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Diabetic Patient With Acute Gallbladder Disease Develops Severe Pancreas Infections and Death from Failure to Perform Gallbladder Surgery

I have prepared the following confidential Case Evaluation for you at your request. This report sets forth our professional opinion based upon the medical records that were submitted. These records included a Statement of Facts as well as outpatient, Emergency Ward and multiple inpatient entries that spanned from 1991 to 2007. In all, approximately 663 pages of medical records were reviewed. Unfortunately, although the records were voluminous, it appears that all available records were not received as indicated by the comment in the Statement of Facts that the patient died but records leading up to his death are unavailable.

Salient aspects of this case are as follows:

  1. The patient, formerly of the Kentucky area and now deceased was a 60 year old diabetic when a CT scan of the abdomen was ordered in the evaluation of right flank pain by his family practice physician. On November 2, 2006 this CT scan was obtained and demonstrated gallstones. The official report of this CT scan indicated that Dr. #1 had ordered the study and he would be the medical person responsible for its follow-through which should have included a Surgical consultation.
  2. Indeed, it is well known that diabetics, unlike the rest of the population at large, are at a heightened risk for complications of gallstones. Whereas it is often acceptable to observe nondiabetics with asymptomatic gallstones for indications for cholecystectomy (gallbladder removal), a diabetic even if asymptomatic should be considered for gallbladder removal pre-emptively to avoid dreaded complications such as occurred in this case. The fact that the patient had already been symptomatic in October 2006 further heightened the need for Surgical evaluation for gallbladder removal at that time.
  3. On May 5, 2007 he developed severe abdominal pain, nausea, vomiting and presented to the Medical Center the following day where he was diagnosed with gallstone pancreatitis. His amylase and lipase were markedly elevated at 1946 for his serum amylase and 8281 for the lipase. These enzymes are released during pancreatic inflammatory conditions and were elevated 20-200x baseline normal values.
  4. He suffered from numerous acute relapses of his pancreatitis which required Emergency Ward and inpatient stays on May 28, 2007, June 7, 2007, August 1, 2007 and others and he had a myocardial infarction (heart attack) which required stent placement in his coronary arteries on a July, 2007 hospitalization.
    His acute pancreatitis eventually was complicated by chronic pancreatitis, necrotizing (gangrene and self-digesting) pancreatitis with pseudocyst and abscess formation. He underwent appropriate drainage, pancreatic resection and cholecystectomy (gallbladder removal) on September 24, 2007 by Dr. #2. He received antibiotic therapy and parenteral (intravenous) nutrition on several of his hospitalizations.
  5. Further details surrounding his death are not available at this time.

In summary, an abdominal CT scan performed under the direction of Dr. #1 indicated that this patient suffered from symptomatic gallstones as early as November 2, 2006. The standard of care for diabetics with gallstones required that a Surgical consultation be obtained to electively consider gallbladder removal as diabetics are at increased risk of gallstone-associated complications including gallstone pancreatitis and cholangitis (bile duct infection), potentially fatal conditions that are completely prevented with gallbladder removal.

The failure to consider the patient for elective cholecystectomy (gallbladder removal) was the direct cause of his acute and chronic pancreatitis as well as contributing to his heart attack and necrotizing pancreatitis. Further, the failure to obtain an ERCP or similar procedure to remove the patient's gallstones on each of his hospitalizations prior to September, 2007 were further examples of deviations from existing standards of care that caused or significantly contributed to his severe pancreatic inflammatory conditions.

Since the gallbladder sits anatomically near the pancreas, and the outflow tracts ("ducts") are joined to each other, the presence of a stone within the gallbladder wall can acutely inflame the nearby pancreas and such inflammation is often accompanied by pancreatic phlegmons, pseudocysts and abscesses, all of which were present at various times in this case. Furthermore, until removal of the gallbladder, or, at the least, its stones is performed with procedures such as cholecystectomy (gallbladder and stone removal), cholecystostomy (removal of a portion of the gallbladder with stone drainage) or ERCP (an x-ray dye study, plus internal removal of common bile duct gallstones by cannulation of drainage ducts), the problem of acute pancreatitis with all of its attendant complications may recur, as happened in this case, over and over again.

While the presence of coronary artery disease can be a contraindication to some of these drainage procedures, it is not an absolute contraindication and a Surgeon, in conjunction with the appropriate Medical caretakers such as a Cardiologist should have been consulted to weigh the risks and benefits and timing of the procedures listed above as early as November 2006.

The failure of these procedures to have been considered were deviations that, more likely than not, caused this patient's multiple bouts of pancreatitis with its complications and contributed to his death. However, as noted, further information regarding the circumstances relating to his death is awaited.

Based upon the information in the records received it would appear that the above issues represent viable avenues of pursuit in this case and the potential to obtain supportive Expert Witness opinions supporting the issues of negligence does exist, and should not be difficult, although no guarantees to that effect can be made.

We continue to remain available to assist you in this case and have the Expert Witness specialties you require for this case. Expert Witness Reports are available through our Firm with the submission of appropriate funds as per our current Fee Schedule.

In this specific case, Expert reports should be strongly considered in the areas of Family Practice, Gastroenterology, General Surgery and Infectious Disease preferably after obtaining a more complete set of medical records as described above.

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Stomach Symptoms Not responsive to Tagament and Further Delay in Diagnosing Stomach Cancer, Causing Loss of Chance of Survival.

Eight years earlier, the patient was treated for a malignant thymus gland condition causing myasthenia gravis. He underwent surgery and radiation therapy and was successfully treated. He did receive follow up care, and this was all appropriate medical therapy.

According to your cover letter and the records, on March he sought care by Dr. #1 because he had stomach pains and a 25-lb. weight loss. The patient was prescribed Tagamet for pain, which he took for two weeks and had no relief. Since the patient had progressive symptoms, including vomiting, and although the blood test was positive for hepatitis A antibody, the other liver function studies would not support a serious case of hepatitis. There was no jaundice and most of the liver enzymes were normal. In my opinion, the patient should have been seen without further delay and should have had an upper GI x-ray study ordered and performed.

In essence, within 3-4 weeks after having first seen Dr. #1, having not responded to Tagamet, and with significant weight loss and persistence of symptoms, the upper GI x-ray would have confirmed the presence of a tumor in the stomach.

Although the ultrasound study is appropriate to order, it is only significant if positive. It was negative for gallstones or gallbladder disease and found no other abnormalities involving that area of the abdomen. Possibly, it was misinterpreted by the radiologist, Dr. #2. He describes the liver as normal in appearance. At that time, this would be evidence against the tumor invading into the left lobe of the liver, or into the adjacent pancreas gland. He describes no gross abnormality of the pancreatic bed or spleen. This was on April.

On April 2 in the office records of Dr. #1, is a note for a GI consult with a doctor whose last name appears to be #2, and the note shows that the patient did not see that physician. Why didn't this occur?

Dr. #1 had a duty to either order the upper GI x-ray study, or have the patient referred to a specialist which, in this case, would be a gastroenterologist. That is what his note does reflect. This issue needs to be clarified. And why didn't Dr. #1 then order the GI x-ray study himself?

Because the patient's condition did not improve and he in fact did worsen, he returned to care under his original treating physician, Dr. #3, and he referred the patient to Dr. #4. By that time, the patient had lost 40 lb. Dr. #4 and Dr. #5 did further evaluations on the patient, including a CAT scan on July 10, at the same radiology facility. This found "a large infiltrating mass involving the gastric antral wall extending towards the duodenal sweep (the first part of the small intestine). The posterior aspect of the thickened stomach wall is inseparable from the pancreatic contour. Rule out gastric neoplasm versus severe inflammation from peptic ulcer disease." Also, enlarged lymph nodes were found in that area.

On July 26 Dr. #5 performed an endoscopy procedure (passing a light telescopic tube down the mouth into the stomach), and found a "large ulcerated mass occupying entire region of antrum (the bottom portion of the stomach) from 55 centimeters from incisors (teeth downward, as measured) to the pylorus (the sphincter muscle between the stomach and the duodenum) displacing pylorus, obvious gastric neoplasm (cancer)." A biopsy revealed the presence of malignancy that looked like adenocarcinoma. A surgical consultation was requested and performed.

On August 6 at the Hospital #1 the patient underwent exploratory surgery and a partial gastrectomy. The cancer was invading the pancreas and the left lobe of the liver, and the surgeon felt he would be able to remove that tumor. Thereafter, the small intestine was sutured back to the remaining stomach for intestinal continuity. To proceed with that surgery at the time was a judgement call, and is acceptable in my opinion.

The pathologist found the cancer and noted microscopically that this was "a lymphoma of mucosa - associated lymphoid tissue (MALT type)." This was a high-grade transformation that also involved the lymph nodes surrounding the stomach.

This is a rare type of cancer that begins in a stomach ulcer and is associated with the Helicobacter germ. When found early, it responds very well to antibiotic therapy for this germ as a cause of an ulcer. However, as time passes, the tumor transforms into a more malignant grade, as occurred here. That resulted in the huge stomach mass that invaded into the liver and pancreas and spread to the adjacent lymph nodes.

When detected early, treatment with antibiotic therapy and low-dose radiation therapy (which is less toxic to the body) has a very high cure rate. I discussed this case with a radiation oncologist, and recent articles reveal that up to a 99% cure rate is attainable when this tumor is detected early.

However, by the time the patient was operated upon, this tumor had progressed to a more advanced state and, despite subsequent treatment with chemotherapy and radiation therapy, the tumor did progress as noted on the follow up MRI scans and the patient died five month later. He developed fluid in the chest that was drained, and complications from the original surgery that were appropriately treated.

Although the expert I spoke with is willing to review the records and testify, there are a number of problems with this case. First of all, by the time the patient saw Dr. #1, he had a 25-lb. weight loss and it is acceptable for a physician to assume the patient had an ulcer based upon his symptoms and treat with an anti-acid type medication, such as Tagamet. This therapy is usually given for two weeks, and even up to a month in time. If that medication does not relieve the symptoms, then further investigative studies are performed, either by that physician or by referral. This would include an upper GI x-ray study, and this generally would take another week or so in scheduling by the treating physician or, if a referral takes place, there can be an additional week or two delay.

Therefore, even under the best of circumstances, the patient would not have had the upper GI series x-ray and report back to the doctor until within about a month of reporting to Dr. #1. This decreases the delay to two months. By that point in time, clearly the tumor had enlarged and was invasive. But even at that time, radiation therapy would have made some difference to prolonging the survival of the patient, according to my initial discussion with his oncology expert. The additional two months did decrease the chances of longer survival.

There is another matter, as I mentioned above, in that there was a referral to a Gastroenterology that the patient did not follow through with. Why didn't that consultation take place? Obviously, the defense will claim contributory negligence. That should be addressed in affidavit format, if you are going to pursue this case prior to expert review.

Obviously, the patient was suffering for a number of weeks or months before he saw Dr. #1, which resulted in that 25-lb. weight loss. Did he see any other physician during that time? That earlier intervention, before he saw Dr. #1, certainly would have made a substantial difference to the outcome.

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Bleeding Incorrectly Diagnosed and Treated Causing Perforation and Abscess

Because of his chronic kidney stone and arthritis conditions, he was prescribed Motrin (ibuprofen). That was reasonable. However, as a nonsteroidal anti-inflammatory drug (NSAID), it can cause stomach ulcers, bleeding, and even a perforated ulcer. On 9/22/01, he complained of vomiting blood and a black stool. As blood from the stomach passes through the intestinal tract, it turns black (melena). He also complained of stomach pain, and on physical examination his abdomen was tender. All of this is consistent with a bleeding ulcer with the potential for perforation. That is an emergency and requires proper medical care for diagnosis and treatment, which he was negligently denied. 

Although the Physician Assistant #1 did correctly stop the Motrin and told him not to smoke, gave him the antacid Maalox and referred him to a Gastroenterologist, he did not prescribe the required (and more effective) acid stopping drug such as Tagamet or Zantac and even after one month, he was not seen by a Gastroenterologist for a potentially life threatening condition. No emergency blood count was ordered. 

Furthermore, was he really receiving the generic form of Motrin or a more dangerous pain medication such a phenylbutazone or indomethacin (Indocin)?

On 9/23 he again had melena. That can be from the original hemorrhage, because it takes a few hours for its passage through the intestinal tract, or persisting bleeding. The patient did not collect a stool sample, but a basic rectal examination could (and should) obtain a fresh sample for immediate testing. 

No blood count was done to look for progressive anemia from blood loss. All that is negligent care. He never checked on the 9/22 blood count; further negligence.

On 9/24, he was again seen and reported “straight diarrhea (black)”. The test by rectal exam for blood was “hemoccult-positive”. And he said, “Awaiting CBC (complete blood count from 9/22) and Gastro referral.” However, Alexander Graham Bell invented the telephone a century ago, and for decades fax machines were operative. Now, even the Internet e-mail service was available to him! Why did he not contact his supervising Medical Doctor? Who was that doctor and what contractual arrangements did the Federal Prison at Allenwood have for all their on-site and referral Doctors, Specialists, and Emergency Care?

The plain (flat) abdominal x-ray on 9/24 showed his pre-existing kidney stone. But it was not an upright study, which would be the only plain x-ray view to show a perforation with gas (air) under the diaphragm (breathing muscle between the abdomen and chest). However, I doubt that it had perforated at that time, since he would have been in severe pain and very ill.

He returned urgently (did not wait for sick call) on 9/26, and the 9/22 CBC result showed significant anemia with the hemoglobin (Hgb) at 12.4 (vs. 13.6-17.6) and the hematocrit (HCT: packed red blood volume percentage) at 36.0 (vs. 40.2-51.4). Each pint (unit) of blood loss in an adult is approximately four points of hematocrit decrease. No repeat CBC (complete blood count) was ordered despite the four day old previous test result and history of continuing blood loss. Further negligence. Any basic laboratory could test for the HCT value in only a few minutes. What laboratory equipment did that government prison facility have at that time?

On 9/28 Physician Assistant #2 saw him, re-ordered the Maalox as an as-needed (p.r.n.) dose, plus correctly ordered Zantac twice a day (b.i.d) for 15 days. He also ordered the blood antibody test for the germ H. pylori, which is a cause of many ulcers. It eventually (on 10/3) was done and was negative, reducing the need for concomitant antibiotic therapy for his ulcer disease therapy.

On 10/3 he was seen by the Pharmacist for his “stomach meds” and was given two antacids: Gaviscon and Maalox. Did he ever get the Tagamet? However, this note also said, “Trial Indocin (indomethacin) t.i.d. (3 x per day)” and was crossed off. Did he ever get that very ulcerogenic (ulcer causing) drug? That would be gross negligence in a patient with acute ulcer disease.

On 10/3 the laboratory test noted the Hgb at 11.7 and the HCT at 33.5. That is consistent with another pint loss of blood. There was no immediate followup. Further negligence.

On 10/14 he was complaining of being dizzy. They considered it might be from the drug Neurontin (gabapentin); however, blood loss was never considered, and his blood pressure was never checked (needed to be tested lying down and standing to assess hypovolemia: low blood volume). That too was negligent. They thought it might be “manipulative behavior,” which is prejudicial and a failure to use a standard differential diagnostic list to rule in/rule out diagnoses.

On 10/15 they noted his Hgb (hemoglobin) was only 11.7 and chose to refer him to an outside hospital for evaluation. During his three hour visit to the Hospital ER, they noted a history of GI (gastrointestinal) bleeding and then injected him with 60 mg of the pain medication Toradol that is contraindicated in ulcer disease because it can worsen that condition; even can cause a perforated ulcer. One hour later, his abdominal pain was worse. Their only focus was for kidney stones, not for his ulcer and bleeding history. That care was deficient and negligent, and may have caused the perforation with its abscess found on 10/23.

On 10/23 he again vomited blood and was in shock. He survived only because the ambulance crew was able to start two I.V.s to refill his depleted blood volume. 

The 9/22 “Gastro” consultation sheet noted his Emergency Hospital Admission on 10/23. The prison’s negligence in not obtaining an urgent consultation and adequate therapy, as well as the ER abuse of Toradol prevented any chance of spontaneous healing. Which days did he actually take the Zantac, and did he always get it twice a day?

He was admitted as an emergency to the Hospital on 10/23. They noted his 35-day history of bleeding ulcer symptoms and noted that his Hgb was 7.4. Dr. #1 attempted to control the bleeding via endoscopic technique, noted a large pyloric channel ulcer (at the exit site between the stomach and small intestine: duodenum) on 10/23. On 10/24 he was able to remove the clot, and decreased but could not stop the bleeding. 

Therefore, he underwent emergency surgery on 10/24 by Dr. #2. He found a perforated ulcer and an abscess next to the spleen and diaphragm that he drained. He closed the ulcer perforation while opening that food stomach drainage site (pyloroplasty). But he did not do an ulcer preventing operation by cutting the stomach stimulating (vagus) nerves and /or removing half of his stomach. Most likely that decision was based on the presence of the perforation and infection, and was a reasonable judgment call.
If he had received proper care and if that failed, then he could have had a definitive ulcer prevention operation without the perforation and abscess. And his negligent care by the prison and the ER increased his risk of perforation and infection.

His kidney blood tests (BUN and creatinine) were always normal (8/10 and 10/03) up until 10/22 when it rose to: BUN 52 (normal is 10-20) and creatinine 1.6 (normal is 0.7-1.5). BUN rises rapidly and the creatinine follows days to a week later. Shock is the most likely cause here. Finally by 11/05 they were 13/1.3 (in this lab its "normal" is high).

He possibly may have sustained irreversible kidney damage. Even if the BUN and creatinine are now normal, he still could have had 80% of kidney functional loss. His doctor could easily get a harmless and inexpensive creatinine clearance test (blood creatinine and 24 hours of urine creatinine are used to determine the amount of blood cleansed per minute: normal is 100-120 cc) done at any time. With his chronic kidney stones, further kidney impairment puts him at greater risk of kidney failure requiring dialysis and kidney transplantation with those costs and risks.

Six days after surgery the ventilation tube was removed (extubation). It is reasonable to restrain (gently and padded) a patient to prevent the patient from removing that tube. He was always shackled by three extremities and guarded. Why?

Is Prison #1 a “minimum security” prison, or Level I “minimum security” facility; even with no perimeter fence? Why was he is prison? These answers are most relevant to the degree of physical restraint necessary in the Hospital. Whose rules were they following for restraint?

Whatever that risk, there is no excuse for the ulcerations on the inner and outer side of his right wrist caused by the excessive tightness of the cuffs (caused by the guards: who was their employer: The Federal Government, the Hospital, or a private security contractor?) Also, the Nurses had a duty to be sure the cuffs were not cutting into his skin (pressure sores) by not being too tight, and with enough padding, and calling the first evidence of injury to the attention of the Doctors and guards. The Physicians were also liable. They may all point fingers of liability against each other.

Also, the Nurses and Doctors had a duty to be sure his elbows were properly padded and protected from pressure. Their negligence caused his right ulnar nerve injury with numbness on his lower right arm and weakness of his right fourth and fifth fingers. Has that nerve damage symptom persisted? Has he had any medical (neurological) consultations, and the EMG and NCV electrical muscle and nerve testing?

For the reasons stated above, the Prison Facility, its Physician Assistants, medical consultants, and the Hospital and Emergency Room are negligent for all the reasons noted above. Who supervised the Physician Assistants, and did they have a written protocol (which is standard and required practice) for Doctor supervision, as well as limits of independent action? Obtain these documents.

Please obtain the information requested. We then suggest Experts in Gastroenterology, Emergency Medicine, Surgery, and Nursing, which we have available on our Independent Consulting Staff.

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Questionably indicated colonoscopy (examination of the inside of the large intestine with a flexible lighted telescopic device) and large perforation.

At age 65, this patient who had been a chronic alcoholic, had lost 15 pounds over six months. There was a concern for cancer and he was taken to outpatient surgery for two procedures: an upper and lower endoscopy, which uses a flexible lighted telescopic tube to examine his esophagus (food pipe), stomach and duodenum (first part of his small intestines), and then a different endoscope to attempt to visualize the inside of his entire colon (large intestine) from his rectum to cecum (where the small intestine ends).

Usually fecal tests are done to look for occult (hidden) blood shed by intestinal cancer. Usually contrast x-ray studies (UGI: upper gastro-intestinal and barium enema x-rays) are first done before the more expensive, uncomfortable and potentially dangerous endoscopic procedures. However, the physician (Dr. #1) would not earn money if those studies were negative and he did not do these endoscopies.

The family physician, Dr. #2 referred this patient to Dr. #1. What studies and evaluations did she arrange to have done before referral for endoscopies? If she did not have them done, then in my opinion, she and her office departed from the proper standards of care. Also, if Dr. #1 had a poor "track record" concerning complications, then she would also be negligent in her referral to him.

Was he informed of the risk of colon perforation with the colonoscopic procedure? I have not seen any consent form. Obtain all documents and information of his informed consent, if any, including an affidavit of this patient.

In performing the colonoscopy, the lumen (hollow passageway) must be visualized at all times as this endoscope is advanced. He had a clean colon by the tap water enemas prior to the procedure. As the endoscope is advanced, it may be uncomfortable but should not be very painful. The only pain the intestines feel is stretching from within (distention). There was much distention from excessive force to ram it through his descending (left side) colon to create the one-inch hole that this colonoscope passed through. However it first caused lots of additional stretching (distention) since at surgery, Dr. #1 noted: "The serosa (shiny outer layer of the colon) tear is in the sigmoid area (between the rectum and descending colon)". He also said: "Multiple bruises of the distal descending colon and sigmoid were seen." In my opinion, that is strong supportive evidence of negligence, and is a quote from this "endoscopist/surgeon."

Fortunately, the one-inch hole was sutured within two hours of the perforation and the colon was previously cleansed from the enemas before the colonoscopy, so no feces entered the abdominal cavity in any large amount and he did not develop any infection.

At the endoscopy Dr. #1 said: "There was a problem with visualization. The scope was withdrawn and then advanced under direct vision with difficulty manipulating the scope was withdrawn (sic) again advanced. At this point vision was lost. Lumen was no (sic) visualized anymore. (He had perforated the colon and was unaware!). The subsequent development of free peritoneal (intra-abdominal) air with abdominal distention, the scope was withdrawn. (Finally), the peritoneal cavity was visualized. Realizing that colon perforation has occurred, the procedure was ended…" One does not push and push and not see where you are going. That is negligent. After the end of the colonscope perforated through his colon and was within his abdominal cavity, he still did not recognize where he was. How skilled is this surgeon in colonoscopies? Who trained him? What, if any, certifications does he have? Has he ever failed his Board examinations? How many colonoscopies has he done every month before and after this event?

The patient received an unknown amount of the sedative Diprivan (propofol) at the start of the endoscopic procedures. I do not see the total amount given by the anesthesiologist, Dr. #3. What does the patient remember of the entire two procedures? The upper endoscopy was normal and he had no complications from that procedure and the colonoscopy found no other pathology than the perforation, confirmed at surgery two hours later. (Apparently the two hour delay was because they were waiting for an empty operating room in this hospital).

Afterward he had post-operative pain and received pain medication. He went home 5 days later. Now he has a small risk of developing intestinal obstruction ("locked bowels") from scar tissue that can form within the abdomen after any operation. If he has symptoms of crampy mid-abdominal pain and distention, that would be consistent with episodes of partial small bowel obstruction. With total obstruction, surgery is needed urgently, and may result in further required operations to cut the scar tissue that binds the small intestines again and again. As he ages, the risks of this potentially needed operation increase substantially.

He had abnormal enzyme blood tests, consistent with active liver disease. Although he claims to have stopped drinking in 1983, that may not be totally accurate and may have been the only cause of his 15 pound weight loss. Please obtain the medical records from the family doctor's office and the surgeon's office.

If the surgeon's credentials were not adequate to perform the colonoscopy, then the hospital would also be negligent for allowing him to perform that procedure on its premises. Also, was there any consent form specific for these two procedures ever signed? Who informed him of the known risks including colon perforation and the need for emergency surgery? Although it is a known risk, in most cases, including his case (with a normal colon) it was preventable and caused by the surgeon's negligence as I described above.

I suggest that the patient be evaluated by a local Clinical Psychologist with courtroom experience for any residual emotional (psychological) damages. Administration of standardized tests such as the M.M.P.I. (Minnesota Muliphasic Inventory) which have been given to millions of people would further support that opinion before a jury.

After you obtain the missing records and information requested, I would suggest that you authorize us to have all the records reviewed by Experts in General Surgery, Gastroenterology and Family practice.

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