This case involves a compounding pharmacy that allegedly used insulin syringes to fill in an anti-cancer drug used off-label to treat eye conditions, including macular degeneration. The syringes were lubricated with silicone oil and not designed to be used for eye injections. However, they were allegedly sold to ophthalmologists for the treatment of macular degeneration. The silicone oil contamination resulted in silicone oil deposit in the eyes. This caused vision interference for patients who took the medication, and many required corrective laser surgery or a vitrectomy.
Question(s) For Expert Witness
1. What is the role of the compounding pharmacist in selecting the type of syringe used for filling in a drug?
2. Are you familiar or involved with USP regulations with compounding solutions?
Expert Witness Response E-163492
I am a member of the USP Compounding Expert Committee and I served as the USP Council of Experts Sterile Compounding Committee Chair for 10 years. I have compounded many injections and a few ophthalmics as a civilian and US Army hospital pharmacist as well as a university faculty member. To comply with US Pharmacopeia General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, i.e., USP 797, compounders are responsible to ensure that containers (e.g., ampules, syringes, and vials) maintain sterility, strength, purity, and stability of compounded sterile preparations, i.e., CSPs. I have consulted on several cases of patient harm and death from pharmacy compounded CSPs, including for the US DOJ.
About the author
Wendy Ketner, M.D.
Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Dr. Ketner's extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. She also provided care in the surgical intensive care unit.
Her research interests have focused on post-mastectomy reconstruction and the surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject. Additionally, she has contributed to research on the percutaneous delivery of stem cells following myocardial infarction.
Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Moreover, she is a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company, contributing her medical expertise to enhance healthcare technology solutions. Her role at Expert Institute involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.
