The US Food and Drug Administration (FDA) issued a safety communication to healthcare providers about the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries that are not already FDA approved.

Robotically assisted surgical devices currently enable surgeons to perform a variety of procedures in a minimally invasive manner through small incisions, which may reduce pain, blood loss, and scarring. However, studies have suggested that these minimally invasive procedures for cancer-related surgeries are more likely to result in recurrence of the disease and/or death than standard, large-incision surgeries. Additionally, research has questioned robot-assisted surgeries for increasing patients’ risks by requiring them to stay longer on the table and under anesthesia.

Concerns are growing that robots and minimally invasive procedures may, in fact, spread cancer during the procedure because the robot fails to visualize and fully remove diseased tissue and spreads cancer cells around the operation site. In the case of a traditional open mastectomy which optimally results in the removal of the tumor in one whole piece to avoid fragmenting the cancerous tissue and possibly leaving residual disease behind, robotic mastectomy may be especially susceptible to tissue fragmentation precisely because it uses a small incision which may disallow the en bloc removal of the tumor.

Interestingly, robotic-assisted mastectomies have been pioneered in Europe and are becoming more popular there because surgeons assert that they have cosmetic and convenience attributes. A Danish study recently published indicated that the risk of severe complications among early-stage endometrial cancer patients who underwent surgery after the national introduction of minimally invasive robotic surgery was significantly reduced.

This caution from the FDA follows the November 2018 publication of a study in the New England Journal of Medicine that reported robot-assisted cervical cancer surgeries had reduced long-term survival when compared with open abdominal radical hysterectomies among women with early-stage cervical cancer; however, the article did note that other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared.

Further, critics of robotic-assisted surgeries for cancer-related procedures also claim that their use unnecessarily increases the patient's cost of treatment; in response, hospitals maintain that utilizing these devices provides them a quality edge in patient care and treatment. Surely, decrease of pain, blood loss and scarring experienced by a patient is a positive result. However, hospitals and providers would be prudent to comprehensively weigh the benefits and temper the desire to keep up with robotic innovation against the unknowns and potential risks before utilizing robotic-assisted procedures in cancer treatments.

Advice for Medical Providers to Minimize Legal Liability:

  • Understand that the FDA has not cleared or approved any robotically assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.

  • Be aware that robotically-assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy.

  • Undergo, pursuant to FDA recommendation, training for the specific robotically assisted surgical device procedures you perform.

  • Talk to your patients about your experience and training, and the clinical outcomes expected with the use of robotically assisted surgical devices. Discuss the benefits, risks, and alternatives of all available treatment options with your patients to help them make informed treatment decisions.

  • Be aware that clinical studies conducted in the United States involving a legally marketed device investigating a new intended use are subject to FDA oversight.

  • Work with your local hospital/clinic to establish patient registries to gather data on the use of robotically assisted surgical devices for all uses, including the prevention and treatment of cancer. Patient registries may help characterize surgeon's learning curves, assess long-term clinical outcomes, and identify problems early to help enhance patient safety.

Updated: Mar 5, 2019

As American Heart Month draws to a close, what a better opportunity to look at the primary reasons underlying medical malpractice suits against cardiologists, who face a slightly higher than average rate of malpractice claims than other types of physicians.

Heart disease is the leading cause of death for men and women in the United States, and, according to the American Heart Association, 1 in 4 deaths is caused by heart disease. Genetic factors often do play a part in cardiovascular disease incidence, but it can often be prevented. In November 2018, the American Heart Association and the American College of Cardiology released revised cholesterol guidelines. High cholesterol leads to hardened arteries that in turn can cause a heart attack or stroke. The last iteration of these guidelines five years ago began moving away from using solely cholesterol numbers to determine who needs treatment and towards a formula that considers age, high blood pressure and other factors to more broadly estimate risk, but were not clear and often led to more treatment confusion than clarity. The new guidelines instead provide for more personalized patient care and set clear treatment targets based on individual circumstances and include other medical conditions, family history of heart disease, as well as traditional factors of age and high blood pressure.

A 2014 study analyzing claims during the period of 1991 - 2005 found that the cost to defend a cardiologist in a medical malpractice claim totaled around $83,593; in comparison, the cost for defending an ophthalmology claim, the least expensive specialty to defend, clocked in around $20,000. The litigation cost discrepancy is likely due in large part to the fact that Cardiologists are unique in the medical malpractice arena because of the diverse type of patient interactions in which they engage and wide scope of treatments and procedures they perform.

A study of 429 closed cardiology malpractice claims between 2007 and 2013 by The Doctors Company, the nation’s largest physician-owned medical malpractice insurer, revealed the most common patient allegations in these claims and the most common factors that contribute to patient injury. According to the study, diagnostic-related issues are the main reason cardiologists are sued and the top cause of patient injury.

The most frequent type of malpractice claim in The Doctors Company study was alleged failure to diagnose, delay in diagnosis or wrong diagnosis, comprising 25% of all malpractice claims. The other top allegations included improper management of treatment, improper performance of treatment/procedure/surgery, and improper medication management. A more recent 2017 Medscape Cardiology Malpractice Report reveals similarly that complications from treatment/surgery (36%), wrongful death (25%), and failure to treat/diagnose (41%) are the most common reasons for malpractice claims.

New data shows that while myocardial infarctions are sometimes misdiagnosed by cardiologists (and more frequently by physicians without cardiac training), cardiologists are more likely to misdiagnose non-cardiac diagnoses with symptomatologies that present similarly to cardiac ailments, such as pulmonary embolism or cancer.

With respect to patient injuries, The Doctors Company study indicated that the top factors contributing to patient injury were:

  • issues with patient assessment, including failure to establish a differential diagnosis (25%);

  • technical performance, including injuries that were known complications (21%);

  • patient factors, including patient non-adherence with the treatment plan (20%);

  • selection and management of therapy, including inappropriate surgical procedure (18%);

  • communication among providers, including failure to review the medical record (15%); and

  • communication between patient/family and provider, including inadequate patient education on the risks of medications (14%).

Eliminating all risk of lawsuits is impossible, but there are strategies that providers can take to minimize these risks:

With respect to improper management of treatment, for example, one way physicians can seek to minimize their risk of these types of claims would be to set standardized processes of care in their practices, such as:

  • adopting standardized hand-off forms for patient care transfers among physicians,

  • implementing protocols for following up on test results to ensure results are timely reviewed and acted upon if warranted, and

  • ensuring all providers are capturing all information into electronic medical records.

Of course, discussing all known and potential risks of any treatment procedures is necessary prior to performance of the procedure/surgery, but it is equally important to consider any related complications that occur; the handling of the complication, rather than the occurrence of the complication itself, is more often what leads a patient to file a claim. Practitioners would be wise to:

  • not hesitate to involve other specialists to consult for issues or complications that arise,

  • document all suspicions and treatments, and

  • have open lines of communication with the patient, the patient's family and any other treatment providers also involved as complications, proposed solutions, and treatment occurs.

Practitioners must be well versed in the potential and common complications of the procedures they perform, and be aware that failure to quickly act when a known complication does arise, e.g., failure to order a CT scan to evaluate a possible retroperitoneal bleed, may have the effect of turning a routine and common complication into a lawsuit.

For cardiologists especially, there needs to be careful attention paid to potential complications arising from prescription medications. Medication-based claims are almost exclusively related to bleeding complications often arising from the use of anticoagulants. Additionally, the potentially significant lung- and liver- side effects from amiodarone cannot be ignored; similarly, the use of Warfarin, which has a narrow therapeutic window, yet is effective at decreasing a patient's stroke risk, and can also cause severe bleeding, can create liability problems for cardiologists.

Interestingly, cardiologists who were involved in litigation most often reported after going through the litigation process that their 'take aways' from the process was to take steps to (1) improve their chart documentation and (2) spend more time with the patient and his/her family in an effort to avoid the occurrence of the lawsuit at all.

Please contact Christina Mott Hesse at 208.336.9777 or if you would like any additional information about this topic.