Credibility of Medical Evidence - National Association of Workers
Transcription
Credibility of Medical Evidence - National Association of Workers
Fourth Annual NAWCJ Judiciary College August 20-23, 2012 I. II. III. IV. V. VI. VII. VIII. IX. X. Judicial Writing and Editing, Professor Terrel Comparative Law Panel Credibility of Medical Evidence, Professor McCluskey Evidence a. Electronic Evidence, Professor Ehrhardt b. Evidence for Adjudicators, Ehrhardt Live Surgery, Biographies To Tell the Truth, Ms. Constantine Keeping the Case on Track, Judge Jones Social Networking, Rissman Wieland Technology a. Technology, Judge Rosen b. Technology, I phone Article Appellate Roundtable a. Appellate Roundtable, Alvey b. Appellate Roundtable, Jones DETERMINING CREDIBILITY OF MEDICAL OPINIONS James McCluskey, M.D. – Univeristy of South Florida Dr. James McCluskey is a Board Certified Occupational Medicine Physician and a PhD-trained Toxicologist. He is the Medical Director of the Center for Environmental/Occupational Risk Analysis and Management at the University of South Florida, Tampa, Florida. In addition, he is an assistant professor at the USF College of Medicine in the Department of Internal Medicine, and a research assistant professor at the USF College of Public Health in the Department of Environmental and Occupational Health. Dr. McCluskey completed an advanced subspecialty residency in Occupational Medicine in which the program curriculum and clinical experiences were extensively in Toxicology and Risk Assessment. Dr. McCluskey is actively involved with a research team investigating the human health effects of chemical exposure(s). His publications include articles on chemical exposures and various pulmonary conditions, as well as co-authorship of a chapter on occupational asthma. He is a frequent lecturer for public, private and academic groups. His medical practice is focused on the evaluation of medical cases involving environmental/occupational chemical, respiratory, infectious and allergen exposures. Work Made Me This Way!!!!! What is an IME? Evaluation of Complex Workplace Incidents, IME’s and Determining the Credibility of Expert Opinions James McCluskey, MD, MPH, PhD University of South Florida Colleges of Medicine and Public Health You’ve Been Exposed! A Question of Fact Arises ….. And The Game Has Actually Just Begun……… ¾How do Two “Qualified Experts” reach Diametrically Opposed Views? Wouldn’t it be nice if an “exposed” monkey was orange? “Simple” = Please Avoid These Mistakes No Objective Testing Poor Quality Objective Testing Ignoring “Quality” Objective Testing Ignoring Common Sense • The Case Facts (or lack thereof) – What, why, how, etc., t etc. t • The Experiences of Each – 1 year x 26 or …… • The Opinions of Each – Style Issues • The Literature Considered …. Or Not • The Interpretation of the Literature • The “What I Believe is Right” Phenomenon Evaluation of a Workplace Claim 9 Evidence of Exposure 9 Exposure Must Result in a Dose 9 The Dose Must be Sufficient to Cause the Effect 9 The Effect Must be Known to be Caused by the Chemical/Insult 9 Effect Must be Temporally Eligible to be Caused by the Exposure 9 Effect Must be Biological Plausible 9 Other Causes Must be Eliminated + 1 Questions the “Captain” Should Ask! • Why has he had MRSA for three years? • Can a PPD become positive 1 week after exposure? • What Wh t iis the th utility tilit off th the that “weird” test? • His allergy testing is “negative”? • Is all wheezing asthma? • She has been coughing (1.5 years) since the exposure? Asking the Right Questions….. Don’t Get a “Muddy” Chart!!!! Subjective Objective 9 Shortness of Breath ≠ Reactive Airways ≠ Asthma ≠ COPD ≠ Hypersensitivity Pneumonitis (Extrinsic Allergic Alveolitis) ≠ etc. Establishing Causation NEEDS IMPROVEMENT (The Tale of Can and Did) In your professional opinion, what is the diagnosis? GENERAL CAUSATION BETTER In your professional opinion, what is the diagnosis and what objective information supports your finding(s)? Chemical CAN cause the particular disease or symptom SPECIFIC CAUSATION Chemical DID cause the particular disease or symptom *******Also Known As – Possible and Probable******** Use of the Medical Literature Anything is Possible, Few Things are Probable • Remember the Chain of Believability – Case Report – Case Series – Case Control/Cohort/Nested Case Control Consistent Results, Repeated by Different Investigators are the Highest Level of Evidence!!!! Don’t Forget The Rest of the Story….. Weeding Out Confounders In a Case 2 Water intrusion Mold growth Renovations painting dry walling Building sources Cleaning chemicals Air fresheners Just Think Airway injury Oxidants Elevated VOCs MVOCs Formaldehyde Terpenes Building conditions/ factors Temperature Humidity Lighting Noise The Typical American…. Ozone outdoors Reduced Outdoor Air supply Airway inflammation Reactive molecules Someday, S d h he may claim that work gave him CANCER! Symptoms & Complaints The Indoor Air Environment Pure Chance Causes Many (MOST) Things The Chemical Soup Where We Eat, Breathe, Bathe and Work Also Referred To As: Bad Luck!!! – Winning The Lottery…. “Planned” Bad Luck – Smokin’, Drinkin’, Lovin’ and Breathin’ Having a Bad Pair of Levi’s (Genes) Special Considerations ….. The Boss Individuals at Increased Risk 9Immunocompromised ¾ Organ transplantation ¾ Immunosuppression ¾ Cancer chemotherapy ¾ Disease with Immunosuppression 9Very Young 9Very Old 9Pregnant Me [email protected] (813) 505-6709 Questions? 3 James McCluskey, MD, PhD, MPH University of South Florida, College of Public Health 13201 Bruce B. Downs Boulevard, MDC 56 Tampa, Florida 33612 jmccluskliV,health.usf.edu Phone - (813) 505-6709 Fax - (866) 615-0928 January 31, 2012 XXXXX, Esquire XXXXXXXXXX Mr. Re: GGGGGG AAAAA Dear Mr. XXXXX: As you know, this was a situation involving a great deal of medical care and hospitalizations, yet the basic facts related to any exposure that Ms. AAAAA possibly had while working for the OCs are quite clear. For purposes of explaining her potential workplace exposures, I have included details related to the various industrial hygiene evaluations and remediation activities that were undertaken at the OC since 2009. INDUSTRIAL HYGIENE EVALUATIONS: October 20, 2009: Asbestos Abatement Report Pre-Cleaning of Attic and Chiller/Boiler Room Abatement - Morse Zehnter Associates - This report documents the contracted precleaning and stabilization of asbestos-containing (ACM) from walkways in the attic space of OC., as well as the abatement of ACM in the boiler and chiller rooms. The attic walkways were cleaned with a HEPA vacuum cleaner, and ductwork (NC) that was likely to be impacted was covered. In the boiler room the area was demarked by asbestos caution tape and friable plaster fittings were removed. In the chiller room the room was isolated with negative pressure containment and insulation for the pipes with stripped and placed in disposal bags. The work area was then cleared for re-occupancy by visual inspection and phase contrast microscopy air sampling. The work area was released for re-occupancy when all five samples were found to have less than .01 fibers/cubic centimeter which is the lowest quantifiable level for the analysis method. All abatement activities were performed in accordance with the 'Technical Specification" dated February 2009 and the Scope of Work developed for this project and revised by MZA dated September 2009. Julv 26, 2010: Site Inspection and Air Sampling Report - Ecotech Environmental Consultants - Air samples were collected on July 23, including I outdoor sample for comparison purposes. The samples were examined by EMSL. This report included comments on 18 samples. Sample I was taken of the outdoors. Comment on Samples 2,7,10,13,14,15 and 17: Despite the fact that indoor spore levels were higher than outdoor levels, the spore counts detected in this area are not very significant when compared to average spore counts in Florida during this time of year. Comment on Samples 12 and 16: Total indoor mold spore levels were moderately elevated when compared to total outdoor mold spore levels, thus mold may be growing and releasing spores somewhere in or near the above mentioned test area Comment of Samples 3,4,5,6,8,9,11 and 18: Total indoor mold spore levels were high compared to total outdoor mold spore levels, thus mold may be growing and releasing spores somewhere in or near the above mentioned test area August 2, 2010: Expanded Fungal Report - EMSL Air Sam le Results in the ARLC Northeast Wing) Spore Type Ascospores Aspergillus Penicillium Basidiospores Cladosporium Curvularia Myxomycetes Torula Total Fungi Hyphal Frag Sample #12 Room 207 Sample #13 TV Room by #207 4980/m 3 484/m 3 211m 3 201m 3 71m 3 Sample #14 Room 194 • Sample #15 Room 193 Sample #16 Room 192 211m 3 359m3 841m3 211m 3 211m 3 71m 3 5010m 3 506/m 3 t- 380/m 3 105/m3 211m 3 August 14-24, 2010: Site Inspection and Air Sampling Report - Ecotech Total Spores were High in the following areas: Conference room; Office #129; East unit rooms 145, 140; Room 238, 235, 245, 249, 252, 255, 267, 264, 285; Office #128; CMO Office; Pharmacy; Medical Records; ARLC Laundry (207). One or more Spore Types were High in the following areas: Client funds office; East unit room 139,140; ARLC kitchen; Rooms 209, 208, 203, 242, 264B, 258: Administration Office. One or more Sport Types were Moderately High in the following areas: East unit room #147, Medical records, Finance office south side, Room #169, ARLC TV room and Room #231. September 10, 2010: OC Indoor Air Quality Report - Morse Zehnter Associates - MZA was asked to conduct a 3'd party review of the Ecotcch data generated in the August 14-24 site collections. MZA was informed that the inspection occurred during a time when the temperature and humidity levels in the building were elevated due to the condition of the AlC system. Thus, the results of Ecotech may reflect a time that may not be representative of the building under controlled conditions. MZA agreed that with their conclusion that certain areas of the building may have been impacted by moisture from AlC condensation, plumbing, window and/or envelope leaks that need to be addressed as soon as is practical. We have prioritized seven areas for remediation where such factors as the mold spore levels were elevated and were in 2 combination with observations of visible mold, moisture and high humidity areas. Remediation will consist of controlled removal of some walls behind dust barriers, identifying root causes of moisture intrusion, correcting moisture intrusion problems, cleaning the space, filtering the air and then conducting real time particulate level measurements in order to release for reoccupancy. September 22, 2010: OC Indoor Air Quality Consulting Report - Post Remediation Verification Rooms 235/238 West Unit - Morse Zehnter Associates - The post remediation process consisted of a visual inspection of the work area for cleanliness following the removal and replacement of water/mold damaged building materials from each of the client rooms by Duraclean Restoration. The level of nuisance particles were also determined. Results for Nuisance Particles: Rooms 235/238 West Unit 235 - Overall average concentration = 0.030 mg/meter cubed 238 - Overall average concentration = 0.028 mg/meter cubed MZA sets the clearance standard at 1/10 the OSHA PEL for respirable particles, or 0.5 mg/meter cubed. September 23, 2010: OC Indoor Air Quality Consulting Report - Post Remediation Verification Rooms 128/129 Pharmacy Area - Morse Zehnter Associates - The post remediation process consisted of a visual inspection of the work area for cleanliness following the removal and replacement of water/mold damaged building materials from each of the client rooms by Duraclean Restoration. The level of nuisance particles were also determined. Results for Nuisance Particles: Rooms 128/129 Pharmacy Area 128 - Overall average concentration = 0.026 mg/meter cubed 129 - Overall average concentration = 0.024 mg/meter cubed MZA sets the clearance standard at III 0 the OSHA PEL for respirable particles, or 0.5 mg/meter cubed. 3 October 8, 2010: OC Indoor Air Quality Consulting Report - Post Remediation Verification Room 145 Pharmacy Area - Morse Zehnter Associates - The post remediation process consisted of a visual inspection of the work area for cleanliness following the removal and replacement of water/mold damaged building materials from each of the client rooms by Duraclean Restoration. The level of nuisance particles were also determined. Results for Nuisance Particles: Room 145 Pharmacy Area 145 - Overall average concentration = 0.002 mg/meter cubed MZA sets the clearance standard at If! 0 the OSHA PEL for respirable particles, or 0.5 mg/meter cubed. October 12, 2010: OC Indoor Air Quality Consulting Report - Post Remediation Verification Room 122 Chief Medical Officer - Morse Zehnter Associates - The post remediation process consisted of a visual inspection of the work area for cleanliness following the removal and replacement of water/mold damaged building materials from each of the client rooms by Duraclean Restoration. The level of nuisance particles were also determined, Results for Nuisance Particles: Room 122 ChiefMedical Officer 122 - Overall average concentration = 0.059 mg/meter cubed MZA sets the clearance standard at 1110 the OSHA PEL for respirable particles, or 0.5 mg/meter cubed. October 22, 2010: OC Indoor Air Quality Consulting Report - Post Remediation Verification Room 252 West Unit - Morse Zehnter Associates - The post remediation process consisted of a visual inspection of the work area for cleanliness following the removal and replacement of water/mold damaged building materials from each of the client rooms by Duraclean Restoration. The level of nuisance particles were also determined. Results for Nuisance Particles: Room 252 West Unit 252 - Overall average concentration = 0.027 mg/meter cubed MZA sets the clearance standard at 1f!0 the OSHA PEL for respirable particles, or 0.5 mg/meter cubed. October 26, 2010: OC Indoor Air Quality Consulting Report - Post Remediation Verification Room 264B West Unit - Morse Zehnter Associates - The post remediation process consisted of a visual inspection of the work area for cleanliness following the removal and replacement of water/mold damaged building materials from each of the client rooms by Duraclean Restoration. The level of nuisance particles were also detennincd. Results for Nuisance Particles: Room 264B West Unit 264B - Overall average concentration = 0.026 mg/meter cubed MZA sets the clearance standard at If! 0 the OSHA PEL for respirable particles, or 0.5 mg/meter cubed. November 1, 2010: OC Indoor Air Quality Consulting Report - Post Remediation Verification Room 267 West Unit - Morse Zehnter Associates - The post remediation process consisted of a visual inspection of the work area for cleanliness following the removal and replacement of water/mold damaged building materials from each of the client rooms by Duraclean Restoration. The level of nuisance particles were also determined. Results for Nuisance Particles: Room 267 West Unit 4 267 - Overall average concentration = 0.025 mg/meter cubed MZA sets the clearance standard at 1/10 the OSHA PEL for respirable particles, or 0.5 mg/meter cubed. Januarv 31, 2011: OC of the Palm Beaches - Moisture Intrusion Assessment - Morse Zehnter Associates - MZA was retained to evaluate the extent of water damage and moisture intrusion in areas that were previously noted in a prior consultants report. Visual Observations: Storage Room (Laundry) 2007 - Mold growth along the edge of the wall to ceiling grid intersection, around the lower base cabinet and in the wall cavity between Room 207 and the hallway. Office 186 and 184 - Water damaged ceiling tiles from the above NC ductwork. MZA observed elevated moisture in the following area - Rooms 258, 249, 245, 280, 207, 139 and hallway wall that backs to kitchen 307. Discussion and Recommendations: Many areas that were stated as damaged from condensation in the previous consultants report consisted mainly of water damaged ceiling tiles. The reported condensation of surfaces in many areas of the building is believed to be an isolated event related to a malfunctioning NC system and that condition does not exist currently. The lay-in acoustic ceiling tiles have already been replaced. The previous consultant performed moisture readings shortly after an event of high humidity related to the NC malfunction. Therefore, many of the identified sites in the previous consultant's report might have been related to high humidity versus a local water intrusion source. Found some elevated moisture conditions during remediation oversight, particularly in the West Wing. These conditions could recur. The majority of previously noted areas of water damage were dry on the date of our inspection. Recently, all windows were resealed and the adjacent sprinkles were checked to assure that they were not spraying the building. MZA has identified one area near room 169 and the adjacent hallway that should be remediated. HOSPITALIZATIONS and HOSPITAL VISITS: May 25 - September 13, 2010 Hospital Visit #1 May 25, 2010: Good Samaritan Medical Center ER - Patient presents with a complaint of vomiting, fever and toothache since yesterday PE: Lungs clear. Impression: Vomitingdehydration. Urinary Tract Infection, tooth pain and anemia. Hospital Visit #2 June 2, 2010: Good Samaritan Medical Center ER - Presenting Complaint: I have an earache and toothache for 1 month. I have a headache for I week. Vitals: Temp - 100.1. PE: Mild pain in the left lower second molar (#18). Breath sounds normal and normal gait. Mild pain of the right scapular area. Differential Dx: Toothache, migraine and back pain. Hospital Visit #3 June 3, 2010: Good Samaritan Medical Center ER - Presenting Complaint: Patient states Right sided back pain that extends to the right upper abdomen for 1 week. Pain to right shin as well. Patient denies trauma to area. Triage Assessment: Complains for pain in right shin, right flank pain currently 9/10. Patient denies fever. Physician Notes: Patient reports fever. PE: Eyes, neck, respiratory, cardiac, abdomen, skin, extremities, neuro WNL. Impression: Urinary tract infection and anemia. 5 Hospital Visit #4 - Hospitalization #1 June 6-16, 2010: Columbia Hospital ER and Hospitalization- CC: Anemia and rash. History of rash/(unreadable word) and erythema of right lower extremity status post insect bite (?). No chest pain or shortness of breath, but + fever and chills yesterday. ROS: Skin rash and joint pain. Vitals: 102.6. PE: Tenderness and (unreadable word) of right lower extremity and knee with erythema. Diagnoses: Anemia, hypokalemia, urinary tract infection and cellulitis. June 6, 2010: Dr. Lagrange, Primary Care - Columbia Hospital- History and Physical Patient presents with complaints of weakness and fever for the past several days. Recently evaluated in the ER with swelling of the left lower extremity and also left wrist pain. On an antibiotic, associated rash and facial swelling. Outpatient labs revealed significant anemia with hematocrit of less than 21. Complains of weakness, but denies chest pain or any other complaints. ROS: Mild dizziness. Denies SOB, cough, sputum production, recent pneumonitis or TB exposure. PE: Temperature: 102.6 and pulse: 125. Chest - clear. Extremities - muscular pain and swelling. Some mild hyperemia in the left calf. Skin - urticarial type eruption about the face and arms. Impression: Anemia, urticarial, cellulitis and dysfunctional uterine bleeding. Admit: Transfuse 2 units ofPRBC, start antibiotic and local care to left calf. Venous Doppler study is negative for deep vein thrombosis. June 16, 2010: Columbia Hospital Discharge Summary - 06/06 - 06/16. Reason for admission: Fever, anemia and cellulitis. Laboratory: ANA was positive. Anti-SSA was elevated at 382 units. Anti-SSB was positive. SM antibody was negative. Anti-DNA was zero. Centromere antibody was negative. CEA and CA was negative. PANCA was elevated and positive. CRP was elevated at 27.1. Scleroderma was negative at 56 units. Histone H2A/H2Bb was negative. Jo-l antibody was negative. MRJ of the lumbar spine and thoracic spine WNL except for small bilateral pleural fluid collections. Hospital Course: Patient initially started on Ancef and steroid pack with fever tracking down. Fever began to rise after 5 days with a spike to 104 degrees. Steroids were begun and patient became afebrile. Dr. Osiyemi (ID) continued to feel that this was rheumatologic in origin. She was discharged to home with outpatient rheumatology follow-up planned. Diagnoses: Fever of unknown origin, UTI (organism not identified), cholecystitis, cellulitis (Left LE), anemia, backache, hypopotassemia, hyponatremia, history of asthma, leukocytosis and lumbago. Hospital Visit #5 - Hospitalization #2 June 16, 2010: Jackson North Medical Center ER - Patient arrived by ambulance. Presents with a complaint of back pain, lumbar pain and lower back pain radiating to lower extremities. Patient states it started today. No history of trauma. Said this happened to her before. Went to a hospital in WPB, was worked up and was not told what was wrong with her. Now comes with same symptoms. The onset was abrupt. Difficulty walking. No respiratory symptoms. ROS: ENT negative. PE: Severe low back pain radiating to the legs and decreased ROM due to lower back pain. Labs: WBC -18.8. Impression and Plan: Epidural abscess to be ruled out. UTI. Patient care transitioned to JMH for further management. Hospital Visit #6 - Hospitalization #3 June 17, 2010; Jackson Memorial Hospital -MRI lumbar with abnormal enhancement of the paraspinal muscles involves bilateral mulifidus, interspinalis and medial aspect of longismus muscles. No abscess. PE: Injected conjunctivae, oral thrush, lungs clear, bilateral calf tenderness with left warmer than right. Admitting Diagnosis: Myositis? Symptoms, 6 leukocytosis and imaging suggestive, however, CPK not elevated. Given immune markers, there may be a rheumatologic process. ? Stills disease. Start IV Vancomycin and cefepime. July 17, 2010: Medicine, Jackson Memorial Hospital - Discharge Summary - Admission Diagnoses: Back pain, fever of unknown origin, anemia and episcleritis. Discharge Diagnoses: Fevers of unknown origin, right upper extremity deep vein thrombosis, cervical epidural hematoma with laminectomies and evacuation and urinary tract infection. Hospital Course: Low back pain, episcleritis and fevers - Rheumatology determined that her findings were nonspecific and they determined that she did not have a rheumatological disorder. She was reportedly exposed to Chinese drywall at work, and she thinks her symptoms may have been a result of this exposure. Her symptoms resolved on their own without any real treatment. She received a couple doses of steroids, but she developed pain and stiffuess all over and the medication was soon stopped. Right UE DVT - Complication of PICC line and heparin was given with subsequent complication of left arm and leg numbness and weakness. On June 28, neurosurgery performed a laminectomy of clot with evacuation and all cultures have been negative. UTI - Blood cultures were negative; however a July 71h urine culture revealed Enterobacter aerogenes. Her urine cleared with antibiotics and she stopped spiking fevers. Anemia - Felt to be due to chronic disease given the consistent iron studies. Hospital Visit #7 August 1, 2010: Palm Beach Gardens Medical Center ER - CC: Nausea and vomiting. She took her pain pill before she ate and thinks that this is what her symptoms are from. Physicians Notes - PE: WNL. Diagnosis: Gastroenteritis. Hospital Visit #8 September 8, 2010: Palm Beach Gardens Medical Center ER - Right knee pain and swelling started last night. She denies any trauma or injury to knee. Physician Notes: CC: Knee Injury. Diagnosis: Knee pain - synovial cyst, abscess. She presents with pain, swelling and tenderness of the right, posterior knee. This is from an unknown cause. Swelling comes and goes and pain radiates up leg. Patient notes draining boil to axilla. Symptoms aggravated by weight bearing and bending knee. PE: Left axilla unroofed small abscess with pus and easily wiped out with gauze. Right knee with pain, tenderness and no swelling. Hospital Visit #9 - Hospitalization #4 September 9 - 13, 2010: Medicine, Palm Beach Gardens Medical Center - Last Tuesday she noticed pain and swelling in the right knee. She came to the ER and was discharged with pain medicine. Dr. Rondon aspirated the knee and found fluid that was suspicious for septic arthritis. She was sent for admission for IV antibiotics and surgical drainage. Continue on IV Rocephin at 2gm/day and add Vancomycin if suspicious for Staphylococcal infection. September 11, 2010: Infectious Disease, Palm Beach Gardens Medical Center - Patient and mother report a potential mold exposure at her workplace; subsequent development of acute hematologic problems for which she went to Columbia Hospital. She went home after the hospitalization and was doing well but had a short course of antibiotics for a tooth abscess. On 9/7/10 she developed pain and swelling of her right knee. She was admitted by Dr. David Rondon and had an I&D as well as a synovectomy on 9/9/1O. Thus far her cultures are negative and she has remained afebrile. Impression: Acute right knee Synovitis of undetermined etiology. At this time, she does not appear systemically ill or toxic. 7 September 13, 2010: Infectious Disease, Palm Beach Gardens Medical Center - Discussed case with Dr. Symes from UM. Right leg with healing incisions, minimal effusion, warm and non-tender. Labs: Right knee fluid cultures (-) so far, no crystals, LDH - 113, CRP - 6, ANA/RF negative. Unclear etiology with no overt evidence of a bacterial infection. She needs close rheumatology follow-up and perhaps a hematology evaluation due to high lymphs. FURTHER COMMENTS: - --- --- - -- - -- ~--- - - --- - -- --- --- - -- ----- st presented to Good Samaritan Medical Center on May 25, 2010, with complaints of a one-day history of vomiting, fever and a toothache. She subsequently visited a hos ital ei ht more times, and she was actuall hos italizcd on four total occasions. 8 Hospital Visit #1: May 25,2010: Good Samaritan Medical Center ER - Vomiting, fever and toothache. Hospital Visit #2: June 2, 2010: Good Samaritan Medical Center ER - Earache, toothache, headache and right scapular pain. Hospital Visit #3: June 3, 2010: Good Samaritan Medical Center ER - Right sided back pain that extends to the right upper abdomen for I week and pain to right shin. Hospital Visit #4 - Hospitalization #1: June 6-16, 2010: Columbia Hospital ER and Hospitalization- Anemia, fever, rash, tenderness/pain of the right lower extremity and knee. Hospital Visit #5 - Hospitalization #2: June 16, 2010: Jackson North Medical Center ERBack pain, lumbar pain and lower back pain radiating to lower extremities. Hospital Visit #6 - Hospitalization #3: June 17, 2010: Jackson Memorial Hospital - Back pain, fever of unknown origin, anemia and episcleritis. Hospital Visit #7: August 1, 2010: Palm Beach Gardens Medical Center ER - CC: Nausea and vomiting. Diagnosis: Gastroenteritis. Hospital Visit #8: September 8, 2010: Palm Beach Gardens Medical Center ER - Right knee pain and swelling started last night. She denies any trauma or injury to knee. Hospital Visit #9 - Hospitalization #4: September 9 - 13, 2010: Medicine, Palm Beach Gardens Medical Center - Last Tuesday she noticed pain and swelling in the right knee. Impression: Acute right knee Synovitis of undetermined etiology. Unclear etiology with no overt evidence of a bacterial infection. With each one of these hospitalizations, the question of whether mold exposure could cause the reported symptoms/illness must be answered by the application of the Hill methodology. The chart below reflects the analysis of the relationship between the symptoms/illness associated with each of Ms. AAAAA's hospitalizations, and the likelihood that mold exposure at her workplace up to June 3, 2010 (last day worked) could have caused those symptom/illnesses Hill Criteria Strength Consistency Sneciflcitv Temporality Gradient Plausibility Coherence Experiment Analogy Confounding Visit #1 Visit #2 Visit #3 - - - + + + - - - - + + - - - + Visit #4 Visit #5 - - - - - - - - - - + + Visit #6 - - - Visit #7 Visit #8 - - - - Visit #9 - - - - - - - - + + + + - - 9 _ Through years of investigation, scholarly interest and general experience the potential health effects of mold exposure in an immunocompetent individual are well known, including the following: As part of the preparation of this report, I had the opportunity to thoroughly review the existing literature on the potential health effects of mold exposure. These symptoms/disease processes encompass all of the known health effects of mold exposure. It is important to remember that every person is exposed to "mold" on a daily basis. Molds are a ubiquitous part of all environments, including commercial buildings, homes, cars, outdoors, etc. Mold exposure does not cause toothaches, fever (in the absence of systemic infection), vomiting, back pain, leg pain, knee pain, synovitis, anemia, episcleritis, gastroenteritis, etc. It is interesting to note that although Ms. AAAAA has a history of childhood asthma, she did not have any reported respiratory or allergy complaints at any time surrounding the initiation or progress of her 2010 medical care. She did not even report transient mucosal irritation symptoms, much less allergy or asthma symptoms. In addition, she had no clinical characteristics consistent with hypersensitivity pneumonitis, and no laboratory tests/cultures were ever consistent with a systemic fungal infection. 10 Up until June 3, 2010, Ms. AAAAA worked in Office #194 of the ARLC, or northeast wing. Examination of the July/August 2010 industrial hygiene data from Ecotech and EMSL revealed that an air sample for non-viable fungi was collected from Ms. AAAAA's office on July 23, 2010. This test revealed a small amount of Aspergillus/Penicillium (It is very difficult to separately identify these two genera of fungi by light microscopy, so they are generally reported together), and a di minimis amount of Ascopores in the air of her office. In fact, the only area of concern in the ARLC was Room #207 (Laundry Room), which was later remcdiated. It must also be understood that the testing completed by Ecotech was done when the AlC was not working appropriately and the air was very humid. Thus, these non-concerning test result was a worst-case scenario. With that said, any industrial hygiene testing result is simply a "picture in time"; however, with resolution of the AlC roblem it is likel that airborne fun i levels fell. - II Ms. AAAAA was also working at the OCs during the refurbishment of the ARLC for a grant application with the Veteran's Administration during March-June 2010. Nuisance dust generated during these activities may have potentially caused building occupants mild, transient mucosal irritation. With that said, nuisance construction dust would also not cause any of the problems described by Ms. AAAAA. In addition, she kept her door closed much of the time that she was at work, which would have further lowered any possible nuisance dust in her office. FINAL CONCLUSIONS: As stated in the introduction to this report, my conclusions are unchanged from my initial report dated January 24, 2012. There is no objective evidence of biologically significant exposure to any compound(s), and we do not have any candidate exposures that could cause the unfortunate symptoms/ailments Ms. AAAAA suffered in mid-201O. Although the absolute cause of her conditions remains elusive, nothing about her ailments is consistent with the known health effects of mold and/or irritant exposures. None of her symptoms, conditions or medical care that occurred in 2010 were related to her work at the OC. In addition, it is unreasonable to anticipate that any symptoms/illnesses/conditions that may arise in the future are the result of her previous employment at the OCs. Ms. AAAAA was at MMI with 0% PIR on the date of our visit. Sincerely, ~~~.~ ·n- .. James McCluskey, MD, MPH, PhD 12 James McCluskey, MD, MPH, PhD University of South Florida, College of Public Health 13201 Bruce B. Downs Boulevard, MDC 56 Tampa, Florida 33612 [email protected] Phone - (813) 505-6709 Fax - (866) 615-0928 January 30, 2012 Mr. James YYYYYYY, Esquire XXXXXXX Re: Dr. Alan GGGGGG Dear Mr. YYYYYY; I had the opportunity to visit with Dr. Alan GGGGGG on August 25, 2011, at rented office space in Bradenton, Florida. Our visit lasted for several hours. The clinic questionnaire was filled out prior to our visit and the patient actively took part in our visit and provided all information requested without hesitation. This is an INITIAL report, as it is my understanding that further medical records, depositions and expert reports may become available in the near future. RECORDS REVIEWED: As you know, your office has been periodically sending records to my attention regarding this patient, and the GGGGGG family. The patient specific medical and family records provided by your office for my review include the following: 1. Medical Records from Dr. RRRRR C. SSSSS - Family Practice 2. Medical Records from Dr. AAAAA XXXXX - Environmental Medicine 3. Medical Records from Dr. GGGG WWWWW - Neurology 4. Medical Report from Dr. AAAAA XXXXX dated November 17,2007 5. Medical Records from The Balance Center of West Florida (Dr. Thomas Moorish) - ENT 6. Limited Medical Records from Dr. Robert P. Hillstrom - Plastic Surgery/ENT 7. Medical Records from Manatee Memorial Hospital 8. Medical Records from L.W. Blake Medical Center - No Records 9. Prescription Records from Walgreens 10. Billing Records from Wellness Pharmacy 11. Various Laboratory, Imaging and Diagnostic Testing Records 12. Deposition Transcript of Alan K. GGGGGG dated July 11,2006 - 66 pages 13. Deposition Transcript of Alan K. GGGGGG dated June 2, 2011 - 134 pages 14. Deposition Transcript of Anna-Marie GGGGGG dated July 11, 2006 - 48 pages 15. Deposition Transcript of Anna-Marie GGGGGG dated June 2, 2011 - 79 pages 16. Deposition Transcript of Alex Michael GGGGGG dated July 11, 2006 - 8 pages 17. Deposition Transcript of Alex Michael GGGGGG dated June 3, 2011 - 18 pages 18. Deposition Transcript of Ryan Brett GGGGGG dated July 11,2006 - 13 pages 19. Deposition Transcript of Tamara GGGGGG dated October 5, 2007 - 86 pages 20. Unsworn Statement of Jaclyn Michelle GGGGGG dated June 3, 2011 - 8 pages 21. Unsworn Statement of Rhyanna Haley Broomfield-GGGGGG dated June 3, 2011 - 12 pages 22. Deposition Transcript of Chin Shan Yang, PhD dated July 6, 2011-172 pages 23. Deposition Transcript of AAAAA F. XXXXX, DO dated August 10, 2011 - 126 pages 24. Deposition Transcript ofGGGG M. WWWWW,MD dated 'July 29, 2011 - 99 pages 25. Report of Florida Indoor Air Quality dated December 4,2003 26. Report of Florida Indoor Air Quality dated May 27, 2004 27. Report ofIndoor Environmental Tec1mologies, Inc. dated May 25,2004 28. Report ofIndoor Environmental Tec1mologies, Inc. dated May 28, 2004 29. Report ofIndoor Environmental Technologies, Inc. dated August 17,2004 30. Report ofIndoor Environmental Technologies, Inc. dated August 23, 2004 31. Report ofIndoor Environmental Technologies, Inc. dated July 10, 2006 32. Report ofIndoor Environmental Technologies, Inc. dated July 18, 2006 33. Report of Indoor Environmental Tec1mologies, Inc. dated June 18, 2007 (Summary of Previous Reports from May 25, 2004; May 28, 2004 and August 17,2004 34. Report ofHSA Engineers & Scientists dated June 8, 2009 35. Burns Instar Services Group Proposal and Billing dated November-December 2003 36. Duetbusters Evaluation and Proposal dated September 6, 2006 37. Report of RJ Koning Consulting dated October 22, 2004 38. Records of Service-Tech of Tampa Bay 39. Documentation of Damages from Plaintiffs - Bills, Receipts, Expenses, etc. 40. Employment Records from Lakewood Ranch Anesthesia for Alan GGGGGG, MD 41. Amended Complaint and Demand for Jury Trial 42. Plaintiffs Notice of Serving Answers to Defendant's First Set of Interrogatories dated September 2, 2005 43. Letter to RRRRR SSSSS, MD from Alan GGGGGG, MD dated May 4,2004 and May 8, 2004 (Addendum) EXPOSURE HISTORY: Dr. GGGGGG first experienced a "problem" on June 25, 2003, while he was in the Day Surgery Center seeing a patient. At the time, he turned around and instantly developed "tunnel vision". In addition, he felt like he was going to pass out; however, he did not fall. He took a seat on a chair and then went over to the patient holding area where an IV was reportedly administered. According to the patient, up to that point on June 251\ he had been feeling "great". From that day forward, he has never felt "normal" again. Dr. GGGGGG subsequently sought a "curbside consultation" with Dr. Moorish for malaise, nausea and balance issues. His head was not "right with balance". He took Meclizine (anti-vertigo medication), but he felt worse and soon stopped. He also tried Loratidine and Motrin. Subsequent to June 251h, he had a number of symptoms appear, including: Vision disturbances (brightness, flat, glossy, letters moving, halo around letters, seeing "pieces" of daughter's face in focus while remainder blurry), brain fog, anxiety (morning) and left arm numbness. Prior to the remediation they had a closet added in Jaclyn's room. He was helping with the work and he noticed "brain fog" with an ill feeling and anxiety. His symptoms were at their worst in August 2003, when they were living in the Holiday Inn. Over time his symptoms 2 have waxed, waned and somewhat changed. Now, he typically has the same reaction, which includes his vision having a "soft focus" and lines on the floor go in and out of focus. In addition, his close up vision gets worse after an "exposure". He also develops "brain fog" with inability to concentrate, poor coordination, sloppy handwriting, poor muscle control, limited multitasking ability, difficulty with swallowing, headache, limited hearing cognition, irritability and anxiety. He has noticed that a number of substances seem to cause a "reaction", including: Freshly painted walls, leather in sporting goods stores, car smells, tire smells, betadine solutions at work, bone cement at work, antimicrobials at work, propane, perfumes, floor stripper, bleach, chlorine, vinegar, laundry softeners, laundry detergents and cigarette smoke. In addition, he has a number of foods which also seem to cause a "reaction" after ingestion. According to Dr. GGGGGG ingestion of cranberries, sage, basil, oregano, wheat, eggs, chocolate, sweet potato, legumes, citrus, aged cheeses, horseradish, deli mustard, sauerkraut, barbecue sauces, ice cream, soy, candy, vinegar, shrimp, pickles, cucumbers, lamb and veal always seem to cause a "reaction". Sometimes, he also has a "reaction" when he eats meatloaf, macaroni & cheese, Mexican food and steak; although at times he can eats these foods with no noted problems. Dr. GGGGGG also avoids com and canola oil. He is able to eat Five Guys hamburgers and tomatoes without any problems. The patient has noted that foods seem to bother hiro less when he has been away from work. He estimated that -50% of his "reactions" result from workplace exposure to chemicals, and the other 50% follows ingestion of certain foods. Interestingly, he has had a "reaction" with no recognized odor present. For instance, he seems to "react" when sitting at the computer in the surgeon's lounge at work. PAST MEDICAL HISTORY: Prior to the onset of his current concerns, Dr. GGGGGG reportedly had a limited number of health complaints. On the clinic questionnaire he reported a history of asthma, chemical sensitivity, chronic pain, chronic rash, GERD, hay fever, intestinal problems and nerve problems. In addition, he reportedly had a hydrocelectomy to repair a hydrocele at age 6. Upon furthering questioning, he reported that he had no objective testing to document the presence of "asthma". However, when they moved to Arizona in 2006, he felt SOB rather suddenly and thought it was related to allergies, particularly to the Palo Verde "yellow" flower. Dr. XXXXX placed him on Singulair and Allegra which seemed to decrease his SOB. His reports of chronic pain center on headaches with "brain fog". In addition, muscle aches follow a "bad" day with chemicals or food. In addition, Dr. GGGGGG reportedly has a malar rash with exposures and this resolves when he goes on vacation. He has never seen a dermatologist to address this issue. He has GERD symptoms when he overeats late at night. A Pepcid pill seems to relieve the symptoms adequately. However, mint flavored Pepcid causes him to have "brain fog". As a child living in Long Island, NY he had hay fever symptoms, but these were essentially gone by adolescence. Sometimes, Dr. GGGGGG has had indigestion and bloating after eating certain foods. In addition, he has had a vagal (cold/sweaty/lightheaded) reaction on one occasion while living in Arizona. He went to the ER at Oro Valley Hospital after waking up feeling clammy with a rapid pulse and dizziness. A CT of the abdomen was clear and the symptoms eventually passed without further problems. Any time he feels that he may have a "reaction" after eating particular foods, he takes a Y:, Benadryl tab. Dr. GGGGGG has also had "nerve problems" primarily involving his sense of proprioception (spatial position ofjoints) in his legs. He feels like his legs are "rubbery" and this sensation lasts several hours. He believes that this is related to inflammation in his "brain". Dr. GGGGGG also noted that after exercising he may have a 3 reaction because his muscles release something into his bloodstream. Finally, at times he experiences slight burning in his bladder, although he has had his prostate checked and it is fine. In addition to the PMH reported in the clinic questionnaire, I found a notation that Dr. GGGGGG had nasal septoplasty for a deviated septum in 1986. MEDICATIONS: Dr. GGGGGG was reportedly taking the following prescription medications at the time of our visit. Allergies 1. Allegra 180mg po QD Heartburn 2. Pepcid OTC 3-4x1week Helps with toxicity and take if eating 3. Vitamin C I gram nitrates (certain foods) Helps with chemical toxicity 4. Epsom Salt Baths 5. Benadryl 12.5mg 1-2x1week When having a bad reaction to food ALLERGIES: The patient reported that he has no known medication allergies. He has been evaluated by Dr. XXXXX for food and environmental allergies; however, he has never been evaluated by a "traditional" allergist. As mentioned in the Exposure History portion of this report, Dr. GGGGGG reportedly has a "reaction" to a large number of foods. FAMILY MEDICAL HISTORY: Dr. GGGGGG's father is 79 years old and he has been treated for colon cancer. He also has benign prostatic hypertrophy. His mother passed away at age 70 due to lung cancer. In addition, she had adult onset diabetes and arthritis. He has a 48-year old brother and a 50-year old sister, both of whom are healthy. Noone in his family has similar complaints, although he believes his wife and children have suffered adverse effects due to "mold" exposure. SOCIAL HISTORY: Dr. GGGGGG reported that he has never utilized tobacco products on a regular, or social basis. He quit all alcohol use in 2007, although prior to that point he had only used it on social occasions. According to the patient, even small amounts of alcohol seem to have exaggerated effects on his "brain fog". In 2007, it took 1-2 hours for him to feel "normal" after a sip of wine. The patient denied any illicit drug use. They have a cat and recently acquired a Wheaton Terrier. He has had no problems interacting with the animals. He denies any hobbies or activities outside of the workplace were there is the potential for inhalation of fumes, gases or dusts. He enjoys playing guitar and piano. The GGGGGG family has returned to live in the house in Holmes Beach on a full-time basis. The house is mostly cement block. They run the air-conditioning on a regular basis and there is a special filtration system, including upgraded pleated filters and a UV light system. The house has had multiple water intrusion events, as detailed in the Industrial Hygiene Evaluation portion of this report. OCCUPATIONAL HISTORY: 4 Dr. GGGGGG is an anesthesiologist and he takes part in surgeries, as well as oversees multiple nurse anesthetists. He has not missed any work due to his health concerns. He has held the following positions: I. 1989 - 1991 2. 1991 - 2006 3. 2006 - Nov 2010 4. Nov 20 I0 - Present Assistant Professor, Dept. of Anesthesia, WV University Anesthesiologist, Premier Anesthesia (Lakewood Ranch Anesthesia) Anesthesiologist, Oro Valley Anesthesia Anesthesiologist, Lakewood Ranch Anesthesia REVIEW OF SYSTEMS: Dr. GGGGGG reported that he had experienced the following signs/symptoms in the year preceding our visit: 1. Chronic or recurring skin condition 2. Rash 3. Decreased vision 4. Pain in the eyes (sharp occasional) 5. Shortness of breath (occasional) 6. Wheezing or chest whistling brought on by house dust, plants or pollens and foods 7. Activity intolerance 8. Pain with urination 9. Frequent urination 10. Frequent or severe headaches I I. Dizziness or faintness 12. Excessive nervousness or worry 13. Excessive fatigue 14. Change in general feeling or personality 15. Increased irritability 16. Loss of sensation or control of muscle movement 17. Frequent heartburn or indigestion 18. Diarrhea (rarely) 19. Abdominal discomfort 20. Constipation 2 I. Chronic muscle aches with and without activity PHYSICAL EXAMINATION: VITAL SIGNS: Afebrile. GENERAL: On examination, the patient was alert and oriented to person, place, and time. He answered all questions without difficulty. He did not utilize any assistive devices, such as a cane or oxygen during the visit. HEENT: The patient was normocephalic. His pupils were equal, round and reactive to light and accommodation. His extraocular muscles were intact. There was no evidence of strabismus. His external auditory canals were normal. His tympanic membranes were clear and mobile with intact landmarks. His oral and nasal mucosa was pink and moist throughout. There were no 5 evident secretions in his nasal passages. There were no evident nasal polyps. There was no cobblestoning of his posterior nasopharynx. There was no sinus tenderness. NECK: The neck was supple on palpation. He was able to move his neck in all directions with no discomfort or tightness. There were no enlarged or tender lymph nodes noted. The thyroid gland was of normal size and consistency. No noted jugular venous distention. There was no stridor. CHESTWALL: Grossly normal by inspection. Non-tender throughout to palpation. RESPIRATORY: The lungs were clear to auscultation in all fields. There were no wheezes, rales or rhonchi. He did not exhibit any USe of accessory muscles of breathing. There were no chest wall contractions with inspiration or expiration. There was no egophony. CARDIOVASCULAR: The heart sounds were normal. The heart had a regular rate and rhythm. There were no murmurs appreciated. His cardiac point of maximal impulse was appropriate in location and force. SI and S2 were normal. No S3 or S4 was noted. ABDOMEN: The abdomen was soft and nontender. There were normal bowel sounds throughout. There was no evidence of organomegaly. EXTREMITIES: On observation there was no evidence of atrophy, contractures, or difficulty with movement. There was no clubbing, cyanosis or edema noted. The capillary refill was good. The patient's color was good and there was no noted pallor. The nail beds was non-tender to palpation. NEUROLOGIC: The patient responded appropriately to questioning and his short-term memory appeared intact. His hearing was adequate in casual conversation with no reported tinnitus. Cranial nerves II-VII and I through XII were within normal limits. His gait was directed and he did not wobble or fall. Romberg examination was within normal parameters. His deep tendon reflexes were 2/4 at the patella and biceps tendon bilaterally. All dennatomes and myotomes were intact. There was no evidence of muscle atrophy in his upper extremities or lower extremities. There was no noted tremor in any appendage. SKIN: The patient had no areas or evidence of hypo- or hyperpigmentation except for sun/age related lesions. In addition, there were no nodules or abnormal appearing lesions present on the exposed skin. CURRENT COMPLAINTS: At the time of our visit the patient reported the following symptoms: I. Brain fog - concentration memory 2. Visual disturbances - blurry, soft focus, difficult reading 3. Irritability/anxiety 4. Muscles aches and weakness 5. Decreased coordination with swallowing, writing, off-balance, speech 6. Headaches 7. Shortness of breath 8. Abdominal bloating - sometimes with dizziness 9. Bladder dysfunction - relaxation and frequent voiding 10. Facial rash II. Heartburn 12. Sharp pains - head or eyes (more so) 13. Malaise 14. Fatigue 6 MEDICAL RECORDS: I have reviewed the limited medical records provided by your office prior to preparing this report. Listed below is a chronological summary of the relevant records: August 13, 2003: The Balance Center of West Florida, Dr. Moorish - Several week history of balance disturbance. Initially he felt quite lightheadedness and had to sit down. He had some associated nausea. This happened on and off. He now is having some problems focusing with his vision. It can happen with head turning, sometimes without any specific inciting event. It is fairly constant, but occasionally it does go away. He has been told he has some fluid behind his ears. There is a question of his house being a sick building. He did have some headaches initially, but very few now. PE: Overactive gag reflex. Romberg shows no significant sway. Tandem gait is fairly good. Assessment/Plan: Balance disturbance. Rule out a vestibular cause, perform vestibular testing and see him back at this time. He may need a neurological workup, especially with some ofthe visual symptoms. Mild rhinitis. May 10, 2004: Dr. RRRRR SSSSS, Family Practice - (Much of this note is illegible) Attic recess in master bedroom with no visible mold. Three weeks into BID CSM. 04/04 increased severe symptoms. Tracking movements and visual changes, tunnel vision, light sensitivity, anxiety. Assessment: SBS PAC Brochure. May 18, 2004: Dr. RRRRR SSSSS, Family Practice - Garage remediated, + visible mold inside car, (unreadable word) steering whecl- vehicle remediated. Put in UV system. Windows ?? not sealed frame, cracks in stucco, couch up against wall, crib mattress and wallpaper mold (wall dry) October 1, 2006: Dr. AAAAA XXXXX, Environmental Medicine - Allergy History: Describe what symptoms bother you the most - vision, irritability, anxiety, muscle aches, mental clarity. When did your condition begin - July 2003. Is there anything else about your problem which you think might be important or unusual? Chemical sensitivity began after toxic mold exposure. October 9, 2006: Dr. AAAAA XXXXX, Environmental Medicine - Referred by Dr. SSSSS who has been treating him for a chemical sensitivity problem, secondary to a mold-related contamination problem in his residence in Holmes Beach discovered sometime between 2003 and 2004. He has taken Cholestyramine and has become more chemically sensitive. Dr. SSSSS referred him so that we can address his chemical sensitivity problem. He's electro-magnetically sensitive. He also has light and sound sensitivity and we discussed adding magnesium and magnesium-rich foods to his diet to decrease that. He had hay fever as a child. ROS: Neck and shoulder pain. Nasal stuffiness and postnasal drip. He has some exercise induced shortness of breath. He has some cognitive dysfunction, which is a big problem when he is in a bad environment. On exposure to certain molds or chemicals he has joint pain for hours. He occasionally gets a red facial rash on exposures. PE: Nasal swelling with redness of the turbinates and significant postnasal drip. Impressions: Allergic rhinitis. Mold exposure related building illness. Chemical sensitivities. He may have exercise-induced reactive airways disease. Recommendations: Allergy skin testing, glutathione intravenous for chemical sensitivity, Dr. Ziem and Paul's protocol for the chemically sensitive and a trial of Singulair. May 15, 2007: Dr. AAAAA XXXXX, Environmental Medicine - The glutathione injections and B 12 injections appear to be working. He is very mold sensitive. He is taking the allergy injections twice per week and the histamine drops. He has been feeling more anxiety, brain fog 7 and shortness of breath lately. This is probably seasonal allergies, they live in Arizona. Recommendations: Add Singulair at bedtime and Allegra in the morning. This summer we will do pollen testing. July 3, 2007: Dr. AAAAA XXXXX, Environmental Medicine - He is feeling well. We are testing him for pollens. His chemical sensitivity appears to be improved. He docs get multisystem symptoms with foods and pollens affecting his airways and his nervous system. He gets an air hunger and Singulair helps him, so this is allergic in nature. He is already on the dust and mold injections, histamine drops and glutathione nasal sprays. Occasionally takes vitamin shots, Bl2 and glutathione. PE: Lungs arc clear. Impressions: Allergic rhinitis and inflammatory airway disease.. Recommendations: Cover him for pollens. October 27, 2007: Dr. GGGG WWWWW,Neurology-He is being seen for toxic mold in his home. GGGGGG Family History: Mold found in home in summer of 2003. It was in the garage and entry doors to the horne. Dr. GGGGGG was the first to get sick. He had blurred vision, lightheadedness, fatigue, severe anxiety and insomnia about 06/03. His wife noted blurred vision and severe fatigue as well. Alex began with blurred vision, hyperactivity, double vision and inability to focus. Adriana (?) began with headaches and blurred vision. Ryan began with decreased concentration and headaches, also with decreased memory/concentration. The house was remcdiated for 3 weeks during which time they did not live there. They moved back in to the house in September 2003. Dr. GGGGGG's vision improved, but was not normal. He had decreased vision and he still does not feel normal. He had brain fog with decreased memory and concentration. In 2004 the home was remcdiated again for 3-4 months and they lived elsewhere. Dr. GGGGGG's symptoms persisted with severe anxiety, irritability, brain fog, blurred vision and GI symptoms. They returned 10/04 and the symptoms continued. Mold was again found in Rhyanna's room in 2005 and they moved out for remediation for 1.5 weeks. They decided to move to Arizona in February 2006. Dr. GGGGGG continued to have symptoms in Arizona and his symptoms increased as soon as the furniture from the Florida house arrived. The symptoms decreased after 6 weeks, but increased with loading and opening boxes from the old house. Symptoms increased in certain stores and environment. Dr. GGGGGG has been able to work, but has to avoid certain procedures. Current Symptoms: He is now doing better with good and bad days depending of food/odor exposures. He has fatigue, brain fog, blurred vision, irritability, anxiety, decreased ability to read, muscle aches, headaches, neck pain and increased symptoms with stress. He has shortness of breath, dysphagia and decreased libido. ROS: Joint pain and stiffness, headaches, diplopia, photophobia, blurred vision, cold intolerance and dyspnea. Neurological Exam: Patient has anxiety and decreased short term memory. Impression: Toxic mold exposure with MCS. June 24, 2008: Dr. AAAAA XXXXX, Environmental Medicine - He is quite allergic to pollens, dust mites and multiple molds and also that he was allergic to selective chemicals that we tested for and his is chemically sensitive. He has been somewhat better in Arizona. He has been off allergy shots for a month now. He seems to be sensitive to his work chemicals in surgery, which seems to affect his nervous system and his thinking. He gets some brain fog and also affecting his nervous system irritability level and anxiety level and also cven affecting his vision. Medications: Occasional Allegra and Singulair. PE: Nasal tissues markedly swollen, the nasal turbinates arc edematous. His nose looks very allergic. He has some postnasal drip. Impressions: He has perennial allergic rhinitis. He has the chemical sensitivity all stemming from the moisture/mold contaminated home that he lived in between 2003 and 2005. 8 Recommendations: Singulair and Allegra. Recommend new nutrients, Vitaleycs. He has tried Dr. Pall's nutrients without any good benefit. IMAGING: August 20, 2003: MRI of the Braiu with aud without Coutrast - Impression: No acute intracranial abnormality. There is a mucous retention cyst or retained secretions in the right maxillary sinus. October 28, 2007: MRI of the Brain without Contrast - (Read by Dr. WWWWW Neurology) Normal MRI of the brain. ALLERGY TESTING: September 3, 2003: Enviro Allergen Cladosporium Penicillium Helminthosporium Epicoccum Aspergillus Botrytis Alternaria Stemphylium Fusarium Rhizopus Pullularia Mucor Candida Dust mite (D pterony) Dust mite (D farinae) Mold IgG Test Results LUs Class 280 4 168 3 141 2 128 2 95 2 92 2 85 2 83 2 82 2 73 2 64 I 18 1/0 11 0 60 I 59 I Response High Positive High Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Equivocal Negative Positive Positive Interpretation: MAST CLASS 0 1/0 I 2 3 Response Negative Equivocal Positive Positive High Positive LUs 0-11 12-26 27-65 66-142 143-242 ***'The remainder of the test results were cut-off the bottom of the sheet. Allergy Testing - Dr. AAAAA XXXXX - 3 Occasions: 10/10/06,07/03/07 and 06/24/08 Allergen Ragweed Mix S.E. Weed Mix S. FI Weed Mix 10/10/06 07/03/07 10 9 8 06/24/08 10 II 10 9 S.E. Tree Mix S. FI Trees Mix S.E. Grass Mix S. FI Grass Mix House Dust Dust Mite (F) Dust Mite (P) Histamine Grass Root Smut Algae Candida Albicans Alternaria Aspergillus Hormodendrum Helminthosporium Penicillium Pullularia Cephalosporium Ethanol Phenol Formaldehyde Glycerin Interpretation: 13 II 18 18 9 9 9 6 7 7 6 9 6 8 6 7 6 7 4 4 6 4 10 10 10 15 13 17 16 13 13 13 6 9 9 10 II 9 10 9 12 7 10 5 7 5 2 = Negative 3 = Moderate 4= Low High 5 = MedHigh 6 = High 7+ = Severe/Chronic ADDITIONAL MEDICAL TESTING: October 28, 2007: Electroencephalogram - Dr. GGGG WWWWW - The EEG is abnormal with dysrhythmia Grade I with mild increases seen in Delta. October 28, 2007: Quantitative Electroencephalogram - Dr. GGGG WWWWW - EEG line format data abnormal with dysrhythmia Grade I with mild increases seen in delta. Computerized topographic analyses with increases seen in delta. Amplitude asymmetry analysis with mild asymmetries seen in delta and theta. Coherence analysis with mild abnormalities seen in all frequencies. Impression: This was a mildly abnormal QEEG. These findings may be consistent with encephalopathic processes such as toxic, metabolic or ischemic etiologies. October 28, 2007: Visual Evoked Potentials - Dr. GGGG WWWWW - Normal and symmetric. October 28, 2007: Brainstem Auditory Evoked Potentials - Dr. GGGG WWWWW - Normal and symmetric. October 28, 2007: Somatosensory Evoked Potentials - Dr. GGGG WWWWW Somatosensory evoked potentials reveal mildly increased latencies in SSEP's in the lower extremities consistent with slowing in the somatosensory pathway. 10 INDUSTRIAL HYGIENE EVALUATIONS: December 4, 2003: Florida Indoor Air Quality - IAQ Investigation Report Background/History: Water intrusion dates back two years. Recent leaks noted in the single car garage on the west end of the home and around the roof and door framing of the main entry. A leak was also found around the chimney cap. In some areas of the home, what appears to be viable fungal activity was noticed. Dr. GGGGGG recently experienced severe symptoms of possible toxic mold syndrome, to the event of balance and depth perception problems. Investigation/Evaluation/Review: Air sampling on August 14, 2003, indicated elevated levels of common and certain uncommon fungal species Aspergillus/Penicillium in the single garage and master bedroom. However, outdoor sampling did show an overall count of (3) three times higher than indoors. Surface sampling revealed elevated counts at their two main air handling units (blower wheels) not yet cleaned. Again Aspergillus/Penicillium species were found on the joist network in the crawl space of the home on the bay wall. Recommendations were made to remediate the affected areas and install HEPA type filtration and an ultra violet lighting system in tile return air pathways of the house. The owner was vacating the home. Air sampling on August 25, 2003, revealed fungal were 120 times higher outdoors than in the family room and fifty-two times higher than the master bedroom suite. Total count in tile attic was 6- 13 times higher than the indoor count. The results of surface swab sampling in the master bedroom air box and carpet were negative. Remediation was continuing and leaks relative to the bay wall causing the crawl space problem were repaired and cleaned. The owner had moved back into the home. Bulk samples from September 18, 2003, were positive for high levels of Aspergillus/Penicillium. With the area under containment the entry area was repaired and remediated. Remediation continued in the single garage area. Dehumidification and air scrubbing was employed. Air sampling on October 21, 2003, in the single care garage and outdoors revealed a level 1.5 times higher outdoors. The count from within the SUV was about 2 times higher than the outdoors and the total count for Aspergillus/Penicillium was over 6 times higher than outdoors. Surface samples from the SUV revealed no elevated levels of common or uncommon species. Recommendations: Clean the SUV interior. Use HEPA type filtration. Use an ultra violet type system in the HVAC. Monitor moisture intrusion. Monitor relative humidity in the home. Remove any wallpaper, particularly on any exterior wall because it acts as an interior vapor barrier. May 25, 2004: Indoor Environmental Technologies, Inc. - Letter to Dr. Alan GGGGGG Site Inspection Date: May 20, 2004. The investigation was performed to evaluated the remediation work done in the attic area adjacent to the master bedroom and to evaluate several other possible water intrusions in the home to see if they impacted indoor air quality. Building Description and History of Water Intrusion: The first evidence of water intrusion was discovered after a storm in September 2001. Water infiltrated the home at tile sliding windows in the media room, living room and dining room. Water also infiltrated the crawl space below the family room due to apparent window leaks in the family room. The homeowner dried the leaks and all windows with leaks were resealed. Other intrusions included minor roof leaks over the powder room, stairway and bedroom closet, all of which have been repaired. A leaking water line in the master bath toilet caused staining on the ceiling of the foyer area. This was II immediately corrected when discovered. Water intrusion also occurred at the front door due to inadequate flashing around the door. The leak and damage was corrected in September 2003, when the entire house was painted and sealed. The only visible mold growth from all of these leaks was some minor growth in the crawl space due to the family room window leak. The most significant water intrusion was an apparent roof leak above the attic space adjacent to the master bedroom, which also affected the fireplace in the master bedroom and resulted in mold growth around the air handling units in the attic. This moisture intrusion was corrected in May 2003. The visible mold growth in the attic was being corrected at the time of this site visit and containment was still in place. Also, there was a water intrusion below the window of the guest bedroom with water staining. This is still an active leak, although the wall paper on the wall was recently replaced. There may have been some mold growth on the back side of the old wallpaper. Visual Inspection: There was some visible water staining below the window sill in the guest bedroom with no visible mold growth. However, there was some visible mold growth behind the baseboard below this window. Inspection of the master bedroom and attic area revealed no visible water damage or mold growth. Elevated moisture levels above 60 RMC were found above the fireplace and on some of the wood framing in the attic space. There may be a minor window leak in the master bedroom. No signs of a roof leak were evident in the attic space, however, future mold growth could occur in the future unless moisture levels are reduced to below 40 RMC, There were also some slightly elevated moisture levels below the sliding windows in the living and dining rooms. There may still be some minor window leaks in this area, although no evidence of water damage or active mold growth was found. Microbial Air and Surface Samples: Initial review of the non-viable indoor air samples appear to indicate normal microbial levels inside the home versus the outdoors. The Penicillium/Aspergillus levels in the attic sample were slightly higher than the indoor air samples; however, they were similar to outdoor levels. Results of the tape-lift sample from behind the baseboard of the guest bedroom indicated moderately high concentrations of Chaetomium and a tape-lift sample from the back side of the drywall at the master bedroom fireplace indicated some minor Pen!Asp activity. Tape-lift samples from the AlC units and vents indicated normal trappings. Microbial levels in viable air sample from the master bedroom and guest bedroom versus the outdoor air sample were normal. Master was 123 total colony forming units (CFU), guest bedroom was 106 CFU and outdoors was 441 CFU. Based upon our initial review of the samples, it does not appear that there has been a significant release of mold spores at this time. Temperature and Humidity: Both were considered normal. HVAC System Recommendations: No further action is recommended for the HVAC system due to any of the water intrusions. Recommendations: No remediation is recommended for the master bedroom area, but the area should be monitored. No remediation is recommended for the water-stained ceiling areas or the living and dining room window areas at this time. It is recommended that the area under the guest bedroom window be repaired. May 27,2004: Florida Indoor Air Quality - IAQ Investigation Report Background/History: Owners noticed possible fimgal growth on the door of the attic air handler closet adjoining the master bedroom. The area was contained and cleaned. There was also some 12 concern for certain small possible fungal spots on the exterior wall of the baby's room. The spots were cleaned and the wall was papered. Investigation/Evaluation/Review: Air sampling on May 14, 2004, indicated that the outdoor total count was 25 times higher than the total count in the baby's room and 4 times higher than the master bedroom. The air handler crawl space was similar to the total count outdoors. Some elevation of uncommon species was noted. These levels will very daily based upon the outdoors and humidity percentages. On May 18,2004, moisture readings beneath the window of exterior wall in the baby's remove displayed high moisture readings. It is quite likely the window is leaking somewhere around the sill. Recommendations: The water intrusion path around the baby's room window should be identified and repaired. Remediate the wall in the baby's room. Dehumidify the air handler closet and seal the door to the closet. May 28, 2004: Indoor Environmental Technologies, Inc. - Letter to Dr. Alan GGGGGG Inspection Date: May 27, 2004. Inspection focused on the two cantilevered windows in the guest bedroom and master bedroom, respectively. The guest bedroom inspection revealed significant water damage and deterioration of the plywood sheathing from a window leak. The master bedroom inspection revealed some evidence of water intrusion with no deterioration of building materials. There was some mold staining of drywall in the wall cavity under the window. August 17, 2004: Indoor Environmental Technologies, Inc. - Letter to Dr. Alan GGGGGG - Site Inspection Date: August 11, 2004. The remediation was performed. It appears that all of the water-damaged drywall has been removed and that drying goals have been met for the remaining surfaces. It appears that there may be some humidity control problems throughout the horne. The HVAC should be inspected by a professional The wallpaper in the master and guest bedroom should be removed. Based upon the slightly elevated moisture levels in some of the remaining drywall, it is possible that some minor microbial activity may exist on the backside of the walls in the guest and master bedroom. August 23, 2004: Indoor Environmental Technologies, Inc. - Letter to Dr. Alan GGGGGG - Site Inspection Date: August 11, 2004. Clearance Summary: Laboratory analysis of mold spore levels in the music room, master bedroom containment and second floor stair landing were generally within a normal range at the time of testing. The air sample from the guest bedroom indicated above normal Penicillium/Aspergillus levels at 6400 spores per cubic meter. However, tape lift samples were normal. The likely source of the elevated levels in the air are most likely the result of the high humidity and construction dust levels present in the room at the time of testing. It appears that the master bedroom has been effectively rerncdlated. However, elevated humidity levels in the room are concerning and the wallpaper should be removed. It appears that there is still a moisture (humidity) problem in the horne and levels were elevated throughout which could lead to additional microbial activity if not corrected. It is recommended that an HVAC professional be consulted to determine if the system is working properly. 13 July 10, 2006: Indoor Environmental Technologies, Inc. - Letter to Dr. Alan GGGGGG Site Inspection Date: July 5, 2006. The GGGGGG family has experienced mold and environmental sensitivities over the years and mold remediation had been performed at their home in 2004. The goal of this project was to determine current microbial level as well as take a critical look at the building performance and make suggestions for improvements to HVAC systems and moisture control in the home and crawlspace. These services included moisture mapping, microbial air and surface sampling and microbial dust sampling to determine ambient airborne mold levels in the air as well as on horizontal surface dust and in carpet and upholstered furnishings dust. Initial Results: Review of microbial air and surface samples prior to laboratory analysis indicated lower mold levels indoors with reference to outdoor levels. Surface tape samples also indicated normal background levels of mold. Problems: Visible staining on the supply vents of the kitchen and master bedroom indicated Cladosporium sp. mold growth. Humidity levels were slightly elevated in the home even though supplemental dehumidification was being used. There was an area of damp drywall on the northern window in the music room. Wallpaper in the downstairs guest bedroom also indicated elevated moisture contact on exterior walls. Interior walls indicated normal levels of moisture. History of Water Intrusion: In May 2004, remediation of the guest bedroom cantilevered window repaired water intmsion and mold damage to the window and adjacent walls. No mold was found in the water intruded bedroom cavity. They moved away and kept ilie home in a conditioned state. Their health has improved and their recent visits to this home have not resulted in any significant onset of past symptoms. Visual Inspection of Home: No evidence of visible mold aside from two areas around supply air vents. The HVAC system had a 95% deep pleated filter and there is a UV light system (although incorrect in guest bedroom AHU). There were no signs of water damage or deterioration of building materials. All exterior windows had been re-caulked and sealed within the last 2 years. Temperature, Humidity and Relative Moisture Content: Humidity levels were as high as 64% and temperature levels were as low as 68 degrees. This indicates ineffective climate control by the HVAC system. Moisture mapping indicated normal levels except for the guest bedroom exterior walls with wallpaper and under the music room north window. HVAC System Description and Recommendations: The HVAC systems looked clean and well maintained. There is a lack of insulation around the SAV in the kitchen and an oversized unit servicing the mast bedroom. Even with the use of two supplemental dehumidifiers, adequate humidity control was not available. July 18, 2006: Indoor Environmental Technologies, Inc. - Letter to Dr. Alan GGGGGG Site Inspection Date: July 5, 2006. (This report supersedes the report of July 10, 2006) Final Results: Laboratory analysis of microbial air and surface samples indicated lower mold levels indoors with reference to outdoor levels. Surface tape samples also indicated normal background levels of Cladosporium mold. At the time of testing, there did not appear to be any indication of elevated mold levels indoors. Carpet dust samples were also well within normal levels. This supports the other microbial findings that indicate that there was not a microbial problem related to air, surface dust or carpet dust at the time of testing. Humidity levels were slightly elevated even though supplemental dehumidification was being used. There was an area of damp wallboard on the northern window in the music room. Wallpaper in the downstairs guest bedroom also indicated elevated moisture contact on exterior walls. Interior walls 14 indicated normal levels of moisture. content. All other areas of the house indicated normal moisture September 6, 2006: Ductbusters Indoor Pollution Control (Proposal) Main House: The air handler for the main house contains a medium build-up of biological growth. The supply plenum is in poor shape and should be replaced. The supply branch lines contain light debris. The fan position is ON. The fan should always be kept in the auto position. A return air (plenum) should be installed in each of the bedrooms. The air handler should be cleaned, removing and replacing the supply plenum and cleaning/coating the ductwork. Master Suite: The air handler for the master suite contains a medium build-up of biological growth. The supply plenum is in poor shape and should be replaced. The fan position is ON. The fan should always be kept in the auto position. The return ductwork is not large enough to accommodate the unit. An additional return air should be added. The air handler should be cleaned, removing and replacing the supply plenum, installing an additional return air and cleaning/coating the ductwork. Game Room: The air handler and supply plenum for the game room contain a medium build-up of biological growth. The sidewall grill is ceiling diffuser and should be replaced with the correct type of grille. The air handler should be cleaned and the ducts should be cleaned/coated. (The work listed above costing $7,006.01 was completed In September/October 2006, along with installation of the Ultra Aire APD (dehumidifier) in the system. In addition, the UV bulbs were changed in February 2007 for $882.) June 8, 2009: HSA Engineers & Scientists, Building Sciences Report - Microbial and Allergy Sampling - Site Visit Date: May 11,2009. Six paired samples were collected from the carpet of the master bedroom and second bedroom for microbial analysis and allergenic analysis. Control samples were collected in the southeast comer of "Alex's room". All samples from dust mites were considered low at <2 mcg allergen/gram dust. Fungi sampling of dust in the southwest comer of bedroom two revealed colony counts of Aspergillus sydowii -12, Aspergillus ustus -I, Paeeilomyees variotii - 12 and Triehodenna harzianum - 2. In addition, there was one sample from near the master bedroom fireplace with colony counts of Peacilomyees variotii - 5. All other samples had colony counts of 1. No interpretation of sample results were provided in the report. HVAC CLEANING: August 14-15, 2003: Service-Tech of Tampa Bay - Clean three air handling units, return ductwork, supply ductwork, diffusers and grilles. After cleaning a sanitizing agent (Oxine) applied to coils, flex ductwork, fan blades, fan housing, diffusers and grilles. After cleaning and sanitizing antimicrobial (Foster 40-20) applied to fiberglass lined plenums and fibrous glass ducts. September 6, 2006: Service-Tech of Tampa Bay - Clean (4) dirty diffusers and grilles. Clean and seal grill boxes. The ceiling around the grilles cleaned and sanitized (Oxine). CONSTRUCTION EVALUATION: October 22, 2004: RJ Koning Consulting, Construction Consultant - The author of the report was retained to evaluate and document the conditions surrounding the moisture intrusion 15 around and through the exterior envelope due to improper window flashing in the front of the home. The plywood sheathing (as a substrate for stucco) was found to be deteriorated and had become an area for fungal deterioration. Contamination extended into the surrounding drywall board and skeletal framing members. There was no evidence of flashing felt/tape/bitumen installed around the window fin/flange juncture. The felt back galvanized lath was found to be butted to the frame of the window and stapled off randomly prior to the application of stucco. The windows installed in the rear elevation of the home (second story) have visual evidence of staining underneath. The condition is indicative of a breech of the envelope flashing as the window juncture. CONSTRUCTIONIREMEDIATION WORK: November-December, 2003: Mold Remediation, Burns Instar Services Group - I) Remediation and containment of entry doors and foyer. 2) Remediation of crawl space. 3) Remediation of single care garage floor decking, insulation and joints. 4) Remediation of interior of vehicle stored in garage. Total Cost = $11,945.21 I) Remediation of front bedroom bay window lookout area and remediation of rear bedroom bay window. Total Cost = $11,865.52 I) Remediation of mechanical closet. Total Cost = $1,960.64 DEPOSITION TESTIMONY: As noted in the record review portion of this report, I had the opportunity to review a number of depositions, including depositions of all the GGGGGG family members, as well as the depositions of Dr. AAAAA XXXXX and Dr. GGGG WWWWW, respectively. Several of the depositions had noteworthy testimony and that is detailed below: Deposition o(AAAAA F. XXXXX, MD -August 10.2011 Page 10, Liues 3-8 Q. What is environmental medicine? A. Environmental medicine is an approach to medicine whereby you look at environmental factors in health and disease in determining causation and determining whether certain environmental factors in the air, food, water, products can be affecting and individual's health or illness. Page 14, Lines 7-10 Q. Are you an allergist? I'm not a regular allergist, correct. A. Q. You are not a regular allergist? A. Right. I'm not board certified in allergy, Page 15 - 16, Lines 21-25 and Lines 2-12 A. Then once I had all those courses and the thesis taken, except that I had to pass the boards and occupational medicine. Q. Is that an exam you have to take at that time? A. Yes. 16 Q. Who puts on that exam? A. The American Osteopathic College of Preventive Medicine, that has a subspecialty in occupational and environmental medicine. Well, it was originally the American Osteopathic College of Preventive Medicine. I think it's separate now. I mean, they're actually by themselves, the American Osteopathic College of Occupational and Environmental Medicine. SO that's an osteopathic college that board certifies you in that arca? Q. A. Yes. Pages 16-17, Lines 25 and 1-4 A. For example, I became board certified by the American Board of Environmental Medicine in 1991, which is both M.D. and D.O. Q. Again, that's taking the test put on by that board? A. Right. Page 17 -18, Lines 6 -15 and 1-15 Q. All right. What would the difference then be between the board certified allergist and what you do in the field of allergy? A. Well in my field, it's a little different because I treat patients with chemical sensitivities. So I diagnose and treat a little differently that a board-certified allergist who generally would treat only what we call IgE-mediated allergic disease. So there's a vague - there's a controversial area out there called multiple chemical sensitivities, which I've addressed with patients. Q. What's the controversy, do you mean between the medical field? A. In the medical field, yes, surrounding multiple chemical sensitivities, the diagnosis and treatment. Q. What controversy are you referring to? A. Well, whether chemical sensitivity exists, what causes it, and what treatments arc available. It's an ongoing controversy. Q. Ongoing controversy in the medical field starting off at even whether chemical sensitivity exists? A. Right. Q. And then there's also controversy in the medical field as to ifit exists, how best to treat it? A. Right. Q. And based on what I saw on your building, you treat multiple chemical sensitivity, I assume it's your opinion that it exists? A. Yes. Q. And you have your own opinions as to what causes that condition? A. Yes. Page 18, Lines 19-24 Q. With regard to board-certified allergist, is it the position that they take that multiple chemical sensitivity docs not exist? A. Some of them do. There are some who recognize its existence but don't know how to treat it or prefer not to treat it. 17 Pages 48-50, Lines 23-25 and Lines 1-25 and Lines 1-16 Q. And do you perform your allergy tests in the same way that a board-certified allergist would do it or do you do it different? A. We do it a little differently. Q. Okay. And the way that you do it is tbe same way that you would have performed the allergy testing on the GGGGGGs back in 2006 and forward? A. Right. Q. How does your practice perform allergy testing? A. Intradermal testing. Q. What does that mean? A. Under the skin. We use what's called Serial Dilution Endpoint Titration, which basically means you find the highest dose that the patient can tolerate and that's the dose that you start with treatment. A. Well, we take an antigen or an allergen such as ragweed or aspergillus, it's diluted out. Each dilution of tbe allergen is a I to 5 dilution, weaker or stronger that the next. So like a Number I dilution would be a l-to-I 00 dilution. Concentrate is about I to 20. Number 2 dilution would be I to 500. I to 3 dilution would by I to 2500 and on and on. So if an individual, when we test then on tbe skin, witb a skin wheal, just underneatb the skin witb a small round wheal, we see if it grows a certain amount in 10 minutes. And if it grows, he's sensitive to that dilution and we go to one weaker and on and on. And we find that the first skin wheal tbat it doesn't grow, so that's the highest dilution the individual can tolerate. That's called a maximum tolerated dose. And that's how we treat. Q. Okay. So you find out the highest dilution that somebody can tolerate and that is given some numerical number attached to it? A. Right. Page 52-53, Lines 19-24 and 1-2 Q. Okay. Do you continue to increase the dosage as an individual becomes more immune to that? A. No, we don't increase tbe dosage, we keep it at that dosage. How does that Q. It's more of a cumulative effect over time. A. Meaning what? Q. Over time, they get a tiny dose over time, which would increase their immunity to it, yes. A. Pages 54-55, Lines 18-24 Q. Now, you said that your allergy testing was different that a board-certified allergist. What does a board-certified allergist do to test allergies? A. They do escalation immunotherapy, where they keep building up the dosage. Q. Isn't that what you do? A. No, we keep the dosage the same all the time. Page 55-57. Lines 16 -25 and 1-25 and Line 1 18 A. The problem with the chemically sensitive patient is that a lot of the chemically-sensitive patients can't tolerate escalation immunotherapy. Q. . ... What do they (board-certified allergists) do and how is it different? A. What they do is they start off at a very, very low dose and then they, over a period of time, increase the dosage. We start off at a dose at the highest dose that the patient can tolerate and just stay there. So we don't have to start at as low of a dose and we don't have to go below the - what we calloptimal dose and we don't have to go above the optimal dose, we stay at a level dose, so to speak. A. We find the highest dose that they can tolerate per allergen and combine those together. Those should not cause an adverse reaction in the body. That's basically it. Q. All right. Is there a specific purpose as to why you don't test in the manner that a boardcertified allergist tests? A. Yeah, because the chemically-sensitive patients don't seem to tolerate the buildup therapy or the escalation therapy. They have more reactions to it. Page 58, Lines 2-10 Q. Okay. Now, it the type of allergy testing that you perform, is that accepted in the medical community? A. Well, it's considered an alternative type of testing. Q. Okay. Considered an alternative, but not accepted in the medical community? It's accepted and not accepted. A. Page 59, Lines 6-8 Q. Are you aware if any boar-certified allergists usc the technique that you use for allergy testing? Not at this point in time, no. A. Pages 60-62, Lines 5-25 and Lines 1-25 and Lines 1-5 Q. Is there anything that you did on this first visit or at any time in order to determine that in fact Dr. GGGGGG does have a chemical-sensitivity problem? A. Other that the medical history? Q. Correct. He tells you, " I have chemical sensitivity." Do you do anything to test to determine for yourselfthat in fact he does have chemical-sensitivity? A. Well, I tested him for three representative chemicals. A. Q. A. Q. A. Phenol, formaldehyde and glycerin and he tested positive. Through the allergy testing that we just discussed? Yes. Do board-certified allergists test for those chemicals? They sometimes test for phenol and glycerin. Q. And so in your determination, that testing indicated to you that Dr. GGGGGG was chemically sensitive? 19 A. Yes. Q. Based on the testing that you performed with regard to the chemicals, I'm assurmng you're not able to take those tests and relate it to a specific event? A. Well, no necessarily, no. Q. Is there anything other than the history from Dr. GGGGGG that you can rely on in causally relating the allergies to the chemicals you tested to the Holmes Beach residence? A. No. Q. Okay. So you totally have to rely on the truthfulness and accuracy of Dr. GGGGGG in giving that history that his condition started after that point? A. That's correct. Pages 63-64, Lines 12 - 25 and Lines 1-13 Q. SO once he became chemically sensitive, how does an individual, such as Dr. GGGGGG, become chemically sensitive as you've described? A. Well, I suspect that his chemical sensitivity was triggered by the mold exposure in the home, in the home that he was in. Q. SO is it your testimony that Dr. GGGGGG was not predisposed to be chemically sensitive, that the actual exposure to mold caused him to be chemically sensitive? A. That's correct. Q. SO is it your testimony that if you had tested Dr. GGGGGG for allergies to the three chemicals that you referred to prior to this issue in the Holmes Beach in Florida in 2003 and 2004, it's your belief he would not have been allergic to those chemicals? A. He may not have been allergic to those chemicals. That's a possibility. I don't know the answer to that question. Q What do you base that opinion on, that it's possible he became chemically sensitive from the exposure to mold in his Holmes Beach residence between 2003 and 2004; everything you base that on I want to know? A. Well, my experience with treating other individuals with similar problems; the fact that the whole family got sick from the exposures; his medical history that was given. Pages 64-65, Lines 20-25 and Lines 1-7 Q. Is there any testing that you can perform in your practice, any type of objective testing that you can perform in order to make that causation opinion that the chemical sensitivity could have been caused by the mold exposure in 2003 and 2004? A. Other than the fact that he tested positive to the molds and significantly positive to the mold allergies. Q. Other than that? A. Other that that, nothing, no. Q. But, again, those testings don't reveal that his allergies to mold was caused by exposure in 2003 and 2004, correct? A. That's correct. Page 66, Lines 4-10 20 Q. My question to you specifically, is there an objective test that you can perform as the osteopathic physician to causally relate Mr. GGGGGG's alleged chemical sensitivity to the mold exposure in the Holmes Beach residence? A. No objective tests that I know of. Pages 71-72, Lines 19-25 and Lines 1-2 Q. You talk about your recommend that Dr. Ziem and Pall's Protocol, the chemically sensitive with certain nutrients; what's that? It's a nutritional protocol. Certain nutrients that may be helpful for the chemicallyA. sensitive patient. Q. What to eat, a list of what to eat or something? It's certain vitamins and minerals and also a special diet, that's true. A. Page 93, Lines 18-22 Q. I understand he's saying that he's having greater sensitivity to chemicals, but I'm asking you from your osteopathic opinion what would cause him to have continued increasing sensitivity to chemicals? A. I don't know. Page 106, Lines 1-11 Q. My question is, within a reasonable degree of medical possibility, would you relate leftsided loss of feeling to chemicals and mold exposure? A. If she complained ofthat, that relationship, yes. Q. SO in order for you to relate a symptom to chemical sensitivity or mold exposure, all that is necessary is for the patient to say that it occurred after coming in contact with some chemical or mold? A. After an exposure, yes. Page 113, Lines 5-8 Q. What's the difference between an IgE and an IgG test? A. The IgE is a Type I allergy. The IgG test is a delayed allergy result. Page 118, Lines 4-7 Q. Okay. And with regard to Alex GGGGGG, his blood test resultsA. His blood test showed just mild mold allergy, delayed reaction. Page 121 -122, Lines 18-21 and Lines 2-9 Q. Are you in any way relating the irritability of Jaclyn as an infant and the difficulty sleeping to a mold event in the home in 2003? A. Possibly. Q. You would obviously accept the fact that young babies often are irritable and don't' sleep well, notwithstanding any potential mold exposure? A. That's correct. Q. SO the only way that you can related any of Jaclyn' s symptoms as a baby to a mold exposure event in 2003 would be solely related to her mother's history? 21 A. That's correct. Deposition of GGGG M. WWWWW.MD - July 29, 2011 Pages 42 - 43, Lines 20 - 25 and Lines 1-21 - Regarding Dr. GGGGGG Q. Okay. I believe you arrived at an impression following your exam of toxic mold exposure with MCS; is that correct? A. Yes. Q. What is MCS? A. Multiple Chemical Sensitivities. Q. What was your impression based upon? Specifically, was it based entirely upon your examination, the history, the testing or a combination of it all? A. I would say a combination of all, but the biggest part is obviously the history, and that at that time again, I came to that conclusion before the testing. That was my - that impression at that time, I would say rather than final diagnosis, but an impression based primarily on his history. Then the testing confirmed to me that was likely what his problem was. So the final diagnosis was based on his history and the testing, some with the examination; but the examination in his case, because it didn't show much wrong, it didn't playa big role. Q. As far as the percentage then, the history would have played a large majority role in your impression and analysis? A. Yes. Pages 59-62, Lines 24-25 and Lines 1-25 and Lines 1-25 and Lines 1-4 Q. Okay. So one physician may read an EEG with an abnormal delta or theta, and another may read it as a normal reading. A. Right. .... Grade I means this is often seen in normal people; yes, there is a little slowing, but sometimes you can see a little slowing in someone who is still normal. .... Grade I, like, it shows, that doesn't say for sure that is abnormal. That could be normal for that individual. It often is. Q. That testing also does not specifically address what is the cause of the abnormality, if it does exist even in class one, two or three, correct? A. Correct. .... Other than those rare instances - even if you see slowing in the left temporal lobe, it doesn't say for sure it is a tumor or what kind of tumor, whatever. It just says there is a lesion. Q. Without having the raw data in front of you are you able to tell us today what Dr. GGGGGG's abnormalities, ifany were, on the EEG? A. Yeah. He had mild increase in the delta just generally. Q. So based upon, I think what you had testified before, this is a condition that may be seen in normal individuals? A. Correct. Q. SO it is not specifically indicative of a specific condition. It just means there may be some abnormality. 22 A. It is consistent with a generalized encephalopathic process. In other words, a generalized process that slows the brain a little bit, but not specifically for which process that might be. And it is also possible that might be normal for this individual person. Pages 73-74, Lines 8-25 and Lines 1-14 Q. With the QEEG is it possible that other physicians, other neurologists may also review these results as normal? A. No. Q. Okay. So everybody who would review these results would say they are abnormal. A. Right. What that abnormality means, you might get more than one opinion, too. Q. Now, you did say all of these were consistent with or may be consistent with the process of toxic metabolic or ischemic etiologies. A. Right. The QEEG by itself doesn't tell you which of those - it says there is an encephalopathy. The brain is not working quite right; mildly abnormal. It is a generalized encephalopathy. In other words, the whole brain has been affected. So, for example, a patient who had a heart attack and didn't have enough oxygen for a while to their whole brain, could have a similar finding ...... So we could say that pattern of a generalized encephalopathy, but it doesn't give you that read out and say, ding, ding, this is the one. COMMENTS: It is clear from our visit and the medical records that Dr. GGGGGG believes that a timelimited "exposure" to mold in their home during 2003-2006, resulted in a myriad of historical and ongoing health conditions. His reported health concerns include: I) Numerous constitutional symptoms and a typical "reaction" following exposure to various chemicals and foods. With that said, there is no OBJECTIVE EVIDENCE to suggest that his possible exposure(s) to mold in his home could have caused persistent symptoms and/or the diagnosed conditions. This conclusion was reached after careful consideration of the following comments. - Literature Precedent Most building-related symptoms are consistent with an allergic etiology. With that said, most allergic problems related to mold exposure arc associated with varieties of mold typically found outdoors. Molds growing indoors are alleged to cause other types of building-related symptoms. Despite a voluminous literature on the subject, the causal association between nonallergic/respiratory complaints remains weak and unproven, particularly with respect to causation by mycotoxins. Massive exposures to spores containing relatively high levels of mycotoxins arc necessary to induce illness in humans. Experts estimate that there must be spore levels in excess of 1,000,000 per cubic meter of air over short periods or there must be constant 23 exposures to levels greater than 1000 toxin-containing spores per cubic meter for many days in order to cause an adverse reaction. This may occur rarely in certain occupational and agricultural situations, such as organic toxic dust syndrome. It is highly unlikely that sufficient mycotoxin exposure could occur with great frequency in indoor situations. This situation is coupled with the facts that mycotoxins arc not inherently volatile compounds found in the air. Even if mycotoxins are inhaled into the body, most will be metabolized and eliminated within hours to days. Consequently, persistent symptoms that patients experience (which are real) are not likely to be caused by mycotoxin exposure. Mold growth in the indoor environment is not a source of infections or mycotoxicosis. Current scientific evidence does not support the conclusion that human health is adversely affected by inhaled mycotoxins in the indoor environment. In addition, mold does not cause unusual syndromes such as chronic fatigue, chemical sensitivity, toxic encephalopathy or neurotoxic manifestations. Although living with mold can be uncomfortable, unsightly and associated with odors, only susceptible individuals are likely to be affected by excessive mold in the indoor environment. The American College of Occupational and Environmental Medicine (ACOEM) published a Position Statement on mold in the indoor environment and it reiterates what I have stated in the above discussion. (Hardin, 2003) The findings of ACOEM were corroborated in the 2006 position paper by The American Academy of Allergy, Asthma and Immunology titled The Medical Effects of Mold Exposure (Journal of Allergy and Clinical Immunology. I 17:326-333), as noted below: • The occurrence of mold-related toxicity (mycotoxicosis) from exposure to inhaled mycotoxins in nonoccupational settings is not supported by the current data, and its occurrence is improbable. The Institute of Medicine published a full review of the topic titled Damp Indoor Spaces and Health in 2004. An executive summary may be found at http://www.nap.edu/books/0309091934/html/. The findings of this report include the following for damp environments: Sufficient Evidence for: I. Nasal and throat symptoms - irritation 2. Cough, wheeze 3. Asthma symptoms in sensitized persons Limited or suggestive evidence for: I. Shortness of breath 2. Lower respiratory symptoms in children 3. Asthma development Inadequate evidence to determine an association for: Airflow obstruction, mucous membrane irritation syndrome, COPD, inhalation fever, lower respiratory symptoms in healthy adults, acute idiopathic hemorrhage in infants, skin symptoms, GI symptoms, fatigue, neuropsychiatric symptoms, cancer, reproductive effects, rheumatologic and other immune disorders III damp environments with mold or other agents the report included the following findings: 24 Sufficient Evidence for: I. Nasal and throat symptoms - irritation 2. Cough, wheeze 3. Asthma symptoms in sensitized persons 4. Hypersensitivity pneumonitis in susceptible persons Limited or suggestive evidence for: I. Lower respiratory symptoms in children Inadequate evidence to determine an association for: Shortness of breath, asthma development, airflow obstruction, mucous membrane irritation syndrome, COPD, inhalation fever, lower respiratory symptoms in healthy adults, acute idiopathic hemorrhage in infants, skin symptoms, GI symptoms, fatigue, neuropsychiatric symptoms, cancer, reproductive effects, rheumatologic and other immune disorders The American Academy of Allergy, Asthma and Immunology position paper drew the following conclusions regarding irritant effects of mold exposure: • The OCC1UTence of mold-related irritant reactions from exposure to fungal irritants in nonoccupational settings are theoretically possible, although unlikely to occur in the general population given exposure and dose considerations. • Such irritant effects would produce transient symptoms-signs related to the mucous membranes of the eyes and upper and lower respiratory tracts but would not be expected to manifest in other organs or in a systemic fashion. Since the publication of the 2004 Institute of Medicine report on the potential health effects of dampness and mold, researchers worldwide have continued to study these questions. Numerous studies have reiterated and strengthened the findings of the 2004 10M report, and the results have remained essentially the same - exposure to dampness, as well as dampness with mold can cause and/or exacerbate allergic symptoms and some respiratory disorders. In 2011, the American College of Occupational and Environmental Medicine updated their position statement on mold titled Adversc Human Health Effects Associated with Molds in the Indoor Environment. The findings were essentially unchanged since the original document in 2003. That is, with eight additional years of intensive research and scrutiny the proven health effects of mold exposure remain the same - allergy exacerbation, triggering of mold-sensitive asthma and rarc systemic infections. The ACOEM guideline may be found at the following web address http://www.acoem.org/AdverseHumanH ealthEffects Molds .aspx. Although several of the GGGGGGs, including Dr. GGGGGG, have been diagnosed with 25 mold "allergies" by Dr. AAAAA XXXXX, I believe that one should take a very close look at the both qualifications of Dr. XXXXX, as well as his diagnostic techniques, particularly related to allergy skin testing. In his deposition, Dr. XXXXX freely admitted that he is not a boardcertified allergist, as noted below: Page 14, Lines 7-10 Q. Are you an allergist? A. I'm not a regular allergist, correct. You are not a regular allergist? Q. A. Right. I'm not board certified in allergy. I am certain that you also noted that Dr. XXXXX did not complete any formal residency training in Allergy, as he took a rotating internship from 1969-1970 and chose to work in an emer enc room after that sin Ie ear of trainin . The primary function of ABMS is to assist its Member Boards in developing and implementing educational and professional standards to evaluate and certify physician specialists." (ABPM website - h :llwww.abms.or IAbout ABMS/) In his deposition, Dr. XXXXX noted the following about his method of allergy testing and treatment: Pages 48-50, Lines 23-25 and Lines 1-25 and Lines 1-16 Q. And do you perform your allergy tests in the same way that a board-certified allergist would do it or do you do it different? We do it a little differently. A. Q. Okay. And the way that you do it is the same way that you would have performed the allergy testing on the GGGGGGs back in 2006 and forward? A. Right. Q. How does your practice perform allergy testing? A. Intradermal testing. ~latdocsthatmean? Q. A. Under the skin. We use what's called Serial Dilution Endpoint Titration, which basically means you find the highest dose that the patient can tolerate and that's the dose that you start with treatment. A. Well, we take an antigen or an allergen such as ragweed or aspergillus, it's diluted out. Each dilution of the allergen is a I to 5 dilution, weaker or stronger that the next. So like a Number I dilution would be a l-to-100 dilution. Concentrate is about I to 20. Number 2 dilution would be I to 500. I to 3 dilution would by I to 2500 and on and on. So if an individual, when we test then on the skin, with a skin wheal, just underneath the skin with a small round wheal, we see if it grows a certain amount in 10 minutes. And if it grows, he's sensitive to that dilution and we go to one weaker and on and on. And we find that the first 26 skin wheal that it doesn't grow, so that's the highest dilution the individual can tolerate. That's called a maximum tolerated dose. And that's how we treat. Q. Okay. So you find out the highest dilution that somebody can tolerate and that is given some numerical number attached to it? A. Right. Un-validated Testing Serial Dilution Endpoint Testing (SET) is also known as skin endpoint titration (SET) and intradermal dilutional testing (IDT). It is generaIly offered by Ear, Nose and Throat (ENT) physicians. Although it is different than "traditional" aIlergy testing, SET has gained some credibility in the last several years, particularly for identifying hymenoptera (yeIlow jacket, honey bee, hornet, wasp and fire ant) sensitivity and determining a safe dose for starting venom immunotherapy. Nevertheless, it's use for diagnosin and treatin inhalant aIler ies (such as mold) is still considered somewhat controversial. This is due to the fact that he actually performs Provocation-Neutralization testing, or a Rinkel Test protocol. This evolved from SET, but ascribes to a completely different methodology. Once a test is positive (objective skin wheal or subjective symptoms), a progressive series of lower concentrations are administered until the patient reports no sensations, or there is no increase in the wheal size. This amount of the test substance is then considered the "neutralizing dose", and is used for all subsequent aIlergy immunotherapy. Provocation-Neutralization allergy testing and treatment is not generally covered by standard-line health insurance companies. In addition, the American Academy of Allergy and Immunology (AAAAI - "traditional" aIlergy training) considers Neutralization-Provocation Testin ex erimental and un roven. 27 There is no objective evidence to suggest that Dr. SSSSS's diagnosed "allergies" are truly allergies. In fact, Dr. GGGGGG did not complain of typical allergy symptoms when in the house, such as runny nose, itchy eyes, sneezing, etc. It is certainly possible that Dr. GGGGGG may have some environmental allergies; however, we cannot utilize the allergy results of Dr. XXXXX to make this diagnosis. This lack of reliability and general illogical nature is made unquestionably clear by his explanation of why he tests patients with alleged Multiple Chemical Sensitivity (MCS) with his allergy testing method, as noted below: Page 55-57. Lines 16 -25 and 1-25 and Line 1 A. The problem with the chemically sensitive patient is that a lot of the chemically-sensitive patients can't tolerate escalation immunotherapy. Q. . ... What do they (board-certified allergists) do and how is it different? A. What they do is they start off at a very, very low dose and then they, over a period of time, increase the dosage. We start off at a dose at the highest dose that the patient can tolerate and just stay there. So we don't have to start at as low of a dose and we don't have to go below the - what we calloptimal dose and we don't have to go above the optimal dose, we stay at a level dose, so to speak. A. We fmd the highest dose that they can tolerate per allergen and combine those together. Those should not cause an adverse reaction in the body. That's basically it. Q. All right. Is there a specific purpose as to why you don't test in the manner that a boardcertified allergist tests? A. Yeah, because the chemically-sensitive patients don't seem to tolerate the buildup therapy or the escalation therapy. They have more reactions to it. Nevertheless, the fact remains that the "allergy testing" methodology is not part of standard medical practice. Any "allergies" he may have diagnosed in thc GGGGGG's with this testing protocol cannot be assumed to be correct, or a true measure of their "allergies", including environmental agents and chemicals. - Positive, and .... Several providers, including Dr. XXXXX and Dr. Weingarten (Dr. GGGGGG only) have chosen to order serum IgG antibody levels to a panel of environmental molds. This testing is of no clinical value and cannot be used to assert mold sensitization or symptoms. In a 2008 28 study, Rydjord et al. quantified IgG antibody levels by flow cytometry in Norwegian children versus the Immunocap method. (Rydjord, 2008) Interestingly, the authors clearly stated the following: In another study examining healthy children living in "normal" homes without evidence of mold or moisture contamination, Korppi et al. found that children of fanners generally developed IgG antibodies to molds earlier in life, yet these differences disappeared by age 7. (Korppi, 2003) Nevertheless, the authors concluded that the available data does not allow the estimation of mold-specific IgG levels that can be considered pathological. Furtherrnore, they stated the following: These same findings were mirrored in a 2004 review article titled Clinical Use ofImmunoassays in Assessing Exposure to Fungi and Potential Health Effects Related to Fungal Exposure, produced by a number of authors affiliated with the National Institute for Occupational Health and Safety (NIOSH). (Trout,2004) In this article they stated the following: With all that said, previous studies in people with very high fungal exposure, such as fanners with farmer's lung or hypersensitivity pneumonitis, have documented a potential rise in specific IgG levels in concert with exposure. (Terho, 1987 and Erkinjuntti-Pekkanen, 1999) However, the relationship between exposure and rising IgG levels is much more tenuous in studies involving mold-damaged buildings, where the exposures are generally orders of magnitude below that found in fanning. For example, multiple studies in children attending schools with moisture problems have failed to show a relationship between IgG levels and exposure to moisture and molds in the schools. (Immonen, 2002; Taskenen, 2002 and Hyvarinen, 2003) In his deposition Dr. XXXXX was forthright about the controversy in the medical community about a collection of disparate symptoms know as Multiple Chemical Sensitivity (MCS), Idiopathic Environmental Intolerance (lEI) or a litany of other descriptors, as noted below: 29 Page 17 18, Lines 6 -15 and 1-15 Q. All right. What would the difference then be between the board certified allergist and what you do in the field of allergy? A. Well in my field, it's a little different because I treat patients with chemical sensitivities. So I diagnose and treat a little differently that a board-certified allergist who generally would treat only what we call IgE-mediated allergic disease. So there's a vague - there's a controversial area out there called multiple chemical sensitivities, which I've addressed with patients. Q. What's the controversy, do you mean between the medical field? A. In the medical field, yes, surrounding multiple chemical sensitivities, the diagnosis and treatment. Q. What controversy are you referring to? A. Well, whether chemical sensitivity exists, what causes it, and what treatments are available. It's an ongoing controversy. Q. Ongoing controversy in the medical field starting off at even whether chemical sensitivity exists? A. Right. Q. And then there's also controversy in the medical field as to ifit exists, how best to treat it? A. Right. Q. And based on what I saw on your building, you treat multiple chemical sensitivity, I assume it's your opinion that it exists? A. Yes. Q. And you have your own opinions as to what causes that condition? A. Yes. I agree with Dr. XXXXX that there is a very large controversy surrounding the existence of MCS/IEI, as well as any purported treatment. The symptoms described b most suffers de the classic dose res onse relationshi found in toxicolo By diagnosing patients with chemical "allergy" via his unproven, untestable and unreliable methods, Dr. XXXXX is doing them a disservice by perpetuating their false beliefs in MCS/IEI. Interestingly, the AAAAI statement directly addressed the types of tests used to diagnose IEI, as noted below: 30 The tests most frequently used by practitioners who diagnose lEI are provocationneutralization and a panel oj immunologic tests. The latter encompasses measurements oj serum immunoglobulins, complement levels, blood lymphocyte subset counts, autoantibodies, and serum antibodies to chemicals. Studies to date have Jailed to confirm that any immunologic tests are diagnostic for chemically induced symptomatology. - Limitations and Overreliance Taken as a whole, Dr. XXXXX has relied upon unproven and unreliable testing methodologies to "diagnose" a condition whose very existence is tenuous at best. In addition, he has offered various "treatments" that were most likely unhelpful in addressing any "real" problem they may have had, except for standard treatments such as Allegra and Singulair for allergic rhinitis. There is no objective proof to suggest that nutrients, vitamins and reduced lutathione offer an clinical benefit to atients with MCS/IEI corn laints. and he ascribed all of their problems to the possible mold exposure in their Holmes Beach home on much the same grounds, as noted below: Pages 60-62, Lines 5-25 and Lines 1-25 and Lines 1-5 Q. Based on the testing that you performed with regard to the chemicals, I'm assuming you're not able to take those tests and relate it to a specific event? A. Well, no necessarily, no. Q. Is there anything other than the history from Dr. GGGGGG that you can rely on in causally relating the allergies to the chemicals you tested to the Holmes Beach residence? A. No. Q. Okay. So you totally have to rely on the truthfulness and accuracy of Dr. GGGGGG in giving that history that his condition started after that point? A. That's correct. Pages 63-64, Lines 12 - 25 and Lines 1-13 Q. SO once he became chemically sensitive, how does an individual, such as Dr. GGGGGG, become chemically sensitive as you've described? A. Well, I suspect that his chemical sensitivity was triggered by the mold exposure in the home, in the home that he was in. Q. SO is it your testimony that Dr. GGGGGG was not predisposed to be chemically sensitive, that the actual exposure to mold caused him to be chemically sensitive? A. That's correct. Q. SO is it your testimony that if you had tested Dr. GGGGGG for allergies to the three chemicals that you referred to prior to this issue in the Holmes Beach in Florida in 2003 and 2004, it's your beliefhe would not have been allergic to those chemicals? 31 A. He may not have been allergic to those chemicals. That's a possibility. I don't know the answer to that question. Q What do you base that opinion on, that it's possible he became chemically sensitive from the exposure to mold in his Holmes Beach residence between 2003 and 2004; everything you base that on I want to know? A. Well, my experience with treating other individuals with similar problems; the fact that the whole family got sick from the exposures; his medical history that was given. Pages 64-65, Lines 20-25 and Lines 1-7 Q. Is there any testing that you can perform in your practice, any type of objective testing that you can perform in order to make that causation opinion that the chemical sensitivity could have been caused by the mold exposure in 2003 and 2004? A. Other than the fact that he tested positive to the molds and significantly positive to the mold allergies. Q. Other than that? A. Other that that, nothing, no. But, again, those testings don't reveal that his allergies to mold was caused by Q. exposure in 2003 and 2004, correct? A. That's correct. Page 66, Lines 4-10 Q. My question to you specifically, is there an objective test that you can perform as the osteopathic physician to causally relate Mr. GGGGGG's alleged chemical sensitivity to the mold exposure in the Holmes Beach residence? A. No objective tests that I know of. - A "Positive" Result Must be Placed into the Appropriate Context Dr. GGGGGG saw Dr. RRRRR SSSSS on at least one occasion in 2004, at which time he offered the assessment of SBS (Sick building syndrome). In addition, there are a number of notes that appear to be phone messages, etc. relatcd to patient complaints in the succeeding years. Unfortunately, most of Dr. SSSSS's notes are illegible. In addition to the office visit, Dr. SSSSS ordered a litany of laboratory tests, but provided no insight into the use, efficacy, sensitivity or specificity of any of this testing. Some of the laboratory values ascertained included myelin basic protein, tumor necrosis factor alpha, erythropoietin, C2, properdin factor B, C3, C4, Immune Complex Clq, C3a, VEGF, c4d Fragments, C3d Immune Complex, HLA DRB DQB Typing, Raji Cells, MSH, Plasminogen Act Inhibitor-l , Anticardiolipin antibodies, Gliadin antibodies, matrix metalloproteinase-9. These are all extremely esoteric laboratory tests with no proven utility in the evaluation of any mold-related condition. Interestingly, these are also the types of tests icall used to "dia ose" MCS/IEI, as mentioned above in the AAAAI Position Statement. 32 Interestingly, Dr. SSSSS also ordered a total Immunoglobulin E = 4 Il.l/ml (Normal Range: 0-158) on 5118/04. This value is not consistent with a significant underlying allergic diathesis, such as that proposed by Dr. XXXXX. What Does It Mean? The GGGGGGs all saw Dr. GGGG WWWWW on at least one occasion and each received a bank of neurological tests. Dr. WWWWW diagnosed each GGGGGG family member with either Toxic Encephalopathy with MCS (Jaclyn) or Toxic Mold Exposure with MCS (Alex, Rhyanna, Ryan, Alan and Anna Marie). Much like Dr. XXXXX, Dr. WWWWW relied primarily upon the history given by the patients to make his diagnosis, as noted below: Pages 42 - 43, Lines 20 - 25 and Lines 1-21 - Regarding Dr. GGGGGG Q. What was your impression based upon? Specifically, was it based entirely upon your examination, the history, the testing or a combination of it all? A. I would say a combination of all, but the biggest part is obviously the history, and that at that time again, I came to that conclusion before the testing. That was my - that impression at that time, I would say rather than final diagnosis, but an impression based primarily on his history. Then the testing confirmed to me that was likely what his problem was. So the final diagnosis was based on his history and the testing, some with the examination; but the examination in his case, because it didn't show much wrong, it didn't playa big role. Q. As far as the percentage then, the history would have played a large majority role in your impression and analysis? A. Yes. Dr. WWWWW ordered and interpreted a number of tests at his office, including an EEG and QEEG on each of the GGGGGGs'. He made it clear that any "abnormal" EEG results that he found were not specific to a disease process, and in the case of the QEEG the cause of any abnormality was not readily identifiable. Pages 59-62, Lines 24-25 and Lines 1-25 and Lines 1-25 and Lines 1-4 Q. Without having the raw data in front of you are you able to teII us today what Dr. GGGGGG's abnormalities, if any were, on the EEG? A. Yeah. He had mild increase in the delta just generaIIy. Q. So based upon, I think what you had testified before, this is a condition that may be seen in normal individuals? A. Correct. 33 Q. So it is not specifically indicative of a specific condition. It just means there may be some abnormality. A. It is consistent with a generalized encephalopathic process. In other words, a generalized process that slows the brain a little bit, but not specifically for which process that might be. And it is also possible that might be normal for this individual person. Pages 73-74, Lines 8-25 and Lines 1-14 Q. With the QEEG is it possible that other physicians, other neurologists may also review these results as normal? A. No. Q. Okay. So everybody who would review these results would say they are abnormal. A. Right. What that abnormality means, you might get more than one opinion, too. Q. Now, you did say all of these were consistent with or may be consistent with the process of toxic metabolic or ischemic etiologies. A. Right. The QEEG by itself doesn't tell you which of those - it says there is an encephalopathy. The brain is not working quite right; mildly abnormal. It is a generalized encephalopathy. In other words, the whole brain has been affected. So, for example, a patient who had a heart attack and didn't have enough oxygen for a while to their whole brain, could have a similar finding...... So we could say that pattern of a generalized encephalopathy, but it doesn't give you that read out and say, ding, ding, this is the one. CONCLUSIONS: From my training and experience, I am familiar with the literature that describes the scientific methodology required to determine the specific cause of a disease or ailment. This same methodology should be rigorously applied in order to establish a causal link between any exposure and an alleged disease or ailment. The application of this methodology allows one to distinguish a result that occurs s ontaneousl , from those which rna result from a known ex osurc. The evaluation of a causal relationship between a specific cause and a specific disease outcorne in an individual should include the following information: 1. 2. 3. 4. Evidence of exposure to the specific compound. The exposure must result in a dose of the specific compound. The dose must be sufficient to cause the specific ailment. The specific ailment is known to be caused in humans by the specific compound in question. 34 5. The ailment is temporally eligible to have been caused by the exposure. 6. The alleged effect(s) is biologically plausible. 7. Confounding factors have been eliminated as possible causes of the ailment. Although mold exposure may potentially cause transient mucosal irritation symptoms, exacerbation of allergy symptoms, as well as triggering of allergen-related asthma, these are all transient and directly related to the exposure. Following cessation of exposure, if symptoms persist eitlIer the exposure was not unique, or the symptoms are related to another offending agent. Simply put, there is no clear, objective relationship between the Holmes Beach house and any of the patient's conditions from mid-2003 to present. It is my understanding that additional depositions are scheduled and further medical records may become available in the near future. As stated in the report introduction, this is an INITIAL report pending receipt and review of all additional records. I reserve the right to amend this report if further information should become available. Sincerely, James McCluskey, MD, MPH, PhD 35 REFERENCES Bailer, J., M. Witthoft, et al. (2005). "Evidence for overlap between idiopathic environmental intolerance and somatoform disorders." Psychosom Med 67(6): 921-929. Hardin, B. D., B. J. Kelman, et al. (2003). "Adverse human health effects associated with molds in the indoor environment." 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