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Biomedical Engineering Expert Witnesses

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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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    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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    Edward E. Elson, MSME, MA MANGT
    President
    4356 E Claytor Circle
    Anaheim CA 92807
    USA
    phone: 714-974-1264
    fax: 714-974-0148
    Edward E. Elson has over 40 years of Engineering Experience including research and development, design, manufacturing and management activities in the Medical Device, Packaging, Toy, Consumer Product, and Aerospace Industries. He holds 30 U.S. Patents, 27 in the medical device field.

    EDUCATION:
    • Adobe Illustrator: North Orange County Regional Occupational Program
    • SolidWorks 3D Design: Orange Coast College, Costa Mesa, CA
    • Graphics Design: University of California, Irvine, C
    • MA Management Peter Drucker School of Management: Claremont Graduate School, Claremont, CA
    • MS Mechanical Engineering: (Bio-Medical Minor) University of Southern California, Los Angeles, CA
    • BS Mechanical Engineering (Deans List): Drexel University Philadelphia, PA
    ORGANIZATIONS:
    • Member, Society of Plastic Engineers
    • Institute of Packaging Professiona
    • Member and former Board Member, Forensic Expert Witness Association (Orange County, CA)
    • Former member of AAMI Standards Sub-Committees: Human Factors for Medical Devices, IV Catheters, Humidifiers & Nebulizers
    AREAS of EXPERTISE:
    • Product Design
    • Patent Infringement, Validity, Trade Marks
    • GMPS, Labeling, Packaging for Medical Devices
    • Syringes, Needles, Catheters
    • Thermal Heating, Thermal Cooling Devices
    • Laser / Thermal Hair Removal Devices
    • Dermal Abrasion Equipment
    • Costume Jewelry
    • Patient Transport Gurneys
    • Patient Walkers, Gait Trainers, Design, Labeling
    • Surgical Staplers
    • Surgical Fluid Warmers
    • External and Implanted Drug Delivery Devices, IV Pumps
  • Failure of Implanted Hip and Spinal Prosthesis
  • Performance and Failure of Pedicle Screws
  • Valuation of Prototypes
  • Valuation of Medical Devices, Equipment, Consumer Products
  • Labeling and Packaging
  • Chiropractic Devices
  • Dental Burr and Drill Failures
  • Defective Seating
  • Exercise Equipment, Pilates Devices
  • Injection Molded Plastic Components
  • Drug Container Packaging
  • Defibrillator Design Issues
  • Shipping Carton Integrity
  • Manufacturing and Assembly

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    Alan Lipschultz, PE, CCE, CSP, CPPS
    11420 Strand Drive, #306
    North Bethesda MD 20852
    USA
    phone: 302-584-1050
    Alan Lipschultz, PE, CCE, CSP, CPPS, President of HealthCare Technology Consulting, has 40 years of experience in all aspects of Healthcare Technology. A nationally recognized expert in Clinical Engineering and Healthcare Technology Management, Alan gained experience working as Director of Clinical Engineering in two major medical centers and through active participation in professional societies at the national level. He specializes in Healthcare Technology, Medical Equipment, Medical Devices, Patient Safety, and Hospital Safety.

    Alan provides Expert Witness and Litigation Support services to attorneys for both Plaintiff and Defense. His services include case evaluation for merit, depositions, and testimony when necessary. Alan's scientific and technical observations are admissible in court.

    Areas of Expertise:
    • Patient Safety
    • Clinical Engineering
    • Forensic Engineering
    • Root Cause Analysis
    • Healthcare Technology
    • Medical Accident Investigation
  • Medical Device Failures
  • Patient Safety
  • Defibrillators
  • Electrosurgical Units
  • Infusion Pumps
  • Medical Equipment Repair
  • View Alan Lipschultz's Consulting Profile.
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    Jon M. Crate, President & Chief Executive Officer
    825 Chance Road
    Marietta GA 30066
    USA
    phone: 770-928-1930
    fax: 770-928-9202
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    FAI Materials Testing Laboratory, Inc. (FAI) is a full service Analytical, Failure Analysis, and Materials Testing laboratory. They are professional scientists, chemists, and engineers with decades of experience solving problems in a host of industries. Founded in 1999, they have served hundreds of companies across the world.

    Litigation Support - FAI leverages their considerable experience in litigation and extensive laboratory resources to support their expert testimony. Their goal is to effectively support their clients in challenging cases. FAI has one of the finest laboratory environments for conducting joint inspections in the nation including photographic, videographic, and microscopic documentation capabilities.

    Areas of Expertise:
    • Analytical Chemistry
    • Cleanliness Testing
    • Composite / Window Lamination Issues
    • Corrosion
    • Electrical and Electronic Failure
    • Failure of Composites

  • Failure of Pressure Vessels
  • Fatigue Failure
  • Foreign Substance Identification
  • Fractography
  • Materials Compatibility
  • Materials Science
  • Optical and Electron Microscopy
  • Particle Characterization

  • Pharmaceutical Analysis
  • Protein Characterization
  • Polymer Chemistry
  • Support for Patent and Product Litigation
  • Textiles
  • Tire Failure
  • Weld Quality

  • Jon Crate Materials Failure Analysis Expert PhotoJon M. Crate is the founding President and CTO of FAI Materials Testing Laboratory. He received his bachelor's degree in Chemistry from University of Central Florida, his Master's in Polymers from the MSE Department of Georgia Tech and three years of postgraduate education in Molecular Cell Biology and Biochemistry at the University of Alabama in Birmingham.

    Mr. Crate is a Analytical Chemistry and Materials Failure Analysis expert witness who has leveraged leveraged his expertise to determine and prove the true causes of failure of many different products enabling many cases to settle out of court. He has testified by deposition in over 50 cases, before juries more than 10 times, and proven failure cause many more times where litigation was not needed.

    Mr. Crate is experienced and well versed in the chemical analysis and physical characterization of Natural and Synthetic Polymers, Metals, Inorganic and Organic Compounds, and Composite Materials. He has performed failure analysis on a wide variety of products and components including underground gas and water pipe, commercial aircraft tires, large equipment, rig, light truck, automotive and motorcycle tires, swimming pools and pool coatings, tank coatings, assault resistant commercial window laminates, numerous aircraft components, sailing vessel components, weapon system components, power generation equipment components, and medical devices including artificial heart valve.

    Jon M. Crate is capable of designing and validating test and inspection protocols that will enable the determination of the causes of failure for a wide variety of products and components.

    View FAI's Consulting Profile.
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    Ernest Chiodo
    M.D., J.D., M.P.H., M.S., C.I.H.
    221 North LaSalle,Suite 1748
    Chicago IL 60601
    USA
    phone: 312-351-0717
    Ernest P. Chiodo, M.D., J.D., M.P.H., M.S., C.I.H. is a physician, attorney, Certified Industrial Hygienist (C.I.H), and biomedical engineer. Dr. Chiodo is board certified in the specialties of Internal Medicine, Occupational and Environmental Medicine, and Public Health and General Preventive Medicine. Dr. Chiodo served as the Medical Director of the City of Detroit and was the chief physician in charge of measures designed to protect the public health of over one million persons. He has also been the lead expert witness in a number of high profile cases including serving as the lead expert witness in a mass toxic tort case for Gerry Spence.

    Areas of Expertise:
  • Toxicology
  • Epidemiology
  • Industrial Hygiene
  • Mold
  • Asbestos
  • Benzene
  • Biomedical Engineering
  • Accident Reconstruction
  • Electrocution
  • Building Related Disease
  • Biomechanics
  • Bed Bugs
  • Genetic evidence in the form of DNA profiles has proven to be a powerful tool in the advance of justice by proving the innocence of accused persons.

    Low speed motor vehicle collisions are a common occurrence. The use of cellular phones, text messaging, and e-mailing while driving has only increased the frequency of low speed motor vehicle collisions. A motor vehicle collision where there is only minor damage to the vehicles may result in personal injury claims for substantial sums.

    10/11/2012 · Toxicogenomics
    In toxic tort litigation, a person is often claiming to have developed cancer or some other serious disease due to having been exposed to a particular substance. Determining if the exposure to the substance was the cause of the disease is often a central focus of the litigation.

    9/26/2012 · Medical
    It is a common error that an attorney retains the wrong type of expert to testify in a lawsuit. This error is particularly common when the expert is a medical specialist. It is widely believed that a medical doctor who specializes in a particular organ system is qualified to formulate opinions and testify as to all issues concerning that organ system.

    Ernest Chiodo, MD, JD, MPH, CIH
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    Dr. Yadin B. David
    M.Sc., Ed.D., P.E., C.C.E.
    1111 Hermann Drive,Suite 12B
    Houston TX 77004
    USA
    phone: 713-522-6666
    fax: 713-522-6686
    Dr. Yadin B. David has over 30 years experience in Managing Medical Technologies from Pre-Purchasing Evaluation phase, to Installation, Training, Servicing and Incidents Investigation. His expertise includes wide variety of medical devices and accessories including infusion pump, laser, electrosurgery unit, monitors, X-ray, defibrillators, implantable, surgical instruments and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) with medical devices and in Telemedicine and TeleHealth systems. His experience also includes review and analysis of IP infringements allegation and patent validity.

    Dr. David serves a Consultant for industry and institutions including the Food and Drug Administration (FDA), General Hospital and Personal Use Devices Panel, World health Organization (WHO)and medical devices manufacturers. His services include testing, adverse events investigation, engineering reports, program review and risk assessment. Dr. David has given many national and international presentations about medical technology management, telemedicine and medical devices regulations.He authored manuscripts, chapters and books.
    4/24/2012 · Medicine
    In a remote village in Central America, an otherwise unmanaged child's infection can take a turn for worse if not for the long distance diagnosis capacity brought about by the recently installed telemedicine system between Zacapa, Guatemala, and Houston, Texas, where subspecialists in the field of Pediatric Dermatology viewed the wound and prescribed the critically needed treatment.

    1/16/2012 · Engineering
    The dependence in medicine on technology to deliver services is continuously growing. The number of microprocessor-based diagnostic, therapeutic, and patient monitoring devices used in the clinical environment is ever-increasing.

    Yadin David, et al
    Clinical Engineering focuses on managing the deployment of medical technology and integrating it appropriately with desired clinical practices. It provides a description of the wide range of responsibilities clinical engineers encounter, describes technology management and assessment in detail, and reviews the standards and regulatory agencies of interest.