Informed Consent Regarding Mastectomy and Breast Reconstruction: Who Makes the Final Decision?

Facts of the Case

A 41-year-old female was diagnosed with infiltrating duct cell carcinoma of the left breast. She underwent a left breast mastectomy, node dissection and breast reconstruction in early December of 2009. Several days prior to the surgery, the patient met with two plastic surgeons to discuss having breast reconstruction immediately following the mastectomy. Several options were discussed with her, including an abdominal/TRAM flap procedure, a latissimus flap procedure and a free flap procedure.

The patient was obese and a “social” smoker. Because of this, she was not an appropriate candidate for the TRAM flap procedure. Nevertheless, the patient “insisted” on having this particular type of reconstruction, and the physicians agreed to perform this procedure. She was advised of the risks of this surgery, including infection, bleeding, scarring, asymmetry, wound healing complications, hernias and the need for possible revision surgery. This discussion was documented in her medical record.

On the day of the procedure, the patient was once again advised of the risks that had been discussed in the office. She then signed a consent form. After the mastectomy was completed, the pathologist reported that the carcinoma was HER-2 positive poorly differentiated invasive ductal carcinoma. Despite knowing this, the plastic surgeon proceeded to perform a right breast reduction. He then reconstructed her left breast with a TRAM flap. The plastic surgery discharge note stated: “Wounds ok…some skin flap necrosis on the left side…treated with nitroglycerin.”

The patient was discharged on pain medication and antibiotics. She continued to see both plastic surgeons regularly that month for her post-operative care. However, by the end of December, the TRAM flap had obvious necrosis. Two weeks later, the patient underwent debridement of the skin flap with a TRAM revision and was treated with a wound VAC. By February of 2010, although the wound had improved, it still had not completely healed. Finally, in May of 2010, the patient’s oncologist ordered a wound culture, which was positive for MRSA. The patient was treated with IV antibiotics. Although the patient was originally scheduled to begin chemotherapy six weeks following the mastectomy, due to the wound infection, the initiation of chemotherapy was delayed for six months. In September 2010, the patient went to see a different plastic surgeon at a large cancer center. This surgeon recommended that she wait until the wound healed before undergoing any further reconstruction.

In February 2011, the patient underwent a latissimus flap breast reconstruction by her new plastic surgeon. However, the patient then began to show symptoms of osseous metastasis, including the spine. Finally, in October 2011, she underwent a kyphoplasty and had palliative radiation therapy to her right hip.

The Lawsuit

The patient commenced a lawsuit against the general surgeon, both original plastic surgeons and their professional entity. She alleged that they had failed to advise her of the risk that the reconstruction would fail and failed to diagnose and timely treat her post-operative infection. She also alleged they had inappropriately recommended the TRAM flap reconstruction to her because she was not a candidate for this type of procedure. She alleged further that during her post-operative care, they had failed to timely perform a culture and sensitivity of the wound drainage so they could properly treat her with antibiotics, debridement, drains and surgery. Finally, she also alleged that they had failed to perform an adequate informed consent discussion pre-operatively.

The damages claimed included a severe infection with loss of the flap and pain and suffering related to the additional corrective procedures (tissue expanders and implant surgery) she had to undergo as a result. The most significant of the damages claimed was a delay of six months in the initiation of chemotherapy due to the infection and ensuing treatment, therefore depriving her of her best chance of survival and increasing her risk of metastasis.

Expert Reviews

The expert reviewers retained on behalf of the defendants were critical of all the treating physicians. They criticized the general surgeon for permitting immediate reconstruction to be performed after the mastectomy. They stated that her obesity and history of smoking increased the risk of complications, which could, and in fact did, delay the onset of adjuvant therapy. This was felt to be a critical potential factor in the onset of her metastatic disease.

The plastic surgery experts criticized the use of a TRAM flap in an obese patient who also smoked. They also felt that the plastic surgeons appeared overly concerned with necrosis of the flap, for which she received topical Silvadene. However, they never documented that they had considered a possible infection at any time until the patient was febrile. This was confirmed by their failure to culture the wound throughout her entire course of treatment. Only at that point did they prescribe systemic antibiotics. As a result, the experts felt strongly that their failure to consider the presence of an infection and perform cultures were clear departures from the standard of care.

Settlement

Due to these numerous, serious deficiencies in the patient’s care and the resulting delay in the initiation of chemotherapy, the case was settled on behalf of the plastic surgeons. The general surgeon, named in the lawsuit but not an MLMIC insured, also participated in the settlement.

Legal Analysis

Several legal issues prompted the settlement of this case. The first was the need to perform an appropriate procedure with due consideration of the patient’s medical history. Two specific risk factors made this patient an inappropriate candidate for an abdominal TRAM flap – she was obese and a smoker. Patients who are obese and particularly those who smoke often do not heal well after plastic surgery procedures. Since this patient potentially had metastatic disease, an abdominal TRAM flap should not have been offered as a viable option. The physician should have explained to her why she was not a good candidate and fully documented this discussion in her medical record. Although a patient, when given several options, can express her preferences to her physician, the physician should not agree to perform a procedure that is either contraindicated by the patient’s condition or not in the patient’s best interests, regardless of the patient’s insistence on having that procedure. The responsibility for patient selection for a procedure lies with the physician, within their judgment and discretion, and not the patient. Thus, in retrospect, these physicians should have declined to perform this particular procedure in light of her obesity and history of smoking, instead of acceding to her demands.

The second legal issue causing a weakness in the defense was the fact that the surgeons performed the attempted reconstruction at the time of the mastectomy. Based on the pathology report, the surgeons were aware that the patient would need to start chemotherapy within six weeks of the mastectomy. Since performing the reconstruction, despite the results of the pathology studies, arguably was not in the patient’s best interests, the patient’s attorney could allege that this, too, was a departure from the standard of care. Further, he could allege that this decision may have been due to both patient pressure and, perhaps, the financial interests of the surgeons, both of which could inflame the jury.

The adequacy of the informed consent discussion was yet another risk management issue in this case. Although the risks discussed were documented in the patient’s medical record, the risks did not include a potential delay in the commencement of chemotherapy, if needed, nor a total failure of the procedure due to infection. In fact, the patient denied being advised of this and was able to claim a breach of informed consent. Finally, when a wound persistently does not heal, infection must be considered, and elimination of that possibility must be documented. Ironically, it was documented that the patient was told that infection was a known risk. However, the surgeons failed to recognize evidence or even consider the existence of an infection. Further, they failed to document that they had eliminated infection as a cause of the patient not healing well. According to plastic surgery experts, this failure was a clear departure from the standard of care.

When obvious and serious departures from the standard of care result in a delay in critical treatment, it is difficult to find an expert to defend the case. An expert for the defense must not only be able to put forth a defense and clearly show that the standard of care was met but must also be able to withstand intense cross-examination by counsel for a sympathetic plaintiff who now has metastatic disease. In this case, finding such an expert to testify was not possible. Therefore, settlement was indicated.

Perhaps the most crucial allegation made against these physicians was the delay in the start of treatment of her cancer due to the wound infection. This delay allowed the plaintiff to seek damages for deprivation of a better chance for survival using the “loss of chance” doctrine. This doctrine was a strong factor in the need to attempt to negotiate a settlement due to a valid concern that the jury might be emotionally affected and choose to “punish” the physicians by rendering a large verdict in favor of the plaintiff. Therefore, when there is a lengthy delay in the diagnosis of cancer, the need to attempt to reach a settlement becomes clear. However, it is important to remember that a reasonable settlement cannot always be obtained pre-trial. Thus, at times, a case that is difficult to defend may go to trial before a settlement can be reached.

MLMIC policyholders can reach our risk management attorneys for questions regarding informed consent or documentation by calling (800)-275-6564 Monday – Friday, 8 a.m. – 6 p.m. or by email here.

Our 24/7 hotline is also available for urgent matters after hours at (844) 667-5291 or by emailing hotline@tmglawny.com.

If you are not already a MLMIC insured, learn more about us here.

This document is for general purposes only and should not be construed as medical or legal advice. This document is not comprehensive and does not cover all possible factual circumstances. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors for any questions related to legal, medical or professional obligations, the applicable state or federal laws or other professional questions.