Does this case show some of the legal issues of office use compounding and how pharmacies and pharmacists claim they have no liablity or duty when the preparation is compounded for office use?

Compounding Pharmacists Sued for Death
from Intravenous Hydrogen Peroxide

Stephen Barrett, M.D.

The Congaree Pharmacy of West Columbia, South Carolina, its owner (J.H. Phillips, Jr., R.Ph.) and a pharmacist/employee (George Dawn, R.Ph.) were co-defendants in a wrongful death suit brought by 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 [1]. 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 [2]. Bibeau's survivors alleged that the pharmacy and its pharmacusts had violated state and federal law in providing the hyrdrogen peroxide compound to Dr. Shortt.  Phillips and Dawn argued that they did not violate any state or federal laws because they provided the compound to Dr. Shortt for in-clinic use and therefore had no duty under the law to any patients receiving it.   In October 2005, both sides both filed motions for summary judgment [3-5]. Plaintiff's supporting memorandum concluded:

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 dealing. 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. . . .” [3]

Defendants' supporting memorandum concluded:

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 [4].

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