Legally Speaking--Failure to perform vulvar biopsy delays diagnosis of cancer

April 1, 2014

Was there an unreasonable delay in making the diagnosis, and did that delay have an effect on the patient’s treatment and overall life expectancy?

 

MS. COLLINS is an attorney specializing in medical malpractice in Long Beach, California. She welcomes feedback on this column via e-mail to dawncfree@gmail.com.

 

 

 

Facts

A Pennsylvania woman saw her gynecologist in 2008 for vulvar erythema with excoriation of the labia and clitoral hood. She was prescribed an ointment and advised that she would need a biopsy if the condition did not improve. She was also referred to a vulvar clinic, where she began treatment 1 month later with a nurse, who diagnosed recurrent vulvovaginal candidiasis. The patient’s treatment at the clinic continued for 2 more years and included several wet prep tests, gram stains, and fungal cultures, and use of various medications, including antibiotics, topical treatments, and washes. She was seen once by a physician during this time.

In mid 2010, the woman complained of increasing pain and underwent a biopsy, which diagnosed invasive vulvar Paget’s disease. A modified radical vulvectomy with removal of the pelvic lymph nodes was performed. The patient then underwent an operative laparoscopy, pelvic lymph node dissection, and removal of the right fallopian tube and ovary. Chemotherapy was begun, but the cancer had metastasized to the liver. In early 2011 the patient was diagnosed with a cervical compression fracture that was attributed to metastasis to the bones. She died a year later.

A lawsuit was filed against the medical center running the vulvar clinic, claiming the nurse failed to properly treat the condition in failing to perform a biopsy and timely diagnose the cancer.

The verdict

A $2.4 million settlement was reached.

Delay in diagnosis of breast cancer

Facts

A Louisiana woman found a lump in her left breast in 1996 and saw her gynecologist for her annual exam that same month. She reported the lump to the doctor and he told her it was consistent with fibrocystic changes and to not worry about it. No further testing was ordered. Three months later the patient returned, still complaining of the palpable lump. She demanded a mammogram, which the gynecologist ordered but was not performed for a month due to delays with the patient’s health insurance coverage. The results of the mammogram were inconclusive and further evaluation was recommended if the palpable lump persisted.

At the time, the patient’s insurance company no longer covered care with the gynecologist, so the woman went to her primary care physician (PCP) early the following month. He examined her, noted a hard lump in the left breast and immediately ordered an ultrasound (U/S), which was performed a few days later. The U/S reported a probable infiltrating ductal carcinoma. In the next few weeks the patient saw 4 surgeons and underwent several needle biopsies, all of which were inconclusive. One of the surgeons performed a lumpectomy, which confirmed the diagnosis of ductal carcinoma. A radical mastectomy was performed the next day, followed by 6 months of chemotherapy. The patient is free of cancer.

The patient sued the original gynecologist, claiming that he was negligent in failing to order further evaluation of the lump at her first visit. She claimed that the 6-month delay in diagnosis necessitated the radical mastectomy and chemotherapy course.

The physician alleged that the patient told him originally that the lump seemed to get bigger and smaller each month and hurt at times, and he claimed that his examination and this information were consistent with fibrocystic changes and she was to follow up in 6 months. He also argued that he continued to order further tests and referrals to surgeons, even when the patient’s insurance carrier required she be followed by her PCP. The defense further argued that the patient’s treatment would have been the same even if the diagnosis had been made 6 months earlier.

The verdict

A defense verdict was returned.

 

NEXT: AN ANALYSIS OF THESE CASES >>

 

Analysis

Malpractice cases involving the claim of negligence in delayed diagnosis of cancer usually involve 2 main issues: Was there an unreasonable delay in making the diagnosis that fell below the standard of care, and did that delay have an effect on the patient’s treatment and overall life expectancy, causing damage to the patient? Both of the elements in these types of cases must be established to prove there was negligence and return a verdict for the plaintiff.

The effect any delay might have had on the patient’s course and cure is usually debated between the physician expert witnesses for each side. Then the jury decides which one they believe. In the first case above, the jury found that a 2-year delay with no biopsy while treating the patient for her symptoms was below the standard and caused her death. In the second case, the jury most likely found that even if there was a 6-month delay in diagnosing the breast cancer, it did not alter the patient’s treatment or long-term life expectancy.

Laparoscopic removal of complex pelvic mass

Facts

A 44-year-old postmenopausal Virginia woman was referred to a gynecologist in 2009 with a complaint of right-sided pelvic pain. An ultrasound (U/S) revealed a 12-cm complex mass in the area of the right ovary with mild free fluid, suggestive of bleeding. The differential diagnosis included both benign hemorrhagic cyst and a malignancy. The gynecologist ordered a CA-125 test, which was reported as normal. The patient was also referred to a gynecologic oncologist and a computed tomography (CT) scan was ordered.

Three days after seeing her physician and prior to the appointment with the oncologist, the patient suffered an acute episode of increased pain. She was instructed by her gynecologist to go to the hospital. Her lab results revealed a low hemoglobin level and hematocrit, possibly suggesting bleeding from a rupture of the mass. The physician performed laparoscopic surgery that evening and finding blood in the pelvis and numerous adhesions but no evidence of malignancy, he punctured the mass to drain it and removed it laparoscopically. He performed a hysterectomy and removed the other ovary as well. Pathology revealed the right ovarian mass to be cancerous and a 2-cm lesion in the left ovary to be cancerous as well. The cancer was of a non-aggressive type and grade. About 2 ½ weeks later the patient underwent surgery by a gynecologic oncologist that revealed pathologic evidence of cancer in 4 other locations.

The woman sued the gynecologist and alleged negligence in failing to arrange that she see a gynecologic oncologist immediately and claiming that he should have involved a gynecologic oncologist in the surgery and should have used an open procedure. She additionally alleged negligence in puncturing the mass to drain it and removing it laparoscopically, claiming that these actions allowed the cancer to spread during the time between the 2 operations, changing the cancer from Stage I to an incurable Stage IV.

The physician claimed that the type of surgery was appropriate in the face of what he believed to be potentially life-threatening bleeding and that the ovarian mass had already ruptured and spilled its contents, as evidenced by the preoperative pain and preoperative fluid seen on U/S. He also claimed there was no evidence of a malignancy prior to the surgery, particularly in light of the normal CA-125 test. The physician also maintained that the patient’s cancer could not have metastasized in the 17 days between operations.

The verdict

A defense verdict was returned.

MORE CASES >>

 

Alleged mismanagement of decreased fetal movement

Facts

A 30-year-old pregnant woman went to a New York hospital at 38 weeks’ gestation in 2008. She reported decreased fetal movement and was seen by a certified nurse-midwife, who performed a non-stress test (NST) for 1 hour and 20 minutes. The test was read by the nurse-midwife as reactive and the patient was sent home with instructions to return in 1 week. The patient returned to the hospital 3 days later in labor. Fetal demise was diagnosed at admission and the woman subsequently delivered a stillborn infant.

The patient sued the nurse-midwife, claiming she suffered emotional distress as a result of having a stillbirth. She alleged negligence on the part of the nurse-midwife in failing to recognize the fetal heart rate (FHR) NST was nonreactive, and failing to discuss the test with a physician. She claimed that a correct reading of a nonreactive FHR would have led to her admission and/or further testing and prevented the demise.

The nurse-midwife contended the FHR test was reactive and the patient was properly managed and sent home, and that whatever caused the demise happened in the subsequent days.

The verdict

A $400,000 verdict was returned for the woman.

 

Claim of failure to perform cesarean delivery results in CP

Facts

A pregnant woman at 41 weeks’ gestation underwent a fetal heart rate (FHR) non-stress test and amniotic fluid volume test at a California medical center. The results were read as normal and she was sent home. She returned to the hospital 3 days later in early labor. She was admitted and 3 hours later had an epidural placed. The FHR showed some late decelerations; about 2 hours later, there was a prolonged deceleration of the FHR, which then returned to normal baseline. About 30 minutes later the patient signed a consent for a cesarean delivery and she was moved to the operating room (OR). Her membranes were ruptured and showed clear fluid. The high-risk obstetrician then decided that a cesarean was not needed and started oxytocin, but the patient was kept in the OR.

More than 2 hours later a new obstetrician took over the woman’s care and was informed that the patient was adamant against a cesarean if at all possible. The patient’s labor progressed and the FHR exhibited variable decelerations and some decreased variability, and a vaginal delivery occurred about 3 hours later. The infant had Apgars of 2, 4, and 6, and a cord blood gas pH was 7.21. The child received a diagnosis of hypoxic brain injury and was subsequently diagnosed with cerebral palsy.

A lawsuit was filed and claimed negligence in failing to deliver the infant by cesarean section.

The hospital and physicians claimed that a cesarean was not required after the patient was moved to the OR and as she desired to attempt a vaginal delivery, she was allowed to continue to labor. She remained in the OR and had consented to a cesarean in case an emergent situation arose and a cesarean was deemed necessary by the obstetrician.

The verdict

After negotiation by both parties a $9 million settlement was reached.

MORE CASES >>

 

 

Colon perforations found after hysterectomy

Facts

In 2008 a gynecologist performed a hysterectomy on a 47-year-old New York woman. The physician removed extensive adhesions and scars related to previous procedures, then removed a large cyst from the left ovary before performing the hysterectomy. Two days later the patient developed nausea and vomiting. After 3 more days she returned to the hospital, where doctors discovered an abscess of the colon, 2 colon perforations, leakage of fecal matter, and infection. The patient underwent resection of the damaged areas of her colon and required a colostomy.

The patient sued those involved with the original operations, alleging that negligence in performing the hysterectomy was the cause of the colon injuries. She alleged that the procedures done prior to the hysterectomy should have been performed by a general surgeon, who would have immediately recognized any colon injury and repaired it in a more timely manner.

The gynecologist claimed there was no need for a general surgeon and that the patient’s colon had been thoroughly inspected. He contended that the colon perforations were a delayed result of a subtle thermal injury and would not have been easily noticed during the operation.

The verdict

A defense verdict was returned.

 

Death after postpartum hemorrhage

Facts

A Kentucky woman was 23 years old when she delivered her second child in 2008. She had a term vaginal birth of a normal female infant delivered by an obstetrician. The patient had excessive vaginal bleeding after delivery. The physician suspected uterine atony and prescribed medication. Over the 90 minutes, the woman continued to have heavy bleeding. The physician evaluated the patient again. For the next 2 hours the patient’s condition worsened, and included drops in her heart rate and blood pressure. The doctor was not informed of these changes until the patient coded. The woman was resuscitated but never regained consciousness. The next morning, surgery revealed an inverted uterus. The uterus was repaired, but the woman died the next day.

In the lawsuit that was filed on her behalf it was alleged that those involved with her care did not properly manage the patient’s deteriorating condition. The lawsuit further alleged that the physician failed to recognize and appropriately treat the hypovolemic shock and to aggressively replace blood loss, which caused the cardiac arrest and eventual death.

The claims against the hospital were settled prior to trial for a confidential amount, leaving the matter to go to trial against the obstetrician only.

The physician claimed that the patient had appropriate monitoring and treatment while the obstetrician was in attendance, and prescribed medication for uterine atony. She argued that she had relied on the nurses to advise her of any change in condition needing further evaluation and treatment, and that she was not informed of any changes. The defense’s theory was that the patient suffered some catastrophic thromboembolic event that caused the sudden arrest. This theory was put forth based on the fact that the patient had voided just prior to the code, which they claimed would not have occurred if she was in hypovolemic shock to the point of cardiac arrest.

The verdict

The jury found both the hospital and the obstetrician equally at fault and awarded a total of $4,739,587. The parties are in negotiations for a post-trial settlement.

Claim that unnecessary hysterectomy led to complications

Facts

A Michigan woman underwent a hysterectomy. Pathology revealed a uterine polyp. After the operation the patient developed a vesicovaginal fistula, which required 2 operations, including a cystoscopy with bilateral stent placement and an open abdominal procedure for repair with reimplantation of the left ureter.

The woman sued the gynecologist who performed the hysterectomy and claimed that the physician should have performed either a dilatation and curettage (D&C) or a hysteroscopy, which would have revealed a bleeding polyp that could have been treated without performing the hysterectomy.

The doctor argued that the woman had undergone years of conservative treatment for continuing complaints of pain and bleeding, including 2 D&C procedures with an additional fibroid embolization without a cessation of symptoms. Further, he claimed that while a polypectomy might have relieved the bleeding from the polyp, it would not have ended the patient’s pain.

The verdict

A defense verdict was returned.

 

 

Placenta accreta results in death after cesarean delivery

Facts

A 33-year-old Illinois woman was diagnosed with placenta previa during her pregnancy in 2007. At approximately 32 weeks’ gestation, an ultrasound (U/S) was performed by a radiologist. Two months later the woman was hospitalized for a scheduled cesarean delivery. No preoperative imaging was done and during the operation the obstetrician noticed a 3- to 4-inch lesion where the placenta had infiltrated through the uterine wall. When the placenta was removed the patient began hemorrhaging and an emergency hysterectomy was performed without summoning any additional surgeons and without administering any blood or blood products. The patient developed life-threatening bleeding/clotting problems, which led to gangrene developing in her extremities. She died 5 days after the delivery.

A lawsuit was filed against those involved with the patient’s care. The claim against the radiologist was that he was negligent in failing to recognize and/or report the presence of the placenta accreta during the U/S examination performed at 32 weeks’ gestation. Negligence was alleged against the obstetrician in failing to obtain any further imaging studies to assess the placenta prior to delivery, and for failing to stop the procedure when he noticed placental tissue had invaded through the uterine wall and call for more surgeons and order blood products before attempting to remove the placenta. It was further alleged that both the obstetrician and the hospital were negligent in failing to summon help, back up surgeons, and appropriate blood product replacement, which ultimately resulted in severe hemorrhaging and the resultant gangrene and the woman’s death.

The verdict

The jury found both the physicians and hospital were liable and returned a verdict of $15.5 million.