shows that there is no genuine issue as to material fact and the moving party is entitled to judgment as a matter of law. See, Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-250 (1986)(if factual matters are clear because of the strength of movant’s evidence or the weakness of non-movant’s evidence, summary judgment for the claimant is appropriate) As set forth below, the material facts are not disputed.
The sole question in this case is whether these facts establish negligence per se under controlling South Carolina law. This is a legal issue properly addressed by way of summary judgment.
STATEMENT OF FACTS
James Horace “Buster” Phillips (“Phillips”) is the owner, operator and pharmacist in charge of Congaree Pharmacy located in West Columbia, South Carolina. As pharmacist in charge, Phillips was responsible for the policies and decisions in filling prescriptions at Congaree Pharmacy and accepts personal responsibility for preparation and delivery of hydrogen peroxide for intravenous administration to Defendant Shortt. Neither Phillips nor Congaree Pharmacy is licensed as a manufacturer. Moreover, Congaree Pharmacy is not registered with the FDA to compound drugs which are not pursuant to a prescription.
George Dawn (“Dawn”) is an employee of Congaree Pharmacy and was responsible for filling orders for hydrogen peroxide which were delivered to Defendant Shortt. Dawn first started filling hydrogen peroxide orders after coming to Congaree Pharmacy in 1999. He understood that following further dilution by Defendant Shortt, the hydrogen peroxide would be injected into the bloodstream. In preparing this solution, Dawn did not do any independent research, but relied exclusively on Phillips.
Testimony by Phillips and Dawn establish the following facts:
1. A pharmacist cannot manufacture a drug without Food and Drug Administration (FDA) approval. Nevertheless, neither Phillips nor Dawn checked with the FDA prior to producing hydrogen peroxide for injection.
2. In providing drugs to a physician, a pharmacist must comply with state law. A pharmacist must also exercise due care. A part of this duty is to consider risks associated with his actions, including potential drug side effects.
3. The Food, Drug and Cosmetic Act requires labeling for medications produced that are not pursuant to prescription.
4. For anything that is compounded, the pharmacist must consider potential adverse reactions and side effects.
5. Independent of a doctor’s responsibility to engage in safe medical practices, a pharmacist has a duty to consider the safety of products he produces.
6. Over a period of years, Phillips and Dawn routinely provided 3% hydrogen peroxide solutions upon verbal request by Defendant Shortt for intravenous administration to patients at Health Dimensions, LLC located in the same building as Congaree Pharmacy. Neither Phillips nor Dawn received a written prescription from Defendant Shortt for hydrogen peroxide even though both were aware that the solution was being administered intravenously by Defendant Shortt to his patients and hydrogen peroxide is not commercially available for intravenous use.
7. Even though Phillips and Dawn were aware that it had not been approved for intravenous use by the FDA, neither provided any caution in writing, on the label or orally to Defendant Shortt, about potential side effects or risks of human injection of hydrogen peroxide. In addition, neither looked up hydrogen peroxide in the United States Pharmacopia (USP), which is a compendium of standards for medications.
8. In providing hydrogen peroxide to Defendant Shortt, neither Phillips nor Dawn consulted Martindale, a recognized authoritative reference on drugs. Martindale warns that “It is dangerous to inject or instill hydrogen peroxide into closed body cavities from which the released oxygen has no free exit”. Martindale also provides notice that “Intravenous administration of hydrogen peroxide solutions as unconventional therapy for AIDS or cancer has resulted in severe acute haemolysis [profuse bleeding]”. It is established that this very condition caused Ms. Bibeau’s death.
9. Material Safety Data Sheets are lists of possible reactions of drugs with other chemicals. Defendant Pharmacists could have obtained a Material Safety Data Sheet for 3% hydrogen peroxide solution from Spectrum2 and could have consulted the FDA in preparing the solution. During the course of providing hydrogen peroxide solutions to Defendant Shortt, however, Defendant Pharmacists never reviewed any Material Safety Data Sheet for hydrogen peroxide and did not communicate in any way with the manufacturer of hydrogen peroxide even though communication was available.
2Spectrum is a licensed drug manufacturer which produces hydrogen peroxide in 35% and 3% solutions. Congaree Pharmacy used the Spectrum 35% solution in making the hydrogen peroxide for intravenous injection by Defendant Shortt and diluted the product to a 3% solution. Both the 35% and 3% solutions produced by Spectrum provide Material Safety Data Sheets which warn that hydrogen peroxide is hazardous to blood.
10. Upon review of the Material Safety Data Sheet for 3% hydrogen peroxide solution, Phillips conceded that there is no indication that it is safe to ingest at any level.
11. Defendant Pharmacists are not aware of any other pharmacy in Columbia or South Carolina that produced intravenous hydrogen peroxide at the request of a physician or for human injection.
12. Defendant Pharmacists understood that the use of hydrogen peroxide injections was not standard medical care and acknowledged that the average physician would not use hydrogen peroxide intravenously to treat multiple sclerosis. Nevertheless, Defendant Pharmacists deferred completely to Defendant Shortt and indicated the doctor’s oral order was “good enough”.
13. Pharmacists must be familiar with the State Pharmacy Act.
14. Good compounding practices are a part of the standard of care for pharmacists.
15. If there is no prescription, there are federal requirements for labeling and a pharmacy must be registered to compound drugs.
16. Any order for a prescription drug must be in writing.
17. Any product prepared for intravenous use needs to be under medical supervision.
18. Hydrogen peroxide could have been dispensed directly to Ms. Bibeau. In that case, she would have been entitled to counseling and warning.
19. The absence of a patient/practitioner/pharmacist (triangular) relationship makes the compounding of hydrogen peroxide inconsistent with good compounding practices and constitutes manufacturing. Defendant Pharmacists did not have this triangular relationship with Ms. Bibeau.
20. Defendant Shortt’s use of intravenous hydrogen peroxide was unique, unconventional, not approved by the FDA and, to Dawn’s knowledge, was not in the standard of routine and customary care in the medical community.
21. Dawn was aware that the Spectrum 35% hydrogen peroxide label contained warnings that it was corrosive at 35%. Dawn never saw any information from Spectrum or any other source indicating that any level of hydrogen peroxide was safe for intravenous use.
22. Dawn examined the Material Safety Data Sheet for 3% solution during his deposition and acknowledged that there is a warning that a 3% solution may cause damage to blood. This is the percentage of hydrogen peroxide sold by Defendant Pharmacists for intravenous use.
23. Dawn did not give a dosage level for hydrogen peroxide even though he was aware of potential risks associated with intravenous administration of the drug.
24. Even though the label provided to Defendant Shortt indicates there was a prescription for hydrogen peroxide, there was never any prescription for the drug.
25. Nothing on the label delivered to Defendant Shortt indicates risks associated with the intravenous administration of hydrogen peroxide or provides any directions for use. This does not comply with FDA labeling requirements.
I. South Carolina Pharmacy Practices Act.
Defendant Pharmacists concede that their conduct is governed by the South Carolina Pharmacy Practices Act. Provisions of this Act relevant to the present proceedings provide:
1. A pharmacist may not engage in “conduct likely to deceive, defraud or harm the public, or demonstrating a wilful or careless disregard for the health, welfare, or safety of a patient, or [engage] in conduct which substantially departs from the standards of care ordinarily exercised by a pharmacist”. S.C. Code Ann. § 40-4386(DD)(5)
2. A pharmacist may not sell “a drug for which a prescription order from a practitioner is required without having received a prescription drug order for the drug.” S.C. Code Ann. § 40-43-86(DD)(6)
3. In order to compound a drug, three elements are required: (1) there must be a pharmacist/patient/practitioner relationship; (2) there must be the presentation of a valid prescription; and (3) the prescription must be for medications that are commercially available in the marketplace. S.C. Code Ann. §§ 40-43-86(CC)(2)(f); 40-43-30(7)( defining “compounding”) See also, Good Compounding Practices.
4. Distribution of compounded products without a patient/practitioner/pharmacy relationship is considered manufacturing. S.C. Code Ann. § 40-43-86(CC)(2)(f); See also, Good Compounding Practices, Subpart A
5. A prescription drug order must be based on a written order signed by a practitioner and must contain, among other information, the name, strength, dosage form and directions for use. S.C. Code Ann. § 40-43-86(E)(7)
6. A prescription drug order must be issued for a legitimate medical purpose by a practitioner acting within the course oflegitimate professional practice. S.C. Code Ann. 40-43-86(F)
7. When dispensed pursuant to a practitioner’s prescription, even non-prescription drugs must be treated in all respects as prescription drugs including drug counseling and labeling requirements. S.C. Code Ann. § 40-43-86(U)
II. Federal Food, Drug and Cosmetic Act.
In addition to the Pharmacy Practices Act, Defendant Pharmacists’ conduct falls within the scope of the Federal Food, Drug and Cosmetic Act. There is no question that Defendant Pharmacists received commercially available hydrogen peroxide from outside of South Carolina. Defendant Pharmacists then altered and labeled this product for a “new use”, intravenous administration, and sale. This conduct is expressly prohibited by U.S.C. § 331 (b)( adulteration or misbranding of any food, drug, device or cosmetic in interstate commerce); 21 U.S.C. § 331 (c) (receipt in interstate commerce of any food, drug, device or cosmetic that is adulterated or misbranded and the delivery or proffered delivery thereof for payor otherwise); and 21 U.S.C. § 331 (k)(alternation … of the labeling of or the doing of any other act with respect to a food, drug, device or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment or interstate commerce and results in such article being adulterated or misbranded).
There is no doubt that Congress holds plenary authority to regulate the sale of drugs through the Commerce Clause. Even Defendant Pharmacists concede that the Federal Food, Drug and Cosmetic Act was enacted to protect the public from the foreseeable hazards which result from sale of unproven drugs. As illustrated in the Shreveport Rate Cases, the Commerce Clause has been long recognized to extend congressional power to the instrumentalists of interstate commerce, or persons or things in interstate commerce, even though the threat may come only from intrastate activities. Houston, E. & W.T.R. Co. v. U.S., 234 U.S. 342 (1914) Addressing an argument similar to that advanced by the Defendant Pharmacists here, in 1964 the United States Supreme Court refused to confine the scope of congressional power to advance the public interests because the defendant operated only on a local basis. Finding the Commerce Clause extended the reach of the 1964 Civil Rights Act even to the Heart of Atlanta Motel, the Supreme Court stated “the power of Congress to promote interstate commerce also includes the power to regulate the local incidents thereof, including local activities both in the States of origin and destination, which might have a substantial and harmful effect upon that commerce”. Heart of Atlanta Motel, Inc. v. U.S., 379 U.S. 241, 258 (1964). For these reasons, it is not required the that the Defendant Pharmacists send their product across state lines to invoke the provisions of the Federal Food, Drug and Cosmetic Act. As stated in U.S. v. Dianovin Pharmaceuticals, Inc., 475 F.2d 100, 103 (1st cir. 1973), if any component of a compound is received in interstate commerce, federal law must be observed. Accordingly, the Court found violation of 21 U.S.C. 331(k) where a vitamin received from out of state was altered for injection.
An examination of the Federal Food, Drug and Cosmetic Act reveals that Defendant Pharmacists violated its safety provisions which:
1. Prohibit alteration or removal in whole or part of the label, or doing of any other act with respect to a drug held for sale after shipment in interstate commerce in violation of 21 U.S.C. § 331(k).
2. Require a written prescription of a practitioner where “because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner.” 21 U.S.C. § 353(b)(1)
3. Prohibit compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application in accordance with 21 U.S.C. § 355(i) and 21 CFR 312. See, Compliance Policy Guide for Pharmacy Compounding
4. Require written instructions on all manufactured drug labels. 21 U.S.C. § 352(£)(1).
5. Require warnings of risks associated with the use of the drug on the label. 21 U.S.C. § 352(£)(2)
6. Prohibit selling a drug without FDA approval and without an investigational new drug application in accordance with 21 U.S.C. § 355(i) and 21 CFR 312
7. Require submission ofa list of drugs compounded. 21 U.S.C. §§ 360 and 331(t)
8. Define a “new drug” as “[a]ny drug … the composition of which .. .is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 321(p)(1)
9. Provide that the newness of a drug may arise from “[t]he newness of a dosage or method or duration of administration or application, or other condition of use prescribed, recommended or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug”. 21 CFR § 310.3(h)(5)
10. Provide that general recognition of safety and effectiveness shall ordinarily be based on published studies which may be corroborated by unpublished studies and other data and information. 21 CFR § 314.200
11. Apply a two step “general recognition” test which requires: first, that there is a general recognition in fact, i.e. that there is an expert consensus that the product is effective; and second, that the expert consensus is based upon substantial evidence as defined in the Act and FDA regulations. United States v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, etc., 725 F.2d 976,987 (5th Cir. 1984)
12. Require substantial evidence of “general recognition of safety and effectiveness” which consists of adequate and well controlled studies that must be generally available to the scientific community. Id.
13. Prohibit the introduction or delivery for introduction into interstate commerce of any food, drug, device or cosmetic that is adulterated or misbranded. 21 U.S.C. § 331(a)
14. Provide that a product is misbranded if it fails to include adequate directions for use. 21 U.S.C. § 352 (f)(1)
15. Require adequate directions for use means directions under which a layman can use a drug safely and for the purposes for which it is intended. 21 CFR § 201.5
III. Negligence per se.
Under the South Carolina negligence per se doctrine, a state or federal statute, rule or regulation may create a legal duty or standard of care. Violation of legislatively established safety provisions constitutes negligence per se which is a form of ordinary negligence. Seals by Causey v. Winburn, 314 S.C. 416, 445 S.E.2d 94 (Ct. App. 1994)(negligence per se established by violation of federal child labor laws created to protect children in the workplace)
Defendant Pharmacists rely upon upon the recent South Carolina Court of Appeals decision Wogan v. Kunze, S.C. ___, ___S.E.2d (2005),2005 W.L. 2352580 in asserting that absent a federally created cause of action, the Federal Food, Drug and Cosmetic Act cannot support negligence per se. This reliance is misplaced. The Wogan decision held that the Medicare Act did not support a negligence per se claim because it was “not created to protect [the plaintiff] from a harm”. Here, Ms. Bibeau clearly falls within the scope of protection provided by the Federal Food, Drug and Cosmetic Act. In this context, application of this Act to Plaintiffs negligence per se claim is in keeping with longstanding South Carolina law. See, Barton v. Southern Railway Co., 171 S.C. 46, 171 S.E. 5 (1933)(failure to comply with requirement of the Federal Safety Appliance Act (45 U.S.C. § 1, et seq.) amounted to negligence per se).
Negligence per se removes from the jury the responsibility of deciding whether the defendant acted in a reasonable fashion. The statute fixes the standard of conduct required of the defendant, leaving as the sole issue whether the defendant’s conduct constituted a breach. Rayfield v. South Carolina Department of Corrections, 297 S.C. 95, 374 S.E.2d 910 (Ct. App. 1988), cert denied 298 S.C. 204, 379 S.E.2d 133 (1989) To establish negligence per se, theplaintiffmust show: (1) that the essential purpose of the statute is to protect from the kind of harm the plaintiff has suffered; and (2) that plaintiff is a member of the class of persons that the statute is intended to protect. Norton v. Opening Break of Aiken, Inc., 313 S.C. 508,443 S.E.2d 406 (Ct. App. 1994) aff’d. 319 S.C. 469, 462 S.E.2d 861 (1995) The causative violation of a statute constitutes negligence per se and is evidence of recklessness and wilfulness, requiring submission of the issue of punitive damages to the jury. Wisev. Broadway, 315 S.C. 273, 443 S.E.2d 857 (1993)
As in any negligence claim, it is incumbent upon the plaintiff asserting liability under negligence per se to establish that violation of the statute is causally linked to the injury. This is ordinarily a question for the jury. Whitlaw v. Kroger Co., 306 S.C. 51,410 S.E.2d 251 (1991) As set forth above, however, Defendant Pharmacists have admitted selling injectable hydrogen peroxide to Defendant Shortt. This conduct not only violated state and federal law, there is no legitimate dispute that Ms. Bibeau’s death resulted from the intravenous administration of the hydrogen peroxide sold by Defendant Pharmacists.
Controlling South Carolina law provides that liability exists for the natural and probable consequences of negligent acts or omissions proximately flowing therefrom. The intervening negligence of a third person does not excuse the first wrongdoer if such intervention ought to have been foreseen in the exercise of due care. It is equally well settled that to establish liability, it is not necessary that the party charged with negligence should have contemplated the particular event which occurred. It is sufficient that the party should have foreseen that his negligence “would probably result in injury of some kind to someone. The wrongdoer may be held liable for anything which, after the injury is complete, appears to have been a natural and probable consequence of his negligence.” Matthews v. Porter, 239 S.C. 620,124 S.E.2d 321,324 (1962)(quoting Hicklin v. Jeff Hunt MachineI)’ Co., 226 S.C. 484,85 S.E.2d 739, 743 (1955»
Neither Defendants Phillips nor Dawn contest Ms. Bibeau’s cause of death and there is no basis in the record to support speculation that the hydrogen peroxide which killed Ms. Bibeau was obtained from any other source. To the contrary, Defendant Pharmacists concede that they are aware of no other source of injectable hydrogen peroxide available to Defendant Shortt. In this context, the only reasonable conclusion is that Defendant Pharmacists’ unlawful sale of hydrogen peroxide for intravenous use was a direct and proximate cause of Ms. Bibeau’s death. Accordingly, there is no factual issue for the jury to resolve regarding the proximate cause and summary judgment is appropriate.3
3This conclusion does not render Defendant Pharmacists solely liable in this case. Nevertheless, it is clear that but for the unlawful sale of hydrogen peroxide for intravenous administration by Defendant Pharmacists, Ms. Bibeau would not have received their product intravenously from Defendant Shortt.
CONCLUSIONS OF LAW
I. Defendants Violated the State Pharmacy Act.
In evaluating Defendants’ conduct, it is important to place hydrogen peroxide in its proper context. Hydrogen peroxide is a drug that has never been approved by the FDA for intravenous use. That hydrogen peroxide is recognized as creating serious risks iftaken internally is evidenced on the label and in the Material Data Safety Sheets for the commercially available product.
Pharmacists in South Carolina are required to use a high standard of care in dispensing drugs. As stated by the South Carolina Supreme Court in Evans v. Rite Aid Corporation, 324 S.C. 269, 275, 478 S.E.2d 846,849 (1996) pharmacists fall into the category of professions which furnish skilled services for compensation and can be held liable for failure to conform to the practices of their profession.
A. Defendants violated state “compounding” requirements.
Defendant Pharmacists admit that they did not have a patient/practitioner/pharmacist ( triangular) relationship in providing hydrogen peroxide for intravenous administration by Defendant Shortt.4 State law requires this relationship as an essential criteria for preparing a lawful drug compound. State law further requires that there must be a prescription and that the prescription must be for medications that are commercially available in the marketplace. Here, however, it is admitted that Defendant Shortt never presented a prescription for injectable hydrogen peroxide and this product is not commercially available in the marketplace. For each of these reasons, Defendant Pharmacists are in violation of S.C. Code Ann. § § 40-43-86(CC)(2)(b); 40-43-30(7) and Good Compounding Practices, incorporated as elements of the standard of care for pharmacists in South Carolina.
4In an apparent attempt to recant their sworn testimony, Defendant Pharmacists offered the Affidavit of Hubert F. Mobley, R.Ph. According to this affidavit, a triangular relationship is not required for compounding and, contrary to their own testimony, Defendant Pharmacists did satisfy the patient/pharmacist/physician relationship. This affidavit fails to establish genuine issues of material fact in two respects. First, the self-serving nature of this affidavit does not diminish the admissions of Defendant Phillips and Dawn. Second, as stated below, the affidavit is inadmissable to address the “legislative intent” of the South Carolina Pharmacy Practices Act.
B. Defendants violated state law in manufacturing hydrogen peroxide for intravenous administration.
Because the Defendant Pharmacists’ conduct does not fall within the explicit state compounding requirements, they are held to standards imposed upon “manufacturers” in preparing hydrogen peroxide for intravenous administration. In fact, state law explicitly provides that distribution of compounded products without a patient/practitioner/pharmacist relationship is considered manufacturing. Code § 40-43-86(CC)(2)(f); See also, Good Compounding Practices Manufacturers have strict duties under federal law to test and obtain approval of a drug before making it available for sale. Moreover, manufacturers cannot rely upon a “learned intermediary” defense when they fail to provide adequate warning to a physician. See generally, Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 5 28 (6th Cir. 1993)(affirming liability of drug manufacturer) In this case, Defendant Pharmacists have admitted that they provided no warning to Defendant Shortt regarding the possible adverse effects of administering hydrogen peroxide intravenously.
C. Defendants violated safety standards established in state law in preparing hydrogen peroxide for intravenous administration.
South Carolina law defines “prescription drug” to include drugs which are required by any applicable state or federal law to be dispensed only pursuant to a prescription order or restricted to use by practitioners only. S.C. Code Ann. § 40-43-30(46)(b) This definition specifically includes compounded drugs. S.C. Code Ann. § 40-43-30(46)(d)5 State law requires any prescription drug order to be signed by the prescriber. S.C. Code Ann. § 40-43-86(E)(7) The order must also designate, among other information, the strength, quantity prescribed, and directions for use. S.C. Code Ann. §40-43-86(E)(4)(5)
5By contrast, a “nonprescription drug” sold without prescription must be labeled for use by the consumer in accordance with the requirements of state and federal law . S. C. Code Ann. § 40-4330(32) Accordingly, even if injectable hydrogen peroxide qualified as a “nonprescription drug”, Defendant Pharmacists violated state and federal law by failing to meet labeling requirements.
Defendant Pharmacists clearly violated state law in providing hydrogen peroxide for intravenous administration without a written prescription. Perhaps the most compelling evidence of liability, however, is the Defendant Pharmacists’ complete deference to Defendant Shortt in producing and delivering hydrogen peroxide for intravenous administration to his patients. Indeed, state law specifically requires that a prescription drug order must be issued for a legitimate medical purpose. S.C. Code Ann. § 40-43-86(F) Accordingly, a pharmacist may not sell a drug for which a prescription order is required without having received a prescription from a practitioner. S. C. Code Ann. § 40-43-86(DD)(6); See also, 21 U.S.C. § 351(b)(1) discussed below.
Even though Defendants Phillips and Dawn were aware that the intravenous administration of hydrogen peroxide was outside the standard of medical care, and even though both had access to information indicating hydrogen peroxide to be dangerous to blood, and even though both knew that hydrogen peroxide had not been approved for intravenous administration by the FDA, and even though both had knowledge that the medical and pharmaceutical communities do not generally recognize the safety and effectiveness of injecting hydrogen peroxide, they provided this dangerous product to Defendant Shortt without any independent evaluation, without any written prescription, without any warning to Defendant Shortt or his patients, and without any regard for the safety and well being of the public. These acts violate clear safety standards established in the Pharmacy Practices Act and each supports a separate finding of negligence per se.
III. Defendants Violated the Federal Food, Drug and Cosmetic Act.
The Federal Food, Drug and Cosmetic Act has one overriding purpose: protecting the public health. United States v. Bacto-Unidisk, 394 U.S. 784, 798 (1969) Section 355 of the Act states “No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug”. The Act defines “new drug” at 21 U.S.C. § 321(p) as:
(1) Any drug … the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof…; or
(2) Any drug … the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
A. Defendants provided hydrogen peroxide for intravenous use without a prescription required by federal law.
It is stipulated that the hydrogen peroxide produced and sold by Defendant Pharmacists was intended for intravenous administration and that they received no prescription for hydrogen peroxide from Shortt. It is further stipulated that any drug to be administered intravenously requires medical supervision. In light of these facts, Defendants’ conduct is in clear violation of 21 U.S.C. §353(b )(1) which requires a prescription for providing any drug which, because of its components or method of use, is not safe except under supervision of a practitioner. This same statute provides that dispensing any drug contrary to its provisions “shall be deemed and act which results in the drug being misbranded while held for sale”.
Defendant Pharmacists admit that the hydrogen peroxide they sold to Defendant Shortt for intravenous use required medical supervision. Nevertheless, they argue that the provisions of § 353(b)(1) do not apply because they did not “dispense” hydrogen peroxide directly to Ms. Bibeau. This is a misreading of the term as used in the Federal Food, Drug and Cosmetic Act. For example, the same language relied upon by Defendant Pharmacists has been held to apply to a physician who sold drugs to an undercover agent without a prescription. This physician was convicted under the “dispensing”provision of § 353(b)(1). Brown v. United States, 250 F.2d 745 (5th Cir. 1958); United States v. Nazir, 211 F.Supp.2d 1372 (S.D. Fla. 2002) Moreover, it is established thatthe prescription requirement in § 353(b)(1) is not confined to the “retail” relationship between a pharmacist and customer but applies equally to the distribution at the wholesale level. As stated in De Freese v. United States, 270 F.2d 730 (5th Cir. 1959), this is necessary “[t]o protect the public from abuses in the sale of potent prescription drugs.” 270 F.2d at 735
B. Defendants produced a “new drug” in violation of federal law.
Whether a compound is a “new drug” is determined by the product as a whole, complete with active and inactive ingredients. United States v. Generix Drug Corp., 460 U.S. 453,459 (1983) Any compound that has not been approved by the FDA for a specified use is considered “misbranded” under § 352(1) of the Act so that production and sale violates §§ 331(a) and (k) of the Act. United States v. Baxter Healthcare Corp., 712 F.Supp. 1352, 1359 (N.D. TIL 1989) Even an otherwise available drug requires FDA approval if its form of administration, such as by way of inj ection, is altered. Id. at 1360 citing 21 U.S.C. § 321 (p) and 21 CFR § 31 0.509( a) Similarly, even an otherwise available drug requires FDA approval if it is to be put to a new use or to treat different conditions. United States v. Articles of Drug Consisting of the Following: 5,906 Boxes, etc., 745 F.2d 105 (1 st Cir. 1984)
Defendant Pharmacists believed that the absence of a prescription from Shortt relieved them of any duties or liabilities in delivering hydrogen peroxide for intravenous use. In fact, the opposite is true. In providing this dangerous drug for intravenous administration, Defendants not only materially altered hydrogen peroxide otherwise “commercially available” for external application, they circumvented federal and state safety standards. Defendants therefore assumed liability for producing a “new drug” without proper testing, approval, or warning to the public. See, T -UP, Inc. v. Consumer Protection Division, 801 A.2d 173, 195 (Md. App. 2002)(finding the preparation of sterile T-UP for intravenous use to be a “new drug” requiring FDA approval pursuant to 21 U.S.C. § § 355(a) and 321 (p)(1»
C. The “new drug” produced by Defendants violated federal testing requirements.
Federal law prohibits compounding drugs from components that are not FDA approved through an FDA sanctioned investigational new drug application. 21 U.S.C. § 355(1); 21 CFR § 312; See also, Compliance Guide for Pharmacy Compounding These same provisions prohibit selling a new drug without FDA approval and review.
More than a decade before Ms. Bibeau’s death, the United States brought an action to enjoin the sale of hydrogen peroxide solutions which were being marketed as curealls. United States v. Vital Health Products, Ltd., 786 F.Supp. 761 (E.D. Wis. 1992) affirmed as U.S. v. LeBeau, 985 F.2d 563 (7th Cir. 1993) enforced a permanent injunction which prohibited the marketing of hydrogen peroxide solutions that had not been approved by the FDA. In an exhaustive opinion, the district court noted that there were no controlled studies to determine the effectiveness of the products, no evidence that there is a responsible body of qualified opinion about the benefits of the ingestion of hydrogen peroxide and overwhelming evidence that hydrogen peroxide was not generally recognized as safe and effective for internal use.
The defendant in U.S. v. Vital Health Products, Ltd. claimed that its compounds should be “grandfathered” because hydrogen peroxide was on the market before 1962, the date established for testing in the Food and Drug Act. The Court correctly rej ected this argument, finding that while the ingredients may have been used and sold before 1962, there was no evidence that the combinations marketed by the defendant were commercially used or sold before 1962 or that they were generally recognized as safe and effective for the proposed use before that date. Accordingly, the Court held, as a matter of law, that the compounds constituted “misbranded” drugs.
The U.S. v. Vital Health Products, Ltd. case establishes beyond dispute that the Defendant Pharmacists in this action violated federal law in providing hydrogen peroxide for intravenous administration by Defendant Shortt. There is simply no evidence to support a claim that the Defendants were operating within the confines of acceptable pharmaceutical practices or that they had the right to rely upon a verbal order by a physician known to be operating outside the standard of care. To the contrary, Defendants attempt to place themselves beyond the reach of the state Pharmacy Practices Act and the federal Food, Drug and Cosmetics Act based upon the illogical assertion that a pharmacist can prepare and provide any product, regardless of its known risks, upon the mere verbal request of a physician. This argument completely ignores the safeguards established by the South Carolina General Assembly and the Congress of the United States which require that drugs be recognized as safe and effective before they are authorized for delivery to physicians for use by patients or for delivery to the public.
D. Defendants violated federal law in producing hydrogen peroxide for intravenous use without approval of the FDA, without a finding that it is generally accepted as safe and effective and without providing appropriate warnings.
Defendant Pharmacists’ admitted conduct in this case must be evaluated in keeping with the purpose of the state Pharmacy Practices Act and the federal Food, Drug and Cosmetics Act to protect the public from the risks of untested, unproven drugs. For example, federal law establishes that a product is “misbranded” if it fails to include adequate directions for use. 21 U.S.C. § 352(£)(1) Similarly, state law provides that a prescription drug must contain the name, strength, dosage, form and directions for use. S.C. Code Ann. § 40-43-86(E) A prescription drug order must also be issued for a legitimate medical purpose by a practitioner acting within the course of legitimate, professional practice. S.C. Code Ann. § 40-43-86(F)
Defendant Pharmacists contend that regardless of FDA approval and regardless of any general acceptance of the safety and effectiveness of hydrogen peroxide for intravenous administration, they may hide behind the verbal request of a physician known to them to be practicing in an unconventional manner not consistent with the standard of care in South Carolina. The South Carolina Supreme Court has repeatedly held that an interpretation of a statute leads to an absurd result must be rejected. Kennedy v. South Carolina Retirement System, 345 S.C. 339, 351, 559 S.E.2d 243,249 (2001) citing GentI)’v. Yonce, 337 S.C. 1,522 S.E.2d 137 (1999); Kiriakides v. United Artists Communications, Inc., 312 S.C. 271, 440 S.E.2d 364 (1994) In this case, Defendants’ numerous violations of safety standards established in the Food, Drug and Cosmetic Act constitute multiple independent grounds for finding of negligence per se. Accordingly, Plaintiff is entitled to an award of summary judgment on the issue of liability.
DEFENDANTS’ MOTION IS NOT SUPPORTED BY STATE OR FEDERAL LAW
1. South Carolina Pharmacy Practices Act.
In support of their motion for summary judgment, Defendant Pharmacists argue that in providing Defendant Shortt hydrogen peroxide for intravenous administration, they complied with the South Carolina Pharmacy Practices Act. In making this argument, however, Defendants ignore the plain language of the Pharmacy Practices Act and isolate provisions in a manner which is inconsistent with its legislative purpose.6
6Defendant Pharmacists have presented an affidavit of Hubert F. Mobley, R.Ph. which purports to offer evidence of the “intent” of the Pharmacy Practices Act. I have carefully considered this Affidavit and find it inconsistent with the plain language of the Act and inadmissable for the offered purpose. Both the South Carolina Supreme Court and this Circuit have determined that testimony regarding legislative intent, even by the author of the legislation, is not admissible. Kennedy v. S.C. Retirement System, 345 S.C. 339, 549 S.E.2d 243 (2001); South Carolina Education Association v. Campbell, 883 F.2d 1251 (4th Cir. 1989)
The Pharmacy Practices Act specifically authorizes “compounding” only in limited, explicit circumstances. The complete statutory definition of “compounding” provided in S.C. Code Ann. § 40-43-30(7) states:
“Compounding” means the preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, or the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner’s prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice, or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. The term compounding does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.
As evident in this definition, compounding must be the “ result of a practitioner’s prescription drug order or initiative  based on the practitioner/patient/pharmacist relationship in the course of professional practice, or  for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing.” These same requirements are stated in Good Compounding Practices Applicable to State Pharmacies. Defendant Pharmacists admit that “good compounding practices” is a component of their standard of care. Furthermore, Defendants admit that they produced injectable hydrogen peroxide to Defendant Shortt “for sale” and that they did not have a practitioner/patient/pharmacist relationship. Accordingly, Defendants’ conduct does not fall within the definition of lawful “compounding” established by the Pharmacy Practices Act. Additionally, this conduct subjects Defendant Pharmacists to the duties and responsibilities of manufacturers. See, S.C. Code Ann. § 40-43-86(CC)(1) and (2)(f); See also, Good Compounding Practices Applicable to State Pharmacies.
Defendants isolate S.C. Code Ann. § 40-43-86(CC)(2)(e) in an attempt to legitimize their conduct. This section provides, in relevant part: “Pharmacists may not offer compounded medications to other pharmacies for resale; however, pharmacists may compound products based on an order from a practitioner for use by practitioners for patient use in institutional or office settings.” Based upon this language, Defendants argue that a pharmacist may provide any combination of ingredients to a physician for use in his office, even if the pharmacist knows that the product is dangerous. There are several problems with this argument.
First, the definition of compounding in S.C. Code Ann. § 40-43-30(7) controls as a matter of law. Purvis v. State Farm Mutual Auto Insurance Company, 304 S.C. 283, 288, 403 S.E.2d 662, 665 (Ct. App. 1991 )(General Assembly has power to prescribe legal definitions by statute and those definitions are binding on courts); Goldston v. State Farm Mutual Auto Insurance Company, 358 S.C. 157, 177, 594 S.E.2d 511, 522 (Ct. App. 2004) Having established specific circumstances under which a pharmacy may compound drugs, the General Assembly clearly prohibited pharmacists from preparing drugs for sale by a physician without the required practitioner/patient/pharmacist relationship.
Second, the argument advanced by Defendants would lead to an absurd result. For example, Defendant Phillips testified that he is authorized to provide “any compound” requested by a physician and is limited only by the physician’s judgment. Accordingly, a pharmacist could provide even lethal combinations of drugs to a physician without fear of prosecution or liability. Clearly, the purpose of the Pharmacy Practices Act is to protect the public from such conduct. As recently confirmed by the South Carolina Supreme Court in Garvin v. State, 365 S.C. 16,21-22,615 S.E.2d 451,453-454 (2005), a statute must be given a reasonable and practical construction consistent with the purpose and policy expressed in the statute. A statute will not be construed in a manner which could not have been intended by the legislature. See, In re Timothy C.M., 348 S.C. 653,655-56, 560 S.E.2d 452, 453 (Ct. App. 2002)(citing Florence County v. Moore, 344 S.C. 596, 601, 545 S.E.2d 507, 509 (2001); Carolina Alliance for Fair Employment v. South Carolina Dep’t of Labor, Lic., & Reg., 337 S.C. 476, 492,523 S.E.2d 795,803 (Ct. App. 1999)
The plain language of controlling legislation and simple logic refute the assertion that upon request by a physician, pharmacists may provide any combination of products for administration to a patient. Accordingly, Defendant Pharmacists cannot rely upon the South Carolina Pharmacy Practices Act to avoid liability in this case.
II. Learned Intermediary Doctrine.
Defendant Pharmacists contend that they are relieved of liability by the learned intermediary doctrine. The limited immunity provided by this doctrine requires that the pharmacist rely in good faith upon a physician’s prescription. In this case, there is no prescription and Defendants were aware that Shortt was operating outside the scope of standard medical practice in administering hydrogen peroxide intravenously.
Because the Defendant Pharmacists were not “acting within the rules and regulations set forth by state and federal governments for the practice of pharmacy”, they are subject to liability for their negligent conduct. See, Madison v. American Home Products Corp., 358 S.C. 449,454,595 S.E.2d 493,496 (2004)(quoting from Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922,932 (Utah 2003) finding no strict liability where pharmacy acts within compounding guidelines) None of the authorities relied upon by Defendant Pharmacists extend the learned intermediary doctrine to acts of independent negligence by a pharmacist. To the contrary, it is clear that a pharmacist may not ignore risks even in filling lawful prescriptions. Happel v. Wal-Mart Stores, Inc., 319 F.Supp.2d 883 (N.D. Ill. 2004)(Pharmacy liable for filling lawful prescription where known side effects were potentially fatal); Dee v. Wal-Mart Stores, Inc., 878 So.2d 426 (Fla. Dist. Ct. App. pt Dist. 2004)(pharmacy liable for filling lawful prescription which was unreasonable on its face) Moreover, because Defendants’ preparation of hydrogen peroxide did not comply with “compounding” requirements, they were bound by federal law to inform the recipient of any risks or contraindications. See, for example, Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir. 1984)(addressing duty of manufacturer of “ethical” (prescription) drugs to warn physicians only)
Defendant Pharmacists argue that their hydrogen peroxide product was “commercially available” and that no prescription was necessary. This is an incorrect statement of fact and law. For example, both Phillips and Dawn admitted under oath that hydrogen peroxide is not commercially available for intravenous use. Defendants also admitted that any drug administered intravenously must be under a doctor’s supervision. Finally, if preparing the injectable hydrogen peroxide as a non-prescription product, Defendant Pharmacists were required by federal law to have FDA approval and to issue warnings to the ultimate consumers. Defendants admit that they made no warnings to anyone regarding their hydrogen peroxide compound.
In summary, Defendant Pharmacists’ argument completely subverts the comprehensive state and federal regulatory system intended to protect the public from unproven drugs. Reduced to its essential elements, Defendants’ conduct is no more or less than unauthorized drug selling. As the record establishes, Defendant Pharmacists did not provide Defendant Shortt an otherwise “commercially available” hydrogen peroxide drug for intravenous administration, did not have the required patient/practitioner/pharmacist relationship which is necessary to compound commercially available drugs, and did not have FDA approval to manufacture hydrogen peroxide for intravenous use. Finally, Defendant Pharmacists did not seek or obtain a prescription as a condition of providing hydrogen peroxide to Defendant Shortt for intravenous administration to his patients. These facts establish beyond dispute that Defendant Pharmacists were operating far outside the narrow scope of the authorized practice of pharmacy and are liable for the foreseeable injuries and death suffered by Ms. Bibeau.
For the reasons set forth above, uncontested facts establish that Defendant Pharmacists violated safety standards enacted in the state Pharmacy Practices Act and federal Food, Drug and Cosmetic Act which render Defendants liable as a matter of law under the controlling South Carolina negligence per se doctrine. Accordingly, Rule 56( c) of the Federal Rules of Civil Procedure entitles Plaintiff to an order granting summary judgment on the issue of liability, with the questions of compensatory and punitive damages to be submitted to the jury as to these Defendants.
AND IT IS SO ORDERED.
Matthew J Perry, Jr.
United States District Court Judge
June 29, 2006
This page was posted on April 18, 2008.