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48 Case 2:06-cv LMA-JCW Document Filed 09/25/2007 Page 48 of 51 MATERIALS REVIEWED BY MICHAEL KASHGARIAN, M.D. RE: TIMOTHY BRACEY A. Plaintiff s Medical Records (1) Culicchia Neurological Clinic; (2) Heart Clinic of Louisiana; (3) Dr. Mar k W or k man ; (4) The Family Docto rs ; (5) Dr. Julio Bravo; (6) Metropolitan Gastroenterology Assoc.; (7) Dr. David C. Tr een; (8) Cardiology Consultants of Louisiana ; (9) New Orleans Nephrology; (10) Walgreens; ( 1 1 ) Bowel Prep Instructions from Dr. Treen; ( 1 2 ) Bowel Prep Instructions from Dr. Reddy; ( 1 3 ) West Jefferson Medical Center; ( 1 4 ) East Jefferson Medical Center; and ( 1 5 ) Dr. Richard J. P addock B Legal Pleadings and Discovery Responses: (1) Complaint; (2) Plaintiffs Responses to C.B. Fleet Company, Inc. s Interrogatories; (3) Deposition Transcript of Miguel Molina, M.D; (4) Deposition Transcript of Sanjeeva Reddy, M.D.;
49 Case 2:06-cv LMA-JCW Document C. (5) Deposition Transcript of Timothy Bracey; (6) Deposition Transcript of David Treen, M.D.; and (7) Deposition Transcript of Rian M. Tanenbaum, M.D. Plaintiff s Expert Disclosure (1) D. Filed 09/25/2007 Page 49 of 51 Report of Eric Brown, M.D. Articles: (1) Ahmed M., Raval P., and Buganza G. Oral Sodium Phosphate Catharsis and Acute Renal Failure. Am. J. Gastroenterol 1996; 91(6): (2) Adverse Drug Reactions Advisory Committee: Electrolyte Disturbances with Oral Phosphate Bowel Preparations. Australian Adverse Drug Reactions Bulletin 16(1), (3) Boivin M.A. and Kahn S.R. Symptomatic Hypocalcemia from Oral Sodium Phosphate: a Report of Two Cases. Am. J. Gastroenterol 1998; 93(12): (4) Orias M., Mahnensmith R.L., and Perazella M.A. Extreme Hyperphosphatemia and Acute Renal Failure after a Phosphorus-Containing Bowel Regimen. Am J Nephrol 1999; 19(1):60-3. (5) Vukasin P., Weston L.A., and Beart R.W. Oral Fleet Phospho-Soda Laxative-Induced Hyperphosphatemia and Hypocalcemic Tetany in an Adult: Report of a Case. Dis Colon Rectum 1997; 40(4): (6) Clarkston, Wendell K., MD, Tsen, Tony N., MD, Dies, David F., MD, Schratz, C. Lynn, RN, Vasawani, Surender K., MD, Bjerregaard, Preben, MD. Oral Sodium Phosphate Versus Sulfate-Free Polyethylene Glycol Electrolyte Lavage Solution in Outpatient Preparation For Colonoscopy: a Prospective Comparison. Gastrointestinal Endoscopy 1996 Jalln; 43(1):42-8. (7) DiPalma, J.A., Buckley S.E., Warner, B.A. Culpepper R.M. Biochemical Effects of Oral Sodium Phosphate. Digestive Diseases and Sciences 1996 Apr; 41(4); (8) Huynh T., Vanner S., and Paterson W. Safety Profile of 5H Oral Sodium Phosphate Regimen for Colonoscopy Cleansing: Lack of Clinically Significant Hypocalcemia or Hypovolemia. Am J. Gastroenterol 1995; 90(1):
50 Case 2:06-cv LMA-JCW Document Filed 09/25/2007 Page 50 of 51 (9) Lieberman D.A.; Ghormley J., Flora K. Effect of Oral Sodium Phosphate Colon Preparation on Serum Electrolytes in Patients with Normal Serum Creatinine. Gastrointestinal Endoscopy 1996 May;43(5): (10) Vanner S.J., MacDonald P.H., Paterson W.G., Prentice R.S., Da Costa L.R., Beck I.T. A Randomized Prospective Trial Comparing Oral Phosphate with Standard Polyethylene Glycol-Based Lavage Solution (Golytely) in the Preparation of Patients For Colonoscopy. Am J Gastroenterol 1990;85: (11) Campisi P., Badhwar V., Morin S., et al. Postoperative Hypocalcemic Tetany Caused by Fleet Phospho-soda Preparation in a Patient Taking Alendronate Sodium: Report of a Case. Dis Colon Rectum 1999; 42: (12) Chan A., Depew W., Vanner S. Use of Oral Sodium Phosphate Colonic Lavage Solution by Canadian Colonoscopists: Pitfalls and Complications. Canadian Journal of Gastroenterology, 1997 May-Jun;11(4):334-8, (13) Barclay R.L., Depew W.T., Vanner S. CarbohydrateElectrolyte Rehydration Protects Against Intravascular Volume Contraction During Colonic Cleansing With Orally Administered Sodium Phosphate. Gastrointestinal Endoscopy 2002; 56: (14) Desmeules S., Bergeron M.J., Isenring P. Acute Phosphate Nephropathy and Renal Failure. New England Journal of Medicine 2003; 349: (15) Gumurdulu Y., Serin E., Ozer B., Gokcel A. and Boyacioglu S. Age as a Predictor of Hyperphosphatemia After Oral Phosphosoda Administration for Colon Preparation. Journal of Gastroenterology and Hepatology (2004) 19, (16) Markowitz G., Stokes B., Radhakrishnan J., D Agati V. Acute Phosphate Nephropathy following Oral Sodium Phosphate Bowel Purgative: An Underrecognized Cause of Chronic Renal Failure. J Am Soc Nephrol 16, (17) Perazella M.A. Drug-Induced Nephrophathy: An Update. Expert Opinion Drug Saf. (2005) 4(4). (18) Tjandra J.J., Tagkalidis P. Carbohydrate-Electrolyte (ELyte) Solution Enhances Bowel Preparation with Oral Fleet Phospho-Soda. Diseases of the Colon & Rectum 2004 Jul;47(7): (19) Vanner S.J., MacDonald P.H., Paterson W.G., Prentice R.S., Da Costa L.R., Beck I.T. A Randomized Prospective Trial Comparing Oral Phosphate with Standard Polyethylene Glycol-Based Lavage Solution (Golytely) in the Preparation of Patients For Colonoscopy. Am J Gastroenterol 1990;85: (20) Oliveira L, Wexner S.D., Daniel N., DeMarta D., Weiss
51 Case 2:06-cv LMA-JCW Document Filed 09/25/2007 Page 51 of 51 E.G., Nogueras J.J., Bernstein M. Mechanical Bowel Preparation for Elective Colorectal Surgery. Dis Colon Rectum 1997;40: (21) Golub R.W., Kerner B.A., Wise W.E. Jr., Meesig D.M., Hartmann R.F., Khanduja K.S., Aguilar P.S. Colonoscopic Bowel Preparation-Which One? A Blinded, Prospective, Randomized Trial. Dis Colon Rectum 1995; 38: (22) Frommer D. Cleansing Ability and Tolerance of Three Bowel Preparations for Colonoscopy. Dis Colon Rectum 1997;40: (23) Kolts B.E., Lyles W.E., Achem S.R., Burton L., Geller A.J., MacMath T. A Comparison of the Effectiveness and Patient Tolerance of Oral Sodium Phosphate, Castor Oil and Standard Electrolyte Lavage for Colonoscopy or Sigmoidoscopy Preparation. Am J Gastroenterology 1993;88: (24) Cohen S.M., Wexner S.D., Binderow S.R., Nogueras J.J., Daniel N., Ehrenpreis E.D., Jensen J., Bonner G.F., Ruderman W.B. Prospective, Randomized Endoscopic-Blinded Trial Comparing Pre-Colonoscopy Bowel Cleansing Methods. Dis Colon Rectum 1994;37: E. Fleet Phospho-Soda Labeling in the PDR ( ) F. Dear Healthcare Professional letters (1993, 1995, 1998, 2002, 2004, 2005, 2006) sent by Fleet G. FDA Backgrounders 2001 and 2006
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Case 2:06-cv-03238-LMA-JCW Document 48-15 Filed 09/25/2007 Page 1 of 17 Case 2:06-cv-03238-LMA-JCW Document 48-15 Filed 09/25/2007 Page 2 of 17 Case 2:06-cv-03238-LMA-JCW Document 48-15 Filed 09/25/2007
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[Insert Date] Dear Colleagues, The enclosed manuscript contains important information for colonoscopists about the safe and effective use of oral sodium phosphate solution (OSPS) for bowel preparation
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