A middle-aged New York male began Trimix penile injections at the advise of his urologist due to his erectile dysfunction. He was not previously trialed on oral medications.
A few months after initiation of treatment he developed some fibrosis of the penis. This fibrosis was first evaluated by the original urologists associate. On re-evaluate by the original urologist a different medication was prescribed. The fibrosis was thought to be due to the patient’s diabetes.
Over the course of just over a year the patient was evaluated multiple times with observation of worsening penile lump. Finally, the urologist discontinued the injections. The patient complained that he could no longer achieve erections and that the treatments left him scarred and disfigured.
He sued the urologist claiming that there was no proper informed consent and that the urologist did not properly manage the penile scarring.
An expert witness for the plaintiff opined that improper monitoring of the injection therapy fell below the standard of care. Moreover, the injections should have been stopped when the scarring developed. The expert additionally opined that because the possibility of fibrosis was not discussed during the informed consent that the urologist again fell below the standard of care. Oral medications should also have been offered prior to initiation of injection therapy.
The defendant argued that informed consent had been properly obtained, pointing to a signed consent form that documented scarring as a possible side effect. He argued as well that the injections were a complication of the patient’s diabetes rather than the injection therapy.
The jury returned a verdict in favor of the patient and a monetary award of $2 million.
Expert witness testimony made this case for the plaintiff, as it convinced the jury of three things: (1) oral medications should have been utilized as a first-line options, (2) a reasonable individual would not have started the therapy given the potential risks as appropriate first-line therapy had not been tried, and (3) proper informed consent had not been obtained.
The key take home from this example is the importance of well-documented informed consent. Key to a good informed consent to to ensure that any reasonable person reading the consent would agree to undergo the procedure or treatment. Documentation of the common and major risks and benefits is recommended.