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Risk management in obstetrics and gynecology
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A 28-year-old Florida woman sued the obstetricians who had delivered her son in 1994 and provided postpartum care. She alleged that the delivering obstetrician injured her by misusing and misapplying forceps during delivery. When the woman experienced severe pain the day after delivery, one of the physicians told her the swelling and bruising were fairly normal.
For several years after the delivery, the patient was seen by various doctors, who diagnosed and treated her for pudendal nerve damage. Her primary complaint was inability to engage in sexual intercourse without pain. She also had chronic vulvar pain and underwent multiple procedures for pain control, including spinal cord stimulation and nerve blocks. Her medical expenses totaled $165,000.
The physicians alleged everything was done appropriately. The patient questioned the accuracy of the delivery notes, which showed no evidence of her injury, and notes on an exam done after delivery that also showed the same thing. The obstetrician's partner noted the nerve injury weeks later, which he alleged was caused by passage of the baby through the birth canal, and referred the patient for treatment. The jury found no negligence by the delivering obstetrician that would have provided a legal basis for any loss, injury, or damage to the woman.
When a malpractice case involves injury from forceps or other instruments used during delivery, the usual issues are that the device was negligently applied and/or the indication for use was below the standard of care. Risk of injury is inherent in use of any device during delivery, and it can be hard to prove that a device was in fact negligently applied, so the indication for use usually becomes the main issue. The injury claimed, of course, must be from the device.
In the case reported here, we do not know the indication for forceps. Nevertheless, because the case was successfully defended, the jury must have believed the indication was appropriate and the woman's injuries were a complication of vaginal delivery that would have occurred even without use of forceps. This points to the importance of documenting an accepted indication for any instrument that is used during delivery.
A 38-year-old woman from Washington, D.C., wanted to undergo uterine fibroid removal while preserving her fertility, and her physician recommended myomectomy. The procedure was performed through a transverse suprapubic incision, which required additional uterine manipulation because the patient's fibroids were large. The woman subsequently developed a life-threatening infection, which necessitated a hysterectomy. She filed a lawsuit, claiming that the infection and hysterectomy could have been avoided, had the physician used a different incision. The jury awarded her $900,000.
A 16-year-old Massachusetts woman was diagnosed with precancerous dysplasia, which her gynecologist treated with a LEEP procedure. Eighteen months later, the woman suffered a miscarriage at 20 weeks' gestation, but she subsequently had another pregnancy and delivered without problems.
The woman sued the gynecologist, alleging that the LEEP procedure was unnecessary and overly aggressive, and that cauterization would have been sufficient to treat the dysplasia. She claimed that too much tissue was excised during the surgery, resulting in an incompetent cervix. As a result, she claimed she was unable to carry her first child to full-term, and indeed lost her pregnancy at 20 weeks.
The physician contended that the LEEP procedure was necessary to prevent the woman from getting cancer, and that the amount of tissue removed from the cervix during the procedure would certainly not have resulted in the loss of a pregnancy more than 1 year later. The jury returned a verdict for the defense.
A Virginia woman with a history of diabetes and renal disease had been treated by a Washington, D.C., physician for previous gynecological conditions, including a high-risk pregnancy. In 1999, at age 46, the woman again went to the physician for removal of a large cyst in her abdomen. During the operation the surgeon thought he might have cut and/or ligated the patient's right ureter, and used indigo carmine dye to assess the ureter's integrity. He concluded, however, that the ureter was not damaged and closed the operative site.
Over the course of the next several days, the woman developed back pain, elevated creatinine level, hematuria, nausea, and fever. Eight days after surgery, the gynecologist brought in a urologist for consultation, who concluded that the patient had a right ureteral obstruction. Four days later, the urologist and a transplant specialist attempted to correct the problem but the ureter was beyond repair and had to be removed, along with the woman's right kidney, which could not be relocated due to extensive swelling, scarring, and adhesions. Several months later, the patient's overall kidney function declined and she was compelled to begin dialysis the following year.
The woman sued her gynecologist, claiming that despite being aware of her postoperative symptoms, the physician failed to investigate their cause in timely fashion and did not request a consultation with a urology specialist to rule out the ureteral damage that subsequently was found to have occurred during the original operation. The woman's experts opined that the physician violated the standard of care by failing to timely and appropriately assess the right ureter and to pursue the need for placement of a catheter or stent. The patient's treating nephrologist opined that she most likely would have been on dialysis in the next few years anyway, but this was accelerated by the ureteral injury. The woman alleged a decrease in life expectancy of 6 to 7 years.
The physician's experts argued that there was no violation of the standard of care intraoperatively or postoperatively. They said that the woman's need for dialysis was caused not by her injury but by lack of aggressive treatment of diabetes with agents such as ace inhibitors for blood pressure control, and by the patient's noncompliance with medical recommendations. Nevertheless, this case settled for $3 million.
A 54-year-old disabled woman complained of a breast lump and was seen by doctors at a local hospital in Florida for a mammogram beginning in May 1997. The woman's grandmother and maternal aunt had developed breast cancer. Her initial mammogram was interpreted as showing two well-defined nodules, one measuring 8 mm and the other 5 mm. The woman's ultrasound was interpreted as showing simple cysts. A 1-year follow-up was recommended.
On September 24 of that year, the woman was again seen by the physician for a complaint that the lump in her left breast was growing and was tender on palpation. No treatment or further tests were done. She was also seen on January 16, April 24, and August 13, 1998 for mammograms, all of which were interpreted as showing no evidence of malignancy. A fine-needle aspiration (FNA) done on one of the masses during the April visit was interpreted as showing a benign lesion. Another FNA done during the August 1998 visit was reported as containing insufficient material for a specific diagnosis, and no follow-up was done at that time.
On November 2, 1998, the woman presented with uncharacteristic thickening of her breasts, retraction, asymmetry, and a palpable mass, which the examining physician concluded measured 6 cm. A biopsy done that day reflected infiltrating ductal adenocarcinoma. On November 12, 1998, the mass was noted to be 10 cm and the woman was diagnosed with Stage III cancer, with 6 of 17 nodes positive. She underwent chemotherapy and a mastectomy, followed by additional chemotherapy. Her subsequent suit against the physicians was settled for $1 million.
In 2000, a California physician on call delivered a full-term female infant with vacuum assistance. The infant's Apgar scores were 9 and she weighed 6 lb, 15 oz. The mother sustained a second-degree perineal laceration that was repaired without incident. When the woman was seen in the physician's office by his nurse 1 week later, she complained of vaginal odor and a feeling that her uterus was "falling out." The nurse examined her and located and removed a 4 x 4 sponge from her vagina without incident. The woman did not have a fever and there was no sign of infection at that time.
The patient sued the physician and hospital, under the theory of res ipsa loquitur, that leaving a foreign object in her body was necessarily negligent. She claimed that the negligence caused her mental and physical injury, that she felt vaginal pressure for approximately 2 months after the sponge was removed, and worried about developing an infection or suffering some other adverse effect.
The physician and hospital moved for summary judgment. The physician contended that the woman suffered absolutely no harm as a result of retention of the sponge for approximately 1 week. The hospital contended that a sponge count by a nurse is not part of the standard of care for a vaginal delivery. The court granted summary judgment in favor of both defendants. Costs to defend the lawsuit were awarded to both the physician and hospital.
In 1999, a 47-year-old woman was referred to a California ob/gyn for workup of an abnormal Pap smear. The physician performed colposcopy of the cervix and an endocervical curettage, but did not note any abnormalities. He recommended a LEEP biopsy, which also was negative for dysplasia or cancer. He then performed a fluid-based Pap test, which revealed that the abnormality found on the prior Pap smear had worsened, from CIN II to CIN III. He recommended another LEEP biopsy, which also did not reveal any abnormal cells or dysplasia. The physician then recommended that the patient undergo a hysterectomy and oophorectomy because in his judgment, the abnormalities must have been further up the endocervical canal and that was why the biopsies were negative. After the woman's uterus and ovaries were removed, however, no evidence of cancer was found. Six months later, she was diagnosed with vaginal cancer.
The woman and her husband sued the ob/gyn, contending that he failed to diagnose vaginal cancer and performed an unnecessary hysterectomy and oophorectomy. Specifically, they contended that the physician failed to perform a colposcopy of the vagina and, in fact, never even looked at the vagina for possible cancer. They contended that he negligently focused only on the cervix, and had he examined the vagina also, the cancer would have been found and treated and the hysterectomy would not have been necessary. Had the cancer been diagnosed in November 1999, when the woman was first referred to the gynecologist, the couple argued, the disease would have been caught in its infancy and the woman's life expectancy would be normal. Her survival rate now is 45% at 5 years.
The physician argued that, based upon the abnormal Pap smear, there was no indication to do a complete colposcopic examination of the vagina. All indications were that the dysplasia came from the endocervical canal and the decision to perform the hysterectomy and oophorectomy was reasonable under the circumstances, so as to prevent the patient's death from cervical cancer. He conceded that, in retrospect, his decisions were in error but did not amount to malpractice. Further, he alleged that even if the cancer had been diagnosed in November 1999, the treatment required would have been the same (radiation) and the woman's life expectancy would be no different. The jury found for the defense.
Many times, the factual information available about the cases presented here is incomplete. Thus it may not always be possible to discuss all of the elements of negligence or nuances involved in a given situation. The outcomes described also may not reflect the current standard of care or the best practice in obstetrics and gynecology. What these cases do represent are the types of clinical situations in the specialty that typically result in litigation and the variation in jury verdicts and awards across the nation. Some of the cases described have merit but many do not.
Dawn Collins. Legally Speaking.
Jan. 1, 2004;49:24-30.