Recent changes in U.S. Food and Drug Administration (FDA) labeling and news reports of lawsuits resulting in million-dollar settlements understandably may deter gynecologists from prescribing the transdermal contraceptive patch Ortho Evra (Ortho-McNeil Pharmaceutical, Inc., Titusville, NJ). Gynecologists who, with all good intentions, prescribe an FDA-approved drug such as the contraceptive patch potentially could find themselves liable for an adverse drug reaction. Although much of the current focus by plaintiff attorneys and the news media is on the contraceptive patch, no prescription contraceptive method is without medical risks to the patient or legal risks to the prescribing gynecologist. The purpose of this commentary is to provide an overview of the medical–legal controversies and pitfalls in prescribing the contraceptive patch as well as to outline how gynecologists can avert legal liability by providing proper informed consent. Despite FDA labeling changes and ongoing litigation, with proper informed consent, the contraceptive patch still may be the best choice for many patients who prefer the convenience of a weekly patch over a daily oral contraceptive. Also, regardless of the contraceptive option chosen, the principles of providing and documenting proper informed consent in medical records are applicable not only to providing quality care to patients, but also to protecting the legal interests of the prescribing gynecologist. By documenting proper informed consent in medical records, gynecologists should feel more at ease in prescribing the contraceptive method that best fits their individual patients’ needs, even in the presence of ongoing litigation.
Documenting informed consent in medical records is important when prescribing any method of contraception, particularly when there is litigation surrounding the product.
From the Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, The University of Texas Medical Branch, Galveston, Texas.
Corresponding author: John Y. Phelps, MD, JD, LLM, Department of Obstetrics & Gynecology, Division of Reproductive Endocrinology and Infertility, The University of Texas Medical Branch, 301 University Boulevard, Galveston, TX; e-mail: JYPhelps@aol.com.
Financial Disclosure The authors did not report any potential conflicts of interest.