Please click on the titles below to go to the corresponding sample Case Evaluation Reports.
Vaginal Lesion Present Before and After Being Operated on the Wrong Side.
On 6/28 this patient saw Dr. H who noted: “Left labia minora (inside the outer edge of the vagina) with a less than 1 cm (2.54 centimeters = 1 inch) warty looking lesion. The right labia minora appears to be separated in the middle part, probably related to vaginal delivery in the past.”
She was referred to Dr. T who operated at the Hospital H on 8/16. His preoperative diagnosis was: “Right-sided pelvic pain and dyspareunia (pain with intercourse), left labial lesion and cervical polyp.” His postoperative diagnosis was the same except he said right labial lesion. The procedure was: “Diagnostic laparoscopy, excision of left labial lesion and removal of cervical polyp.” But he removed right-sided flesh.
He said: “A 1.5 cm right labial lesion was excised…” The laparoscopy was negative except for “three or four small clear vesicle lesions that may represent mild endometriosis” (implantation of the uterine lining flesh that bleeds with each menstrual cycle, and has a maroon sponge like scar tissue appearance). It was NOT biopsied. This was a revised operative report dictated on 9/26. Where is the original and what did it say? Why did he revise it?
I have not seen his office records and they should be supplied. The patient alleges that Dr. T did not do a preoperative pelvic examination and that failure is negligent, especially when he recommended and performed a laproscopy procedure, which has known risks including bleeding, infection and even death. Was she informed of the risks and the alternatives (a pelvic exam and hormonal therapy)? Why didn’t he biopsy these three or four lesions that did not resemble endometriosis?
Why did he negligently operate on the wrong side and do so without consent (all the hospital records refer to the lesion being on her left side)? Is this assault and battery? Why did the hospital personnel allow that to occur without signed permission (obtain the signed operative consent form)? The Hospital is also liable. Did the Hospital investigate this error? Obtain those documents.
The Pathology report notes minimal nonspecific inflammation. It apparently was at the site of the vaginal opening separation from the birth trauma of her large babies.
On 8/17 Dr. H noted she had pain on the right vaginal area, and “along the left labia the lesion in question was still there and appeared undisturbed.” Dr. H spoke with Dr. T who said: “could not see lesion on left. Saw right labial lesion and removed a ‘1-cm’ area.” So why did he proceed, since it was obviously on the left, before and after the operation? When did he last have his vision checked?
She was referred to Dr. S who saw her on 8/24 and noted all of the above. He noted the obvious lesion on the left and felt that it probably was a cyst and that was consistent with its history of being present since February with initial drainage and partial healing, and recommended just observation. Also, her pain with intercourse was to be treated with pelvic muscle strengthening (Kegel) exercises. Is the right operative site still painful?
In my opinion Dr. T was negligent in his vaginal operation and unnecessary laparoscopy without a proper pelvic exam and conservative therapy. How much was he paid for it all?
Obtain the missing documents. Then I would recommend reviews by Board Certified Experts in Gynecology, and a Nurse with Operating Room experience. The Medical Review Foundation, Inc. have these Board Certified Medical Experts on our consulting staff available assist you.
We await your written instructions to proceed.
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Woman age 32 who has persistent right lower abdominal and pelvic pain undergoes a hysterectomy and right ovary removal. Now has left pelvic (ovarian) pain.
At age 32, after suffering pelvic pain and dyspareunia (pain with intercourse) for 17 years she was hospitalized for severe lower abdominal/pelvic pain, nausea and vomiting, and inability to eat. The pelvic ultrasound (sonograms: x-ray like study using soundwaves) was normal on 9/24 but abnormal on 9/28, consistent with some pelvic bleeding (usually from ovulation) and a thickening and in-growth of the lining of the uterus (adenomyosis: where the uterine lining glands grow into the muscle causing pain and excessive bleeding).
Most of her symptoms were on the right side. The kidney x-rays (IVP) were normal and the gallbladder ultrasound did not show stones. The uterus and left ovary were tender on pelvic examination. Dr. #1 called a General Surgeon, Dr. #2 in for consultation. He noted: "They (the patient and her husband) wish to have a hysterectomy done and we will try to retain at least one ovary."
Ovaries contain eggs, and after they are released they are replaced by cysts (fluid sacs) of various sizes. That is a normal finding. As the egg breaks free from the ovary, there often is some bleeding and pain which is called mittelschmerz.
The hysterectomy and removal of one ovary was medically indicated. She signed a detailed consent form on 9/29 noting: "h. possible pelvis pain due to adhesion, scar tissue or residual ovary."
Because of her age, 32, it is preferred to leave one ovary behind, if it looks normal, than to totally castrate a young woman and try to adjust female hormones in daily oral doses. The risk to leave one behind is the slight risk of ovarian cancer and residual or recurrent pain.
At surgery Dr. #2 ("we") noted bloody fluid in the cul-de-sac (lowermost pelvis, behind the uterus) but said: " It is not obvious which ovary this has come from." The preoperative pelvic examination found tenderness to the left ovary and uterus and: "The right side is not really tender to either pelvic or rectal exam." The appendix was diseased because of adhesions (scarring) and was correctly removed. Dr. #2 removed her uterus and right ovary. The left ovary was left behind. That was a "judgment call." Her persisting preoperative pain was only on the right side.
The pathology report did not find adenomyosis but the hysterectomy was still indicated prospectively on clinical grounds as was removal of the right ovary: a reasonable "judgment call." The right ovary had cysts, which are normal, as would the left side too. Her appendix had "fibrosis" (scar tissue and was abnormal from previous inflammation). It was not acutely inflamed and probably not the cause of her pain, but its removal eliminated another "attack" of appendicitis.
She developed recurrent pain (assumed) and had another ultrasound (sonogram) a few months later that showed a cystic left ovary and pelvic fluid (probably blood). She claims that she was told that the "the wrong ovary was removed." To remove the left ovary is not very difficult by a skilled physician.
The ovary on the side that had all her clinical symptoms was removed. Tenderness on a pelvic examination would be similar to someone squeezing a male's testicles. One side may be more tender, but that alone would not justify removal of both, or the left side if it looked and felt grossly "normal" at surgery.
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Unnecessary hysterectomy and misdiagnosis of pulmonary embolism causing preventable death.
First, I will review the earlier hospital admissions and comment as relevant.
On 7/16/93 she was properly treated for a diagnosis of viral gastroenteritis. Her chest exam revealed that her "lungs are clear".
On 5/5/94 she underwent a colonoscopy exam (examining the inside of her entire large intestine with a lighted flexible telescopic device) and it was normal except for a benign polyp on biopsy. She also had internal hemorrhoids that were inflamed but not bleeding. The blood count revealed her hemoglobin (red blood cell pigment that carrier oxygen) to be 12.9 with the normal range of 12-16. Her hematocrit (percentage of the red blood cells that contain the hemoglobin compared to the total blood volume) was 37.9% with the laboratory normal range of 37 to 47. Women who menstruate often have low normal values and often are treated with iron supplements.
On 5/11/94, seven days after this colonoscopic exam she developed abdominal pain. They were concerned about appendicitis. The pelvic examination by the Emergency Room Doctor, which is usually only a manual exam, was negative. Dr. #1 performed a laparoscopic examination (puncturing the abdomen and inserting a rigid lighted telescopic device) and found a 3.5 centimeter (one inch = 2.54 cm) mass on the mesentary (layer of fatty flesh containing the blood vessels to the intestines). He performed a biopsy that revealed "partially necrotic (dead) fibrofatty tissue". The appendix was normal and there was some possible scarring in her pelvis.
Because of that mass, a follow up operation to remove it was indicated. That operation took place on 5/13/94 at which time he removed that mass which the pathologist confirmed was benign fibrofatty tissue with some internal hemorrhage (bleeding). He correctly removed her normal appearing appendix to eliminate confusion as to the cause of any future abdominal pain. Both operations were done at the same time under general anesthesia without any problems. The oxygenation was normal. She recovered uneventfully from these indicated and properly performed operations.
On 11/17/95 she underwent a left breast biopsy. The mass was benign. The general anesthesia was uneventful with normal blood oxygen content. Her hemoglobin was 13.3 and her hematocrit was 39.1%.
On 2/6/96 she had an upper GI x-ray contrast study that revealed gastro-esophageal reflux (acid regurgitation) from a "sliding esophageal hiatal hernia" (the food pipe-stomach connection was weak with the upper stomach pushing into the entrance way of the lower chest). This was treated conservatively, which is the standard of care.
On 6/5/98 she tripped and fell and landed on both knees. She was 56, and able to walk normally. She also strained her shoulder and received proper symptomatic care. I do not believe that contributed to her death three months later. She did not injure her calf muscles.
Very importantly, she underwent Urodynamic testing on 8/14/98 to evaluate the status of her bladder. The results were normal. There was no incontinence even with the valsalva maneuver in which you hold your breath and strain.
The office records of an unknown doctor begin on 3/3/93. She had no pelvic complaints. She complained about 2 moles on her back. The pelvic exam appears to be normal but I cannot interpret one of the illegible words.
On 4/30/93 the pelvic exam was negative, her last menstrual period was 5/5/93 and she had a pap smear and she was rechecked for the female hormones she had been started on. She also complained of hot flashes and cold sweats. There were no pelvic or urinary complaints.
On 4/18/94 the pelvic exam was normal. She had no pelvic or urinary complaints.
On 4/19/95 the pelvic exam was normal and she had no pelvic or urinary complaints.
Again, all negative on 7/1/96.
On 9/9/97 the pelvic exam revealed no masses. I cannot make out the next few words. But I find no reference to a prolapse of her uterus or urinary symptoms. This was the last office note of that doctor whose name appears on a pap smear report of 4/30/93 as Dr. #2. You need to have Dr. #2 interpret the illegible notes in her office records.
As the uterus enlarges from pregnancy (she delivered vaginally in 1961 (7lb. 8 oz.), 1963 (8lb. 12 oz.) and in 1965 (7lb. 10 oz.), all within normal size, there can be some stretching of the ligaments that hold it in position in the pelvis. These ligaments include the utero-sacral and cardinal ligaments. With excessive stretching the uterus can prolapse (hang downward) into the vagina. There are different degrees of prolapse from minimal, to allowing the uterus to project outside of the vagina. Minimal to moderate prolapse only occasionally has symptoms of pelvic pressure, vaginal fullness and/or pain with intercourse. Some gynecologists put a clamp like device on the uterus and pull on it to assess for prolapse, but this is excessive and not a natural force. Some gynecologists see prolapse when it is only in their eyes and used as a "justification" for a hysterectomy.
If there is real prolapse and if the uterus is not significantly enlarged, then a vaginal hysterectomy operation in relatively easy since it is already "loose", and is less traumatic for the patient.
She saw Dr. #3 for the first time on 7/15/98. Her last menstrual period was "4 years ago". She had no symptoms relating to her pelvis or urine incontinence noted. The pelvic exam noted that the utero-sacral ligaments were "lax". He also notes cystocele and rectocele. His diagnosis is partially illegible but the third word is "prolapse".
With vaginal deliveries, the supporting fibrous flesh for the bladder is stretched resulting in the bladder hanging down into the top surface of the vagina (cystocele). As it hangs down it can pull on the sphincter muscle responsible for holding urine in the bladder. This pull stretches the sphincter temporarily, and urine leakage with coughing or straining may occur.
Rectocele is the stretching of its supportive ligaments and the rectum can project into the upper-posterior surface of the vagina. It can cause constipation.
If a patient has some symptoms of urine incontinence from a cystocele, the Kegel exercises often will help. The patient is instructed to empty a full bladder one-third of the way and stop her urine stream. The same when it is two-thirds empty. This strengthens the pubo-coccygeus muscles and aids the sphincter function. It appears this was not offered to her as an option, and that failure is a departure from the standards of care (negligent).
It appears she first came to the office of Dr. #3 on 7/15/98 and filled out an insurance and medical history questionnaire.
She was next seen on 8/4/98 where the pelvic findings were noted above. That page says she was referred by Dr. #2. Why? Dr. #3 arranged for her to have the urodynamic testing for her bladder and said: "consider TAH-BSO (total abdominal hysterectomy and bilateral salpingo-oophorectomy: removal of the uterus and both fallopian tubes and ovaries)".
On 8/24/98 his typed office note says: "Patient is seen for pelvic and pap smear. The urodynamics study "has been done but not dictated". A discussion was held with this patient as to her hormonal replacement therapy, her stress incontinence, and she has agreed at this point to proceed with a hysterectomy, vessicle (bladder) suspension (to correct the cystocele if it was the cause of urine stress incontinence), and to continue her hormone replacement". How could he intelligently discuss surgery with her without the test results!?
Dr. #4, at Hospital #1 performed the "urodynamic study" on 8/14/98. It was dictated on 8/14 but not typed until 8/29 (why the negligent delay?). Copies were sent to Dr. #3 and Dr. #2. The result of the study was: "Impression: 1. Normal urodynamics". There was only a 5 cc (one-sixth of an ounce) residual urine, which is inconsequential and evidence against any significant sized and symptomatic cystocele. The bladder (muscle) contractions were normal. And: "At no point with valsalva (straining) did the patient leak".
Therefore, the uterus hanging down and possibly pulling on the bladder ligaments, or just stretched bladder ligaments were not the cause any urinary incontinence.
The pap smear Dr. #3 took on 8/4/98 revealed it was benign and it said: "benign cellular changes associated with infection/inflammation". That needed to be treated with intra-vaginal antibiotic creams. Her "leakage" may have only been increased vaginal secretions from this infection. And that irritation may have given her a sense that she had to void.
Dr. #3 also performed an aspiration (suction) biopsy of the hollow lining (endometrium) of her uterus. In a post menopausal patient (of 4 years and with the hormone blood tests confirming that status), it was justified to rule out endometrial cancer, even though she had no post menopausal bleeding. That test, plus the hormone tests were "overkill". However, the result of that endometrial biopsy said: "The specimen is insufficient for endometrial evaluation". Doesn't he read the results of the studies he orders?? Why didn't he repeat it, especially if he intended to remove her uterus since if cancer was found, the operation would be more radical and may be done with or replaced by radiation therapy.
Also, the infected cervix should be treated before any abdominal hysterectomy operation to decrease the risks for infection. He did not do this. Again and again negligent.
His drawing shows the prolapse to be only to the upper fourth of the vagina. Why didn't anyone else find it? Did she have pain with intercourse? Did she have any pelvic discomforts made worse with straining, which would maximize the prolapse?
She signed a consent form for the total abdominal hysterectomy and bilateral salpingo-oophorectomy on 8/24/98. Why did Dr. #3 change the operation to leave out the vessicle (bladder) suspension. Was it because she had no incontinence and that a bladder suspension could not be "justified"? The consent says she was explained the benefits and risks as well as the alternatives. Was she told that the reasonable alternative was to treat her cervicitis (mouth of the womb infection) with antibiotic creams and not to do an unnecessary hysterectomy? Was she told that the endometrial biopsy had insufficient tissue for a diagnosis? Was she told that the urinary dynamics study was normal? Why did she consent to an unnecessary operation that has risks? One of those risks is blood clot formation in leg veins and her vena cava (major vein bring blood from her legs and recently operated pelvic organs) to her heart and those clots can break loose and travel through the heart blood flow path into the pulmonary (lung) arteries (pulmonary embolism) causing her death!
This unnecessary surgery was performed by #3 with the assistance of #5 on 9/1/98. Their description, technically, was correctly describing the TAH, BSO operation. The pathologist described a normal size uterus at 106 grams and normal appearing fallopian tubes and ovaries. There was chronic cervicitis. The endometrial lining in some area(s) projected into the muscle (adenomyosis) but she had no uterine tenderness or bleeding so it was an innocuous finding. Nothing else of any significance was found. The cervix had some metaplastic (benign) changes which usually respond when the chronic infection is treated and if really necessary can be cauterized (burned) or frozen (cryotherapy) to cure it.
In my opinion, there was nothing except financial gain to Dr. #3, and training experience for Dr. #5 (who dictated the operative report and may have done some or all of the surgery under "supervision").
The discharge summary must be an accurate reflection of the hospital stay of the patient. Dr. #5 dictated the 8/28/98-9/3/98 report on 9/10/98 for Dr. #3 who would sign it and it said she "presented on 8/28/98 for hysterectomy, bilateral salpingo-oophorectomy, secondary to dysfunctional uterine bleeding (false), pelvic discomfort (not documented that I can find, and she received no pain medication for such an allegation), and pelvic organ prolapse (in the eyes of Dr. #3. Did Dr. #2 find that too?), with urinary incontinence (again, false)".
She had post-operative anti-thrombophlebitis "venodynes" on to reduce the risk. She developed dyspnea (shortness of breath) and had consultations properly called who ordered a VQ (ventilation/perfusion) lung scan which showed an "intermediate probability for pulmonary embolus". She was properly anti-coagulated with the "blood thinner" Heparin for a few days until the results of the pulmonary angiogram (pulmonary artery x-ray dye study) was completed, which is the "gold standard" and allegedly was negative. It may have been misread and I suggest obtain a good copy for one of our radiology experts to review with relevant documents.
The leg veins of both legs were evaluated to rule out clots with the "venous duplex ultrasound study" and was "negative for deep venous thrombosis". A good copy should be obtained for expert review.
Based on her symptoms resolving and the negative studies on her leg veins and pulmonary angiogram, she was discharged to go home on 9/3. Assuming those studies were correctly interpreted, her post-operative care met the standards of care.
The chest x-rays report of 8/31 showed "prominence of pulmonary vascularity" and a suggestion of fluid in the left chest, also consistent with pulmonary embolism. The "fluid" cleared by the x-ray of 9/2.
By the time the pulmonary angiogram (arteriorgram) was done on 9/2, the clots may have been dissolved and broken up by the body's natural processes of healing.
The pre-operative hemoglobin was 13.1 and the hematocrit was 39.2, evidence against any significant vaginal or intestinal bleeding.
On 9/4 she developed recurrent dyspnea (shortness of breath) and returned to the same hospital. She was under the care of Dr. #6 with additional consultation and care by Dr. #7 In the Emergency Room her arterial blood had a profound decrease in PO2 (pressure of oxygen in the blood) at 55 (normal is 80 to 90) on room air (which is 21% oxygen). This decrease is usually seen with pulmonary embolism.
Prior to surgery she never had any exertional shortness of breath, evidence against any clinically symptomatic pre-existing lung or heart disease. Her lung examination was clear; there was "no wheezing". The chest x-ray on 9/4 was "normal" and usually is normal with pulmonary embolism. Her heart (myocardial thallium adenosine tomography) chemically induced stress test/scan was normal, evidence against any significant heart disease as the cause of her problem.
So why was her PO2 55? That, plus her symptoms, with no wheezing and a negative chest x-ray is "classic" for a pulmonary embolus.
On 9/5 the venous duplex study of her leg veins was negative (obtain a good copy). I want to point out the forrest from the trees. She had pelvic surgery. The ovarian and uterine veins were cut and the cut ends sutured closed. They are blind tubes that contain blood that can clot and those clots can migrate upward into the vena cava, which also can and did clot (seen at her autopsy). The leg studies would be "negative". As time passes, those clots in the vena cava can propagate (clots form on existing clots) downward into the illiac veins (the division of the vena cava) and their extention into the femoral (thigh) veins, which also were found at her autopsy. They also propagate toward the heart and can and did break loose a few times causing negligently misdiagnosed symptoms and then her death on 9/9.
Furthermore, on 9/5 she underwent a heart study (echocardiogram) that uses sound waves to assess the internal structure of the heart. The ejection fraction (heart pumping efficiency) was normal at 60%, evidence against heart failure or disease as a cause of her symptoms. However, it found "moderate pulmonary hypertension" which is exactly what you see with a symptomatic pulmonary embolus (and clear chest x-ray, no wheezing and a low PO2 of 55!)
That study was done by Dr. #6, who along with Dr. #7 were negligent. A copy was sent to Dr. #2, who depending upon her specialty training may also be negligent. Dr. #3 received a copy but may not be expected to know this analysis as an OB/GYN, who was negligent for doing the unnecessary operation which was the proximate cause of her pulmonary embolism and death.
On 9/9 the chest x-ray (obtain a good copy) showed: "the pulmonary vascularity is mildly prominent centrally". That report was sent to "Attending: Dr. #8." who was the second Emergency Room Doctor who was there just prior to her fatal arrest. He was the Emergency Room Doctor who saw her as she was dying and began CPR.
Dr. #2 in my opinion is responsible for a negligent referral to Dr. #3. Did she gain monetarily? Did previous referrals undergo unnecessary operations?
She was discharged home on 9/7. Dr. #6, in his discharge summary dictated on 9/7 (typed on 9/17) noted that in addition to her 9/4 complaint of shortness of breath, "She also complained of chest pain described as a pressure-like sensation that occurred each time she walked. She states when she got up to walk, she noticed shortness of breath, and when she took deep breaths, it hurt. Symptoms were aggravated by movement and activity." He said " on admission, she demonstrated a PO2 of 55".
I cannot fathom why none of them ordered another VQ lung scan (which would have positive) and then if any doubts, another pulmonary angiogram (which certainly would have also been positive) on 9/4. Then they should have begun therapeutic doses of Heparin, the "blood thinner" she was on only for a few days during the previous hospitalization.
On 9/4, Dr. #9 apparently in the Emergency Room spoke with Dr. #7 who wanted to send her home. Then he called the Cardiologist, Dr. #6 who saw her and admitted her for "atypical chest pain". But Dr. #9 obtained a "Family History: DVT (deep Vein Thrombosis) and hypercoagulability (increase in blood clot formation)". This 9/4 history and examination was not dictated until 9/11, after she died. Dr. #9 was negligent in not making that very relevant Family History information available to her Physicians, and they were negligent in not questioning her for this very relevant information for aiding in her diagnosis and treatment. It was also a risk not discussed with her by Dr. #3, so she did not give "informed consent" for another reason.
The EKG of 9/4 also is abnormal and consistent with pulmonary embolism with a negative thallium/adenosine stress test scan.
On 9/4 the hemoglobin was 12.2 and the hematocrit was 35.6, basically unchanged. Stomach and intestinal bleeding is not an issue in this case and the autopsy found no ulcers or intestinal pathology for bleeding.
She returned to the Emergency Room on 9/9 at 21:15 (9:15pm). She had one black stool (yesterday) and 5 episodes of diarrhea. She also was short of breath (SOB) and lightheaded. An intravenous was started at 2155 which raised her blood pressure from 100/56 to 118/68 but her pulse remained elevated at 117. Dr. #10 was treating her. The patient became anxious at 2210 and was on supplemental oxygen. She complained of epigastric (upper abdominal) pain, was seen by Dr. #11 2250 and arrested at 2310. The hemoglobin was 11.4 and the hematocrit was 34.5, unchanged and evidence against any significant bleeding.
They attempted to do the advanced CPR in accordance with the standard of care. Her arrest occurring only two hours after her arrival (2115 until 2310) did not allow them enough time to intervene further. They did all appropriate initial studies and began therapy for her symptoms.
The autopsy confirmed her death was caused by "massive fresh non-adherent pulmonary emboli measuring up to 1/2 inch in cross section and obstructing the main pulmonary artery branches of both lungs". "Transection of the inferior vena cava shows the presence of a 2 1/2 inch long mildly adherent blood clot".
The clots broke loose and entered the heart/lung circuit, causing its obstruction and her preventable death.
She should have been diagnosed on 9/4 and received Heparin, anticoagulation at the therapeutic levels for days to a week or more until the clots were cleared and then started on the pill anti-coagulant coumadin (warfarin) for 6 months or longer. She would not have died, to a reasonable degree of medical certainty, and lived a normal and healthy life.
All of the treating physicians noted above, for those specific reasons stated, were negligent and caused her death.
Furthermore there appears to be liability of the hospital for its trainee Dr. #5's negligence in assisting an unnecessary operation and misrepresenting the facts in the discharge summary. In addition, the hospital was negligent for allowing Dr. #3 to perform this unnecessary operation on its premises. Determine what, if any contractual arrangement or monetary considerations each of these physicians have with Hospital #1. They are also liable for Dr. #9's failure to disclose the relevant clotting history and the delays in typing relevant records for the use of physicians for her benefit. If there is a separate Emergency Room corporation that hired Dr. #9 or supervised him, then that corporation should also be a defendant.
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I would suggest that you authorize us to obtain the services of Experts in Gynecology, Pulmonary Diseases, Cardiology, Radiology and Emergency Room Medicine. They all are available through our firm.
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Delayed diagnosis of ovarian cancer.
According to the records, the patient was admitted to Hospital #1 from April 10 through April 11, because of unstable angina. The patient had had previous angioplasty operations, had an elevated cholesterol, and at age 52 had repetitive episodes of chest pain radiating to the left arm and then developing pain in the chest. This hospitalization was appropriate to rule out a heart attack. The abdomen examination was "benign," and it would be contraindicated and inappropriate to perform a pelvic examination during that hospitalization. Her care appears to have been appropriate at that time.
The next hospitalization was exactly one year later, from April 10 through April 11. She was transferred to Hospital #1 from the Emergency Room of Hospital #2, with pneumonia involving the lower lobes of both lungs. She also had some diffuse abdominal pain, but had not had a bowel movement in a few days. The abdomen was slightly distended and diffusely tender, more in the upper abdomen. She responded to intravenous antibiotics, enemas and was sent back to the family practice clinic to see Dr. #1.
Since the patient had pneumonia documented by x-rays, had received intravenous antibiotics for her documented pneumonia, plus considering the fact that the patient did develop bowel movements following enemas and the rectal exam was negative with no blood in the stool, that could be considered reasonable care. However, there was no pelvic examination performed. Depending upon the amount of discomfort the patient had in the lower abdomen, it would have been appropriate to perform a pelvic examination.
Before discharge, they were considering getting an abdominal ultrasound as an outpatient. That was after the abdominal pain had decreased, on April 11, when she was discharged to the clinic.
Five weeks later, she was re-hospitalized, and they noted that her abdominal pain had been present for about three weeks and had become increasingly more severe. During this admission, the abdomen was diffusely tender in its lower half, and they noted a mass to palpation (by feeling) in the left lower quadrant of the abdomen. A CAT scan was obtained which revealed a thickening of the omentum, which is the large fat pad that hangs down from the stomach and large intestine. Because of this mass and the abnormality on the CAT scan, operative intervention was indicated.
Surgery was performed by Dr. #2 on May 22. The patient had previously had a hysterectomy operation and had had her appendix and gallbladder removed. There were adhesions in the abdomen (scar tissue), and they noted "the mass was the omentum which was very caked and firm to palpation. This was adherent not only to the abdominal wall, but to the sigmoid colon and superior rectum." A biopsy revealed that to be metastatic adenocarcinoma (spreading cancer). Dr. #2 noted "the patient's ovaries were still in place. The right ovary was somewhat larger than the left."
He removed her ovaries, the omentum, as much tumor as possible, and a segment of the large intestine. This was a "debulking" operation to remove as much cancer as possible so that the patient would have a better opportunity for any response with subsequent chemotherapy.
The Pathologist confirmed the vast amount of adenocarcinoma removed, and that was consistent with a primary cancer involving the ovary. The left ovary was normal in size, measuring 3 x 2.5 x 2 centimeters (1 inch = 2.54 centimeters). There were three segments removed on the right side, one of which most likely was a fallopian tube, according to the pathologist. The largest segment removed measured 4.2 x 1.7 x 1.5 centimeters. This is only slightly enlarged.
There was no large ovarian tumor that subsequently spread by bursting through the capsule, with the cancer cells implanting throughout the abdomen. This appears to have been a tumor that began on the surface of the right ovary and spread very quickly into the abdominal cavity.
Therefore, even if a pelvic exam would have been performed earlier in time on this 130-lb. patient, most likely there would not have been any mass to discern by pelvic examination. The ovary was not even two times its normal size. The omentum does not hang down in the pelvis, and generally that would not be felt by a routine pelvic examination. Only when the tumor mass began to grow dramatically in size, after it had spread, was an abdominal mass discernible during this hospitalization. In my opinion, that cancer had already spread from the ovary many months before in time and began to grow slowly over time. As the cancer grows, and as the cells duplicate, there is an exponential growth in the size with each doubling of the tumor subpopulation.
They also noted that her abdominal pain was approximately three weeks in duration, and getting worse prior to the admission. However, in retrospect, it was probably about five or six weeks considering the previous hospitalization in April of the same year.
On July 30, she was hospitalized for the insertion of a Port-A-Catheter for chemotherapy. The patient received chemotherapy and had a remarkable response. The cancer marker, CA 125, dropped from the elevation of over 300 down to approximately 35.
The patient had some abdominal discomfort and was hospitalized on May 29, with partial small bowel obstruction, and she responded to stomach suctioning and intravenous fluids. That was proper care.
She was hospitalized in August with some abdominal discomfort. An ultrasound revealed some thickening of the descending colon (large intestine), and a CAT scan also showed what appeared to be enlarged lymph nodes and a mass deep within the pelvis. Because of that, exploratory surgery was performed on April 26, by Dr. #2. After dissecting through extensive adhesions involving the intestines, he found no residual cancer. The mass in the pelvis, adjacent to the rectum, was a collection of fluid entrapped by the intestines. There was no evidence of recurrent cancer at that time. That was consistent with the diminishment of the cancer antigen described above.
On September 20, she had a CAT scan of the abdomen and pelvis, and that did not find any recurrent cancer (mass).
In the office records of the Family Practice Clinic, beginning two years earlier, all the office visits related to her cardiac condition, her anticoagulation, and the past history of thrombophlebitis (clots in the leg veins). Unless she was seen for full gynecological care, it appears that she was only seen for chest pain. However, a family practice clinic should take care of the entire patient. In my opinion, it is a departure from the accepted standards of care, in a patient age 53, not to perform at least an annual pelvic examination. However, as I described above, even if that would have been done, it most likely would have been negative. I say this because, as I mentioned, at surgery the right ovary was only slightly enlarged. Therefore, earlier in time, it would not have been enlarged at all. On pelvic examination, where one hand is placed deep into the vagina and the other on the anterior abdominal wall, unless there were a significant enlargement, a slight enlargement would not be detectable. The failure to detect such a small enlargement would not be a departure from the accepted standards of care.
So, even though, in my opinion, they departed from the standards of care in not doing a pelvic examination, with a high level of medical certainty, it would have been negative.
On November 18, six months before surgery, her weight was stable at 129 lb., as it had been for a long period of time; there was some tenderness in the right lower quadrant of the abdomen; the abdomen was not distended; and there were good bowel sounds. In my opinion, because of localized pain, Dr. #1 should have performed a pelvic examination on November 18, 1995. Even at that point, with cancer having most likely spread to the omentum, I do not believe that she would have felt a mass. The omentum is high up in the abdomen, and the ovaries, as I mentioned, would not have felt enlarged.
When she saw Dr. #1 on April 19, there was tenderness over the right half of the abdomen and some guarding (muscular rigidity) secondary to internal pathology. The x-rays showed a distended colon and possible small bowel obstruction, and she was sent over to the Emergency Room for further evaluation. The patient responded to conservative care and within a month was diagnosed as having diffuse metastatic ovarian cancer. It was only in the middle of May when the abdominal mass was detectable by one of the physicians. In the initial evaluation during that admission to the emergency room, they did not detect any abdominal mass.
In October, she was hospitalized for anemia and depression of her platelet count, which are the clotting particles produced by the bone marrow. Most likely, this was secondary to the chemotherapy, and she received blood transfusions and proper medical attention.
Although some Physicians would have obtained an ultrasound in April, and that may have shown some enlargement of the right ovary and possibly would have shown a mass developing in the greater omentum, in my opinion that is a judgement call. Even if it would have been done and if she would have had surgery a month earlier in time, I do not believe it would have made any significant difference to the outcome. When they did the "debulking" operation, there was still studding of tumor in her abdomen, and that would have been present earlier in time. They removed as much tumor as possible, and basically left her at the same stage as if the operation would have been performed four weeks earlier.
In brief summary, this patient had ovarian cancer, but most likely it spread from a tumor on the surface of the right ovary, rather than being a large tumor that eventually burst through its containing outer membrane. This cancer spread into the abdomen, and as it grew over time, gave the patient symptoms and was eventually detected as an abdominal mass. That is, the cancer that had spread to the omentum had grown into such a large size that it was detectable by the abdominal examination. She underwent major surgery that was indicated, and apparently had a remarkable response to the chemotherapy.
Based upon my review of all the above, although there were some discrepancies which I would call departures from the accepted standards of care, I do not believe that they made any significant difference to the final outcome of the case, for all the reasons stated above.
As I reviewed the records I placed paper clips on the more relevant pages and highlighted the most significant facts. I believe this will assist you in understanding the problems associated with this complex case. The records will be returned to you under separate cover.
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Attempted laparoscopic tubal ligation with puncture of aorta (main artery in the abdomen).
An outpatient entry dated September 24 from a Hospital #1 Gynecologist (signature is illegible) documented that the patient had requested tubal ligation as a means of sterilization. Risks and benefits of this procedure were allegedly given to her, although the details of this discussion are unavailable.
On November 12 she was 35 years old when she was admitted to Hospital #1 for a laparoscopic tubal ligation by Dr. #1. Three separate attempts were made by Dr. #1 to insufflate the abdomen with carbon dioxide. All three attempts were unsuccessful. The first two attempts failed due elevated intra-abdominal pressures (above 14mm). The third attempt at placement of the Verres needle was complicated by puncture of the aorta, an uncommon therapeutic misadventure that further suggests inexperience with this procedure.
It is my opinion that three failed attempts at abdominal laparoscopic insufflation with resultant perforation of the aorta represents deviations from existing standards of care. The Verres needle and the trochar (sharp introducer) of the laparascope needs to be pointed toward her sacrum (tailbone), which would avoid hitting the aorta.
Puncture of the aorta, the primary arterial conduit in the body, could well have proved fatal in this case. Instead, an additional extensive surgical procedure with considerable scarring and a more protracted recuperation period was required to stabilize the peri-aortic hematoma and to successfully complete the tubal ligation procedure.
It would be very important to learn if the risk of bleeding and aortic perforation were explained to her on September 24 or on any other pre-operative date. It is also important to realize that three failed attempts at abdominal insufflation with an aortic perforation as a peri-operative complication is, more likely than not, an example of surgical negligence.
In this specific case, Expert opinions in the areas of Gynecology and General Surgery should be strongly considered. Also discovery or similar means may be useful to elucidate the full scope of Informed Consent that was given to this patient by Dr. #1.
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Partial hystercectomy and laparoscopy, hemorrhage, acute respiratory distress syndrome (ARDS), blood transfusion reaction and infection.
The patient was a 34-year-old white female on June 30, when she was referred by Dr. #1 to Dr. #2 for abnormal Pap smears which included abnormal cervical biopsies, and allegedly had shown cancer in situ of the cervix.
On July 28, the patient was admitted to Hospital #1 for a laparoscopy and a partial hysterectomy to address the issue of her cancer in situ of the cervix. It appears that the patient signed the consent form for this procedure on July 23rd, although this may be an error as it appears more likely that the actual date should have been July 28. The consent form clearly delineated the possibility that hemorrhage, infection and other risks of this procedure could result from this cervical procedure.
On July 28, the patient underwent the surgical procedure, as mentioned, which was complicated by an apparent laceration of a superficial inferior epigastric blood vessel (in the abdominal muscles). This is from a "blind" puncture during the insertion of the laparoscope. An 800-cc blood loss was estimated by Dr. #2 during the operation. The patient's blood count, called a hematocrit, declined precipitously on July 29th, and in fact her hematocrit fell to 17.9, one-half normal: severe anemia. The patient developed a fever to 102.3 at that time. Around midnight on that date, the patient experienced the onset of an acute respiratory disturbance known ARDS (adult respiratory distress syndrome) during the course of a blood transfusion. The patient additionally alleges in her diary that a "code" was called and that the patient could hear the entire disaster team all around her. The end result of this hemorrhagic crisis was that the patient was in the Intensive Care Unit for approximately five da ys. The patient was extremely ill during this time, requiring sedatives, and she experienced multisystem organ involvement, which is not uncommon during the course of such transfusion reactions or in its aftermath.
The patient, on July 30th, was seen by a Dr. #3 and also a Dr. #4, whose name is mentioned on that consultation sheet. A transfusion reaction was diagnosed, and appropriate measures, such as her cessation of the transfusion followed by a leukopenic filter, were instituted. Also corticosteroid therapy was appropriately begun. It should be mentioned that at this time the patient had tachycardia as well as tachypnea and had an oxygen saturation that fell well below 50%. The patient was finally discharged from the hospital on August 2nd in stable condition.
During her outpatient visits with Dr. #2, the patient was found to be stable on the first postoperative visit and underwent staple removal. After the patient's second postoperative visit on August 18th, the nothing untoward was found by Dr. #2, but the very next day the patient developed severe stomach pain, chills and fever to 102 degrees, and was readmitted on August 19th to Hospital #1 with abdominal distension and tenderness. Antibiotics were appropriately begun. A CAT scan performed and subsequently repeated revealed two densities or collections of fluid, one around the spleen and the other around the left adnexa (ovary area). Surgery was appropriately consulted. However, given the patient's slow improvement on her medications and the absence of drainage, it was elected not to invasively intervene but to continue the patient's antibiotic therapy.
On August 24th, the patient had the onset of severe diarrhea, which was thought to be antibiotic-associated, and indeed her antibiotic therapy was discontinued. The patient was discharged home on August 25th. Prior to her being discharged, she developed an intravenous site associated cellulitis which was treated with amoxicillin-clavulanate without further complications being noted.
The patient, due to her severe diarrhea, was seen by Dr. #5 on September 1 who concurred with the diagnosis of a probable antibiotic-associated colitis and subjected the patient to a sigmoidoscopy, which was otherwise negative.
On September 8th, the patient was seen by Dr. #2 for another office visit. She was cleared to go back to work on September 11.
It would appear that this unfortunate patient fell victim to numerous adverse outcomes. However, these adverse outcomes, by no means, by themselves represent medical negligence or malpractice. For example, it is very unfortunate that she suffered severe hemorrhagic complications from her hysterectomy surgery, and indeed this is a noted and expected complication in a minority of patients, and she was informed of this risk and accepted it. It does not appear that the physician could have known that this blood loss would occur, nor did it appear that he was liable for negligent hemostasis technique. However, it should be noted that the patient's consent was for a video pelviscopy, and indeed it is very possible that a copy of this video exists to determine that proper surgical standards of hemostasis were employed throughout the procedure.
It should also be mentioned that a transfusion was indeed indicated during the patient's rapid fall in her hematocrit and the occurrence of transfusion-associated reactions, although uncommon, are a well recognized risk. Unfortunately, the patient sustained a very serious variant of this transfusion-reaction syndrome. Although her complications, including adult respiratory distress syndrome, tachycardia and several other complications were unfortunate outcomes of this hemorrhage with its associated need for transfusion, again, these adverse outcomes do not indicate medical negligence per se.
Similarly, from the available records, it is clear that Dr. #2's office visits with this patient on August 18 show no evidence of an intra-abdominal process (infection: abscess). There would have been no deviation in the standard of care in the way this patient was evaluated on August 18th. However, for reasons that are often unclear, the very next day, an acute abdominal process is very well documented, but there is no way to retrospectively hold Dr. #2 liable for the results of the office examination on August 18.
Indeed, once the patient was admitted to the hospital, her medical management was again quite appropriate, as it had been on July 28, and included appropriate use of antibiotics, serial CAT scans and nonoperative intervention.
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