Medical Devices Expert Witnesses: 18

John B. Everlove, MS, NRP has over 25 years of experience providing Emergency Medical Services. Currently licensed and practicing in California, Mr. Everlove has the following licenses and credentials:

• National Paramedic Certification
• State of California Paramedic License
• State of Michigan and State of Florida Paramedic License
• Ventura County Paramedic Certificate of Accreditation
• Advanced Cardiac Life Support Provider
• Pediatric Advanced Life Support Provider
• Basic Life Support Healthcare Instructor
• Basic Life Support Healthcare Provider
• Drug Abuse Recognition Evaluator
• Federal Emergency Management Agency Emergency Response Team Member
• National Association of Emergency Medical Services Association of Education Instructor
• National Incident Management Systems Provider
• Emergency Vehicle Operations Course Instructor

Litigation Support - Mr. Everlove provides dependable and professional litigation and support services for both plaintiffs and defendants. As a Supervisor and Clinical Manager for an organization of 150 employees, he conducted numerous investigations related to all aspects of Pre-Hospital Emergency Care from inception, to final review and root cause analysis. Mr. Everlove has participated in the research, development and implementation of clinical care equipment, policy and procedure design and implementation, as well as clinical educational services for Paramedics and EMTs. 

Areas of Expertise:

Pre-hospital Standard of Care EMT / Paramedic Standard of Care EMT / Paramedic Misconduct Ambulance Driving & Operations Patient Transportation Patient Care Documentation Patient Drop Moving Patient

Patient Reports Medical Legal Consent EMT / Paramedic Training & Education CPR / AED Wheelchair Securement Wheelchair Patient Stretcher Accident Gurney Accident

View John Everlove's Consulting Profile.

Karl R. Leinsing, MSME, PE, President of ATech Designs, Inc., is a Professional Mechanical Engineer who specializes in Medical Device Product Development from concept to production. Mr. Leinsing has been granted over 34 patents (needle free IV valves, laparoscopic devices, needlescopic devices, suture lockers, catheters, mitral valve repair devices, knitting machines) and excels in solving the most complicated problems and design challenges. His company has a fully equipped medical lab with calibrated measurement and test equipment and all is fully documented with high quality reports with pictures and video to provide credible results and easy to understand compelling data.

The winner of five design awards, Mr. Leinsing is recognized as one of the top 100 medical device professionals in the nation by MD&DI. For dedication to his industry, he was made the 2014 Chairman of the Medical Device and Manufacturing Conference in Anaheim, CA. Mr. Leinsing has also been acknowledged for his work in a publication by Life Magazine. Mr. Leinsing offers litigation support services to the legal community. He has extensive experience with Patent and Product Liability cases including report writing, depositions, and testimony.

Areas of Expertise:

Intravenous (IV) Systems & Disposables Hernia Repair Endometrial Ablation Laparoscopic Instruments Injection Ports Catheters Heart Valve Repair / Replacement Subcutaneous Ports

Bed Rails Cervical Screws Syringes, pen injectors, auto-injectors IV / Insulin Pumps Glucose Monitors Peritoneal Dialysis Pumps Abdominal Aortic Aneurysm (AAA) Repair Sleep Apnea Devices (CPAP)

View Karl Leinsing's Consulting Profile.

Peter A. Crosby has over 35 years experience in the Medical Devices Industry. He has been the CEO of six medical device companies (public and private) in four countries, and has been a member of the board (including chairman of the board) of over 10 companies.

Mr. Crosby is an accomplished entrepreneur and company builder, and has brought many medical device products to the world market. In 2017, he retired as CEO from Mainstay Medical, after spending over 8 years as the founding CEO, doing several rounds of financing, taking the company public in Europe, and bringing Mainstay’s ReActiv8 to market in Europe. Although he continues to work with the company on a consulting basis, he has shifted his focus to helping other companies grow, as a board member, advisor, and in interim management.

With a university education in Biomedical Engineering, Mr. Crosby is the inventor on over 30 US patents and applications pending. He has managed the intellectual property portfolio of several companies. His clinical domain experience includes ophthalmology, otolaryngology, cardiology, cardiac surgery, orthopedics, pain management, anesthesia, and intensive care.

Litigation Support - Mr. Crosby has served as an expert witness in many cases including product liability, intellectual property (patent disputes), and commercial contracts disputes. He has testified in three cases in which the outcome hinged on interpretation of “commercially reasonable efforts.” Mr. Crosby's services are available to attorneys representing plaintiff and defendant.

Product Expertise:

Implantable Devices Cochlear Implants Cardiac Pacemakers Implantable Defibrillators Artificial Hearts and LVADs

Neurostimulation Devices In Vitro Diagnostics Medical Device Software Patient Monitoring Imaging / Ultrasound and X-Ray)

View Peter Crosby's Consulting Profile.

Dr. Olen R. Brown, PhD is a board certified Diplomate in Toxicology and member of the standards of knowledge committee. He has the PhD in Microbiology With over 35 years of experience in Life Sciences and more than 150 publications. Dr. Brown specializes in complex, multidisciplinary cases, and he focuses on Human Medicine using the disciplines of bacteriology, virology, immunology, epidemiology, biochemistry, physiology, analytical chemistry, toxicology, and environmental sciences. Dr. Brown has provided litigation support services for 180+ cases in 25 states and 1 in Canada. Dr. Brown has served in Plaintiff/Defense, and Criminal/Civil cases. He has testified in 20 trials and 31 depositions. Dr. Brown's expertise include: cause-and-effect determination after medical record review; risk assessment and causation determination from toxic exposure; evaluation of the therapeutic and harmful effects of ethical drugs, antibiotics, alcohol, and drugs of abuse; the toxicity of solvents, pesticides, heavy metals, ozone, carbon monoxide, particulates, and most organic chemicals for most organ systems including the lung (Asthma, COPD, RADS) and the brain (Parkinson's), Dr. Brown has evaluated human medical and veterinary medical devices and pharmaceuticals for safety. Areas of Expertise

• Toxicology (General, Academic, Pharmacologic, Forensic, Regulatory)
• Medical Sciences - Microbiology, Immunology, Bacteriology, Virology, Cell Physiology, Infectious Diseases, Cancer, Allergy, Mechanisms of Diseases
• Microbiology - Medical, Molecular Biology, Veterinary Medical, Environmental
• Environmental Biology - Hazardous Wastes; Air, Water and Soil Pollution
• Chemistry - Biochemistry, Analytical, Organic
• Veterinary Sciences - Cell Physiology, Mechanisms of Disease

View Dr. Brown's Consulting Profile.

Alexander R. Marmureanu, MD, is a prominent Thoracic and Cardiovascular Surgeon, with a special expertise in the field of minimally invasive surgery where he developed and pioneered several techniques and procedures. He maintains a busy and active cardiothoracic surgery practice performing over 400 surgical cases per year with outstanding results.

Litigation Support - Dr. Marmureanu provides expert witness case review for issues involving Cardiothoracic Medical Malpractice. His services are available to counsel representing both Plaintiff and Defense.

Education and Background Experience - Dr. Marmureanu completed his General Surgery Residency and a research fellowship at New York University Medical Center in New York City. He continued his surgical training at Mount Sinai Medical Center, also in New York City, where he was actively involved in the field of thoracic and cardiovascular surgery research. His cardiothoracic surgery fellowship was completed at UCLA, where he continued to practice as UCLA faculty/Clinical Instructor, and then joined Cedars Sinai Medical staff.

Achievements - Dr. Marmureanu is nationally and internationally recognized in the field of thoracic and cardiovascular surgery and has authored numerous research papers and clinical publications. He has built several very successful cardiothoracic surgery programs, and appeared as guest speaker on numerous TV and radio shows discussing the benefits of cutting edge surgical techniques as well as the advantages of minimally invasive surgery for the thoracic and cardiovascular patients. He is a member of multiple organizations Boards and committees, both nationally and internationally.

View Dr. Marmureanu's Consulting Profile.

Dr. Roberto Contreras, II, MD, CLCP, is the CEO of the California Life Care Planning Association, a company created by experts in the field of Life Care Planning with more than 30 years of experience working in the health care industry. 

Dr. Contreras is a Certified in Life Care Planner with over120 hours in Life Care Planning coursework. He graduated from George Washington University School of Medicine with specialty training in Internal Medicine / Hospitalist Medicine at the University of Southern California with a fellowship in Physician Leadership at the University of California at San Francisco.

The Physicians employed by the California Life Care Planning Association have diverse backgrounds allowing them to provider Expert Witness services as well in Internal Medicine, Addiction Medicine, Obstetrics & Gynecology, as well as Psychiatry.

Areas of Expertise: Medical Billing, Life Care Planning, Hospitalist, Medical Devices, Medical Management, Medical Coding, Legal Medicine, Legal Nurse Consulting, Nurse Practitioner, Obstetrics and Gynecology, Addiction Medicine, Family Medicine, General Practice
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Services:

• Life Care Plan Development - Life Care Plans are generated to meet the specific needs of an individual and their family. A Life Care Plan will provide an organized, detailed plan that estimates a person’s estimated future medical needs.
• Life Care Plan Critiques - Life Care Plans are developed for people with injuries such as spinal cord injury, birth injury, traumatic brain injury, amputations, chronic pain, chronic health conditions, geriatric needs, people with special needs. Dr. Contreras work with both plaintiff and defense attorneys with Life Care Plan generation as well as critiques.
• Medical Cost Projection - Dr. Contreras and his team provide assessments of an individual's medical condition, future medical requirements, and associated costs.
• Medical Bill Review - Reliable, transparent, and consistent reports on past medical bills for both plaintiff and defense attorneys, as well as individuals looking for an assessment of their medical bills.
• Consultative Examinations - Communicate, Interview and Examine the injured party to provide an assessment and discuss future care. In areas of high Covid-19 infectivity, or for clients who prefer to be seen remotely, Dr. Contreras also offers telehealth consultative examinations, that allow us to fully assess the client without risk of infection to anyone.

Kenneth A. "Kenny" Stein, MD
Board Certified Emergency Medicine & Internal Medicine 
Subspecialty Certified in NeuroCritical Care 

Kenneth A. Stein, MD, ABPS, ABIM, UCNS, is Assistant Professor in the Department of Emergency Medicine, St. Louis University School of Medicine (a Level 1 Trauma Center). Dr. Stein has practiced Emergency Medicine and Critical/Intensive Care Medicine for 29 years. For 20 years, Dr. Stein was an Emergency Physician at St. Anthony's Medical Center of St. Louis, one of the busiest emergency departments in the State of Missouri. 

Dr. Stein has extensive experience in providing medical-legal expert services, having reviewed over 500 cases (both plaintiff and defense) and having given testimony over 200 times. Dr. Stein furnishes an unbiased opinion on medical malpractice/negligence cases. He also provides medical opinion concerning causation. Dr. Stein does not guarantee a favorable outcome but provides an honest assessment.

Dr. Stein has lectured nationally, and consults in the area of Pharmaceutical and Biomedical Product Development and Marketing.

Dr. Stein reviews cases (for both Plaintiff and Defense) of alleged Medical Malpractice / Negligence in areas including:

• Emergency Medicine        
• Critical Care Medicine / Intensive Care Medicine          
• Internal Medicine

Services provided include:

• Medical chart review and analysis   
• Providing opinion concerning the presence or absence of Negligence / Breach of the Standard of Care, Damages / Injury and Causation
• Survey of case for merit 
• Preparation of reports and / or affidavits        
• Preparation for opposing expert deposition and cross-examination        
• Medical literature search    
• Expert witness testimony at deposition and trial

Call 314-495-7009 for a complete CV, including presentations.

Envista Forensics is a global leader in Forensic Engineering & Recovery Solutions. They provide Cause & Origin, Failure Analysis, Fire and Explosion Investigations, Accident Reconstruction, Damage Evaluations and Equipment Restoration Services following disasters of all kinds. Envista has offered Consulting Services to the insurance, legal and risk management industries, as well as businesses, public entities, and universities for over 25 years.

Their Experts travel globally from 30 offices located across the U.S., Canada, Mexico, the U.K., Australia and Singapore. Envista's experience counts when equipment, systems, structures, or data have been threatened by catastrophe or litigation. Their experts and advisors determine cause and responsibility, and identify the nature and extent of damage or loss and provide a full range of solutions to protect their assets.

Envista's technical professionals are trusted advisors and industry leaders. Their expertise is broad and deep, capable of withstanding all forms of scrutiny. Envista's services are available globally so that certainty is assured no matter where in the world it is needed. As the recovery from disasters has grown more complex, Envista has developed a comprehensive array of services to help their clients and has associates located around the globe to provide assurance no matter the type of loss or location of the disaster. Envista helps attorneys quickly get to meaningful answers on the many technical issues at the center of a dispute. Their engineers have decades of experience working with both defendants and plaintiffs.

They offer effective Expert Witness Testimony, with the ability to communicate effectively, build rapport with juries and judges, and maintain adherence to structured, methodical approaches in drawing conclusions are all extremely critical. Envista Forensics understands how critical the selection of an expert can be, and we understand what makes experts effective. Their court qualified experts have extensive experience providing expert testimony on a wide variety of engineering and technical matters.

Areas of Expertise:

Aviation & Aerospace Biomechanics Construction Defects Digital Forensics Electrical Injury & Electrocutions Causation Chemical Computer / Network Equipment Failure Construction Defect Disputes over Reparability of Damage Electrical Failure Equipment Restoration Fire & Explosion Analysis Equipment Restoration

Industrial / Manufacturing Equipment Materials Failure Mechanical Accidents Mechanical Failure Medical / Laboratory Equipment Product Failure / Liability Project Management Structural Failure Subrogation Utility & Energy Valuation of Structures or Equipment Vehicle Accident Investigation Workplace / Premises Accidents

View Envista's Consulting Profile.

Jason C. Goodwin, MS, MPH, RN, CNOR, is a highly skilled and decorated Veteran Nurse Corps Lieutenant, honorably discharged in 2006. As a Registered Nurse, Operating Room Manager, Director, and Administrator, he has extensive experience with regulatory mandates, expertise in national clinical standards, and ensuring best practices in procedural safety culture.

As a procedural department administrator and clinician, Mr. Goodwin has personally supervised the safe care in and around various procedures and operating room venues for 17 years, totaling approximately 300,000 individual patient encounters. An expert with quality and safety compliance regulation, he has successfully prepared teams for Joint Commission, AAAHC, Medicare, Inspector General, and State audits.  Mr. Goodwin has experience managing as many as 20 managers, 4 Lean/Six Sigma process-improvement personnel, 500 total employees, and $1.8 Billion in annual gross revenue.

Clinical Experience Medical Surgical Nursing Shock / Trauma Intervention Procedural Services Preoperative, Intraoperative, and Postoperative Care Procedural Sedation Clinical Educator

Operational / Leadership Experience 2003 Iraqi War Veteran Multi-site Surgical Venues - UC Davis Medical Center, Kaiser Permanente Level 1 Trauma Academic Medical Center – UC Davis Medical Center Military – Naval Hospital Camp Pendleton, Operation Iraqi Freedom Fee for Service Ambulatory Surgery Services – ABSMC Surgery Center Clinic Management – Perioperative Medicine Clinic, Kaiser Permanente

Litigation Support - Mr. Goodwin provides expert witness services to attorneys representing plaintiff and defendant. He has been retained in approximately 30 cases. His services include medical record review, thorough reporting, depositions, and trial testimony as needed. 

Areas of Expertise:

Surgical Standard of Care Medical / Surgical Units Operating Room Injuries Sterile Processing Adverse Quality / Safety Events Pre & Postoperative Complications Pain Procedures / Procedural Sedation Positioning Injuries Wrong Site Surgeries

National Nursing Standards Regulatory Guidelines Nursing Administration Medical Devices Patient Falls Medication Errors Failure to Rescue Team Communication Emergency Preparedness

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.

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)

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.

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.

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.

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