A 62-year old Floridian was referred to a urologist by his primary care physician for evaluation of an elevated PSA.
In the documentation of the first visit the urologist noted the elevated PSA, but not plan was set for prostate biopsy.
Approximately 4 months later the patient returned to the urologist with an unchanged repeat PSA. Again, no biopsy was performed.
The patient returned to his primary care physician about a year after the initial urology referral and was noted to have an increase to his already elevated PSA. The primary care physician re-referred the patient to the urologist, at which time a biopsy was then performed confirming aggressive, metastatic, incurable prostate cancer.
While undergoing treatment for the metastatic prostate cancer the patient committed suicide, citing the grueling nature of the treatment.
A malpractice suit was filed on behalf of the man’s estate alleging negligence due to failure to perform a biopsy with an elevated PSA. The plaintiff’s side argued that had a biopsy been performed earlier the disease could have been caught before it had become so aggressive and wide-spread.
The urologist argued that he recommended a biopsy at each visit, but that the patient declined further evaluation because of a bad experience with a prior negative prostate biopsy. Additionally, the defendant argued that the prostate cancer was already metastatic upon initial presentation and that earlier biopsy would have resulted in no significant change in outcome.
After a 10 minute deliberation the jury returned a verdict in favor of the defense.
The key takeaway from this case is the importance of documenting not only pertinent positives and treatments provided, but also documenting recommended treatments that were declined. This is particularly important in patients with elevated PSA who decline biopsy due to concerns about infection, pain, or prior negative experiences.
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.
Dr. Tygenhof was interviewed for OC Catholic magazine for an article about the launch of the new St. Jude Comprehensive Kidney Stone center.
WHEN THE ROLLING STONES PLAY YOUR KIDNEYS