Ms. Goodwin is manager of clinical risk and patient safety at Cambridge Health Alliance, Cambridge, MA.

Brianne Goodwin, JD, RN

A 61-year-old male with medical history including a cardiac condition, four back surgeries, and lung cancer presented to his urologist for erectile dysfunction, which he had been suffering from for approximately 5 years. He was first given the options of vacuum pump therapy and penile injections, both of which he tried, but which failed to help his condition.

Less than 2 years later, after exhausting these two options, the patient opted to undergo placement of an inflatable penile prosthesis. The surgery was done by an attending physician, with the assistance of a senior resident and observation by a junior resident. Based on measurements done by the attending and resident, it was documented that an 18-cm implant would be used in conjunction with two rear tip extenders.

The prosthesis was inflated during the procedure after placement, and it was documented that a sufficient erection was produced with a mild deviation to the right. The patient tolerated the procedure well and there were no complications. He stayed overnight in the hospital and was discharged the following day.

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The man was seen in clinic 3 weeks postoperatively, where he was examined by another resident who noted a bulge on the left side of the man’s penis. The patient noted he had not yet used the prosthesis, had soreness with sitting, but had no other complaints.

The resident inflated the prosthesis and brought the surgical attending into the room to examine the patient as well. It was documented that the man had no bruising, his incision was healing well, and the bulge could represent a kink in the cylinder of the prosthetic device. He was scheduled to return 3 weeks later to be reassessed.

Reassessment 3 weeks later revealed the bulge was still present and upon inflation of the prosthesis, there was a severe bend to the right. The man was bothered with the hardware and ultimately decided to have it removed. The same surgeon who placed the prosthesis removed it approximately 14 months later.

The man began treatment with another urologist several months later with complaints of pain in his penis and scrotum and ultimately filed a lawsuit alleging negligence on the part of the surgeon who implanted the prosthesis. The man’s claims were three: the defendant did not accurately measure the left corpora; the prosthesis was never properly seated in the proximal end of the penis, making it too large; and the defendant punctured the tunica albuginea when they dilated the left corpora, allowing the prosthesis to bulge. All of these, the plaintiff alleged, were deviations from the standard of care.

In this case, as in most, the standard of care in medical malpractice proceedings is established by expert witnesses and testimony. The defendant’s expert witness, who had performed several hundred penile implant prosthesis procedures over the years, testified that if a prosthesis is not properly sized, it will buckle out through the incision in the corpora. To assure proper sizing, the prosthesis should be inflated during the surgery. This was documented in the operative note to have occurred three times during the surgery while checking the appearance of the implant.

In addition, the defendant’s expert testified that tearing the tunica albuginea while dilating the corpora is nearly impossible. He elaborated that the corpora are dilated in proximal and distal directions, meaning that a surgeon would need to rotate the dilator 90 degrees, and with enough force, to tear a membrane that is fibrous in nature. Moreover, had that membrane been torn, there would be thickened scar tissue in the area, which was not noted on the patient’s exam at the time of prosthesis removal.

The plaintiff’s expert witness, also his treating urologist, failed to establish the credibility needed to come close to that of the defendant’s expert. As an initial matter, the plaintiff’s expert testified that in 27 years of practice he had performed six inflatable penile prosthesis procedures, with the most recent one being 10 to 15 years ago. Furthermore, plaintiff’s expert had not previously examined one patient with the symptom of a bulge after penile prosthesis surgery.

The plaintiff’s expert demonstrated lack of knowledge on cross examination when asked about the standard of care postoperatively. Specifically, the expert testified that the standard of care after penile prosthesis surgery is to leave the implant in a semi-inflated state for 4 to 6 weeks, when in fact the standard is to keep the implant in a deflated state. Credibility further suffered when the plaintiff’s expert testified that the tunica albuginea and the Buck’s fascia were the same anatomy.

Expert’s testimony changed during trial

Further questioning revealed that plaintiff’s expert made no attempts to stay current on urologic research, was not a member of any professional urologic organizations, did not subscribe to any medical journals, and could only provide the title of one journal in his field of practice. This expert changed his testimony during the trial, further crippling the plaintiff’s case.

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The plaintiff himself contributed negatively to his case as well. His description of events at postoperative visits differed significantly from what was documented in the medical record. He also was found to have exaggerated and omitted important portions of his medical history when testifying in other unrelated administrative proceedings.

Accordingly, the court found that the plaintiff failed to prove that defendant deviated from the standard of care and judgment was entered in favor of the defendant.

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"The expert testified that the standard of care after penile prosthesis surgery is to leave the implant in a semi-inflated state for 4 to 6 weeks, when in fact the standard is to keep the implant in a deflated state," writes Brianne Goodwin, JD, RN.

IPP suit hinges on expert’s lack of credibility

In the case discussed below, the plaintiff attempted to make use of what is known as the “continuing course of treatment doctrine.” The continuing course of treatment doctrine allows the statute of limitations to be tolled while the defendant is still providing medical care to the plaintiff. The general policy on this doctrine is that if a patient continues to be treated by a physician or provider, the patient should not be required to stop the treatment to commence litigation simply because a statute of limitations is about to expire.

Anchor driver piece found near pelvic bone

In 2001, a defendant urologist performed a bladder suspension surgery on the plaintiff to address incontinence. During the surgery, the defendant urologist placed titanium anchors into the plaintiff’s pelvic bone by the use of an anchor driver, a metal device. In 2015, part of an anchor driver was found inside the plaintiff’s body near her pelvic bone and was removed. In 2016, the plaintiff filed a medical malpractice complaint against the health care facility and multiple physicians, including the urologist who performed the 2001 procedure.

In her complaint, the plaintiff alleged she presented to the facility in January 2001 with a symptomatic cystocele and some stress incontinence. She was seen by the defendant urologist, who performed surgery on her in the form of an endoscopic bladder suspension.

Resident, attending sued over BPH procedure

During the procedure, the defendant urologist used anchors to support the suspension. The plaintiff asserted that after the bladder suspension surgery, she experienced unusual pain in her pelvic area. The plaintiff alleged that she notified the urologist of her continuing pain and was told there was nothing wrong. Specifically, she alleged that she returned to defendants twice in 2004, again in 2009, and in 2012, complaining of continued pain that she associated with the surgical procedure in 2001.

The plaintiff asserted that diagnostic imaging was performed at all four visits and each time she was informed that the imaging showed nothing that could account for her painful symptoms. However, according to the plaintiff, the x-rays from 2009 and 2012 clearly showed a foreign body in her pelvis.

The plaintiff additionally alleged that she underwent a second surgical procedure with the defendant urologist in 2012 in the form of a bladder instillation and transvaginal obturator tape procedure. When consulting with the urologist about the second surgery, the plaintiff complained that she felt as if something were poking into her in her pelvic region. The plaintiff asserted that the urologist dismissed her concerns.

In 2014, the plaintiff presented to an emergency department with pain. At this visit, the plaintiff underwent a computed tomography scan of her abdomen and pelvis. According to the plaintiff, a radiologist read the scan and noted a 2.2-cm metallic object.

The plaintiff alleged when she next returned to the health care facility in 2015 reporting pain, she was ultimately diagnosed with pubic cellulitis overlaying retained public symphysis hardware. She stated she was informed that she might have an anchor in her pubic bone that needed to be removed and was transferred to a tertiary hospital. The plaintiff alleged that another x-ray report noted the anchor device from her surgery and opined that it may represent a piece of broken hardware.

The plaintiff subsequently underwent surgery at the hospital to remove the object, which she asserted proved to be the instrument part that was used to place anchors for the bladder surgery and was abandoned by the defendant urologist and left within her.

"The plaintiff alleged that the health care facility and the defendant urologist were negligent in several respects"

The plaintiff alleged that the health care facility and the defendant urologist were negligent in several respects, including failing to account for the medical devices used or placed in the plaintiff’s body during the 2001 bladder surgery; continually misinforming or misleading the plaintiff regarding the presence of the foreign body in or around her pelvis through 2015; allowing the foreign metallic body to remain in the plaintiff through June 2015, despite specific complaints, examinations, and radiology studies that demonstrated its presence; failing to follow up on the 2014 radiology report indicating the presence of a metallic object; and failing to diagnose or recognize the presence of a foreign body instrument left within the plaintiff.

Not your patient? You can still be sued for malpractice

As to only the defendant urologist, the plaintiff additionally alleged negligence based on his/her failure to adequately examine plaintiff’s 2009 and 2012 radiology films and 2014 CT scan and report, adequately examine the plaintiff, refer the plaintiff to another treatment provider, and consult with radiologists or other medical professionals regarding the plaintiff’s long-term and continuing complaints of pelvic pain.

Given that there was a span of 14 years between the original surgical procedure and the 2015 procedure where the metallic object was removed, the plaintiff had to set forth a legal theory that tolled the statute of limitations. She purported that the continuing course of treatment doctrine applied and cited the several times in between 2001 and 2015 that she returned to the defendant reporting pelvic pain.

What was discovered at trial, however, was that in 2004, the plaintiff moved out of state, not returning to the health care facility or the defendant urologist until 2009 and 2012, respectively. When the plaintiff did return in 2009 and 2012, she returned for complaints unrelated to her previous pelvic pain. Therefore, the court held that the plaintiff’s course of treatment ended in 2004, and therefore the doctrine did not apply.

Not all states have applied the continuing course of treatment doctrine, and where it has been applied, there are many nuances and variations. Providers interested in knowing the rule in their own jurisdiction should consult with the appropriate legal authority in their facility or organization. 

"The plaintiff alleged that she notified the urologist of her continuing pain and was told there was nothing wrong," writes Brianne Goodwin, JD, RN.

Retained metallic object prompts lawsuit

Below is a review of a recent court case where the defendants were found to have deviated from the standard of care during a surgical procedure. This case helps to highlight important considerations around the level of involvement and supervision for trainees, and perhaps more importantly, what the patient knows.

The plaintiff had long-standing problems with urinary frequency and difficulty emptying his bladder, lasting nearly 30 years. He had undergone two transurethral resections of the prostate 2 years apart that provided some relief, in addition to taking a 5-alpha-reductase inhibitor.

The plaintiff sought treatment with a new urologist some 25 years after the TURPs had been done with complaints of nocturia, frequency, and urgency. A GreenLight laser procedure was recommended and performed. Postoperatively, the plaintiff experienced significant pain and bleeding, and more importantly, complete urinary incontinence. The plaintiff testified to soaking numerous adult incontinence pads per day.

A few months after the procedure, the plaintiff obtained his medical records from the hospital where the procedure was performed and learned that it had been performed by a third-year resident and not the physician he saw at the outpatient visit. In the complaint, the plaintiff alleged that the resident performed an unnecessary procedure, and that he performed it negligently.

The appropriate standard of care in medical malpractice litigation is proven-or not-by way of expert testimony. In the jurisdiction where this case was tried, the applicable rule is that expert testimony must explain what a medical professional of ordinary skill, judgment, care, and diligence in the same medical specialty would do in similar circumstances.

The plaintiff’s expert witness, a board-certified urologist, testified to a few key points:

He explained the anatomy of the male urinary system.

Performance of the GreenLight laser procedure deviated from the standard of care.

The GreenLight laser procedure was not the appropriate treatment for the plaintiff.

As in most any medical malpractice case that reaches trial, the court and/or jury often must be educated by expert witnesses about the involved anatomy, pathophysiology, and surgical procedures, along with other medical jargon, to fully understand the issues at trial.

The plaintiff’s expert explained the three continence mechanisms that control urine in a male in great detail, and the critical importance of the external sphincter. He additionally testified as to the verumontanum’s importance as a urologic landmark that signals proximity to the external sphincter. The expert then provided a detailed explanation of a GreenLight laser procedure, describing how the laser and camera get into the bladder, that the laser is controlled by a foot pedal, and the importance of continuously monitoring anatomy as the device is withdrawn from the urethra.

This background, coupled with undisputed testimony that the plaintiff was continent prior to the procedure and completely incontinent after the procedure, led the plaintiff’s expert to opine that the defendant resident physician inadvertently ablated the external sphincter and that this was a deviation from the standard of care.

On cross-examination, the plaintiff’s expert also testified that at a post-procedure exam, the plaintiff’s external sphincter was wide open and the plaintiff could not squeeze it closed. The plaintiff’s expert went on to opine that the GreenLight laser procedure was not appropriate for the plaintiff due to the fact that he suffered from irritative symptoms and not obstructive symptoms.

Defendants: Prior TURPs contributory to outcome

The defendants themselves (both the resident and the supervising attending) testified that the injury did not occur during the GreenLight laser procedure, and offered that the two prior TURPs were contributory to the outcome. The defendants’ experts also testified to that line of reasoning and added that urinary incontinence is a known risk factor of the GreenLight laser procedure.

Ultimately, the court found that offering the GreenLight laser procedure to the patient was within the standard of care. However, the court found that the performance of the GreenLight laser procedure fell below the standard of care and determined that the plaintiff’s injury resulted from a misapplication of the GreenLight laser, and this misapplication was the cause of the plaintiff’s urinary incontinence.

While the defense experts’ argument that urinary leakage is a complication of ablative procedures was entertained, the court was not convinced that the severity of the plaintiff’s injury-complete lack of urinary control-was the same as leakage. The argument that the TURPs were contributory to the outcome lacked strength given the temporal remoteness of those procedures to the injury.

Statistically speaking, defendants are more likely to prevail in medical malpractice cases that go to trial. However, that was not the case here. 

The court found that treatment performance was below the standard of care.

A recent state Supreme Court decision in Minnesota has cast a broad definition of when a legal duty applies to a provider, and therefore, perhaps broadened the range of circumstances under which a physician who has no patient-physician relationship might be sued.

 the patient sought medical care for abdominal pain, fever, and chills, among other symptoms. She was evaluated by a nurse practitioner (NP). Her lab results demonstrated an elevated white blood cell count, and the NP suspected an infectious process. The NP placed a call to the local hospital to discuss admission with the admitting hospitalist.

During this conversation, which lasted approximately 10 minutes and during which the admitting hospitalist was unable to view the patient’s medical record, the decision was made by the hospitalist to not admit the patient. Her symptoms were attributed to her diabetic condition and outpatient follow-up was recommended. The patient died 3 days later of an untreated staph infection 

The patient’s son brought a medical malpractice action against both the NP and the hospitalist. The trial court granted summary judgment to the defendants, and the Minnesota Court of Appeals affirmed the decision, holding there was no duty of care owed by the hospitalist because there was no physician-patient relationship. The hospitalist had only spoken to the NP by phone and had not seen the patient. The Minnesota Supreme Court overturned the lower court rulings, stating in part that it had “never held that such a relationship is necessary to maintain a malpractice action under Minnesota law” 

As it pertains to foreseeability, the Court stated: “When there is no express physician-patient relationship, we have turned to the traditional inquiry of whether a tort duty has been created by foreseeability of harm” 

In fact, the first line of the decision reads: “A physician-patient relationship is not a necessary element of a claim for professional negligence. A physician owes a duty of care to a third party when the physician acts in a professional capacity, and it is reasonably foreseeable that the third party will rely on the physician’s acts and be harmed by a breach of the standard of care” 

The Court highlighted a few points in coming to its conclusion 

The NP did not have admitting privileges, and it was the hospitalist’s sole duty to make decisions around patient admission.

The hospitalist knew or should have known that the decision to admit or not would have been relied upon by the NP and her patient.

The hospitalist knew or should have known that breach of the standard of care could result in harm.

The Court repeatedly referred to the hospitalist in this case as the “gatekeeper,” distinguishing him from a “curbside consult” in that the hospitalist was the individual with the sole authority to make a decision around hospital admission 

Although this case pertains in detail to primary care and internal medicine, it can easily be extrapolated to other areas of medicine, urology included, and offers a good opportunity to revisit issues surrounding curbside consults, documentation, applicable hospital and insurance carrier policies and guidance, and legal differences between jurisdictions.

For example, a small study from 2013 looked at the accuracy and completeness of curbside consults versus formal consults 

 With a sample size of 47 patients getting both curbside and formal consults, information was either inaccurate or incomplete in 24 of 47 of the curbside consultations. Management advice after formal consultation differed from that given in the curbside consultation for 28 of 47 patients. Lastly, when inaccurate or incomplete information was received, the advice provided in the formal versus the curbside consultation differed in 22 of 24 patients, a statistically significant result.

Many hospital and insurance carriers have either policies or guidance around curbside and formal consults, and documentation of these. Given that jurisdictions differ in how the physician-patient relationship arises, it is prudent for providers to know the law of the jurisdiction where they practice and any applicable policies surrounding consult and documentation.

Diagnostic errors still top driver of claims

Minnesota and a handful for other states fall into the “minority view,” in that a physician’s duty is not tied to personal contact with the patient. Despite that, and given the ever-changing communication landscape and the use of technology in medicine, close introspection of personal practice may be worthwhile to ensure your practices align with what your state and medical facility or organization permit.

Between text messaging, emails, phone calls, and electronic medical record portal messaging, plenty of communication about patients occurs outside of the exam room. Protect yourself by knowing the law in the state where you practice and what your insurer or counsel’s office recommends when it comes to your duty as a consultant, whether formal or informal.

"It is prudent for providers to know the law of the jurisdiction where they practice and any applicable policies surrounding consult and documentation," advises Brianne Goodwin, JD, RN.