Medical Devices Expert Witnesses: 25

Steven Burres has over 30 years of experience in the practice of Facial Plastic and Reconstructive Surgery. Dr. Burres provides all aspects of care including surgery, evaluation, treatment, and complications. He specializes in:

• Ear, Nose, and Throat
• Facial Plastic Surgery
• Liposuction
• Allergy

Dr. Burres has in-depth expertise in procedures such as cosmetic plastic surgery including hair, forehead, eyelids, nose, lip, facelift, neck lift, ear pinning and reshaping, cheek and chin implants, fillers, Botox, lasers, skin, scars, liposuction, and others except for breast implants and tummy tuck.

Dr. Burres' ear nose and throat experience includes broken noses and other facial fractures, hearing loss, vertigo, dizziness, smell, taste, nasal obstruction, sinusitis, tinnitus, hoarseness, GERD, sleep apnea, cancer, headaches, TMJ, skin disorders, facial nerve, and allergy.

Dr. Burres also has expertise in medical manufacturing having creative from concept-to-sales two medical businesses, one an injectable filler and the second a set of ear cleaning tools sold at major retailers.

Litigation Support - Dr. Burres has 20 years of experience serving as an expert witness and evaluator. He is a licensed QME/IME in California. His services are available to attorneys representing plaintiff and defendant for any medical legal matter including personal injury, workman's compensation, QME, IME, medical malpractice, or other medical manufacturing issues.

Education / Training:

• BA - University of Chicago, 1975
• MD -University of Chicago-Pritzker School of Medicine, 1979
• Residency Otolaryngology / Head and Neck Surgery, 1983
• Fellowship Facial Plastic surgery - Stanford University, 1985

  
  

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 knowledge 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

David E. Saintsing, MD, is a board certified, residency trained, highly experienced Emergency Medicine Physician. Serving as chief resident during residency, he has been a leader for years - including in his current practice. 

For 20+ years, Dr. Saintsing has also been an educator of medical students, physician assistants, and residents. He currently serves on the physician assistant education faculty in a group of 200 ER doctors.  In addition he is on faculty as an Assistant Professor of Medicine at Rocky Vista University.   This has helped hone his skills as a concise and clear communicator - critical ingredients to enhancing efficiency and knowledge of the legal team.  Serving on his practice's professional peer review committee furthers Dr. Saintsing's exposure to standard of care conversations and enhances his insight as an expert witness. Additionally, he is on the board of directors of his large multi-specialty physician owned corporation. 

Litigation Support - Dr. Saintsing offers expert witness services to attorneys representing plaintiff and defendant. He has reviewed approximately 20 cases and has been deposed 3 times.  

Areas of Expertise:

Emergency Medicine Trauma Head Trauma Myocardial Infarction Heart Attack Stroke Pulmonary Embolism

Ectopic Pregnancy Sepsis Myocardial Infarction Appendicitis Hypothermia Altitude Medicine Opiate Related Death

Services include:

Medical Chart Review & Analysis Provide Opinion Regarding Breach of Standard of Care Provide Opinion Regarding Injury & Causation Survey of Case for Merit

Preparation of Medical Summary Report and/or Affidavit Aid Legal Team in Preparing for Expert Deposition or Trial Attorney Liaison to Treating Physicians & Family Members Medical Literature Search

Tobias A. Mattei, MD, is a academic Neurosurgeon specialized in Complex Spine / Deformity Surgery. Dr. Mattei is currently practices as an Assistant Professor of the Division of Neurosurgery of St. Louis University. He has been an active member of the North American Spine Society, American Association of Neurological Surgeons, Congress of Neurological Surgeons, World Federation of Neurosurgical Societies, as well as many other international societies. 

Dr. Mattei is a member of the editorial board of The Spine Journal and Deputy Editor of the North American Spine Society Journal, the new open access initiative of the North American Spine Society. He is an active reviewer of several other neurosurgical journals including World Neurosurgery, Clinical Neurology & Neurosurgery, Journal of Clinical Neuroscience, Osteoarthritis & Cartilage, Journal of Engineering in Medicine: Part H, British Journal of Neurosurgery and Neurological Sciences.

As a researcher, Dr. Mattei has published more than 130 original research articles, having been cited more than 1400 times. He holds an unrestricted medical license in the states of Ohio, Missouri, New York, and Maine, and has never been submitted to any sanction or disciplinary action by any medical boards.

Litigation Support: Dr. Mattei provides expert witness services in the field of Spinal Injuries, Spine Surgery, Spinal Care, and Neurosurgery. He has provided expert review services for several scientific funding agencies in the U.S. (including the NIH Panel for Clinical Neurophysiology, Devices, Neuroprosthetics, and Biosensors) as well as abroad (including the Innovation and Technology Commission/ Hong Kong SAR Government and The Brain Tumor Charity - New Ideas Award/UK). 

Dr. Mattei's  litigation support services are available to attorneys for plaintiff and defense and include review of hospital records, medical reports, imaging results, operative reports, patient's evolution, depositions, and trial testimony.

Areas of Expertise:

Lumbar Disc Herniation Cervical Disc Herniation Spinal Stenosis Laminectomy Spinal Fusion Spinal Fracture Spinal Injuries

Kyphoplasty Vertebroplasty Artificial Disc Spinal Cord Injury Spinal Tumors Scoliosis Back pain

Christopher M. Daft, PhD, is an award winning, Oxford Educated Materials Scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing, and image processing. A serial inventor who holds 23 United States Patents with several pending, Dr. Daft has diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung, and Siemens as well as several start-ups. He is a well-published winner of grants from the National Institute of Health. Dr. Daft has been an Institute of Electrical and Electronic Engineers (IEEE ) Senior Member since 2004. He has three years of experience teaching electrical and computer engineering at the University of Illinois. Dr. Daft holds a BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials Science.

Litigation Support - Dr. Daft provides litigation support in the areas of Intellectual Property and Medical Devices including Imaging, particularly Medical, Patents, Minimally Invasive Surgical Guidance, and more. His experience includes a variety of cases in the areas of wearable electronics, imaging systems, and surgical technology. Dr. Daft has extensive deposition and trial testimony experience.

Areas of Expertise:

Design Engineering Electrical Engineering Electromagnetic Engineering Microelectronics Medical Imaging Electronics Semiconductors

Medical Devices Sensors Software Engineering MEMS Signal Processing Image Processing Physics

View Dr. Christopher Daft's Consulting Profile.

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

Rod O'Connor, C.P.O. has over 30 years experience with Prosthetic and Orthotic Devices. His company has been Orange Countie's premiere Orthotic and Prosthetic supplier. After almost three decades of excellence, Mr. O'Connor sees client’s from around the globe including Spain, Iran, Japan, and more. He uses a combination of tried and true techniques combined with cutting-edge technology to tailor each device to the client’s needs.

O’Connor Orthopedic is the first orthotics and prosthetics clinic in Southern California to incorporate 3d printing and scanning into our everyday practice. Patients will see a reduction in the time it takes them to get their device and also a vast increase in the comfort due to the precision fit they can offer.  

Litigation Support - Mr. O'Connor is available for consulting, expert witness services, forensic work, case viability and second opinions. He is certified by the American Board for Certification in Orthotics & Prosthetics. He has expertise in all types of artificial limbs and orthopedic appliances (braces).

Mari S. Truman, PE, has more than 37 years of experience in Orthopedic Product Design and Development. As Principal Engineer with her company, Orthobiomech, LLC, she acts as an R&D design and development consultant to the orthopaedic industry and an injury biomechanics and medical device forensic expert.

Ms. Truman's design experience includes implants and instrumentation systems used to repair fractured bones, torn ligaments and/or to reconstruct spine, knee, wrist, hip, ankle, elbow, thumb based cmc, and other finger and toe joints for many of the USA based orthopaedic conglomerates and a few Asian, Australian and European firms.

Having designed and developed implants and instruments used for both human joint reconstruction and skeletal trauma repair, Ms. Truman is named on 12 Orthopaedic Patents and frequently gives talks on implant design and injury biomechanics on topics such as: knee and thumb-based joint surfaces and kinematics, joint design, rapid prototyping, medical device design control, and injury biomechanics.

Litigation Support - Ms. Truman has been providing Forensic Impact and Injury Biomechanics and Orthopedic Biomechanics to the legal industry for over 15 years. She draws on her strong knowledge of FDA and ISO EN13485 compliant design control processes, failure modes and effects analysis, clinically relevant tissue loading, and design safety assurance, including device performance requirements and warnings, during her medical device litigation reviews. Ms. Truman has a strong knowledge of the production and quality assurance processes used in the manufacture, cleaning, and sterilization of medical devices and the effects of such processes on product performance.

Analysis of Traumatic Injuries Related To:

Falls and Fall Recovery Vehicular Collisions Assaults and Fights Projectile Impacts Occupation or Workplace

Failed Medical Implants Assistive Devices Orthotics Consumer Products Sports and Recreation, Occupational Overuse / Injury

View OrthoBioMech LLC's Consulting Profile.

John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.

Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices. 

Litigation Support - An FDA expert and seasoned business professional, Mr. Stevens is uniquely qualified to opine on cases involving the FDA's regulation of medical devices. He has served as an expert witness for over 30 court cases involving the FDA regulation of medical device firms. His services include thorough reporting, depositions, and trial testimony. 

Areas of Expertise:

• Submissions (510(k), IDE, PMA, De Novo)
• Medical Device Quality Systems
• FDA Inspections

View Mr. Stevens' Consulting Profile.

Lloyd Marks, MD, MBA, FACC, is an MIT trained Electrical Engineer, Johns Hopkins trained Pediatric Cardiologist, and Inventor. Always active in both medicine and medical engineering, Dr. Marks has been granted 22 Medical Device Patents. He currently gives advice to academic institutions, investors, and corporations regarding the commercialization of medical technology.

Background Experience - Dr. Marks was in academic medicine for 15 years, as the Director of the Cardiac Cath Lab at St. Christopher's Hospital for Children and the Division Chief of Pediatric Cardiology at the Children's Hospital of New Jersey. He was then in private practice for 18 years. In 1997 he opened his clinical practice, specializing in Pediatric and Adult Congenital Heart Disease, where he provided clinical evaluation, electrocardiography, echocardiography, stress testing, Holter/event monitoring, diagnostic cardiac catheterization, and interventional cardiac catheterization.

After closing his clinical practice in 2015, Dr. Marks went to business school and obtained an MBA from the Haslam School of Business, University of Tennessee. While there, he wrote a business plan with financial projections for his startup company, MGI Medical, LLC, commercializing a non-invasive patient monitor for the detection of post-operative bleeding. Dr. Marks has successfully licensed 9 of his inventions to industry and assigned 8 to MGI.

Litigation Support - With his unique background in the field of medical device commercialization, Dr. Marks has been involved in protracted Patent Infringement litigation with a successful outcome. He is adept at explaining to a jury in lay terms complex medical technology and terminology, ranging from MRI readings to the difference between "clinical" and "statistical" significance. Dr. Marks' cases include all matters pertaining to:

• Pediatric Cardiology Medical Malpractice
• Medical Devices Standard of Care
• Intellectual Property Protection
• Invention Commercialization

Areas of Expertise:

Medical Devices / Medical Monitors Cardiology / Pediatric Cardiology  Medical Record Review Medical Technology IP, Patents, Licensing, Royalties

Medical Device Inventions Medical Device Due Diligence Medical Technology Business Plans Medical Technology Financial Projections

View Dr. Lloyd Marks' Consulting Profile.

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.

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)

Martin L. Lee, PhD, CStat, Csci, FIBMS has more than 42 years of experience in clinical research as the head of departments in the Management of Clinical Research and Analytical Modeling of Healthcare Data for major pharmaceutical and medical device companies, as well as start-up biotech companies.

Dr. Lee is trained as a clinical biostatistician and has consulted with numerous healthcare companies around the world in the design, management and analysis of clinical research studies. Importantly, he has helped to start up a handful of companies and has been involved in the initial planning and funding of these companies. 

In addition, Dr. Lee is an Adjunct Professor of Biostatistics at UCLA where he has taught courses in basic and advanced biostatistics and clinical research design for the past 42 years.

Litigation Support - Dr. Lee has served as an expert witness for numerous cases over the past 31 years. He is an expert in sampling techniques, clinical research design and the conduct of clinical trials. As a trained clinical and non-clinical biostatistician, he is knowledgeable in the use of statistical methods in the legal arena. 

Dr. Lee's expert witness experience includes numerous healthcare fraud cases involving Medicare / Champas (for the U.S. Department of Justice, EPA, FTC), worker’s compensation (FBI), various state health insurance agencies (California, West Virginia, Florida, New  York, etc.), as well as patent infringement and product liability cases.

Dr. Lee has written expert reports, given depositions, and testified in administrative hearings and actual trials. His experience in sampling and statistical inference has been extremely useful in the prosecution of healthcare cases.

Areas of Expertise:

Healthcare Biostatistics Healthcare Fraud Medical Patent Infringement

Medical Product Liability Environmental Issues Consumer Protection

View Dr. Martin L. Lee's Consulting Profile.

Dr. Mayer is an independent consultant and scholar that (for identification only) holds the position of Visiting Fellow in Human Flourishing,  Harvard University. He has been a full-time tenured professor with recent appoints in statistics, biostatistics, epidemiology, biomedical informatics, public health and medicine (psychiatry). He held various titles including, Professor (Part-time), Bloomberg School of Public Health and School of Medicine, Johns Hopkins University, Affiliated Professor, Mayo Clinic/ASU joint program in Biomedical Informatics, a member of the Research Staff at Mayo Clinic, and Professor at Arizona State University. 

Dr. Mayer continues to do research and mentor young physicians and medical students while doing a limited amount of consulting in epidemiology, biostatistics, statistics, observation studies and clinical trials. His consulting projects often focus on model development, execution and inferences. He is one of the few MD/PhD epidemiologists. He leads a Facebook group of 4000 physicians and epidemiologists on reviewing  science daily on Covid-19.

Ronald E. Gots, MD, PhD, DABT, is Board Certified in Toxicology and a Diplomate of the American Board of Toxicology. He has over 30 years of experience as CEO of a successful, highly-regarded biomedical consulting firm dealing with Toxicology, Pharmacology, and Epidemiology.

Dr. Gots has assisted hundreds of clients in analysis, strategy, and testimony in chemical and mold injury claims, regulatory matters, mass tort claims, environmental and workplace exposure issues, and risk communication. 

Dr. Gots has shared his expertise with workers and community groups in dozens of toxic exposure matters across the country. He has been consulted for indoor environmental and air quality assessments for numerous office buildings, schools, and manufacturing facilities. He has lectured at numerous national meetings of claims executives, attorneys, policy makers, and physicians in the fields of medicine and science, toxicology, regulation, and claims resolution. He has testified in congressional subcommittee hearings concerning victim compensation legislation.

Dr. Gots has been honored for outstanding achievement from the AOA Medical Honor Society, Sigma Xi Research Honor Society, and the Society of Toxicology Membership. He is the author of six books, chapters in six books, and more than 70 articles on biochemistry, toxicology, mold and mold toxins in insurance and legal literature.

Litigation Support - Dr. Gots has provided expert witness services nationwide. He provides scientific / medical support in individual tort and mass tort claims, involving a range of biological and chemical agents, as well as pharmaceuticals. With over 100 jury trials, he and his team at the International Center for Toxicology and Medicine offer services including:

•  Mitigating Liability    
•  Managing Complex Mass Tort Data;
•  Preparing Courtroom Presentations;
•  Providing Health Risk Communicating;       
•  Integrating Law, Science, and Medicine;     
•  Performing Regulatory Risk Assessment;
•  Investigating Indoor Environmental Issues.

Areas of Expertise:

Toxicology Environmental Medicine Occupational Medicine Indoor Environmental Regulation Pharmacological Agents Toxins Mold and Mold Toxins Contaminated Drinking Water / Groundwater

Fires / Explosions  Pesticides Alcohol / Illicit Drugs Lead Carbon Monoxide Medical Devices Food Borne Illnesses Volatile Organic Compounds, and many more.

Education/Training: AB Chemistry, University of PA; MD, University of PA School of Medicine; Internship, Johns Hopkins University School of Medicine; PhD Pharmacology, University of Southern CA.