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Medical Devices Expert Witnesses

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5380 Old Bullard Rd
Suite 600-326
Tyler TX 75703
USA
phone: 414-218-4310
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Seth Womack Emergency Medicine Expert PhotoSeth P. Womack, MD, FAAEM, is Board Certified in Emergency Medicine by the American Board of Emergency Medicine. A fellow of the American Academy of Emergency Medicine, Dr. Womack is recognized for his expertise in pediatric, trauma, neurological, and cardiac resuscitation. Dr. Womack is also ATLS (Advanced Trauma Life Support) certified and has completed the Difficult Airway Course: Emergency ™. He is currently licensed to practice in Louisiana, Texas, and Wisconsin.

With an undergraduate Degree, Magna Cum Laude, in Biomedical Engineering, Dr. Womack is an experienced flight physician, skilled in the utilization of video laryngoscopy for emergency airway management and bedside ultrasound procedures. He has treated over 25,000 patients over the course of his medical career.

Litigation Support - Dr. Womack is highly experienced and able to serve as an Emergency Medicine expert witness. His case review services are available to counsel representing both Plaintiff and Defense. Dr. Womack works on cases involving an alleged breach of the standard of care committed by an emergency room physician. The issues he may be called upon to address include standard of care, breach, and causation.

Areas of Expertise:
  • Heart Attacks
  • Myocardial Infarction
  • Strokes
  • Pulmonary Embolism
  • Airway Management
  • Appendicitis
  • Ectopic Pregnancy
  • Pneumonia
  • Aneurysm Trauma
  • Testicular Torsion
  • Mental Health / Suicide
  • Sepsis
  • Airway Management
  • Central Line Placement
  • CASE: 43-year-old male presents to the ER with chief complaint of vomiting blood and epigastric (upper stomach) pain. Approximately 1 hour prior to presenting to the ER, he finished dinner with his family of 5; became nauseated and sweaty; and vomited his meal mixed with a large amount of dark red blood. His wife states that it seemed "like a gallon!" Pertinent past history included weekly ibuprofen use for chronic knee pain and alcohol use consisting of beer only on the weekends when he is not working.

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    Amitkumar Dharia, PhD
    8418 Sterling St., Suite A
    Irving Texas 75063
    USA
    phone: 972-915-0516
    fax: 972-915-0518
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    Amitkumar Dharia, PhD has over 27 years of direct experience in new Plastics and Polymer product and process, research and development, market research and analysis, product and project management, and commercialization.

    After working with various organizations throughout the United States, Dr. Dharia founded Transmit Technology Group, LLC in 1999. Since then, he has helped numerous clients in conceptualizing, exploring through experimentation, and screening best and novel alternatives, in connecting and coordinating external resources to drive concepts to commercialization. In 2006, he developed a novel testing equipment, Technoform, to determine the thermoformabiltiy of thermoplastics materials. Technoform has been used in over 60 industrial projects related to thermoforming.

    During 1999-2014, Dr. Dharia was named inventor or co-inventor on six US and international patents and is named a co-inventor on two pending applications. A patent agent registered with USPTO, he himself has been issued 21 United States patents and has been responsible for more than 30 disclosures of inventions. He has also authored over 24 technical publications.

    Litigation Support - Dr. Dharia provides expert witness services in the area of Plastic Part Failure. His services are available to attorneys representing plaintiff and defendant and include product failure analysis, written reports, depositions, and trial testimony.

    Areas of Expertise:
    • Plastic Materials
    • Polymer Materials
    • Additives
    • Conductive Plastics
    • Reinforced Materials
    • Flame Retardants
    • Thermoplastic Elastomers (TPE)
    • Thermoplastic Olefin (TPO)
    • Thermophotovoltaic (TPV)
    • Plastic Blends
  • Alloys
  • Reactive Modifications
  • Foams
  • W & C Applications
  • Automotive Applications
  • Packaging
  • Consumer Goods
  • Sensors
  • Medical Devices
  • Construction Markets
  • View Dr. Dharia's Consulting Profile.
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    Matthew I. Stein, PE
    Principal
    10591 Belford Place
    Truckee CA 96161
    USA
    phone: 530-587-7618
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    Matthew I. Stein, PE, principal of Stein Design, has 12 patents to his name, 30+ years of Mechanical Engineering experience specializing in Product Design & Development, and 10+ years of Expert Witness experience with Patent Litigation and Product Liability. Multiple Injury cases relating to drinking fountains or involving the use of Safety Showers/Eyewashes. He has designed highly successful products for industry leaders such as Hewlett Packard, Seagate, IGT, Duraflame, Plantronics, and Haws.

    Litigation Support - Mr. Stein’s background as a National Merit Scholar, MIT graduate, and bestselling author, combined with his extensive media experience on television, radio and in public speaking engagements, make him a formidable expert witness who is not only technically savvy but also presents exceptionally well in front of judge and jury.

    Most cases settled out of court, but in one patent infringement case where Stein was the key expert witness for plaintiff, the jury awarded an 8 figure judgment, and in a recent liability case where Stein testified on behalf of plaintiff, the jury awarded $1.8 Million. As a former world class rock climber, and licensed general contractor, he can also offer testimonial on climbing accidents and job site safety.

    Expert Witness Experience:
    • 21 cases total (15 patent related, 2 related to trade secrets, and 4 related to product liability)
    • Authored approximately 34 expert reports
    • Provided deposition on 12 different occasions
    • Provided expert witness court testimonial on multiple days for each of 3 jury trials
    Areas of Expertise:
    • Patent Infringement and/or Invalidity
    • Consumer Product Design & Liability
    • Cash Machines & Paper/Membrane Handling Devices
    • Telephone Head Sets & Small Scale Sonar Devices
    • Water Filtration, Drinking Fountains, & Misc Plumbing Products
    • Safety Showers & Eyewash Equipment
    • ANSI/ISEA/OSHA for Emergency Eyewash & Shower Equipment
    • Plumbing Fixtures & Valves
    • Medical Filters
    • Photovoltaic Panels
    • Plastic Part Design & Application
    View Matthew Stein's Consulting Profile.
    Matthew Stein, PE
    Disasters often strike without warning and leave a trail of destruction in their wake. Yet armed with the right tools and information, survivors can fend for themselves and get through even the toughest circumstances. This book provides a thorough, practical guide for how to prepare for and react in many of life's most unpredictable scenarios.
    Matthew Stein, PE
    This book, comprehensive primer on sustainable living skills—from food and water to shelter and energy to first-aid and crisis-management skills—prepares you to embark on the path toward sustainability. But unlike any other book, Stein not only shows you how to live “green” in seemingly stable times, but to live in the face of potential disasters, lasting days or years, coming in the form of social upheaval, economic meltdown, or environmental catastrophe.
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    Songer Evans Legal Nurse Experts
    Joahnna D. Evans Budge RN, CCRN, CLNC
    RN Legal Nurse Consultant, Expert Witness Experience
    Offices in Bluffdale, UT & Kerman, CA
    CA, UT USA
    phone: 559-741-3054
    fax: 18667282119
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    California Office
    15662 Orchard Way
    Kerman, CA 93630
    Utah Office
    1581 W Iron Horse Blvd
    Bluffdale, UT 84065
    Joahnna Evans Budge RN, CCRN, CLNC (formerly Songer) is co-founder and lead Legal Nurse Consultant with Songer Evans Legal Nurse Experts. Ms. Evans Budge has 26 years of Critical Care, Emergency / Trauma, PACU/ Recovery Room, and Cardiac-Cardiovascular Surgery nursing practice at multiple university teaching hospitals, regional medical centers and level-one trauma centers. She is a specialist on CODE BLUE Issues and Procedure.

    Ms. Budge actively practices in the hospital setting in Critical Care, Emergency Nursing, Nursing Supervision, Recovery Room/PACU and trauma neuro critical care. She has extensive knowledge and experience in the health care environment. She has more than 25 years of experience as both an Expert Witness & Medical-Legal Consulting Expert, reviewing medical records for case merit, case development and trial preparation.

    Services Offered:
    • Critical Care / Intensive Care
    • Emergency Nursing
    • Case Screening for Merit: Screen and investigate medical-legal cases for merit; define the applicable standards of care; identify deviations from and adherences to hospital, state and nationally-accepted standards of care
    • Organize, analyze, summarize and interpret relevant medical records
    • Identify and request additional documents and tangible items relevant to the case
    • Research medical literature relevant to the case
    • Develop comprehensive case evaluations and reports for the attorney's study and case development
    • Identify and recommend potential defendants and witnesses
    • Assess alleged damages / injuries: Identify causative or contributing factors to the alleged damages/injuries
    • Review and analyze Expert Witness reports and testimony
    • Consult with health care providers
    • Attend depositions, trials, arbitration and mediation hearingsReview, analyze and summarize testimony, including past testimony
    • Prepare interrogatories, health care-related questions
    • Assist with medical / health care demonstrative evidence preparation
    • Attend IME sessions / IME reports
    View Consulting Profile.
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    Prosthetics and Orthotics Expert Witness and Consultant
    792 Eastern Point Road
    Annapolis MD 21401
    USA
    phone: 410-533-1960
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    Mr. John F. Schulte, is an accomplished Orthotic and Prosthetic practitioner with 40 plus years of experience consulting and treating Body and External powered upper and lower extremity prosthetics for all age groups.

    Mr. Schulte has vast knowledge and experience in clinical practice prosthetic and orthotic component development, design, and manufacturing. A Clinician, Patient Care Consultant, and Senior Manager of 27 offices throughout 5 states, he is considered an expert in his field. Mr. Schulte continues to be asked to consult on Clinical ‘Best Practices’ by physicians, third party payors, peers, and patient users on the most appropriate component utilization and outcome measurements.

    A published author, consultant, and Clinical Board Examiner, Mr. Schulte has treated and been involved with the treatment of persons of all ages with congenital birth defects, limb weakness and loss, and spinal cord injury.

    Litigation Support - John Schulte's intimate knowledgeable in prosthetic and orthotic clinical practice and management, component prescription recommendation, and selection and utilization for all patient ages and levels of function make him an excellent expert witness resource. His services are available to attorneys representing plaintiff and defendant and include medical record review, second opinions, written reports, depositions, and trial testimony.

    Areas of Expertise:
    • Appropriate Prosthetic / Orthotic Component Selection Recommendation
    • Utilization and Failures Due to Improper Manufacturing Processes
    • Prescription Appropriateness
    • Clinical Applications and Negligence Directly Related to Limb Weakness and Loss
    • Spinal Cord Injury and Treatment
    • Wrongful Death Investigation and Determination
    • Limb Damage and Loss in Diabetics as Related to Footwear
    • LifeCare Plan Consultation and Preparation as Related to Orthotics and Prosthetics
    Education:
    • New York University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Prosthetist, 1973
    • Northwestern University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Orthotist, 1973
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    Richard K. Baer, MD
    2727 N Lakewood Ave
    Chicago IL 60614
    USA
    phone: 773-477-0201
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    Richard K. Baer, MD, is a Healthcare Coverage consultant with over 20 years of experience in medical director roles for the Medicare Administrative Contractor (MAC), the Recovery Auditor (RAC), and regional home health and hospice contractors. He most recently served as the Medical Director for the RAC, Region A, in the northeast US.

    Dr. Baer is a Distinguished Life Fellow of the American Psychiatric Association, and a member of numerous state and national medical societies. He served as President of the Illinois Psychiatric Society, Editor of its newsletter, and Chairman of its Ethics Committee.

    During his tenure with the Medicare program, Dr. Baer authored several hundred Local Coverage Determinations (LCDs) and other medical review policy articles and documents for new technologies, pharmaceuticals, and highly utilized services covering millions of Medicare beneficiaries. He has provided medical policy assistance to CMS on national coverage issues, and has been involved in federal investigations and audits of Medicare improper payments and fraud matters for a variety of health care providers.

    Litigation Support - Dr. Baer has extensive experience consulting and testifying for the United States Department of Justice in Medicare criminal and civil fraud trials and other civil proceedings. He provides expert medical consultation on Payer Coverage Requirements for the Medical Device Industry.

    Areas of Expertise:
    • Medical Devices
    • Medical Device Design
    • Medicare Rules
    • Medicare Regulation Compliance
  • RAC Audits
  • Medical Billing
  • Medical Coding
  • Pharmaceutical Compliance
  • View Dr. Baer's Consulting Profile.
    Richard Baer, MD
    A Doctor’s Harrowing Story of Treating a Woman with 17 personalities.
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    Daniel Rapperport
    8 Wallis Court
    Lexington MA 02421
    USA
    phone: 781-862-9001 or 339-222-2822
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    Rapperport Associates, Inc., provides exceptional capability in Failure Analysis, Fire and Explosion Investigation, Accident Reconstruction, Structural Analysis, Mechanical and Electrical Engineering, Metallurgy and Materials Science.

    We have provided superior technical support for litigation since 1974, and possess an extraordinarily talented technical team with impeccable academic and industrial credentials and proven analysis capability. Our team of distinguished scientists and engineers is drawn principally from Massachusetts Institute of Technology (M.I.T.) and Stanford University.

    AREAS OF EXPERTISE:

    Failure Analysis
  • Structural Design Analysis
  • Metallurgical Failures
  • Finite Element Stress Analysis
  • Fracture and Fatigue Analysis
  • Scanning Electron Microscopy
  • Corrosion

  • Accident Reconstruction
  • Automobiles / Trucks
  • Biomechanics / Injury Mechanism
  • Off-Road Vehicles
  • Occupant Motion
  • Aircraft
  • Animation

  • Fire & Explosion Analysis
  • Cause and Origin
  • Electrical
  • Gases, Liquids and Dust
  • Industrial Processes
  • ........Safety
  • Machine and Industrial Safety
  • Machine Guarding
  • Construction Failures
  • Slips, Trips, Falls


  • Engineering
  • Mechanical
  • Structural / Civil
  • Metallurgy
  • Materials Science
  • Aeronautics and Astronautics
  • Electrical
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    T. Kim Parnell, PhD, PE
    Principal
    1150 Kelsey Dr.
    Sunnyvale CA 94087
    USA
    phone: 408-203-9443
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    Medical Devices, Biotech, Failure Analysis, Mechanical Eng, Materials, Reliability, Expert Witness

    Kim Parnell Mechanical Engineer Expert PhotoT. Kim Parnell, PhD, PE is a Professional Mechanical Engineering consultant with strong experience in a number of technology areas. He holds PhD and MSME degrees from Stanford University in Mechanical Engineering and a BES from Georgia Tech. He specializes in the mechanical engineering design and behavior of Biomedical Devices, Superelastic and Shape Memory Metals (Nitinol), Bioabsorbable Polymers, Composites, Fiber-Reinforced Materials, Electronics, and Consumer Products. Dr. Parnell consults actively in these areas using finite element analysis and other advanced technologies to improve designs, to perform failure analysis, and to improve reliability.

    Dr. Parnell served on the Mechanical Engineering faculty at Santa Clara University from 2010-2012 and was previously a Visiting Associate Professor at Stanford University. He lectured in the Stanford Composites Design Program, and is a coach and mentor for the innovative Stanford Biodesign Program. He has worked for companies including MSC Software, Rubicor Medical, Exponent Failure Analysis Associates, SST Systems, ATT Bell Laboratories, Stanford University, and General Motors.

    Dr. Kim Parnell has experience as a medical device patent litigation expert, as an expert in product liability matters (including heavy truck crashworthiness), and frequently serves as an expert witness and litigation consultant. He has testified in both trial and deposition, and has also authored expert reports. Dr. Parnell's litigation support services are available to attorneys for both plaintiff and defense.

    Areas of Expertise:
    • Patents and Intellectual Property
    • Medical Devices
    • Medical Instrumentation
    • Composite Materials
    • Finite Element Analysis (FEA) & Simulation
    • Cell Phones, Personal Electronic Devices
    • Gas Leaks, Pipe Failure, Vapor Cloud Explosions
  • Shape Memory Materials
  • Heavy Truck Crashworthiness
  • Consumer Products
  • Product Design Refinement
  • Piping, Pressure Vessels
  • Failure Analysis
  • Reliability
  • Selected Professional Memberships:
    • Registered Professional Engineer (Mechanical), California
    • ASME (American Society of Mechanical Engineers), Fellow
    • SAE (Society of Automotive Engineers), Member
    • IEEE (Institute of Electrical & Electronics Engineers), Senior Member
    • ASM International, Member
    • SMST (Shape Memory and Superelastic Technologies), Member
    View Dr. Parnell's Consulting Profile.
    Rail residual stress distributions can be complex and variable in nature, as different manufacturing techniques produce varying stress magnitudes and distributions. To evaluate the effect of residual stresses on rail integrity, an analysis technique was sought that could quantify the effect of these stresses on web crack propagation.

    The computer program LS-DYNA3D was used to simulate the behavior of a specific, though representative, heavy truck cab-over tractor-trailer vehicle during a full 180° rollover event. These simulations provide a key component in the development of a physical testing procedure for evaluating structural integrity and occupant crash protection system designs in heavy trucks.

    2/18/2014 · Medical
    The United States Food & Drug Administration (FDA) requirements for Class III implantable medical devices requires a 10 year life, or approximately 400 million cycles of service.

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    George Pappas, MD, PhD
    9100 Medcom Street
    N. Charleston SC 29406
    USA
    phone: 617-513-8572
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    George Pappas, MD, PhD, is fellowship trained in Orthopaedic Sports Medicine (Stanford University) and Trauma Surgery (Santa Clara Valley Medical Center).

    As a former MIT and NASA trained aerospace engineer with a doctorate in biomechanics from Stanford, Dr. Pappas has a strong background in engineering and product design. His engineering background is particularly useful in the analysis of injury mechanisms and causation, surgical technique, and medical device product design. He currently serves as a team physician for professional baseball and hockey teams and teaches medical students and residents from the Medical University of South Carolina (MUSC).

    Dr. Pappas has published in the fields of applied physiology, biomechanics, radiology, shoulder surgery, and sports medicine and has authored book chapters in aeronautical engineering, biomechanics, and orthopaedic surgery.

    Litigation Support - Dr. Pappas provides expert witness services for counsel representing Plaintiff and defense. His cases include issues of Injury Mechanism and Causation. Dr. Pappas is available for consultation, medical record review, deposition, and trial testimony.

    Areas of Expertise:
    • Arthroscopic Surgery
    • Hip Arthroscopy
    • Shoulder, Hip, Knee Injuries
    • Rotator Cuff Injury and Repair
    • Hip and Shoulder Labral Tears
    • Orthopaedic Trauma
  • Injury Mechanism
  • Sports Injuries
  • Slip, Trip and Fall
  • Biomechanics
  • Orthopaedic Surgical Technique
  • Medical Product Design Failure
  • View Dr. Pappas' Consulting Profile.
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    Ade Akande, MD, MBA
    11315 Catherines Mine Circle
    Charlotte NC 28277
    USA
    phone: 704-293-7728
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    Adewunmi Akande, MD., MBA, is Board Certified in Internal Medicine, Anesthesiology, and Pain Medicine. He has 24 years of experience specializing in Interventional and Non Interventional Pain Management and Pain Medicine.

    Dr. Akande is the Founder and President of Charlotte Pain Associates, PA, a private practice pain management specialty with four regional satellite offices in North and South Carolina. The practice offers consultation, diagnosis, and treatment of all Chronic Pain conditions. The practice has a volume of greater than 1,200 consultations, 10,000 office visits, and 2,000 outpatients interventional procedures annually.

    Dr. Akande is also the Founder and Chairman of Nead Medical, PC, and outpatient JCAHO certified single specialty surgical suite for interventional pain management. The surgical suite handles a volume of greater than 1,300 cases of various types of complex interventional pain management procedures annually.

    Litigation Support: Dr. Akande provides expert witness services in cases involving complications with Anesthesia and Pain Medicine. He has testified 10 times in the past several years. Dr. Akande's services are available to attorneys representing both plaintiff and defendant and include medical record review, written reports, depositions, and trial testimony as needed.

    Areas of Expertise:
    • Spinal Anesthesia
    • Epidural Hematoma
    • Intrathecal Catheter
    • Opioid Therapy
    • Opioid Overdose
    • Pain Medicine Complications
    • Narcotic Use / Abuse
    • Facet Rhizotomy
  • Facet Injection
  • Cervical Epidural
  • Epidural Abscess
  • Nerve Root Block
  • Epidural Adhesions
  • Spinal Injections
  • Spinal Catheter
  • Blood Thinner
  • Education:
    • Internal Medicine Residency - Columbia University College of Physicians and Surgeons, New York, NY
    • Anesthesiology Residency and Pain Management, Fellowship - Brigham and Women's Hospital (Harvard Medical School, Boston, Mass)
    • Interventional Pain Management Fellowship-University of Medicine and Dentistry of New Jersey. Newark, NJ
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    Rod O'Connor
    C.P.O.
    1287 n. Tustin Ave.
    Anaheim CA 92807
    USA
    phone: 714-635-2650
    fax: 714-635-0223
    Rod O'Connor, C.P.O. has over 30 years experience with Prosthetic and Orthotic Devices. He is available for consulting, expert witness services, forensic work, case viability and second opinions. Mr. O'Connor is certified by the American Board for Certification in Orthotics & Prosthetics. He has expertise in all types of artificial limbs and orthopedic appliances (braces).
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    Glenda Flemister MD, FACP, FCCP
    President/Medical Director
    21200 S. La Grange Road
    suite 273
    Frankfort Illinois 60423
    United States
    phone: 815.534.5677
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    Glenda E. Flemister, MD, FACP, FCCP, is Board Certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine. Dr. Flemister has over 30 years of experience in her field. She received her MD from Loyola University Chicago Stritch School of Medicine and is licensed to practice in Illinois, Kentucky, New Mexico, and Oklahoma.

    Dr. Flemister has over 10 years of experience in national insurance and payer companies. She has served as Medical Director for Aetna, Blue Cross Blue Shield Association, and Next Level Health Partners. She is currently the Executive Medical Director for Medical Health Solutions, a company involved in predicting trends to optimize healthcare at an affordable and sustainable rate. In this capacity, she provides education, consultation, and resources to the medical industry, medical providers, and managed care organizations.

    Litigation Support - Dr. Flemister has been providing medical legal chart review, depositions, and trial testimony to the legal community since 1994. Her cases involve Pulmonary and Critical Care medical issues. She has performed over 100 file reviews. Her services are available to counsel representing both plaintiff and defendant, private hospitals, ISMIE (Illinois State Medical Inter-Insurance Exchange), and the AMA. Dr. Flemister's cases involve:
    • Pulmonary Medicine / Disease
    • Critical Care Medicine
    • Internal Medicine
    • Pulmonary Medical Malpractice
    • Pulmonary Care Quality Assurance
  • Thoracic Surgery
  • Transplant Issues
  • Asthma
  • Obstructive Lung Disease
  • Medical Devices
  • View Dr. Flemister's Consulting Profile.
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    George Yanulis, MEng, MS, DEng
    210 Ashley Run
    Voorhess NJ 08043
    USA
    phone: 216-571-1532
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    George Yanulis, MEng, MS, DEng, is a nationally recognized Cardiovascular Device Product Development and Research Engineer and has conducted cardiovascular device research at the Cleveland Clinic Foundation. He has published in the areas of atrial fibrillation (AF), cardiac pacing, and congestive heart failure devices.

    Dr. Yanulis has a Doctorate in Engineering in a joint program between Cleveland State University and the Cleveland Clinic Foundation in Biomedical Engineering; a Master of Science from the University of Pittsburgh; and a Master of Engineering in Biomedical Engineering from the University of Virginia.

    Dr. Yanulis’ Medical technology experience has consisted of familiarity with the design, use, and applications associated with a variety of medical devices and software used for: cardiac pacing, ventricular assist, cardiac echocardiography and electrophysiology, vascular stents, physiological monitoring, medical imaging, neurological therapy, surgery, among others. He is currently teaching a cardiac device course in Temple’s Bioengineering Department and has been involved in research and development of cardiac pacing systems at the Cleveland Clinic.

    Litigation Support - Dr. Yanulis has provided testimony in 6 depositions in the last 4 years (without a Daubert Challenge) and has been an Expert Witness and medical device consultant for 10 years and has been involved in numerous medical device liability and patent infringement cases for both the Plaintiff and the Defendant sides. He has been involved in cases involving:
    • Implantable Cardiac Defibrillator (ICD) Device Systems
    • ICD Lead Design and Failures (including the St. Jude medical Riata leads)
    • Cardiac Pacemaker Systems Research and Development
    • Cardiac Pacing Lead Design and Development
    • Cardiac Pacing Lead Failures
    • Heart Failure Therapy Devices
    • Cardiovascular Imaging (including cardiac echo and MRI system design and maintenance)
    • Atrial Fibrillation Therapy Device Systems
    • Ventricular Assist Devices: Cardiac Stents; and Cardiac Valves
    View Dr. Yanulis' Consulting Profile.
    7/12/2017 · Failure Analysis
    Plaintiff was admitted to a health care facility with ventricular tachycardia (VT). He had a normal coronary angiography with moderate left ventricular (LV) function and was referred for an implantable cardiac defibrillator (ICD) implant procedure. A diagnosis of right ventricular outflow tract tachycardia was made. He was then admitted for an ablation procedure in March 2005, which was successful. In April 2005, he was readmitted with a further occurrence of tachycardia which required emergency cardio version due to hemodynamic compromise and a temporary pacing wire was placed. There was a further attempt at ablation that was again successful and the LV function noted now to have deteriorated and was noted as having poor functioning. On this basis he was considered a candidate for an ICD implant. There was a further reoccurrence of an episode of ventricular tachycardia (VT) in March and April 2006 which was treated medically and he was discharged.

    6/13/2017 · Medical
    The Medtronic's Enpulse Model E2DR21P Serial number PMU411109 as well as the Atrial Lead (model #496525, SN: LBT042477R-Epicardial Unipolar and the Ventricular Lead (model #496525, SN: LEN036731R- Bipolar Epicardial had been used to continually pace patient in the DDD pacing mode during patient's lifetime. The expert referred to all Medtronic specifications; warnings; and advisories relevant to both the pacemaker and pacing leads used for pacing this completely pacemaker dependent patient).

    8/30/2012 · Medicine
    Protocols for producing experimental heart failure by rapid ventricular pacing are well established [1]; however, for safety reasons, commonly used clinical pacemakers do not allow pacing rates that are sufficient to induce either heart failure (HF) or atrial fibrillation (AF).

    6/27/2012 · Medical
    Cardiac resynchronization therapy (CRT) has been shown to improve symptoms and survival in patients with systolic dysfunction and prolonged ventricular depolarization (wide QRS).1-8 However, atrial fibrillation (AF) may cause significant problems in these patients, particularly when the ventricular rate exceeds the device programmable rate.

    4/23/2012 · Medical
    Recent studies have demonstrated that ventricular rate control is a viable treatment strategy for patients in atrial fibrillation (AF). The purpose of this study was to determine whether or not the benefits of coupled pacing (ie, a proposed rate control therapy) could be used during persistent AF.

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    Alan Schwartz
    Executive VP
    55 Northern Blvd.
    Great Neck NY 11021
    USA
    phone: 516-482-9001
    fax: 516-482-0186
    mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

    OUR APPROACH

    We utilize the following three part approach to providing high quality services to our clients:
  • Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients
  • Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment
  • Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)
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    Lawrence S. Mayer
    MD, PhD
    3607 N. 55th Pl
    Phoenix AZ 85018
    USA
    phone: 410-336-2100 or 602-549-4885
    fax: 480-247-4989
    Dr. Mayer is a full-time professor of biostatistics, epidemiology, biomedical informatics, public health and psychiatry. He splits his time between Annapolis/DC and Scottsdale, AZ. He does a limited amount of consulting in epidemiology and biostatistics.

    He focuses on evaluating data, methods and models used in assessing risks. Over several decades he has worked equally for plaintiffs and defense. He trained as a physician epidemiologist and then as a statistician and biostatistician.

    Prides himself on being able to communicate complex ideas in simple language. Prefers problems in which the medical and epidemiological/statistical issues are complex, the methods and models are varied and the data are of limited quality or controversial.

    Has worked on problems in drug and device development, testing and regulation, product liability, patent disputes, occupational and environmental exposures, and medical malpractice.

    Has given about 100 depositions over the last 30 years in a variety of cases ranging from major federal litigation to state personal injury and malpractice cases.
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