Sample Case Evaluation Reports - Nephrology Expert Witness

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Diabetic with Kidney Failure and Infected A-V Graft Fistula for Dialysis Has It Removed Four Days Later; Develops Sepsis and Knee Infection.

When patients have kidney failure, hemodialysis is required to remove the toxins (poisons) from the blood that their failed kidneys no longer can remove.  The test to measure the quantitative amount of kidney function is the creatinine clearance.  Under 15 cc (cubic centimeters) of blood cleansed per minute requires dialysis.  Over 20 usually can do without dialysis if they strictly follow a special low protein and low potassium diet.  Her creatinine clearance was 21 and she was noncompliant with her medications and diet.

Therefore, in this visually impaired chronic diabetic patient, the insertion of an arterial-venous (A-V) graft on 6/14 to make a fistula (high blood flow circuit) into which needles can be inserted for the few hours dialysis was indicated.  Through one needle blood is withdrawn and sent to the dialysis machine, and the blood is returned to her body through the second needle.

With each puncture, there is a risk of infection, even though the skin was “sterilized” with Betadine.  Germs can still persist in sweat glands and be pushed deeper, into the A-V graft.  Diabetics are at much greater risk for infection, and she received steroids during her 7/15 to 7/24 hospitalization for a painful gout problem with her foot that did not respond to other medical therapy.  Steroids further increase that risk, but its use was acceptable.

She had dialysis on 7/20 and 7/24 without any complications.  Her temperature during that entire JH Hospital stay was normal and she had no complaints re: the A-V site.  Therefore, she did not get the infection at the 6/14 graft operation (whose records I have not seen).  Most likely she became infected from the 7/24 dialysis procedure even though: “site prepped per protocol.”  And she signed the consent which specified many risks, including infection.  Prophylactic (preventive) antibiotics are not indicated for dialysis.

She arrived in the Emergency Room on 7/26 at 1125 a.m. with an obvious infection of her right arm A-V graft, and signs of sepsis (germs in her bloodstream) confirmed as Staphylocus aureus in her blood and arm site.  She had fevers over 103 degrees.

The standard of care is emergency surgery to remove that A-V graft, and intravenous antibiotics.  That surgery did not take place until the dialysis treatment of 7/30 was done, and the operation took place that evening by Dr. Mark.  All that time (four days) she was febrile through 8 a.m. on 7/29 when she spiked her temperature to 102.8 degrees.

In my opinion the delay to remove the obviously infected graft until 7/30 was negligent as was the decision to use it for dialysis on 7/30.  When she needed dialysis afterward, a temporary large needle catheter was inserted through her femoral (groin) vein.  It could have been done earlier instead of using an obviously infected A-V fistula site that was causing sepsis.

She had a left knee replacement operation 15 years earlier.  They are always at risk of sepsis, where germs can “seed out” at that foreign body site.  On admission, her left knee range of motion was good and she had no pain or swelling there.  But at 2130 (9:30 p.m.) on 7/26: “voiced complaint of (c/o) left lower leg pain in calf just below knee.  No redness, swelling or increased warmth noted.

On 7/27 at 0700: “unable to lift left leg.” 

On 7/28 at 1045:  “complains of left knee pain,” and at 1130: “The pain meds never fully relieves my pain.”

On 7/29 0750: “Slow to move s/p (status post) left total knee replacement.”  But that was a new finding, not present on 7/26.

On 7/30 1110 “Complains of left knee pain.”  At 1455 she was sent to the operating room to have the infected A-V graft finally removed.

On 7/31 “c/o pain to left knee area.”

On 8/1 one ounce (30 c.c.) of pus was removed with a needle and syringe from that knee by Dr. Frank.  The laboratory gram stain found no bacterial germs but many WBC (white blood cells).  And the culture of that fluid for germs after three days had no growth.  He concluded that it was infected on 8/1, but her temperature remained normal from 7/30 – 8/9 when she was transferred to FT Hospital.  With no germs seen on the gram stain and none growing out, it seems that the antibiotics may have “sterilized” that site.  I have not seen any FT Hospital records to know if she had to have that knee joint prosthesis removed because of infection.  That would be the only damages caused by their negligent delay in removing the obvious (on 7/26) infected A-V graft site.

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The Defense would contend that on admission she had sepsis, and then received potent antibiotics (Vancomycin) to which that germ was sensitive, so the greatest chance of live germs to enter the knee joint took place prior to that re-hospitalization.  And in support of that position, they would refer to the Nurse’s notes I quoted above from as early as the night of 7/26. 

Therefore, because of her creatinine clearance of 21 and her noncompliance, dialysis was indicated.  Unfortunately (and NOT negligently, unless you can show breach of sterile technique: perhaps obtaining the personnel records of the involved Nurses and technicians from 7/24 and also 7/20, I cannot read their signatures) it became infected.  The sepsis brought her back to JH Hospital on 7/26 where despite negligent care, she survived.  And the arm infection resolved.  The cause of the knee “infection” is speculative for the reasons noted above. 

If you want to proceed, after further discovery, I would suggest authorizing the Medical Review Foundation, Inc. to obtain Board Certified Medical Experts in Infectious Disease and Nephrology.

The Defendants would be Dr. Wade, who admitted her to the hospital on7/26 but did not call Dr. Mark until 7/29, and even he negligently delayed one day until “after dialysis tomorrow.”  Also, Dr. Maury, the Nephrologist (Kidney Specialist) is also liable.

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Unnecessary Kidney Biopsy Causes Major Complications and Further Kidney Failure.

The patient was being taken care of by the Clinic. In April the patient had iron-deficiency anemia and had mild renal (kidney) failure, and Dr. A in a letter to Dr. B, a member of the same medical association, recommended performing a colonoscopic examination

In the office progress note of April by Dr. B, a Nephrologist, she noted that the month before, the patient had a creatinine clearance of about 10 cc per minute. This is a measurement of the amount of blood cleared of toxic products by filtering, per minute, by the kidney. This value is approximately 10% of normal. Consistent with that are creatinine values in the range of 3.7-4.1. This is a waste product within the blood produced by muscles. The BUN (blood urea nitrogen) is another waste product, but that is based upon protein metabolism based mostly what is eaten, and that can vary widely. Dr. B also noted that the total urinary protein in 24 hours was 6.2 grams, and normally there would only be a trace amount of protein. Other blood tests were performed for various types of diseases and were negative. She said, “Impression: Renal insufficiency with proteinuria and kidneys with fair preserved cortex.” In her differential diagnosis of diseases, she listed “amyloid.”

Amyloid is an abnormal protein that is deposited in various organs, including the kidneys, heart muscle, liver, spleen, and is usually associated with certain chronic diseases, which the patient did not have. It is also be deposited in the lining of the intestinal tract.

Since the patient was going to have a colonoscopic examination, and possible biopsy procedure by Dr. A, I am concerned that Dr. A was not informed of the differential diagnosis of Dr. B, and that he could have performed one or more biopsies during the colonoscopic procedure, and they can be stained with Congo red dye, specifically looking for amyloid.

Since Dr. B, a Kidney Specialist, considered amyloid in the differential diagnosis, in my opinion, she should have recommended that Dr. A be sure to have a biopsy performed and that it be stained with Congo red. In fact, Dr. A did perform a biopsy of a “sessile (flat) polyp,” and that was submitted for standard examination, which would be to rule out cancer. No additional biopsies were performed, nor was this submitted for a specific stain on one of the microscopic slides that could be made from this 0.3-cm polyp for amyloid.

In my opinion, based upon their differential diagnosis and all of the above, it is a departure from the accepted standards of care not to perform this simple microscopic staining analysis by the Pathologist. If in fact that would have been done, there is a reasonable likelihood that it would have been positive for amyloid. With that diagnosis being made, there would be no real indication to perform a kidney biopsy on this patient.

The colonoscopic examination and polyp biopsy was on May 26. Then, looking for other sources of bleeding for her diagnosis of anemia, including to rule out a gastric ulcer or mass, Dr. A performed a gastroscopy examination on this patient with biopsies on July 6. In essence, he passed a lighted telescopic tube down the esophagus (food pipe) and performed a brush biopsy for the cells lining the lower esophagus, as well as an actual cutting-type biopsy of the lining of the descending duodenum (the early part of the small intestine), and that was to rule out “celiac sprue,” but no staining was requested for amyloid. Again, based upon the diagnosis of chronic kidney failure that had progressed within the previous year and a concern in the differential diagnosis for amyloid expressed by Dr. B, that should have been communicated to Dr. A, and the Pathologist should have examined this specimen for that consideration. There would have been a reasonable likelihood that between the biopsies of the upper intestinal tract, as well as the rectum, that the diagnosis of amyloid would have been made, sparing the patient the need for the kidney biopsy.

I have not seen the ultrasound reports that were done by the radiologist prior to the renal biopsy. According to the office records of Dr. B, there was a renal ultrasound performed on July 8. I have an office record ending on July 7 th, and then the next record I have is September 7, and I am missing the office records between those two dates.

On July 7 th, the BUN was 66, but the creatinine was reasonably stable at 4.5.

With a creatinine clearance of 10.0, most patients would need chronic dialysis (being on the kidney machine). With a creatinine clearance more than 15 cc per minute, very careful dietary restriction of protein can sometimes manage the patient without the need for dialysis. With a creatine clearance of about 10 cc per minute, it is at the very edge where most patients would need to be on dialysis.

One of the problems with amyloid protein infiltration of that protein (amyloidosis) is that it will progress, although the progression of the condition is variable and unpredictable, but these patients will end up on kidney dialysis no matter what is done. There is no specific treatment for amyloid deposition in the kidneys.

I have not seen the ultrasound report, but in the preliminary review, it is noted that the renal sonogram (ultrasound) performed on July 8 showed a right kidney length of 7.6 cm, no hydronephrosis (blockage of urine flow), but increased echogenicity. This note also says that a second sonogram done the day of the biopsy (I have not seen that report, and that should be obtained also) showed the right kidney to be 7.2 and the left 8.0 cm. A normal kidney is approximately 10.0-11.0 cm in length. Thus, these kidneys were already shrunken. Amyloid infiltration usually initially causes an enlargement of the kidneys, not a shrinking. Thus, if this patient truly had amyloid disease, this would be of a chronic nature, and at the point where the kidneys were not amenable to any further treatment, specifically if it were caused by amyloid infiltration.

In my opinion, the patient should have been advised as the probable lack of any therapy available under all the circumstances with shrunken kidneys, and also should have had the rectal biopsy analyzed for the presence or absence of amyloid, as I mentioned above.

The patient had a kidney biopsy on July 26. The records submitted from the Hospital on the pathology report states, “Received is a renal biopsy, sent to Brigham and Women’s for evaluation and diagnosis.” I have not seen that report. According to the review summary, this showed amyloid deposits involving subcapsular glomeruli and liver tissue with the vessels staining positive for Congo red material (amyloid). The needle went too deep and punctured the liver.

Initially the patient did well following this biopsy, which required four needle passes of the Tru-Cut 14-gauge kidney biopsy needle, and had noted that the right kidney was localized by ultrasound, which helps guide the insertion of the needle. But with a smaller than normal kidney, the risk is greater. The target is smaller to hit.

A few hours later, the patient developed sudden right upper quadrant abdominal pain, and in the process of evaluating her, there was no evidence of bleeding on the renal sonogram, but the pain had re-occurred later that day. The surgeon was called in consultation, x-rays studies showed fluid and air in the abdomen, a CAT scan performed that day was also consistent with an intestinal perforation, and the patient, at that time, had signs consistent with a possible heart attack that was ruled out. Thus, there was a day delay in taking her to the operating room, because of the concerns for a heart attack.

At surgery, there was a perforation of the second portion of the duodenum (first part of the small intestines), and that was oversewn. But because of the poor health of the patient and a localized infection, a bypass of the stomach to the small intestine (gastrojejunostomy) was performed and the pylorus (the connection between the stomach and the small intestine) was suture closed. Also, a feeding tube was inserted in the jejunum. In my opinion, this does meet the standard of care. The patient was also placed on antibiotics.

Initially, the patient appeared to do well, and the creatinine blood levels were stable. The surgery was on July 26 th. On July 29 th, the creatinine was 4.2.

On August 3 rd, the patient developed further upper gastrointestinal bleeding that previous endoscopies done the prior day were not able to control. Therefore, the patient underwent further surgery which consisted of opening up the abdomen using the previous incision, opening up the stomach and placing sutures in the small intestine, just adjacent to the anastomosis between the stomach and the small intestine (jejunum), and because there was a tear of the spleen occurring during the surgery and bleeding was unable to be controlled (the oozing persisted), the removal of the spleen was indicated. The pathology report also found some amyloid in the spleen.

The patient did well from the surgical point of view, and a day after this operation took control of bleeding, the creatinine was 3.8. The BUN was 125, but that would be related to the breakdown of the blood within the intestinal tract, which is high in protein.

On August 5 th, the creatinine was 3.8. On August 9 th, it was 4.6. On August 10 th, it was 5.1. Because there was further kidney (renal) insufficiency, and there was concern it may be secondary to antibiotics, the antibiotics were stopped. This meets the standard of care in my opinion.

On August 12 th, the creatinine had risen from 5.2 to 6.4. On August 13 th, it was 7.1. On August 14 th, it was 7.5. They noted progressive kidney failure and expected to have the patient on hemodialysis. On August 16 th, the creatinine was 8.5 when she was placed on dialysis.

Based upon all of the above, I believe that since the patient was going to have the endoscopy procedures, those biopsies should have also been analyzed for the presence of amyloid. Most likely, they would have been positive, sparing her the need for a kidney biopsy of small kidneys that were consistent with chronic kidney disease that would not respond to any meaningful therapy.

Without the kidney biopsy, she would not have had a duodenal perforation, or the need for two operations and a number of endoscopic procedures, which were quite uncomfortable for the patient as noted in the records. All of this “shock” to her body compromised her diseased kidneys even more.

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However, based upon the shrunken kidney and the diagnosis of amyloid based on the kidney biopsy, as well as seen in the spleen, this patient would have progressed in any event to be on dialysis. The condition of amyloid infiltration within the kidney and its causing kidney failure has a variable progression, but the patient had already experienced significant kidney failure with creatinine levels in the range of 4.0, and prior to that, her creatinine clearance was a 10.0. Thus, the patient had progressed even further over two years, and most likely would have, within a reasonably short period of time, been on dialysis in any event.

A needle biopsy is a “blind” procedure. That is, it is thrust through the back muscles in the area of the kidney where it is localized by the ultrasound (sonogram) procedure. Who actually performed the biopsy? Was this the Nephrologist who was the Attending Physician, or a Student or Intern? Was there supervision?

Was the patient advised that, based on the smaller kidneys seen on the ultrasound studies, that there probably would be no real meaningful intervention with therapy no matter what was found on the biopsy?

The Defense will contend that there was adequate cortex or outer part of the kidney where the filtering mechanism, the glomeruli, are located, so that Therapy could help in many conditions and the diagnosis was uncertain before the biopsy. It is important to obtain copies of those reports, and if it is going to go to an Expert, I would suggest you obtain copies of the actual ultrasound studies themselves. They look somewhat like x-rays, and with a good copy, you cannot tell it apart from the original when compared side by side on the x-ray lighted view box.

Based upon the pain and suffering of the patient and the extensive hospitalization and procedures performed, there may be justification in pursuing this case, although most likely the patient would have had to be on kidney dialysis within some reasonable period of time.

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