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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs LEIB SINGER, M.D., 16-005752PL (2016)

Court: Division of Administrative Hearings, Florida Number: 16-005752PL Visitors: 24
Petitioner: DEPARTMENT OF HEALTH, BOARD OF MEDICINE
Respondent: LEIB SINGER, M.D.
Judges: F. SCOTT BOYD
Agency: Department of Health
Locations: Lauderdale Lakes, Florida
Filed: Sep. 30, 2016
Status: Closed
Recommended Order on Tuesday, March 28, 2017.

Latest Update: Jul. 11, 2017
Summary: The issues in this case are whether Respondent violated section 458.331(1)(t), Florida Statutes (2009),1/ by committing medical malpractice as alleged in the Amended Administrative Complaint; and, if so, what is the appropriate sanction.Medical malpractice was not proven where the standard of care was not clearly shown to require a liver biopsy prior to a colonoscopy under the particular circumstances of the patient involved.
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STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS


DEPARTMENT OF HEALTH, BOARD OF MEDICINE,


Petitioner,


vs.


LEIB SINGER, M.D.,


Respondent.

/

Case No. 16-5752PL


RECOMMENDED ORDER


On January 23, 2017, the final hearing was held by video teleconference at sites in Lauderdale Lakes and Tallahassee, Florida, before F. Scott Boyd, an Administrative Law Judge assigned by the Division of Administrative Hearings.

APPEARANCES


For Petitioner: Zachary Bell, Esquire

Ross Daniel Vickers, Esquire Department of Health Prosecution Services Unit

4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265


For Respondent: Richard T. Woulfe, Esquire

Billing, Cochran, Lyles, Mauro & Ramsey, P.A.

SunTrust Center, Sixth Floor

515 East Las Olas Boulevard Fort Lauderdale, Florida 33301


STATEMENT OF THE ISSUES


The issues in this case are whether Respondent violated section 458.331(1)(t), Florida Statutes (2009),1/ by committing medical malpractice as alleged in the Amended Administrative Complaint; and, if so, what is the appropriate sanction.

PRELIMINARY STATEMENT


On December 2, 2014, the Department of Health (Petitioner or Department) issued an Amended Administrative Complaint against Leib Singer, M.D. (Respondent or Dr. Singer). The complaint related to Dr. Singer's provision of medical care to

Patient J.R.R. Dr. Singer performed a colonoscopy and esophagogastroduodenoscopy (EGD or upper endoscopy) on Patient

J.R.R. Dr. Singer disputed allegations of fact in the complaint and requested a formal hearing. The case was forwarded to the Division of Administrative Hearings (DOAH) for assignment of an administrative law judge on September 30, 2016.

The hearing was initially set for December 7 through 9, 2016, but after continuance upon Respondent's unopposed motion, the final hearing took place on January 23, 2017. The parties stipulated to certain facts, which are accepted and included among the Findings of Fact below. Petitioner offered Exhibits P-1 through P-8, including depositions of Dr. Paul Goldberg and Dr. Robert Goldberg, all of which were admitted into evidence without objection. Respondent testified and offered the live


testimony of one other witness, Dr. Robert Goldberg. Five of Respondent's exhibits were admitted: Exhibit R-8, the transcript and video deposition testimony of Dr. Robert Firpi; and Exhibits R-10 through R-13, with the caveat that Exhibit

R-10, an affidavit of Dr. Robert Goldberg, was hearsay and could only be used to supplement or explain other evidence. Exhibit R-8 was admitted over the objection that Dr. Firpi was not an

appropriate expert, as discussed in the Conclusions of Law below. Respondent's Exhibits R-1 through R-3 and Respondent's Exhibits R-6 and R-7 were duplicative of Petitioner's exhibits and so were not separately admitted. Exhibits R-4, R-5, and R-9 were withdrawn by Respondent. Petitioner's objections to Exhibits

    1. and R-15 were sustained, and they were not admitted.


      Proposed recommended orders were timely filed by both parties within ten days after February 24, 2017, when the one- volume Transcript was received and posted to the docket. They were considered in preparation of this Recommended Order.

      FINDINGS OF FACT


      1. The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43, chapter 456, and chapter 458, Florida Statutes (2016). The Board of Medicine is charged with final agency action with respect to physicians licensed pursuant to chapter 458.


      2. At all times material to the complaint, Dr. Singer was a licensed physician in the state of Florida, having been issued license number ME 34494.

      3. Dr. Singer's address of record is 4800 Northeast 20th Terrace, Suite 105, Fort Lauderdale, Florida 33308.

      4. Dr. Singer is board-certified in internal medicine and gastroenterology by the American Board of Internal Medicine.

      5. An EGD uses a scope to look at the esophagus, stomach, duodenum, and small bowel. A colonoscopy similarly looks at the colon, using a slightly different scope.

      6. Patient J.R.R. underwent an EGD and colonoscopy on January 11, 2007, under monitored anesthesia care (MAC).2/ A two- millimeter polyp was removed from the transverse colon.

        Dr. Singer's notes indicate that Patient J.R.R. tolerated the procedure well. The pathology report on the polyp concluded there was no evidence of dysplasia or malignancy.

      7. Patient J.R.R. suffered from chronic renal failure and became dependent on dialysis in June of 2008. He was being considered as a candidate for a kidney transplant.

      8. Patient J.R.R. underwent an abdominal ultrasound on August 5, 2008.

      9. The report for the August 5, 2008, ultrasound indicated the study was interpreted by Michael Digiorgio, M.D., to show a


        hyperechoic mass within the left lobe of the liver compatible with hemangioma.

      10. Patient J.R.R. underwent an abdominal computerized tomography (CT) scan without contrast on August 16, 2008.

      11. The report for the August 16, 2008, CT scan without contrast indicated the study was interpreted by Michael Alboucrek, M.D., to reveal no significant abnormality.

      12. On September 30, 2009, Patient J.R.R. had a pre- transplant clinic visit at Jackson Health System with Linda J. Chen, M.D., who assessed the patient as being clinically very robust and having no absolute contraindications to rule him out for organ transplant. Also, Dr. Chen reported that Patient J.R.R., among other things, would need a screening colonoscopy and upper endoscopy.

      13. In her report, Dr. Chen described multiple medical issues for Patient J.R.R. She noted that he was a 69-year-old male with more than a 35–year history of diabetes mellitus and longstanding hypertension. He was in end-stage kidney disease and was hemodialysis-dependent. He had a history of congestive heart failure and coronary artery disease, as well as gastroesophageal reflux disease. He suffered from ischemic cardiomyopathy, underwent a three-vessel coronary artery bypass graft in August of 2008, and had a pacemaker since that time. His August 2009 echocardiogram showed a relatively good ejection fraction of


        35 percent to 40 percent with akinesis in the apex and hypokinesis in the lateral and inferior ventricle. As part of a full pre- transplant workup, Dr. Chen recommended an abdominal ultrasound and the screening colonoscopy, as well as the EGD because of his chronic reflux.

      14. It is not uncommon to request these endoscopic procedures in anticipation of immunosupressants to be given after a transplant.

      15. Patient J.R.R. underwent an abdominal CT scan with contrast on February 26, 2010.

      16. The report for the February 26, 2010, CT scan indicated the study was interpreted by Michael Arch, M.D., to show mild changes of cirrhosis with tiny bilateral pleural effusions. Multiple hepatic lesions, some of which appeared to demonstrate faint enhancement and to be new since the non-contrast CT on August 16, 2008, were found suspicious for malignancy, particularly metastases.

      17. A CT scan conducted with contrast generally enhances the image and permits more detail to be observed. The report for the February 26, 2010, CT scan indicated the possibility that some abnormalities in the scan that appear to be new might actually have been present earlier at the time the CT scan without contrast was done.


      18. Without specialized training, a gastroenterologist is not independently qualified to review and interpret radiological imaging. Neither Dr. Singer, nor any of the experts who testified at hearing, had this specialized training.

      19. On March 2, 2010, Patient J.R.R.'s referring physician, Dr. Luis Cortez, requested an evaluation of Patient J.R.R. That prescription referred to the recent CT scan showing possible metastatic disease and ascites, stated that there had been a prior colonoscopy in 2007 that was positive for a left-sided polyp, and noted Patient J.R.R. had "congestive heart failure and renal failure."

      20. Ascites is an accumulation of fluid in the abdomen.


        Ascites can make a liver biopsy more difficult and increase the risk of bleeding, because the liver is displaced from the skin, and it can be difficult to apply pressure.

      21. There was no indication of malignancy in Patient J.R.R.'s liver other than radiologic findings.

      22. When advised of the possibility of cancer, without confirmation, a gastroenterologist's responsibility is to attempt to locate the cancer, determine its primary source, and determine how extensive it is.

      23. The vast majority of cancers found within the liver do not originate solely within the liver, but are metastases from a different location, termed the primary source. The colon is the


        single most common site of primary tumors, but the primary could also be in the lungs, stomach, or other organs.

      24. When it is suspected that cancer may be present in the liver, liver function tests may be ordered, which can indicate if cancer may be blocking a bile duct or if there is damage to the liver that might have been caused by cancer.

      25. The April 14, 2010, history note by Dr. Singer indicated that the liver function tests conducted for Patient J.R.R. were normal.

      26. Weight loss can be an indicator of cancer. Patient


        J.R.R. had not experienced weight loss.


      27. Tumor markers from the blood may also be ordered to assist in identifying possible cancers and helping to locate them. Various markers are highly associated with certain specific organ cancers and so can indicate where to focus attention. For example, CA-125 is highly suggestive of ovarian cancer, CA 19-9 is highly suggestive of pancreatic or biliary cancer, carcinoembryonic antigen (CEA) is highly suggestive of gastrointestinal malignancies--though it can be seen with other malignancies as well--and alpha-fetoprotein (AFP) is suggestive of primary liver cancer.

      28. Laboratory work for Patient J.R.R., dated March 8, 2010, showed readings for the AFP tumor marker at less than 1.3 ng/mL, CEA at less than .5 ng/mL, and CA 19-9 at 22 units/mL. The


        April 14, 2010, history note by Dr. Singer indicated that CEA, AFP, and CA 19-9 were normal. The normal AFP reading suggested that if there was cancer in the liver, it was most likely metastatic, and not primary, though not all patients with primary liver cancer exhibit elevated AFP. The reading did not confirm the presence of cancer.

      29. Diagnostic imaging, such as CT scans and ultrasounds, can help locate suspected cancer. Radiologists examine the imaging and issue a report. Radiological imaging can tell a radiologist if there is something abnormal in the body that could be potentially malignant and can help to identify its location.

      30. Dr. Singer ordered an abdominal ultrasound and a liver/spleen scan for Patient J.R.R., which Patient J.R.R. underwent on April 28, 2010.

      31. The abdominal ultrasound report dated April 28, 2010, indicated the study was interpreted by George Koshy, M.D., to show multiple echogenic lesions throughout the liver suspicious for metastases as previously described by CT scan.

      32. In a liver spleen scan, a radionuclide is injected into the body, and is picked up by various cells. A liver spleen scan has limited utility for evaluating nodules or lesions, but gives information on how the liver is functioning.

      33. Patient J.R.R. might also have been referred to an interventional radiologist for a directed percutaneous biopsy of


        the liver. In 2010, most interventional radiologists used conscious sedation when they performed liver biopsies, although other forms of sedation might be used. Conscious sedation is a state of sedation in which the patient is sleepy, but arousable, comfortable for the procedure, and generally without loss of protective reflexes, like the gag reflex, or withdrawing from painful stimuli.

      34. The tissue obtained from a liver biopsy would then have been sent to a pathologist. A pathologist can usually tell if the tissue obtained is malignant or not. If metastatic malignancy is identified, the pathologist can frequently narrow down the location of the primary cancer through the use of immunoperoxidase stains.

      35. Interventional radiologists use radiologic imaging to guide a percutaneous liver biopsy. This slightly decreases the risk of perforation of large blood vessels or bile ducts, and allows a specific portion of the liver to be targeted for biopsy. The primary risks associated with liver biopsy include perforation and bleeding. There are also risks related to the anesthesia used.

      36. In conducting a liver biopsy, tissue must come from the mass or the filling defect, so the needle must get right into the abnormal area to be successful. If the tissue sample taken is


        from a part of the liver that is normal, it will fail to diagnose the suspected cancer.

      37. Dr. Singer did not order a liver biopsy for Patient J.R.R., but decided to proceed with an EGD and colonoscopy.

      38. Patient J.R.R. was scheduled to undergo a colonoscopy and upper endoscopy on April 30, 2010, at Broward General Medical Center, and Dr. Singer was scheduled to perform the procedures.

      39. Complications related to colonoscopies performed under MAC include perforation and bleeding.

      40. Complications related to upper endoscopies performed under MAC include perforation and bleeding.

      41. Risks with MAC, usually used to perform an EGD or colonoscopy, include respiratory and cardiac arrest and respiratory insufficiency. Patients are breathing for themselves. If their breathing is suppressed or they are obstructing their airway--with their tongue, for example--their oxygen saturation drops. Propofol, the most commonly used anesthetic, is cardio- reactive and can cause a drop in blood pressure. These are reasons why sedation is monitored by an anesthesiologist or nurse anesthetist. The anesthesiologist determines what form of sedation is best for a particular patient. A gastroenterologist must consider anesthesia along with all of the risks of a procedure. The anesthesiologist is the "final gatekeeper" with respect to risks of anesthesia.


      42. Conscious sedation is usually considered less risky than MAC, but with some patients, the anesthesia risks of conscious sedation can be even higher than those with MAC. As Dr. Paul Goldberg testified, sometimes an anesthesiologist might decline to do MAC:

        Or they'll say to you, they won't—they'll say I'm not doing it. You can do it on your own, but that's called insanity. If the anesthesiologist think's it's too risky to do the case then the—only the fool goes ahead under most circumstances and does it without them because the risk of doing conscious sedation to that patient is higher than the risk of doing managed care.


      43. Prior to performing the colonoscopy and upper endoscopy, Dr. Singer was aware that Patient J.R.R. had multiple documented comorbidities.

      44. The comorbidities of primary concern with endoscopic procedures relate to the need for MAC sedation, and include respiratory issues, cardiac issues, and metabolic issues.

      45. Patients with significant comorbidities have a higher chance of complication during surgery compared to those without comorbidities.

      46. Patient J.R.R.'s April 30, 2010, colonoscopy and upper endoscopy procedures were performed under MAC using Propofol.

      47. Dr. Singer has the authority to forego proceeding with a surgery, or cancel a surgery, if he believes the surgery is not in the best interests of the patient.


      48. Statistically speaking, the risks for a liver biopsy are lower than the risks for a colonoscopy. While the risks for either procedure are low, in general the risks in a colonoscopy are approximately five times the risks of a liver biopsy.

      49. A gastroenterologist attempts to minimize risks to the patient and so attempts to diagnose as noninvasively as possible. A gastroenterologist must carefully consider the individual patient and his comorbidities when weighing how safe it is to undertake a given procedure. What is safe for one patient may not be safe for another. Especially with elderly patients who exhibit numerous comorbidities, it is necessary to look at the risk of a procedure versus the benefit to be gained from it. All of the experts agreed that each patient must be considered individually.

      50. Despite knowing of the possible liver malignancy, Dr. Singer elected to continue with the colonoscopy and upper endoscopy.

      51. Patient J.R.R. expired in the operating room immediately following the completion of the April 30, 2010, colonoscopy and upper endoscopy, while still under the effects of anesthesia.

        Experts and Standard of Care


      52. Dr. Paul Goldberg is licensed to practice medicine in the state of Florida. He is board-certified in the specialty of internal medicine and in the subspecialty of gastroenterology. He is a fellow of the American College of Gastroenterology and the


        American Gastroenterological Association. He is a member of the American Society for Gastrointestinal Endoscopy and of ASPEN, the American Society for Parenteral and Enteral Nutrition.

      53. Dr. Paul Goldberg has active privileges at the Villages Regional Hospital, Florida Hospital Waterman in Tavares, and Leesburg Regional Medical Center in Leesburg. He also has affiliate staff privileges at Halifax Health in Daytona Beach and at Memorial Hospital Daytona Beach. He was in the active practice of gastroenterology in the three years before April 2010.

      54. Dr. Paul Goldberg conducted a review of Patient J.R.R.'s pertinent medical records, including records created by

        Dr. Singer. He did not review the March 2, 2010, request of Dr. Luis Cortez for an evaluation of Patient J.R.R. or the references there to the CT scan showing possible metastatic

        disease and ascites, and noting Patient J.R.R.'s "congestive heart failure and renal failure."

      55. Dr. Robert Goldberg is a licensed Florida medical doctor who specializes in internal medicine and has a subspecialty in gastroenterology. He has been board-certified in both for more than 25 years. He is a full-time faculty member of the University of Miami. He teaches medical students from that school--as well as students from Florida International University and Nova Southeastern--how to conduct histories primarily related to gastroenterology and provides opportunities for them to observe


        endoscopic procedures. He gives lectures to residents on gastrointestinal physiology and teaches sedation and monitoring during endoscopic procedures.

      56. Dr. Robert Goldberg has hospital privileges at Mount Sinai Medical Center and concentrates about 90 percent of his practice in the subspecialty of gastroenterology. He was in active clinical practice of gastroenterology and routinely performed EGDs, colonoscopies, and dilations in the three years before April 2010. He used to perform liver biopsies, but no longer does so.

      57. Dr. Robert Goldberg conducted a complete review of Patient J.R.R.'s pertinent medical records.

      58. Dr. Roberto Firpi is a licensed Florida medical doctor who specializes in internal medicine and has subspecialties in gastroenterology and transplant hepatology. He is a fellow of the American College of Gastroenterology and a fellow of the American Gastroenterological Association. He is also a member of the American Association of the Study of Liver Disease and the European Association of the Study of Liver Disease. He has hospital privileges at the University of Florida and the Veterans Administration Hospital in Gainesville. He had an active clinical practice for at least three years prior to April 2010, in which he practiced in gastroenterology and liver diseases.


      59. Dr. Firpi is also an associate professor of medicine at University of Florida, Department of Medicine, Division of Gastroenterology and Hepatology. During the three years prior to April 2010, he taught medical students liver disease and instructed fellows on procedures such as colonoscopies, endoscopies, and liver biopsies. He also gave lectures to residents on gastrointestinal physiology and taught sedation and monitoring during endoscopic procedures.

      60. Dr. Firpi conducted a complete review of Patient J.R.R.'s pertinent medical records.

      61. Dr. Paul Goldberg, Dr. Robert Goldberg, and Dr. Firpi are all experts in gastroenterology and have knowledge, skill, experience, training, and education in the prevailing professional standard of care recognized as acceptable and appropriate by reasonably prudent gastroenterologists.

      62. There was considerable divergence in their testimony and opinions as to the applicable standard of care for a gastroenterologist treating a patient similar to Patient J.R.R.

      63. Dr. Paul Goldberg indicated that a liver biopsy should be done before a colonoscopy unless there was a strong indication that the metastases was originating in the colon, testifying:

        Q: If you suspected that the cancer—the origin source of the cancer—was in the colon, would the colonoscopy help you determine that?


        A: Based upon—I mean it depends upon how strongly I suspect it and what I'm seeing. If I had a CT scan that showed a mass in the colon, yeah, absolutely I would look with a colonoscope. If I had a mildly elevated CEA, no, that wouldn't be—and holes in liver, no, that wouldn't be my first choice because it's, you know, I would get the liver biopsy first because it tends—it would be more useful to get that information because I'm not—I really don't have a good indication it's coming from the colon.


      64. Dr. Paul Goldberg testified that due to the risks of sedation, the risk of a liver biopsy is less than the risk of a colonoscopy in a patient with heart disease, congestive heart failure, diabetes, respiratory issues, and sleep apnea.

      65. It was Dr. Paul Goldberg's opinion that scheduling and performing the EGD and colonoscopy procedures, which required Patient J.R.R. to be placed under MAC, before more thoroughly evaluating the abnormalities identified in the radiologic findings by conducting a liver biopsy, fell below the standard of care applicable to a prudent gastroenterologist with training similar to that of Dr. Singer.

      66. Dr. Robert Goldberg concurred that if metastases in the liver were strongly shown, a liver biopsy would be appropriate, but concluded that it was not strongly shown in Patient J.R.R., testifying:

        Q: And if those imaging studies indicated that the nodules in the liver were potentially metastatic, and the blood tests did not


        indicate any particular cancer, would you go to a colonoscopy as your next diagnostic tool?


        A: Yeah. You are creating a hypothetical. I would look at the case and, you know, specifically, what are their blood tests? Has the patient lost weight? Is the patient having abdominal pain? Is the patient anemic? Are the liver function tests abnormal? Is – am I strongly thinking that this is metastatic cancer, or am I thinking these are benign nodules – regenerating nodules? For example, in the context of cirrhosis, hemangioma, et cetera. So it all depends on the specifics of the case.


        Q: What if the report from the CT scan said the nodules were suspicious for metastases, and then an ultrasound confirmed the same report?


        A: Were they present before? Q: What if that was unclear?

        A: Well, I -– I would have to, again, review the reports and see what is being said, and if the information strongly supported that this was metastatic liver disease, I would consider doing a liver biopsy.


        Q: Okay. And what evidence would you be looking at to strongly support that?


        A: Weight loss, abnormal liver function tests, lesions which radiologically are suggestive of metastatic liver disease, lesions which have clearly changed over a period of time. It would have to be a clinical suspicious – suspicion of metastatic liver disease.


      67. Dr. Robert Goldberg further testified:


        Q: Finally, doctor, do you--is it your opinion that Dr. Singer acted appropriately and within the standard of care for physicians


        like him--as a gastroenterologist--in his care, treatment, assessment and evaluation of this patient and going forward with the colonoscopy when he did?


        A: It is. I believe that Dr. Singer acted appropriately, prudently, thoughtfully, and as I go over the records, even in retrospect, I suspect I would have acted very similarly.


      68. Dr. Robert Goldberg found it significant that the report of the later scan, with contrast, also seemed to indicate that there were several lesions that had not changed at all. He thought it unlikely that if these were cancerous lesions present a year and a half before, that there would have been no weight loss, no evidence of impaired liver function, and no direct symptoms accompanying metastatic liver disease. He also noted that if Patient J.R.R. had regenerative nodules and hemangioma, there was an increased risk of bleeding with a liver biopsy that could be significant.

      69. It was Dr. Firpi's opinion that even if metastatic disease was clearly shown, that a liver biopsy would not be necessary for a patient similar to Patient J.R.R., testifying:

        Q: Would you order a colonoscopy? A: Yes, I would.

        Q: And what would you be looking for? How would that help you?


        A: It will help me find out if the primary is colon cancer. You need to know is the primary from there and do staging.


        Q: Would you order the colonoscopy regardless of the results of the liver function tests and cancer markers?


        A: If they're telling me in radiology that this is metastatic disease or it looks like metastatic disease, I would have ordered the colonoscopy.


        Q: So for every patient that's referred to you for a liver evaluation you do a colonoscopy?


        A: Not for a liver evaluation. For liver metastasis.


        Q: So for every patient that's referred to you for lesions in the liver suspicious for metastases you do a colonoscopy?


        A: They should have a colonoscopy.


        Q: Even patients with significant comorbidities?


        A: Yes.


        Q: Would you include a liver biopsy?


        A: I'm not sure why. I don't think so. I would say no.


      70. Dr. Firpi testified that the standard of care for a patient with all of the conditions and circumstances of Patient

        J.R.R. required that a colonoscopy and endoscopy be conducted if a CT scan determined that there was metastatic disease in the liver. He testified that he would not have done anything differently than Dr. Singer did.

      71. Dr. Singer testified that in the particular case of Patient J.R.R., he concluded that the risks of a liver biopsy were


        in fact greater than the risks of an EGD and colonoscopy, due to the greater ability to control complications in endoscopic procedures, possible liver hemangioma, coagulation problems, ascites, and renal failure. Dr. Singer testified that there were multiple reasons to conduct a colonoscopy: elapsed time since the previous colonoscopy; the possibility of metastatic liver cancer; and the transplant clearance. Given increased risk for a liver biopsy and the fact that the colon was the most likely spot for a primary tumor, he testified that he decided to perform the EGD and colonoscopy before a liver biopsy.

      72. It was not clearly shown that, in scheduling and performing the EGD and colonoscopy on Patient J.R.R. prior to further evaluation of the abnormal radiologic evaluations of possible metastatic lesions or cirrhosis of the liver, Dr. Singer deviated from the standard of care recognized as acceptable and appropriate by reasonably prudent similar health care providers.

      73. It was stipulated that Dr. Singer did not deviate from the standard of care in his actual performance of Patient J.R.R.'s April 30, 2010, colonoscopy and upper endoscopy procedures.

      74. No evidence was introduced to show that Dr. Singer has had any prior discipline imposed upon his license.

      75. Dr. Singer was not under any legal restraints on April 30, 2010.


      76. It was not shown that Dr. Singer received any special pecuniary benefit or self-gain from his actions on April 30, 2010.

      77. It was not shown that the actions of Dr. Singer on April 30, 2010, involved any trade or sale of controlled substances.

        CONCLUSIONS OF LAW


      78. The Division of Administrative Hearings has jurisdiction in this proceeding pursuant to sections 120.569 and 120.57(1), Florida Statutes (2016).

      79. A proceeding to suspend, revoke, or impose other discipline upon a license is penal in nature. State ex rel.

        Vining v. Fla. Real Estate Comm'n, 281 So. 2d 487, 491 (Fla. 1973). Petitioner must therefore prove the charges against Respondent by clear and convincing evidence. Fox v. Dep't of Health, 994 So. 2d 416, 418 (Fla. 1st DCA 2008)(citing Dep't of

        Banking & Fin. v. Osborne Stern & Co., 670 So. 2d 932 (Fla.


        1996)).


      80. The clear and convincing standard of proof has been described by the Florida Supreme Court:

        Clear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the testimony must be precise and explicit and the witnesses must be lacking in confusion as to the facts in issue. The evidence must be of such weight that it produces in the mind of the trier of fact a firm belief or conviction, without hesitancy,


        as to the truth of the allegations sought to be established.


        In re Davey, 645 So. 2d 398, 404 (Fla. 1994)(quoting Slomowitz v.


        Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983)).


      81. Disciplinary statutes and rules "must always be construed strictly in favor of the one against whom the penalty would be imposed and are never to be extended by construction." Griffis v. Fish & Wildlife Conserv. Comm'n, 57 So. 3d 929, 931

        (Fla. 1st DCA 2011); Munch v. Dep't of Prof'l Reg., Div. of Real Estate, 592 So. 2d 1136 (Fla. 1st DCA 1992).

      82. Before consideration of the charges of the Amended Administrative Complaint, two evidentiary issues merit discussion. First, Respondent objected during deposition, on grounds of hearsay and bolstering, to portions of Dr. Paul Goldberg's testimony in which he indicated that he had relied upon literature in forming his opinion. The general rule is that an expert may not bolster his testimony by testifying that a particular treatise supports his opinion. The evidence code specifically addresses this issue. Under section 90.704, Florida Statutes, data that is of a type reasonably relied upon by similar experts may form a basis of an expert opinion, but data that is not otherwise admissible may be disclosed to a jury only if its probative value substantially outweighs its prejudicial


        effect. See also Linn v. Fossum, 946 So. 2d 1032, 1036 (Fla.


        2006).


      83. The rules of evidence in administrative proceedings are less strict than those applicable to civil proceedings, and hearsay is admissible to supplement or explain other competent evidence. § 120.57(1)(c), Fla. Stat. Here, where Dr. Paul Goldberg did not mention any particular literature or treatise by name, but only mentioned that he had reviewed some literature along with the medical records, there was no inappropriate bolstering or prejudice to Respondent. Further, the hearsay information he referenced may properly be considered because it supplements and explains his opinion that the risks of the EGD and colonoscopy under sedation were greater than the risks of a percutaneous liver biopsy. Orasan v. Ag. for Health Care Admin., 668 So. 2d 1062, 1063 (Fla. 1st DCA 1996)(error for hearing officer to sustain objection that hearsay evidence was inadmissible as bolstering appellant's testimony).

      84. Second, Petitioner objected, through its Motion in Limine, to the admission of the deposition testimony of Dr. Firpi on the grounds that while he is board-certified in the specialty of internal medicine with a subspecialty in gastroenterology, he also holds certification in another subspecialty, that of transplant hepatology, while Respondent is only board-certified in internal medicine with a subspecialty in gastroenterology.


      85. Section 458.331(1)(t)1. provided that the Board of Medicine shall give great weight to the provisions of section 766.102, Florida Statutes, in proceedings involving allegations of medical malpractice as grounds for disciplinary action.

      86. Section 766.102(5)(a) provided in relevant part that an expert must:

        Specialize in the same specialty as the health care provider against whom or on whose behalf the testimony is offered; or specialize in a similar specialty that includes the evaluation, diagnosis, or treatment of the medical condition that is the subject of the claim and have prior experience treating similar patients[.]


      87. Even were the subspecialty of transplant hepatology not sufficiently similar to the subspecialty of gastroenterology under this provision, this is not a situation in which the testimony of a specialist is being offered against a generalist, or conversely where the testimony of a generalist is being offered against a specialist, both clearly forbidden. Instead, the proffered expert here is certified in the same specialty, as well as the same subspecialty, in which Respondent is certified. Dr. Firpi also had both an active clinical practice, and instructed students and residents, in gastroenterology within the three years immediately preceding April 2010. Dr. Firpi is qualified by his education, training, and experience to testify as to the prevailing professional standard of care applicable to an internal medicine


        specialist with a subspecialty in gastroenterology, such as Respondent. § 766.102(5)(a)2.a., b., Fla. Stat. To the extent that Dr. Firpi is also a subspecialist in another area, this does not disqualify him as an expert in the same subspecialty as Respondent, but rather places responsibility on all parties to ensure that offered testimony is relevant as to the standard of care governing Respondent. After argument on the Motion in Limine at hearing,3/ Respondent's Exhibit R-8 was admitted over Petitioner's objection (subject to objections made within the deposition).

      88. The Amended Administrative Complaint alleged that Respondent committed medical malpractice in violation of section 458.331, which provided, in relevant part:

        1. The following acts constitute grounds for

          . . . disciplinary action . . . .


          * * *


          (t)1. Committing medical malpractice as defined in s. 456.50.


      89. Section 456.50(1)(g), Florida Statutes, defined "medical malpractice" in relevant part as the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure.

      90. Section 766.102(1) further provided in part that "the prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which,


        in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers."

      91. Petitioner alleged that Respondent committed medical malpractice in:

        1. failing to cancel or postpone J.R.R.'s April 30, 2010, surgical procedures, pending an evaluation of J.R.R.'s potential liver malignancies; and/or


        2. failing to pursue the abnormal findings of the multiple radiologic evaluations of possible metastatic lesions, and/or cirrhosis of J.R.R.'s liver prior to performing the April 30, 2010, procedure on Respondent.


      92. The essence of Dr. Paul Goldberg's analysis in support of the complaint was that the least invasive diagnostic procedure should be utilized and that, primarily due to the type of anesthesia necessary, a liver biopsy entailed less risk than an EGD and colonoscopy.

      93. While Petitioner presented convincing evidence that, statistically, an EGD and colonoscopy does involve more risk than a liver biopsy for patients generally, due in large part to the anesthesia used, this showing alone was insufficient to clearly and convincingly demonstrate malpractice. Under appropriate "risk-benefit" evaluation, the relative benefits of the two approaches in a patient similar to Patient J.R.R. must also be considered. The evidence that the liver biopsy would have


        provided sufficient benefits in light of its risks as compared to the overall risks and benefits of the EGD and colonoscopy for Patient J.R.R. was strongly contested, and not clearly and convincingly shown.

      94. Petitioner failed to establish by clear and convincing evidence that Respondent committed medical malpractice in violation of section 458.331(1)(t)1., as charged in the Amended Administrative Complaint.

RECOMMENDATION


Based on the foregoing Findings of Fact and Conclusions of Law, it is

RECOMMENDED that a final order be entered by the Department of Health, Board of Medicine, dismissing the Amended Administrative Complaint against Dr. Leib Singer.

DONE AND ENTERED this 28th day of March, 2017, in Tallahassee, Leon County, Florida.

S

F. SCOTT BOYD Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us


Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 2017.


ENDNOTES


1/ Citations to statutes are to those versions in effect during the time of Respondent's treatment of J.R.R. in April 2010, except as otherwise indicated.


2/ EGDs and colonoscopies are usually performed under monitored anesthesia care (MAC). Patients receive a sedative, in most cases Propofol, and they are unconscious during the procedure. Patients are monitored by a nurse anesthetist or anesthesiologist.


3/ Although ruling on the Motion in Limine was deferred to the hearing, neither party offered evidence, instead agreeing that the specialties and subspecialties were identical on their face, and focusing argument upon the effect of the additional subspecialty certification held by Dr. Firpi. Section 766.102 by its terms governs the qualifications of an expert at hearing. That statute has been applied by Florida courts in the version that exists at the time of the incident. See, e.g., Williams v. Oken, 62 So. 3d 1129, 1131 (Fla. 2011) (referencing the 2005 version of presuit requirements, not the version later in effect). The Florida Supreme Court declined to adopt the "same specialty" amendment made by chapter 2013-108, § 2, Laws of Florida. See In re Amendments to the Fla. Evidence Code, No. SC16-181, 2017 Fla.

LEXIS 338, at *21 (Feb. 16, 2017). Whether or not the "same or similar specialty" or "same specialty" language is applied, the result would be the same in this case, as discussed above.


COPIES FURNISHED:


Zachary Bell, Esquire

Ross Daniel Vickers, Esquire Department of Health Prosecution Services Unit

4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed)


Richard T. Woulfe, Esquire Billing, Cochran, Lyles, Mauro

& Ramsey, P.A.

SunTrust Center, Sixth Floor

515 East Las Olas Boulevard Fort Lauderdale, Florida 33301 (eServed)


Nichole C. Geary, General Counsel Department of Health

4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed)


Claudia Kemp, J.D., Executive Director Board of Medicine

Department of Health

4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed)


NOTICE OF RIGHT TO SUBMIT EXCEPTIONS


All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.


Docket for Case No: 16-005752PL
Issue Date Proceedings
Jul. 11, 2017 Petitioner's Exceptions to Recommended Order filed.
Jul. 11, 2017 Respondent's Response to Petitioner's Exceptions to Recommended Order filed.
Jul. 11, 2017 Agency Final Order filed.
Mar. 28, 2017 Recommended Order (hearing held January 23, 2017). CASE CLOSED.
Mar. 28, 2017 Recommended Order cover letter identifying the hearing record referred to the Agency.
Mar. 06, 2017 Petitioner's Proposed Recommended Order filed.
Mar. 06, 2017 (Proposed) Recommended Order filed.
Feb. 24, 2017 Transcript of Proceedings (not available for viewing) filed.
Jan. 23, 2017 CASE STATUS: Hearing Held.
Jan. 23, 2017 Respondent's Exhibit 12 - Roberto Firpi, MDs CV filed.
Jan. 23, 2017 Respondent's Exhibit 11 - Robert Goldberg, MDs CV filed.
Jan. 23, 2017 Respondent's Exhibit 10 -Robert Goldberg, MDs Affidavit dated 6/13/13 filed.
Jan. 23, 2017 Respondent's Exhibit 9 -Robert Goldberg, MDs Affidavit dated 5/10/12 filed.
Jan. 23, 2017 Respondent's Exhibit 8 -Roberto Firpi MDs Deposition filed.
Jan. 23, 2017 Respondent's Exhibit 7 -Robert Goldberg, MDs Deposition filed.
Jan. 23, 2017 Notice of Filing Respondent's Exhibits filed.
Jan. 20, 2017 Notice of Filing of Petitioner's Exhibits filed (Exhibits not available for viewing).
Jan. 20, 2017 Amended Notice of Hearing by Video Teleconference (hearing set for January 23, 2017; 9:00 a.m.; Lauderdale Lakes and Tallahassee, FL; amended as to date and hearing type).
Jan. 18, 2017 Respondent, Leib H. Singer, M.D.'s Response In Opposition To Petitioner's Amended Motion In Limine To Exclude Expert Opinion Testimony of Dr. Roberto J. Firpi filed.
Jan. 13, 2017 Joint Pre-hearing Stipulation (16-005752PL) filed.
Jan. 13, 2017 Petitioner's Amended Motion in Limine to Exclude Expert Opinion Testimony of Dr. Robert J. Firpi filed.
Jan. 13, 2017 Respondent, Leib H. Singer, M.D.'s, Response in Opposition to Petitioner's Motion in Limine to Exclude Expert Opinion Testimony of Dr. Roberto J. Firpi filed.
Jan. 11, 2017 Petitioner's Motion in Limine to Exclude Expert Opinion Testimony of Dr. Roberto J. Firpi filed.
Jan. 11, 2017 (Respondent's) Cross-notice of Taking Video-taped Deposition (Roberto J. Firpi, M.D) filed.
Jan. 09, 2017 Notice of Taking Deposition Duces Tecum filed.
Dec. 28, 2016 Notice of Taking Deposition Duces Tecum (Dr. Robert Goldberg) filed.
Dec. 23, 2016 Leib H. Singer, M.D.'s Notice of Service of Amended Answers to Petitioner's First Set of Interrogatories filed.
Dec. 23, 2016 Respondent, Leib Singer's, Amended Response to Petitioner's First Request for Production filed.
Dec. 23, 2016 (Respondent) Amended Response to Request for Admissions filed.
Dec. 14, 2016 Subpoena Duces Tecum (to Paul B. Goldberg, M.D) filed.
Dec. 14, 2016 Cross Notice of Taking Deposition Duces Tecum (of Paul Goldberg, M.D) filed.
Dec. 12, 2016 Notice of Service of Petitioner's Response to Respondent's First Set of Interrogatories and Consolidated Exhibits filed.
Dec. 12, 2016 Notice of Service of Petitioner's Response to Respondent's First Request for Production and Consolidated Exhibits filed.
Dec. 07, 2016 Notice of Taking Telephonic Deposition in Lieu of Live Testimony (LeibSinger, M.D.) filed.
Dec. 07, 2016 Notice of Taking Telephonic Deposition in Lieu of Live Testimony (Paul Goldberg, M.D.)filed.
Nov. 14, 2016 (Respondent, Leib H. Singer, M.D.) Response To Request For Admissions filed.
Nov. 14, 2016 (Respondent) Leib H. Singer, M.D.'s Notice of Service of Answers To Petitioner's First Set Of Interrogatories filed.
Nov. 14, 2016 Respondent, Leib Singer's, Response To Petitioner's First Request For Production filed.
Nov. 10, 2016 Leib H. Singer, M.D.'s, Notice of Service of Interrogatories to Petitioner, Department of Health filed.
Nov. 10, 2016 Leib H. Singer, M.D.'s, Request For Production To Petitioner, Department of Health filed.
Oct. 25, 2016 Order Granting Continuance and Re-scheduling Hearing (hearing set for January 23 through 25, 2017; 9:00 a.m.; Fort Lauderdale, FL; amended as to ).
Oct. 25, 2016 Respondent's Motion for Continuance of Hearing filed.
Oct. 24, 2016 Respondent's Answer and Affirmative Defenses to Petitioner's Amended Administrative Complaint filed.
Oct. 17, 2016 Order of Pre-hearing Instructions.
Oct. 17, 2016 Notice of Hearing (hearing set for December 7 through 9, 2016; 9:00 a.m.; Fort Lauderdale, FL).
Oct. 14, 2016 Joint Response to Initial Order filed.
Oct. 06, 2016 Order Granting Extension of Time.
Oct. 05, 2016 Petitioner's Notice of Appearance of Co-Counsel (Ross Vickers) filed.
Oct. 05, 2016 Notice of Appearance (Ross Vickers) filed.
Oct. 04, 2016 Notice of Serving Petitioner's First Request for Production, First Request for Interrogatories and First Request for Admissions to Respondent filed.
Oct. 03, 2016 Petitioner's First Request for Admissions filed.
Oct. 03, 2016 Petitioner's First Set of Interrogatories filed.
Oct. 03, 2016 Petitioner's First Request for Production filed.
Oct. 03, 2016 Initial Order.
Sep. 30, 2016 Election of Rights filed.
Sep. 30, 2016 Amended Administrative Complaint filed.
Sep. 30, 2016 Agency referral filed.

Orders for Case No: 16-005752PL
Issue Date Document Summary
Jul. 07, 2017 Agency Final Order
Mar. 28, 2017 Recommended Order Medical malpractice was not proven where the standard of care was not clearly shown to require a liver biopsy prior to a colonoscopy under the particular circumstances of the patient involved.
Source:  Florida - Division of Administrative Hearings

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