Medical Devices Expert Witnesses

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

• State of California Paramedic License P03889
• 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

Electronic Patient Care Records Medical Legal Consent EMT / Paramedic Training & Education CPR / AED Lifting Opiates / Antidotes

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 32 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. Yadin B. David has over 35 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, implants, monitors, warmers, surgical instruments and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) medical devices and in Telemedicine and TeleHealth systems. His experience includes review and analysis of patent infringements allegation and validity. Dr. David serves a Consultant for industry and institutions including the Food and Drug Administration (FDA), General Hospital and Personal Use Devices Panels, World health Organization (WHO)and medical devices manufacturers. His services include testing, adverse events investigation, engineering reports, equipment management 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.

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.

John Hoschette, BSEE, MSEE is an Electrical Engineer and Engineering Manager with over 25 years of experience at companies such as Smiths Medical, Lockheed Martin, Honeywell, Loral, Alliant Techsystems and Rockwell Collins. This has provided him exposure to the engineering methods of organizations nationwide and an acute understanding of all aspects of an engineering career.

Mr. Hoschette has managed engineering groups as large as 125 people with overall responsibility for business operations, employee salary administration, hiring, termination and career development. He has been involved in cases of employee termination for drugs, layoffs, harassment, non-performance and violation of company business ethics issues.

His primary responsibility as an engineering manager when dealing with employee issues has been to enforce company policies and procedures to ensure fair and lawful handling of employee discipline and terminations cases when necessary. This involves coordination of Human Resources and Legal Counsel to ensure company liability is minimized.

Mr. Hoschette's technical work encompasses developing the next generation mission computers for the F-35, P-3, F-16 and F-22 jet fighter aircraft and his technical expertise is Optical Data Networking. His career has covered designing, testing, and fielding of advanced electronics in areas such as: developing infrared sensors for night vision, laser sensors for weapons, helmet mounted displays and fiber channel networks.

Mr. Hoschette is also an author of two books, “Career Advancement and Survival for Engineers” and “The Engineers Career Guide." He has also been adjunct professor and instructed career development courses for engineers at Tufts University in Boston, Santa Clara University and University of Minnesota.

View Consulting Profile.

Anthony C Chang, MD, MBA, MPH, MS is internationally recognized as an expert in the field of Pediatric Cardiology. Dr. Chang has 30 years of experience and special expertise in Congenital Heart Disease and Perioperative Care as well as Cardiomyopathy and Sudden Death in pediatric patients.

Dr. Chang has a master’s degree in Healthcare Administration from University of Miami School of Business and a master's degree in Biomedical Data Science from Stanford University. He also has a master’s degree in Public Health from UCLA, from which he graduated with the Dean’s Award for academic excellence.

Doctor Chang - Being A DoctorDr. Chang has been offering litigation support services to the legal community for many years. His expertise is available to attorneys for both Plaintiff and Defense. Dr. Chang has been deposed and/or testified over 200 times since 1990.

Areas of Specialization:

Congenital Heart Disease Cardiac Surgery Sudden Death Cardiac Intensive Care Heart Failure

Postoperative Care Pulmonary Hypertension Public Health Sports Medicine Artificial Intelligence in Medicine

A world-renown leader in pediatric cardiology innovation, Dr. Chang is a member of the grant review committee for pediatric research at the National Institutes of Health. Respected in his field, Dr. Chang is a member the board of directors for the American Heart Association. Providing leadership in education, he has served with the faculty of UCLA School of Public Health (eMPH program) and has taught global health for UCLA’s eMPH. He also teaches pediatric cardiology to cardiology fellows and holds a volunteer faculty appointment at the UCLA School of Medicine.

A prolific author, Dr. Chang is the chief editor of the textbook Pediatric Cardiac Intensive Care and the past president-elect of the Pediatric Cardiac Intensive Care Society (PCICS). He is the chief editor of the textbook Heart Failure in Children and Young Adults. He is a regular reviewer for “Circulation,” “Pediatric Critical Care Medicine,” “Critical Care Medicine,” and numerous other journals.

Dr. Chang has been voted “Physician of Excellence” by the Orange County Medical Association and also selected as one of America’s “Top Doctors,” “Top Pediatricians,” and “Best Cardiologists” by several organizations.

View Dr. Chang's Consulting Profile.

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

Kenneth A. Stein, MD, ABPS, ABIM, UCNS, is Assistant Clinical Professor in the Department of Emergency Medicine, St. Louis University School of Medicine (a Level 1 Trauma Center). Dr. Stein currently practices Emergency Medicine and Critical Care / Intensive Care Medicine. 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.

Mary B. Gloeckner, RN, MS, APN, is a Medical-Surgical Clinical Nurse Specialist who specializes in Wound Care and Ostomy Nursing. She has been a nursing consultant at Trinity Medical Center in Rock Island, Illinois, a 500 Bed hospital, for over 35 years. Ms. Gloeckner started the Wound & Ostomy Clinic (WOC) program at Trinity when she began there in 1983. She currently sits on 2 National Boards, the WOC Certification Board, and the Friends of Ostomates Worldwide. Ms. Gloeckner was also elected to sit on the International Board(ISTAP) on Skin Tears. She was honored with receiving the 2011 Iowa Affiliate Wound, Ostomy and Continence Nurses Society's (WOCN) Nurse of the Year Award and the 2016 USA WOC Nurse of the Year Award. Ms. Gloeckner provides litigation support service to attorneys for Plaintiff and Defense. Her cases include issues related to Wound Care and Colon and Rectal Surgery. Ms. Gloeckner is available to review medical records for standard of care and causation. Areas of Expertise and Consultation:

Wound Care Decubitus Ulcers Colostomy Ileostomy Urostomy

Pressure Ulcers Venous ulcers Vascular ulcers Fistulas Diabetes

Dr. Mayer is an independent consultant and scholar that holds the position of Visiting Fellow in Human Flourishing, Faculty of Arts and Sciences,  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 He continues to do research and mentor young physicians and medical students while doing a limited amount of consulting in epidemiology, biostatistics, statistics, observatioan 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 now resides in Dana Point, California.

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)

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.

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 10 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.