Product Safety Expert Witnesses: 39

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 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 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, 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.    

Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more

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

Susan Maccoy is an actively practicing Cosmetologist and experienced Expert Witness on Beauty Salon and Spa Products, Processes, Procedures, Policies and Standards. With over 45 years of experience, Ms. Maccoy combines an extensive background and foundation of knowledge in cosmetology and salon business and operations with critical and analytical thinking to provide solid, informed support for litigation. She is a salon owner and has been a manager of independent and franchise chain salons. She holds current cosmetology licenses in Illinois and Florida. Ms. Maccoy has assisted the legal profession on issues related to the cosmetology, beauty salon and spa industries for over 35 years. Her expertise and professional experience encompass the full range of cosmetology products, services, techniques and salon management. Ms. Maccoy also provides valuable insight for cases involving consumer and employee personal injury, product liability, professional liability including salon/spa customer injury and allegations of discrimination in the salon and spa. To date,(2015) Ms. Maccoy has been retained by the defendant in approximately 30% of her engagements and by the plaintiff in 70%. In 2011, her investigative work and expert opinions were instrumental in obtaining dismissals with prejudice in two actions, one in state court and one federal. Zoom Conferencing   Available.Areas of Expertise:

• Salon Policies and Procedures
• Cosmetology Standards of Care, Processes, Procedures, Timelines, Workflow Protocols
• Salon / Spa Incidents and Injuries
• Salon / Spa Incident Investigation and Re-Creation - Chemical Formulations and Usage
• Salon Contractual Agreements - Employment, Rental, Salon Rental / Sale, Independent Contractor / Booth Rental
• Certified in  Milady Salon Infection Protocols 2020
• Certified Covid 19 Protocols for Salons and Spas 2020 (Barbicide)

In her book, Down the Shampoo Bowl - The ABC's of Hair Salon Management, Ms. Maccoy explains the management and financial side of the beauty business and how to motivate employees, handle difficult clients, and promote business and services through traditional channels and social media. View Consulting Profile.

Thomas W. Caldwell, PE, has over 40 years of experience in Materials Research and Development, Process and Product Development, and Manufacturing Operations in the Precision Cast and Machined Products industry.

Mr. Caldwell has designed and manufactured components for consumer and industrial products, including safety-critical applications such as aircraft landing gear brakes, seat belt lockup devices, windshield wiper, and window lift motor systems. He has experience creating and guiding technology development and manufacturing partnerships in Europe and Asia, licensing and selling intellectual property and creating supply chains in China.

Mr. Caldwell has lectured in the USA, Germany, Switzerland, and India on manufacturing premium quality metal products and manufacturing processes, and was a technical paper peer reviewer for 20 years for the Society of Automotive Engineers. A United States patent holder, he has published peer reviewed research in electrochemistry and materials processing, and has written and spoken numerous times on the subject of Materials Selection.

Litigation Support - Thomas W. Caldwell, PE, is a testifying and consulting expert for both plaintiff and defense counsel. His cases involve product failure for ferrous and non-ferrous alloy products such as hand tools, recreational and exercise equipment, fire fighting apparatus, rotating industrial machinery, construction hardware, piping, and lighting fixtures. Mr. Caldwell utilizes destructive and non-destructive methods for insuring product integrity.

Areas of Expertise:

Design Engineering Materials Failure Analysis Materials Engineering Mechanical Engineering Metallurgy Power Tools Products Liability Design Defects

Manufacturing Defects Fitness for Use Equipment Operation and Maintenance Accident Reconstruction Material Selection Manufacturing Process Design and Scale Up Safety Component Product Quality Control Safety Component Quality Systems Management

View Thomas A. Caldwell's Consulting Profile.

More than 40 years experience: defective packaging; unreasonably dangerous products; failure-to-warn; materials-handling; warehousing; cargo loading and securement; falling cargo; insurance claims for loss or damaged cargo; falling merchandise; patent infringement; trade-dress infringement. Has testified in state and federal courts and knows how to connect with a jury. Has worked for Plaintiffs and Defendants. Services: consulting; analysis; cite inspections; exemplar testing; opining; report writing; testifying. Long list of attorney references. Self-employed consultant. Former employee at Fortune 100 firms. Former university instructor. Many published articles and speaking engagements. Knows how to combine theory and practice.

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.

Richard A. Lazar is the nation’s leading Automated External Defibrillator (AED) Program Compliance Expert. He and his company, Readiness Systems, design and document complete AED programs, remotely monitor AEDs, provide AED law and public policy resources and publish industry standards

An AED program consists of a design and supporting set of policies and practices that ready an organization for Sudden Cardiac Arrest (SCA) emergencies, suggest what actions should be taken if SCA is encountered and help manage the legal risks that come with owning AEDs. Industry standards and AED laws guide what to include in an AED program’s policies and practices.

Background Experience: For over 25 years, Mr. Lazar has designed and documented AED programs for AED programs nationwide. Examples include Microsoft, the Federal Aviation Administration, 24 Hour Fitness among many others. Earlier in his career, he practiced emergency medical services law, designed emergency medical services (EMS) systems, served as an EMS system administrator, and was an emergency medical technician. He also holds a law degree from Lewis & Clark School of Law and a Bachelor of Science degree in Public Affairs from the University of Oregon.

Mr. Lazar develops and publishes national AED Program Design Guidelines that describe industry standards for AED programs and the AED Law Center, the only comprehensive online information resource that helps AED owners learn about the AED laws for every state, understand the AED laws in plain English, and stay informed about pending AED legislation nationwide.

Litigation Support: As the leader in his industry, Mr. Lazar has provided both consulting and testifying expert services to lawyers in a variety of cases around the U.S. involving sudden cardiac arrest response in workplace and community (non-medical) settings. His deep understanding of AED programs has led him to testify before the U.S. Congress in support of the Cardiac Arrest Survival Act, the FDA on AED over-the-counter and reclassification issues, and numerous state legislatures on AED public policy issues and immunity laws.

View Readiness Systems' Consulting Profile.

Expert Background: Dr. Thomas L. Read is the Principal and CEO at A. Read Consulting, LLC. He received his PhD. from Stanford University in 1972 and has over 25 years of manufacturing experience in electronics, metallurgy, factory safety, failure analysis, glass fracture, glass failure and bottle failure. As a member of the electronics industry, he has earned process patents and has an extensive background in manufacturing techniques.

In parallel, Dr. Read has spent over twenty five years as a consultant to attorneys and engineers. He has given more than 100 depositions and has appeared in court numerous times.

Company Profile: Read Consulting, LLC is a full service laboratory providing services in the following areas:

Failure Analysis; Factory Safety and Personal Injury (including machine guards and manufacturing safety)

Glass Failure Analysis - Glass Fracture, Glass Failures and Bottle Failure

Metal and Ceramic Failure

Grinding Wheel Failures

Intellectual Property and Patent Disputes

Product Liability and Product Quality

Manufacturing Disagreements (such as Intellectual Property, Failed equipment and Contract Disputes)

Reverse Engineering

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

R. Kevin Smith PE, BSME, MMAE, has been a specialist in Engineering Forensic Safety and Design for 35 years. He has consulted on over a 1,000 matters nationwide.

Mr. Smith is a registered professional engineer and holds a BSME and MMAE from the Illinois Institute of Technology in Chicago. He specializes in Material Handling Equipment Safety, including lift trucks, dock safety, truck loading, conveyors, and aerial work platform safety.

Mr. has been actively involved as a member of the committee that writes the Safety Standard for Low Lift and High Lift Trucks (ASME/ANSI B56.1) for over 30 years. He also serves on the B56.6 committee (rough terrain lift trucks) and the ANSI A92.5 and A92.6 subcommittees (self-propelled elevating work platforms).

Litigation Support - Mr. Smith formerly worked for Triodyne, Inc. for over 15 years as a forensic engineer/principal engineer. As President of R. K. Smith Engineering Inc., he currently has a laboratory for examination and testing, and owns or has access to varied testing equipment and tools.

Kevin Smith has testified at depositions and trials on several hundred matters. He has performed hundreds of investigations into product failures involving injury and property damage, and has reconstructed numerous accidents. His expertise is available to counsel representing both Plaintiff and Defendant. Mr. Smith also is on the Adjunct Math faculty at Prairie State College.

Areas of Expertise:

Forklift Trucks Aerial Work Platform Lifts Product Testing Material Handling / Lifting / Rigging Equipment Accident Reconstruction Machine Guarding Safeguarding Warnings

Agricultural and Construction Equipment Skid Steer Loaders Stability Testing Loading Dock Safety Consumer Products / Testing OSHA Citations Codes & Standards Standard of Care in Design

View R. Kevin Smith's Consulting Profile.

Quality Forensic Engineering, LLC is a full-service forensic engineering and accident reconstruction firm, providing engineering support to clients in the areas of collision reconstruction, premises liability, and product liability.  With over 20 years of experience for each of our senior engineers, we utilize the latest technology for documenting evidence and retrieving data including FARO 3D scanning, aerial drone imaging, and black box downloads.  Our forensic engineers are mobile, supporting clients throughout the U.S. Headquartered in Tallahassee, Florida with a satellite office in Jacksonville, Florida, we look forward to serving you.

Dr. Brian Pfeifer, P.E., With over 20 years of experience investigating and testifying in cases involving a variety of forensic engineering issues, Dr. Pfeifer is a leading expert in accident reconstruction, roadside safety, maintenance of traffic, and analysis of mechanical systems, and product failures. Dr. Pfeifer has a strong background in the design, development, and implementation of roadside safety hardware including guardrails, bridge rails, and crash cushions. Over 33 patents have been filed worldwide on behalf of Dr. Pfeifer and associated colleagues who invented safer guardrail systems and terminals, vehicle storage systems, shipping container handling systems, and material handling and storage methods.   Dr. Pfeifer has published numerous papers to various organizations including the Transportation Research Board and Port Technology International, covering topics ranging from new guardrail systems, energy-absorbing guardrail terminals, and breakaway mechanisms incorporated in traffic signs to material handling technology.  Dr. Pfeifer’s expertise has been shared with many organizations such as the Florida Justice Association, Palm Beach County Justice Association, American Bar Association, Defense Research Institute, and Alabama Defense Lawyers Association with presentations he’s made on topics including vehicle collisions, bicycle accidents, roadway constructions zones, and accident reconstruction expert witness utilization.  Dr. Pfeifer is a registered Professional Engineer in three states and stays current with learning new technology in the field of forensic engineering.  He has refined his skills and knowledge of accident reconstruction and roadside safety by taking dozens of continuing education courses over the span of his career. Expertise: Vehicle Collisions Tractor / Trailer Collisions Bicycle Accidents Pedestrian Accidents Motorcycle Accidents Occupant Kinematics Roadside Safety/Guardrails Construction Zones Black Box Analysis Product Failure Analysis Premises Liability Maintenance of Traffic (MOT) evaluation  Restraint System Analysis

Ms. Traci Campbell, P.E., CXLT, Ms. Campbell is an Industrial engineer with specialties in industrial accident reconstruction, including slip, trip, and fall analysis, human and environment interaction, forklifts, applicable standards and guidelines, and workplace-safety issues.  Her expertise also includes vehicular accident reconstruction involving automobiles, trucks, tractor-trailers, and recreational vehicles, as well as, product failure analysis. Expertise: Industrial Accidents Slip / Trip / Fall Retail Facility Safety Human and Environment Interaction OSHA Regulations ADA Regulations ANSI / ASTM / Building Codes Workplace Safety Guarding & Warnings Forklifts and Construction Equipment Theme Parks / Recreation Safety and Facilities Automobile Collisions Tractor / Trailer Collisions Bicycle Accidents Motorcycle Accidents Pedestrian Accidents Occupant Kinematics Airbag and Black Box Analysis Product Design / Failure Analysis General Engineering

Mr. Chris Yates, P.E., Mr. Chris Yates, P.E., is a Mechanical Engineer with specialties in accident reconstruction, including electronic module downloads for both automobile airbag modules and tractor-trailer electronic control modules.  His expertise includes auto accidents, tractor-trailer accidents, bicycle accidents, pedestrian accidents, and other roadway accidents.  His expertise also includes seat belts, occupant kinematics, product failure analysis, and other general engineering issues. Expertise: Automobile Accidents Tractor / Trailer Accidents Bicycle Accidents Pedestrian Accidents Airbag and Automobile Black Box Analysis ECM and Tractor-trailer Black Box Analysis Occupant Kinematics Roadway Safety Product Design / Failure Analysis >General Engineering

Dr. J. P. Purswell, PhD, PE, CPE has extensive experience in Human Factors, Ergonomics and Safety Engineering. He holds a doctorate in Industrial & Systems Engineering from Virginia Tech. He has taught Safety Engineering Ergonomics in the Industrial Engineering Department at CSU-Pueblo since 1999. A member of the Human Factors and Ergonomics Society and the American Industrial Hygiene Association, Dr. Purswell also served as the Chair of the Industrial Engineers PE exam from 2005 to 2009. He continues to serve on the committee which is responsible for the preparation of the national professional engineering examination in industrial engineering. Dr. Purswell is the author of more than 20 publications and presentations on Product Safety, Occupational Safety, Printed Warnings, and Auditory Warnings. Examples of products addressed include silica, asbestos, cleaning chemicals, gasoline containers, and recreational equipment. Dr. Purswell maintains NIST-calibrated equipment for the measurement of light, sound, force, and whole-body and hand-arm vibration in addition to standard photo and video equipment. Dr. Purswell has been an Expert Witness in the legal industry since 1997. He has been qualified as an expert in state and federal courts across the nation in safety engineering, including safety analysis techniques such as Fault Tree Analysis and FMEA as well as product warnings / instructions and OSHA compliance issues. Dr. Purswell's services include site inspections, document review, drafting Rule 26-compliant reports, deposition, and trial testimony. He has been retained by attorneys for both Plaintiff (40%) and Defense (60%) more than 100 times, has been deposed approximately 50 times, and has testified at trial over 20 times. Areas of Expertise:

Warning and Safety Instructions OSHA Compliance Chemical Accident Prevention Product Safety Lockout / Tagout & Machine Guarding Trucks and Forklift Accidents

Power Tools Safety Hazard Communication - Audible Alarms Employer Safety Training and Supervision Perception / Reaction Time Ergonomic Work Practices Working and Walking Surfaces - Slip, Trip and Fall

View Dr. Purswell's Consulting Profile.

Richard L. Hall has nearly 40 years of international experience in On and Off Road Product Development and Management consulting. An expert in product planning and development, process management and reengineering, and design and development engineering, he provides consulting services in the off-road vehicle and automotive industries. Clients include off-road, construction, and agricultural equipment companies.  

Background: Mr. Hall worked with CNH Global/Case Corporation for 34 years. He served as Vice President of Product Planning and Process Improvement from 2006-2009, leading a team of (17) Global Product Managers to create and maintain the Construction Equipment Product Evolution Plan and associated schedules and documents. He acted as the main interface  between engineers and the CNH Global patent office, reviewing all applications from both internal and external sources before they were sent to the company Patent Office.

Mr. Hall also led the Products Liability Support Team (litigation engineers) for Case Construction in North America on and off for nearly 20 years. Among other duties, he was responsible for:

• Global Construction Equipment (CE) Product Portfolio Management and Planning
• Engine Strategy and Program Management
• Telematics and Diagnostics Strategy
• Process Improvement and Engineering
• Tools Development and Deployment

Litigation Support: As president of Product Development Services, LLC, founded in 2009, Mr. Hall offers Technical Expertise in On and Off Highway Mobile Equipment. Providing legal support for many years, his services are available to attorneys for plaintiff and defendant and include, examination thorough reporting, deposition, and trial testimony as needed. 

Areas of Expertise:

Mobile Construction and Earthmoving products Agricultural Products

Material Handling Products Over-the-Road Trucks

Technical Competencies include:

• Powertrain Systems
• Hydraulic Systems
• Systems Integration, Controls, and Interfaces

View Richard Hall's Consulting Profile.

Georgia J. Persky RN, MBA, PhD, CLNC, CNOR is a Columbia University trained nurse researcher with over 40 years of broad Clinical Nursing experience and 25 years of senior leadership in Hospitals, Nursing Homes and Home Health organizations. She also has 20 years of Surgical Nursing and Operating Room experience. Dr. Persky has expertise in the micro issues in nursing for adult patient care and the broad management, quality, and regulatory issues in hospitals. 

Background Experience - Dr. Persky served as Vice-President of Nursing and Patient Care Services for the past 25 years and most recently at New York Presbyterian Hospital/Columbia University Medical Center. For nine years, she was responsible for Patient Care Services, Risk and Quality Management and Patient Satisfaction for a 750-bed academic hospital. She directed a $200 million budget with 33 patient care units and Care Management, Respiratory Therapy, Social Work and Admitting Departments with 9 direct reports and 2,000 patient care employees.

Litigation Support - As a Certified Legal Nurse Consultant and Quality Reviewer, Dr. Persky has investigated hundreds of Malpractice and Injury cases as a quality reviewer and can assist in legal case review with chronologies, timelines, and evidence-based reports. She has testifying experience in malpractice and personal injury cases, as well as, with human resource and employee discrimination with an ability to attest to standards of care in clinical litigation. Dr. Persky's services are available to attorneys for the plaintiff and defense seeking an expert in nursing and patient care with a strong understanding of how heath care organizations work.

Areas of Expertise:

Nursing/Hospital Standards of Care Nursing Home and Skilled Nursing Surgical and Perioperative Nursing Quality and Risk Management Fall and Pressure Ulcer Prevention

Hospital Policy and Procedure Medication Safety Medical Device Safety Hospital Administration State, Federal, Joint Commission Regulatory Compliance

View Dr. Persky's Consulting Profile.

Mukul K. Verma, PhD,  (University of Michigan) brings more than 35 years of Engineering & R&D experience to his consulting practice in the areas of Vehicle Engineering, Automotive Safety, and Mechatronics Systems Design. 

Dr. Verma's experience includes multiple asignments in automobiles’ design and testing at one of the largest vehicle manufacturers the USA. In addition, he has significant R&D experience which led to several advances in automotive engineerin. These include areas such as automatic crash notification systems for post-crash protection, vehicles designs & pedestrians’ safety, airbag & passive protection systems design, motorcycle dynamics, heavy truck rollovers, etc. Also in his role as technical expert, he led international industry-wide teams of experts to successfully develop engineering solutions to urgent problems in traffic safety. 

As a consultant, he has worked with the US National Highway Traffic Safety Administration and the Environmental Protection Agency on future lighter vehicle designs and their occupants' protection in traffic accidents. He has also provided consultation to overseas government organization and research agency on electric vehicles' functional issues and traffic safety, as well as on test facilities.

Dr Verma has also taught several graduate-level and professional courses at universities in Mechatronics and Mechanical Engineering, Intelligent vehicle systems, Structural dynamics analysis and Vehicle Design Integration. He has published more than thirty papers in peer-reviewed journals and at international conferences and has been active in professional organizations as invited speaker, session chairman and organizer. He is well-known for his expertise in Vehicle Engineering and Traffic Safety and his interviews and opinions have appeared in US and in international media on several occasions 

Litigation Support – Dr. Verma’s recent litigation-related work has been in two fields:

(a) Product Liability cases related to the performance of automobiles and components in accidents in the area; and 

(b) Intellectual Property claims related to mechatronics systems in automobiles and the validity / infringement of patents.

 View Dr. Verma's Consulting Profile.

Timothy W. Monsees, is a partner with the firm of Monsees & Mayer, P.C. For over 30 years, he has focused his practice on litigating complex Personal Injury cases.

Background - Mr. Monsees graduated with honors from the University of Missouri-Columbia School of Law in 1981. He is admitted to practice in Missouri, Kansas and Texas. Mr. Monsees is recognized by Best Lawyers in America, Missouri Super Lawyers, Kansas City Business Journal “Best of the Bar”, and for many years has been recognized by Martindale-Hubbell with an “A/V” rating. He regularly presents at seminars helping to instruct other attorneys on trial practice skills.

Mr. Monsees restricts his practice to representation of injured parties in litigation of product liability, construction & industrial accidents, professional negligence, and medical malpractice. Mr. Monsees’ firm has received national recognition for litigation related to injuries from defective sporting equipment and from defective firearms.

Litigation Support - Mr. Monsees provides expert witness services for counsel representing injured parties. He addresses issues related to rules violations, time limits, discovery omissions, trial strategies, procedure, standard of care, and ethical violations.

Areas of Expertise:

• Legal Ethics
• Legal Malpractice
• Medical Malpractice
• Personal Injury
• Demonstrative Evidence / Exhibits

View Timothy Monsees' Consulting Profile.