Source: https://quackwatch.org/pharmacy/legal/congaree/memo3/
Timestamp: 2020-07-12 03:34:44
Document Index: 4699665

Matched Legal Cases: ['§ 40', '§ 40', '§ 40', '§ 1075', '§ 40', '§ 40', '§ 40', '§ 40', '§ 40', '§ 40', '§ 301', '§ 331', '§ 321', '§ 355', '§ 331', '§ 352', '§ 331', '§ 355', '§ 312', '§ 355', '§ 312', '§ 312', '§ 312', '§ 301', '§ 331', '§ 355', '§ 312', '§ 301', '§ 331']

Bibeau v. Shortt et al. Defendants' Memorandum in Support of Motion for Summary Judgment Memo 3 | Quackwatch
Bibeau v. Shortt et al. Defendants’ Memorandum in Support of Motion for Summary Judgment Memo 3
The Congaree Defendants submit this Memorandum in Opposition to the Plaintiff’s Motion for Summary Judgment. The Plaintiff has set forth many arguments in his Motion for Summary Judgment. However, the Plaintiff has misinterpreted statutes, case law and the testimony of the Defendants, J.H. “Buster” Phillips, Jr., R.Ph., and George Dawn, R.Ph. This balance of this Memorandum in Opposition will address each of the Plaintiff’s arguments and why they fail.
I. There is No Negligence Per Se
To begin with, the Plaintiff claims the conduct of the Defendants Congaree Pharmacy, Inc., George Dawn, R.Ph. and J.H. “Buster” Phillips (referred to hereafter collectively as “Congaree”) violated various state and federal statutes, amounting to negligence per se, and entitling the Plaintiff to summary judgment. The Plaintiff is correct in that it is incumbent upon the plaintiff asserting liability under negligence per se to establish that the violation of the statute is causally linked to the injury. No such causal link exists in this case.
The Plaintiff erroneously asserts that Defendants Phillips and Dawn admitted providing injectable hydrogen peroxide in violation of state and federal law. These Defendants made no such admission, and the Plaintiff simply assumes providing the hydrogen peroxide is a violation of state and federal law. As set forth below, there was no violation of any applicable law. Accordingly, if there is no statutory violation, there is no negligence per se.
Moreover, the Plaintiff alleges that “there is no question that Ms. Bibeau’s death resulted from the intravenous administration of these same hydrogen peroxide solutions.” In fact, it is unknown whether the hydrogen peroxide Congaree provided to Dr. Shortt on March 9, 2004, was the hydrogen peroxide administered to Ms. Bibeau. Assuming arguendo that the hydrogen peroxide given to Ms. Bibeau by Dr. Shortt was the same hydrogen peroxide provided by Congaree, it was certainly not given in the same form as was provided to Dr. Shortt. Congaree provided Dr. Shortt a 3% injectible sterile hydrogen peroxide. Dr. Shortt diluted it by a factor of one hundred, and various minerals, vitamins and/or other additives were mixed into the solution, thereby rendering a totally different solution than what was originally provided to him. The Plaintiff certainly has not shown that Ms. Bibeau’s death resulted from the intravenous administration of the same hydrogen peroxide solution provided by Congaree.
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. As such, since there is no duty, there can be no statutory violation giving rise to negligence per se.
II. Congaree Defendants Did Not Violate the State Pharmacy Practice Act
(7) “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.
S.C. Code § 40-43-30(7). The Plaintiff states that under this definition, compounding must be either [1] the result of a practitioner’s prescription drug order or initiative [2] based on the practitioner/patient/pharmacist relationship in the course of professional practice, or [3] for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale or dispensing. The Plaintiff is correct in that there are multiple definitions of compounding under the Practice Act, and recognizes as much because there is an “or” between definitions. He also breaks down the definition into numbered parts, further indicia of multiple definitions. Nonetheless, the Plaintiff conveniently ignores the first definition: “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.” Id. This is exactly what the Congaree Defendants did. Dr. Shortt ordered 3% hydrogen peroxide for use in his office. Congaree prepared a sterile hydrogen peroxide solution by diluting 35% hydrogen peroxide with sterile water to the proper percentage (3%). The Practice Act clearly allows Congaree to provide the product in such a manner. Unequivocally, the conduct of the Congaree Defendants falls squarely within the definition of compounding pursuant to the Practice Act. Since that definition of compounding controls as a matter of law, there was no violation of state law by the Congaree Defendants.
The Plaintiff further claims that the definition of compounding in the Practice Act establishes only those specific circumstances under which a pharmacy may compound drugs. In doing so, the Plaintiff claims pharmacists are prohibited from preparing drugs for sale by a physician without the required practitioner/patient/pharmacist relationship. He supports this argument with the above-referenced definition of compounding in S.C. Code § 40-43-30(7), as well as the Good Compounding Practices Applicable to State Pharmacies. (Attached as Exhibit B).1
Footnote 1: The Good Compounding Practices Applicable to State Pharmacies is put out by the National Association of Boards of Pharmacy as a general guideline, but is by no means the law of the state of South Carolina. In fact, the Good Compounding Practices acknowledges that respective State Pharmacy Practice Acts are the controlling law:
“The following definitions from the NABP Model State Pharmacy Act apply to these Good Compounding Practices. States may wish to insert their own definitions to comply with State Pharmacy Practice Acts.”
The definition of the S.C. Pharmacy Practice Act, as demonstrated supra, is broader, and the Act itself specifically provides for a pharmacy to provide a compound directly to a physician for in-office use. As a result, there is no violation of state law.
The Plaintiff again chooses to conveniently ignore aspects of the Practice Act, as well as the Good Compounding Practices, which provide for the very conduct the Plaintiff alleges is a violation of state law. As discussed above, the conduct of the Congaree Defendants falls within the definition of compounding in the Act. What is more, both the Practice Act and Good Compounding Practices allow for a pharmacist to provide compounds to a physician for in-office use. S.C. Code § 40-43-86(cc)(2)(e) provides:
(e) 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. Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services, e.g., chemicals, devices, and information, when requested; however, they may not solicit business by promoting to compound specific drug products, e.g., like a manufacturer; (Emphasis added).
Correspondingly, the Good Compounding Practices provides that “Pharmacists shall not offer compounded drug products to other State-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a prescriber to administer to an individual patient.” (Exhibit B at Page 2) (Emphasis added). Indisputably, both the controlling state law and national guidelines promulgated by the National Boards of Pharmacy not only acknowledge that a compounding pharmacy may provide a compound directly to a pharmacist for in-office/clinical use, but both expressly allow for it.
Further evidence that the conduct of the Congaree Defendants was not in violation of any applicable state law or national guidelines may be found in the “Good Compounding Practices” section applicable to compounding pharmacies, in the United States Pharmacopeia (USP). That section also expressly allows for a compounding pharmacy to provide a compound directly to a pharmacist for in-office/clinical use. The USP is recognized in the 1938 Federal Food, Drug and Cosmetic Act, and is an authoritative source of numerous standards of pharmacy practice. Available at http://www.usp.org/USPNF. Specifically, the USP provides that “compounders may prepare compounded drug products for a prescriber’s office use pursuant to federal and state requirements.” USP 27 § 1075 (Attached as Exhibit C) (Emphasis added). It is well recognized in state and federal sources that compounding pharmacies may provide compounds to a physician for in-office/clinical use. Accordingly, the Congaree Defendants did not violate any state law (or national guidelines).
As discussed supra, the conduct of Congaree was clearly within the definition of compounding in the Practice Act. The Plaintiff is correct because there was no prescription drug order, as defined in the Practice Act. S.C. Code § 40-43-130(47) 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.” (Emphasis added). As discussed supra, a pharmacy may provide a compound to a physician for in-office use. See S.C. Code § 40-43-86(cc)(2)(e). There was no order for hydrogen peroxide for a specific patient, but rather for in clinic use. Therefore, there was no prescription drug order. There was, however, still a practitioner/patient/pharmacist (“triad”) relationship. The relationship did not exist as the Plaintiff would have the Court believe. Nowhere does the Practice Act mandate that the triad relationship is where a patient sees a doctor, is given a prescription, and then takes the prescription to the pharmacy to be filled (basically where the patient has direct contact with both the physician and pharmacist). In the case at bar, there exists a perfectly valid practitioner/patient/pharmacist relationship, only instead of a triangle, the triad relationship is in the form of a ‘V’. The relationship still exists, only the doctor acts as the point between the patient and pharmacy. The Practice Act clearly acknowledges this type of relationship, because it acknowledges that a pharmacy may provide compounds directly to a physician for in-office use without prescribing the compound directly to a patient. The Plaintiff manipulates and distorts the provisions and definitions of the Practice Act so as not to construe a valid practitioner/patient/pharmacist relationship unless the patient has contact with both the physician and pharmacist. While the traditional triad relationship where all three parties interact is more common, a triad relationship in a ‘V,’ as with the Congaree Defendants, is just as valid under the Practice Act. Thus, a pharmacy may still have a valid practitioner/patient/pharmacist relationship while providing a compound to a physician for in-office use without a prescription drug order.
Finally, the Plaintiff alleges that the Congaree Defendants violated the Practice Act, specifically S.C. Code § 40-43-86(cc)(2)(b), because they compounded a product that is not commercially available in the marketplace. This again is a fuzzy reading of the statute relied upon by the Plaintiff. S.C. Code § 40-43-86(cc)(2)(b) provides:
The Plaintiff has obviously missed the word “may” within that provision. This statute provides that compounding pharmacies are allowed to compound commercially available medications. Prior to this provision in the Practice Act, many pharmacists were sued for compounding medications that were commercially available. The reason this provision is included in the good compounding practices section for South Carolina pharmacists is to prevent compounding pharmacists from being sued for any trademark or patent infringements for compounding a commercially available product. The statute does not say a compounding pharmacist shall only compound commercially available medications. This argument by the Plaintiff would lead to an “absurd result,” and is clearly not a reasonable or practical construction of the statute.
B. Congaree Defendants Did Not Violate State Law
in Manufacturing Hydrogen Peroxide for Intravenous Administration
The Plaintiff alleges that since the conduct of the Congaree Defendants failed to meet the definition of compounding in the Practice Act, there conduct amounts to manufacturing. However, as discussed supra, the Plaintiff again chooses to obfuscate the issue by distorting the plain and clear language of the Practice Act. The Plaintiff relies upon S.C. Code § 40-43-86(cc)(2)(f) which states that “the compounding of drugs in anticipation of receiving prescriptions without a historical basis or the distribution of compounded products without a patient/practitioner/pharmacist relationship is considered manufacturing.” First of all, the Congaree Defendants were “compounding” as defined in the Practice Act. Also, as discussed above, it is well recognized in both the Practice Act and federal authority that a pharmacy may provide a compound to a physician for in-office use. That is not “manufacturing.” Likewise, a valid patient/practitioner/pharmacist relationship existed that warrants § 40-43-86(cc)(2)(f) moot. Assuming arguendo that this provision somehow applies, the Plaintiff follows his argument up by claiming that, as manufacturers, Congaree violated federal law. Those same federal laws relied upon by the Plaintiff are the same ones, as demonstrated infra, that do not apply to this case because they are only applicable to interstate commerce.
C. Congaree Defendants Did Not Violate Safety Standards Established in State
Law in Preparing Hydrogen Peroxide for Intravenous Administration
The Plaintiff alleges the Congaree Defendants violated state law in providing a compound without a written prescription. Yet, as discussed at length supra, the Practice Act clearly and explicitly authorizes a pharmacy to provide a compound to a physician for in-office use. Not only is doing so allowed by state law, it does not require a written prescription.
III. Congaree Defendants Did Not Violate the Federal Food, Drug and Cosmetic Act
The Plaintiff alleges the Congaree Defendants violated the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq. (referred to hereafter as “FDCA”). Quite simply, the FDCA does not apply to this case. The FDCA explicitly outlines the acts which it prohibits in 21 U.S.C. § 331, entitled “Prohibited Acts.” Specifically, the FDCA prohibits acts which involve interstate commerce.2 Interstate commerce is defined as “(1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.” 21 U.S.C. § 321(b). Obviously there was no interstate commerce involved in this case. There was no commerce between any states. Rather, this case involves a South Carolina pharmacist who provided a compound to a South Carolina physician located within the same office building. This unquestionably does not constitute interstate commerce, and therefore the FDCA is inapplicable. The Plaintiff conveniently chose to gloss over the application of the FDCA to interstate commerce, and instead focus on other language within the FDCA, such as the term “new drug” in 21 U.S.C. § 355. Because there was no interstate commerce, the FDCA is wholly inapplicable. Therefore, Plaintiff’s argument that the Congaree Defendants violated the FDCA is fundamentally and absolutely flawed, and fails as a matter of law.
Footnote 2: 21 U.S.C. § 331. Prohibited Acts.
(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 355, or 360bbb-3 of this title.
(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, orcosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.
(v) The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 350b of this title. (Emphasis added)..
A. A Prescription for Hydrogen Peroxide for Intravenous Use is Not Required by Federal Law
As stated supra, the FDCA is inapplicable because it applies to interstate commerce. Since this case involves a South Carolina pharmacist who provided a compound to a South Carolina physician located within the same office building, there is no interstate commerce. The FDCA does not apply, and therefore a prescription for hydrogen peroxide for intravenous use is not required by federal law.
B. Congaree Defendants Did Not Produce a “New Drug” in Violation of Federal Law
As stated supra, the FDCA is inapplicable because it applies to interstate commerce. Since this case involves a South Carolina pharmacist who provided a compound to a South Carolina physician located within the same office building, there is no interstate commerce. The FDCA does not apply, and therefore the Congaree Defendants did not produce a “new drug” in violation of any federal law.
Moreover, the Plaintiff claims any compound not approved by the FDA for a specified use is considered “misbranded” under § 352(l) of the FDCA, so that production and sale violates §§ 331(a) and (k) of the FDCA. Those sections prohibit:
Again, these sections clearly apply to food, drugs, devices or cosmetics in interstate commerce. As previously stated, there was absolutely no interstate commerce involved in Congaree providing a compound to Dr. Shortt. As a result, there was no violation of the FDCA because it does not even apply.
C. Congaree Defendants Did Not Violate Federal Testing Requirements
The Plaintiff claims the Congaree Defendants did obtain an FDA sanctioned investigational new drug application (IND) pursuant to 21 U.S.C. § 355(I) and 21 CFR § 312. However, once again the Plaintiff has ignored the fact that these federal laws do not apply to Congaree in this case. 21 U.S.C. § 355(a) provides that “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.” (Emphasis added). An IND is required for the introduction of new drugs into interstate commerce. A pharmacy providing a compound for a physician within the same office building located in the geographic center of the state does not rise to the level of commerce between states. Therefore, it is not interstate commerce, no IND is required and the provision of the FDCA relied upon by the Plaintiff does not apply.
Similarly, 21 CFR § 312.1, as relied upon by the Plaintiff, provides the scope of that section:
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND’s). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.
It merely refers back to the process and requirements of IND’s through the FDA, and as demonstrated, no IND is required because that is necessary only when dealing with interstate commerce. Therefore, the provision of the CFR relied upon by the Plaintiff does not apply either.3
Footnote 3: For further evidence that this provision relied upon does not apply, § 312.2 outlines the applicability of that provision:
21 C.F.R. § 312.2 Applicability.
In addition, the Plaintiff misconstrues case law yet again to conform to his own liking. The Plaintiff cites United States v. Vital Health Products, 786 F.Supp. 761 (E.D. Wis. 1992), affirmed as U.S. v. LeBeau, 985 F.2d 563 (7th Cir. 1993), for the proposition that hydrogen peroxide is not generally recognized as safe and effective for internal use. While that case enforced a permanent injunction prohibiting the marketing and sale of hydrogen peroxide solutions that had not been approved by the FDA, the reasoning renders Vital Health Products wholly inapplicable to the case at bar. The court in Vital Health Products recognized the authority to act against Vital Health Products was through the FDCA.
The Federal Food, Drug, and Cosmetic Act of 1938 (“the Act”), 21 U.S.C. § 301, et seq., was designed to protect public health by regulating certain products moving in interstate commerce. United States v. Kordel, 164 F.2d 913 (7th Cir. 1947); United States v. Two Bags, Poppy Seeds, 147 F.2d 123 (6th Cir. 1945); Barnes v. United States, 142 F.2d 648 (9th Cir. 1944). One of the Act’s primary purposes was to ensure the safety of food and drugs before they became available to the public. United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 84 S.Ct. 559, 11 L.Ed.2d 536 (1964). Section 331 of the Act prohibits the introduction or delivery of a misbranded drug or an unapproved new drug through interstate commerce. 21 U.S.C. § 331(a) and (d).
U.S. v. Vital Health Products, 786 F.Supp. at 767. (Emphasis added). The reason the court enforced the injunction was because Vital Health Products was violating the FDCA by marketing and selling its products in interstate commerce. The Congaree Defendants were not engaged in interstate commerce, and therefore, the FDCA does not apply. As a result, the Congaree Defendants did not violate federal testing requirements.
As discussed in Section C, the Plaintiff erroneously relies on Vital Health Products to make an argument that the Congaree Defendants violated federal law. The Plaintiff again attempts to use Vital Health Products to claim the Congaree Defendants violated warning and labeling requirements under the FDCA (and state law). However, as clearly demonstrated supra, the FDCA applies to drugs in interstate commerce. The Congaree Defendants were not engaged in interstate commerce, and therefore, the FDCA does not apply. As a result, the Congaree Defendants did not violate federal warning and labeling requirements.
E. Congaree Defendants Did Not Violate Federal Law by Producing Hydrogen
Peroxide for Intravenous Use Without Approval of the FDA
Likewise, as explained supra, no investigational new drug application (IND) was required from the FDA pursuant to 21 U.S.C. § 355(I) and 21 CFR § 312. Because those provisions do not apply, and because the Congaree Defendants do not need approval from the FDA in the form of an IND, they did not violate federal law.
The Plaintiff is partially correct in asserting that the purpose of the FDCA is to protect the public health. The Plaintiff cites various sections of the FDCA to support his argument that the Congaree Defendants violated federal law by not having FDA approval to provide Dr. Shortt a hydrogen peroxide compound. However, as is the pattern in the Plaintiff’s arguments, he “cherry picks” isolated parts of the provisions of the FDCA in a manner which clearly ignores the actual purpose of the FDCA. “The Federal Food, Drug, and Cosmetic Act of 1938 (“the Act”), 21 U.S.C. § 301, et seq., was designed to protect public health by regulating certain products moving in interstate commerce.” U.S. v. Vital Health Products, 786 F.Supp. at 767. (Emphasis added). The Plaintiff chooses to ignore that the FDCA is not applicable to a South Carolina pharmacy providing a compound to a South Carolina physician some fifty feet down a hallway. He also chooses to ignore that the FDCA clearly sets out what are “Prohibited Acts” under its own provisions, and that those prohibited acts involve interstate commerce. See 21 U.S.C. § 331. The Congaree Defendants were not engaged in interstate commerce, and therefore, the FDCA does not apply. As a result, the Congaree Defendants did not violate federal law by producing hydrogen peroxide for intravenous use without approval of the FDA.
The Plaintiff’s arguments in support for his Motion for Summary Judgment amount to a house of cards. The arguments loosely build on each other without any real foundation. The Plaintiff distorts and perverts the law to attempt to bolster his arguments. Despite this, there was no violation of any applicable state or federal law. The conduct of the Congaree Defendants clearly falls within the definition of “compounding” under the South Carolina Pharmacy Practice Act. Moreover, both state and federal authorities specifically allow for a pharmacy to provide a compound to a physician for in-office use. Finally, the Plaintiff’s allegations of violations of various federal laws are inapplicable because those federal laws apply to products in interstate commerce. Since there was no interstate commerce involved with the Congaree Defendants and the compound they prepared for Dr. Shortt, federal law does not apply. Not only do the arguments of the Plaintiff fail to provide any support for his motion for summary judgment, they fail to establish any genuine issue of material fact. Therefore, granting summary judgment for the Congaree Defendants is proper.