Guest Column: Unnecessary mastectomy: $6.5 million verdict in NY
Unnecessary mastectomy: $6.5 million verdict in NY
By Radha V. Bachman, Esq.
Buchanan Ingersoll & Rooney PC
Tampa, FL
Barbara Reding, RN, LHCRM
Citrus Memorial Health System
Inverness, FL
After a 31-year-old student and part-time clerk underwent an excisional biopsy on her left breast, the physician diagnosed the woman with cancer and recommended commencement of chemotherapy. About six months later, the woman came under the care of a hospital breast clinic and was evaluated by a general surgeon employed by the hospital who recommended a mastectomy. The pathology studies from the removed breast did not reveal any evidence of cancer in the breach or the 28 lymph nodes that were removed at the time. The surgeon conducted further testing, all of which revealed no cancerous tissue.
The woman sued the physician who made the cancer diagnosis and claimed that he failed to properly perform the biopsy.1 She alleged that the biopsy did not clearly indicate the margins of the cancerous tissue and that the physician should have made a second incision. The woman also sued the surgeon, an employee of the hospital, alleging that she failed to obtain the necessary informed consent, because no alternative treatment options were provided, and alleging that the mastectomy was, in fact, unnecessary.
The woman's counsel argued that the woman's cancer was eradicated by chemotherapy, and he claimed that chemotherapy typically resolves 15%-30% of cancerous masses. He contended that the woman's medical records indicated that the cancerous mass had been "resolved," and he also contended that the woman's records indicated that a pre-surgical evaluation did not reveal the presence of a "palpable mass." The woman maintained that the surgeon should have suggested a less invasive surgery, such as lumpectomy or a sentinel-node biopsy, rather than a mastectomy, which would have revealed that the woman's cancerous mass had been resolved. The woman's expert stated that the mastectomy was "like shooting a fly with a cannonball." The woman further claimed that the surgeon never discussed any alternative procedures.
The woman also sued the hospital-employer, the hospital's operator, and many other doctors and hospitals that were alleged to have been involved in her care. Her claim maintained that the hospital and the hospital operator were vicariously liable for the actions of the surgeon.
The defendants countered the woman's argument and claimed that the woman had failed to attend all her pre-surgical evaluations, which they said made her partially liable for the failure to properly diagnose her condition.
The woman underwent a mastectomy and reconstruction of her left breast. The reconstruction included the use of a flap that was harvested from her abdomen. The woman claimed that her left breast is horribly disfigured and scarred. She also claimed to suffer from residual lymphedema, which is painful swollenness caused by the body's retention of fluid. She contended that the condition stems from the surgeon's removal of some of her lymph nodes. The woman sought recovery of damages for her past and future pain and suffering.
The jury rendered a mixed verdict. It found that the woman was not offered the option of undergoing less invasive alternatives to the mastectomy that the surgeon performed. It further found that a reasonable, properly informed patient would have declined to undergo the mastectomy. It also found that the mastectomy was not necessary. Thus, it concluded that the surgeon was liable for the woman's injuries. The physician performing the biopsy was not assigned liability. The jury determined that the woman's damages totaled $6.5 million: $3 million for past pain and suffering, and $3.5 million for future pain and suffering.
Reference
- Case No. 14520/01, Bronx (NY) County.
What mastectomy case means for providers By Radha V. Bachman, Esq. Barbara Reding, RN, LHCRM Two of the pivotal points in the case of an unnecessary left mastectomy on a 31-year-old involve informed consent without specifying or discussing alternatives to the mastectomy and appropriate pre-surgical evaluation.1 The Joint Commission defines informed consent as the "Agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment." The Joint Commission requires that the hospital's written policy describes the process used to obtain informed consent and how informed consent is documented in the patient record (Joint Commission Standard RI.01.03.01, EP 4,5). It is imperative that informed consent is properly executed. It is the responsibility of the physician or surgeon to explain the risks, benefits, and alternatives of a procedure in a clear and concise manner to assist the patient and/or patient's representative in understanding what they are agreeing to and giving consent for. Key to informed consent is the inclusion of a list of risks, benefits, and alternatives to the procedure. Failure to offer information regarding any of these three components is a failure to achieve true informed consent. A patient is not fully enabled to make a good decision if information is lacking. In this case, the patient being duly informed of alternatives to the recommended surgery might have resulted in more desirable outcomes. Physicians and surgeons work within a busy schedule and might feel rushed. They might view informed consent as a task to be accomplished rather than an opportunity to educate, to entertain patient questions, address concerns, and to engage in discussion regarding a procedure. The process of obtaining informed consent also is an opportunity to develop a trust relationship between physician and patient, thus reducing the risk of litigation. Patients who trust in their physician or surgeon and who believe they have a good relationship with their practitioner are less likely to consider litigation in the event there is a negative outcome as a result of a procedure. Health care organizations must invest in educating medical staff in the content, importance, and ramifications of informed consent. While informed consent remains the full responsibility of the physician or surgeon, the facility also must work to ensure that informed consent is properly defined by policy and executed by the medical staff for the safety and well-being of their patients. In this case, the jury also found the mastectomy was not necessary. Contributing to this decision was the fact that "a pre-surgical evaluation did not reveal a palpable mass." It was contended that the patient's record indicated "that the cancerous mass had been resolved" post-chemotherapy. This finding begs the question, how extensive was the pre-surgical exam? A complete history and physical preoperatively would take into account the biopsy results and subsequent course of chemotherapy. It would be prudent to complete additional testing to verify the continued presence or resolution of cancer in the left breast. The Joint Commission, in its introduction to Standard PC.01.02.01, states, "The goal of assessment is to determine the care, treatment, and services that will meet the patient's initial and continuing needs. Patient needs must be reassessed throughout the course of care, treatment, and services." This assessment includes collecting and analyzing information regarding the patient's health history, followed by care and treatment decisions appropriate for the patient based on the information obtained. Given the jury findings in this case, it is evident the pre-surgical evaluation did not meet the assessment goal as defined by The Joint Commission. It behooves managers to ensure that their history and physical policies meet Joint Commission standards and that the medical staff adhere to such policies in order to provide safe and appropriate patient care. Reference
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