Medical Devices Expert Witnesses: 22

Joel Gagnier, PhD, is an experienced clinical Epidemiologist with over 25 years of experience in the assessment of general and specific causation in cases of Exposures to Chemicals and Medical Interventions, and the Risks of Disease or Adverse Events. He is a tenured professor with over 20 million dollars in funding and over 210 peer-reviewed publications.

Dr. Gagnier has methodologic expertise in human subject epidemiologic research (and more generally epidemiology), clinical research, systematic reviews and meta-analyses, as well as basic science research, statistics and biostatistics  

Litigation Support - Dr. Gagnier is an expert at finding the relevant literature, assessing the quality of the evidence, extracting the data, performing meta-analyses, finding the magnitude of the association, doing a causation assessment (Bradford hill analysis) and coming to final conclusions. He has been an expert on 15 separate cases, been deposed 10 times, and testified 4 times.

Areas of Expertise:

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.

As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.    

Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness  and consultant to litigation in over 20 cases in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Antitrust, Patent, and Product Liability.

View Timothy Anderson's Business Consulting Profile.

Shawn A. Hayden MD, PhD, MBA, President and CEO of ONTO Orthopedics, has over 25 years of experience as an Orthopedic Spine, Trauma and Sports Medicine Surgeon in the Dallas Fort Worth area. Dr. Hayden’s focus has always been in providing high-tech, high-quality care to his patients. For this reason, he is constantly training on some of the latest diagnostic and operative technologies. 

Litigation Support - Dr. Hayden assists medical doctors, scientists, lawyers and law firms with civil matters, malpractice cases, business guidance, and idea generation. His services include medical record review, thorough reporting of causation, depositions, and trial testimony as needed.

Areas of Expertise:

Dr. Hayden graduated from Harvard College. He received his medical degree from the University of Massachusetts Medical School and his orthopedic training at the Harvard Combined Orthopedics Residency Program. Dr. Hayden is also fellowship trained in orthopedic trauma and spine surgery at The Massachusetts General Hospital and The Beth Israel Deaconess Medical Center. Diplomate of the American Board of Orthopedic Surgery and a Fellow in the American Academy of Orthopedic Surgeons. Dr. Hayden is board certified in Orthopedic Surgery. 

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:

Gary D. Fletcher, PhD,  is the Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm founded in 2015, focused on Industrial Mechanical Engineering and Biomedical Engineering and Research and Product Development.  In his 30 years of experience, he has been co-inventor on 23 patents for devices and methods in blood collection and processing.

Litigation Support - Dr. Fletcher has subject matter expertise in Medical Device Mechanical Engineering and subject matter expertise in Medical Devices for blood and specimen collection and sample processing for in vitro diagnostics, point of care diagnostics, and therapeutics, including glucose monitoring. He serves as an expert witness in patent infringement cases involving medical device and diagnostic biomedical engineering, blood collection, separation, fluidic preparation, glucose monitoring, and cell therapy preparation devices.

Dr. Fletcher offers patent litigation services to law firms and lawyers supporting medical device and diagnostic industry clients, who need physical science and mechanical and biomedical engineering expertise for District Court, PTAB, and ITC patent cases. As an industry consultant, his ideal clients are R&D, product development, and innovation leaders in startup, emerging, and established medical device and diagnostic companies, who face product development and competitive challenges.

Areas of Expertise:

Dr. Fletcher is an entrepreneurial executive with expanding R&D roles in business, technology, and new product development leadership and execution, building and guiding teams in both Fortune 500 and startup companies. With a PhD in physics from Yale, he has a proven record of leadership in creating innovative new businesses and products in healthcare, medical devices, diagnostics, life, materials, and optical sciences.

Christopher M. Daft, PhD, is an award winning, Oxford Educated scientist whose areas of expertise include medical imaging, artificial intelligence, semiconductors, medical devices, sensors, MEMS, signal processing, and image processing. He holds 23 United States Patents with 20 applications 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 has testified at trial 5 times and been deposed 15 times.

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, 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:

View Dr. Christopher Daft's Consulting Profile.

Consultants. Experts. Innovators.™

Operating from more than 110+ offices around the globe, we provide services to corporations, insurance companies, law firms, and government agencies.

Rimkus Life Sciences experts have a wealth of specialized expertise to help clients comprehend and improve how humans interact with their facilities, products, and systems.

Our experts offer significant professional experience related to studying and understanding human behavior and experience. Our experts have extensive knowledge involving but not limited to human health and medical devices, warnings and signage, perception and reaction, medicine and patient care, and health and sports activity.

The scientists, engineers, and researchers in Rimkus Life Sciences specialize in human based research to support product design and development, product validation, and development of instructions and warnings for use. Our experts work with clients across the globe in every major product sector. They understand how to leverage rigorous research and thoughtful analysis with creative problem solving to support the development of products.

Rimkus Global Services Overview

LIFE SCIENCE EXPERTISE

Biomedical Engineering

Human Factors

Legal Nurse Consulting

Product Safety

Sports Science Consulting

Toxicology Food Safety

View our full suite of Life Sciences Expert Services.

GLOBAL OFFICES

Rimkus operates from 110+ offices worldwide, with headquarters in the following cities.

View a full list of Rimkus Office Locations.

View Rimkus Quantum and Delay Expert Services Profile.
View Rimkus Forensic Expert Services Profile.

• BACKGROUND:

40+ years' experience including in product design, product development, and manufacturing in consumer, medical, and industrial product markets. Product innovation part-time academic since 2009, public speaker since 1985. Certified New Product Development Professional (NPDP) since 2008 by the Product Development and Management Association. Member of: Society of Plastics Engineers, Society of Manufacturing Engineers, American Society for Quality. Expert witness services to Product Liability, Intellectual Property, and Commercial Dispute litigators.

• PRODUCT LIABILTY EXPERTISE:

Retained by both plaintiff and defense counsel. Specialize in personal injury cases involving product defects, manufacturing defects, product safety, engineering design, mechanical failures, material failures, product quality assurance, and foreseeable misuse. 

• CASE EXAMPLES:

• Retained in cases involving 3M, Honeywell, Clorox, Ace Hardware, and others. 
• 3M Combat Arms earplug case, retained by two plaintiff firms. More at, https://bit.ly/Forbes-on-3M Daubert ruling at, https://bit.ly/EPR-3MEP-Daubert (Page 98). Two depositions. (Plaintiff) 
• Furniture review of the state of competitive product safety, mechanisms, warnings. Counsel represented major insurance company. Settled after report. (Defense) 
• N95 mask commercial dispute, settled after report. (Plaintiff) 
• Consumer electronics patent infringement, settled after report. (Defense) 

• MORE INFO AT:

Expert witness services offered can be seen at, https://bit.ly/PDEWS Preferred contact: eric@pinnaclepi.com

Content above is a selection of work, current case history available upon request. Expert witness testimonials at, https://bit.ly/EPR-EWT

• EXPERT WITNESS PODCAST INTERVIEW

Mari S. Truman, PE, has more than 40 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:

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.

Dr. Ronnie I. Mimran, a Board-Certified Neurosurgeon, and former Oakland Raiders NFL Team Neurosurgeon, specializes in Spinal Cord Injuries, Traumatic Brain Injury, and Complex Spinal Surgeries. He is the Medical Director of Neurosurgery and the Neuroscience Department Chair at Sutter Medical Center where he maintains an active clinical practice. 

Litigation Support - As an award-winning teacher, Dr. Mimran brings the capacity to effectively and succinctly communicate complex neurological concepts to his medical-legal practice. He provides Forensic Neurosurgery, Neurosurgery Malpractice / Standard of Care services to attorneys for plaintiff and defendant, including medical record review, thorough reporting, depositons, and trial testimony as needed.

Areas of Expertise:

Selected Background Experience

• Neurosurgeon Sutter West Bay Medical Group, San Francisco, CA December 2020 – present
• Chairman, Department of Neuroscience Sutter Eden Medical Center, Castro Valley, CA December 2021 – present
• Medical Director, Neurosurgery Sutter Eden Medical Center, Castro Valley, CA 2015 -- present
• Adjunct Clinical Professor UCSF Department of Neurosurgery 2006 – present
• Vice Chairman, Department of Neuroscience Sutter Eden Medical Center, Castro Valley, CA December 2019 – December 2021
• Neurosurgeon Pacific Brain and Spine, Danville, CA July 2005 – December 2020
• NFL Team Neurosurgeon Oakland Raiders, Alameda, CA 2009 – 2020

Dr. Mimran completed medical school at the University of Southern California. He subsequently completed a General Surgery Internship, Residency in Neurological Surgery, and Fellowship in Minimally Invasive Spine Surgery, at the University of Florida. During residency and fellowship, Dr. Mimran received the Charles Shank Award for Excellence in Neurosurgery, was a Delegate Fellow for the Council of Neurosurgical Societies, and was honored as the Outstanding Resident Educator in 2002. 

Between 2016-2018, Dr. Mimran completed an MBA at Cornell University. Dr. Mimran has published chapters and peer-reviewed articles in the Journal of Neurosurgery, Journal of Spinal Disorders and Techniques, Clinical Intervention Aging and the Journal of Stroke and Cerebrovascular Diseases. He has successfully patented two neurosurgical devices.

Paul J. Michaels, MD, is a nationally renowned Anatomical and Clinical Pathologist with over 20 years of experience in his field. Dr. Michaels completed his medical residency and earned a Fellowship in Cytopathology from Massachusetts General Hospital / Harvard Medical School.

Litigation Support - Dr. Michaels offers expert witness services to attorneys representing plaintiff and defense. He has written over 100 general causation reports focusing on pathology and providing an extensive differential diagnosis in order to provide an opinion with a reasonable degree of medical certainty. Dr. Michaels has participated in numerous MDLs, been deposed over 60 times, and testified in court 6 times.

Areas of Expertise:

Background Experience - Dr. Michaels is currently a member of a 10-pathologist group that operates the largest and most comprehensive anatomic pathology services laboratory within Central and Coastal Oregon. He is one of two pathologists responsible for covering Bay Area Hospital, the largest hospital on the Oregon Coast, which serves as a regional referral center.

Dr. Michaels' roles at Bay Area Hospital include: Chairman of Pathology; Member of the Hospital Medical Executive Committee; Medical Director for Transfusion Medicine, Hematology, and Cytopathology; Member of the Cancer Committee; and Member of the Trauma Committee.

At Southern Coos Hospital and Medical Center, Dr. Michaels serves as Laboratory Medical Director where his Anatomic Pathology responsibilities include frozen sections, gross evaluation and sign-out of complex surgical specimens, review of numerous outpatient biopsies, GYN and NON-GYN cytology, presentation at tumor board conferences, and performing hospital autopsies. Clinical pathology responsibilities include peripheral blood smear and body fluid review, crystal identification, and evaluation of blood transfusion reactions.

Speaking Engagements and Presentations - Dr. Michaels has delivered seminars and presentations in Canada, Japan, and throughout the United States. Topics have included cytopathology, breast cancer, acute cellular rejection, and many more. 

Tom LeTourneau, LPO, CPO, FAAOP, has over 45 years of experience in the Design, Manufacture, and Fitting of Orthotic and Prosthetic Devices, including all Myoelectric applications and all Microprocessors.  He is a Certified Orthotist and Prosthetist by the American Board of Certification of Orthotist and Prosthetists and Fellow of the American Academy of Orthotist and Prosthetists.

Litigation Support - Mr. LeTourneau has over 20 years of experience  providing Orthotics and Prosthetics expert opinions to life care planning care management personnel and law firms for both plaintiff and defendant. Licensed Prosthetist and Orthotist by the state of Texas, he is available for record review, thorough reporting, depositions, and trial testimony as needed.

Areas of Expertise:

Memberships, Certifications, & Highlights:

• Member of the Upper Extremity and Lower Extremity scientific society of the American Academy of Orthotists and Prosthetists
• Member of the American Association of Orthist and ProsthetistsCertification extensions in all myoelectric upper extremity Orthotics and Prosthetics, Micro-processor prosthetic Knee and feet applications, and X-finger applications
• Inventor / and or co-designer in Te-Evolution Above the Knee socket design, Stealth Ankle foot orthosis, " No more knee pain " Knee orthosis, acti-ankle
• CEO and Founder of a Multi-million dollar ( licensed and certified ) Orthotic and Prosthetic company
• Featured in articles and news organizations ( local and National )including CNN, NBC., CBS, the History Channel, and family circle magazine
• Awarded Freedom award for exceptional service for veterans ( only 35 companies nationwide receive an award )

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 led a  group of 6000 physicians and epidemiologists that reviewed the science of COVID-19