Case Experience
The following representative matters illustrate the breadth of my experience as an expert witness involving medical devices, in vitro diagnostics, pharmaceuticals, biologics, and other FDA-regulated healthcare products. These engagements include individual litigation, mass tort proceedings, FDA regulatory matters, product development issues, and commercial disputes. Over the course of my career, I have been retained by both plaintiff and defense counsel to evaluate product design, FDA regulatory compliance, engineering performance, clinical evidence, manufacturing and quality systems, adverse event reporting, product commercialization, and standards of care.
Because many matters remain confidential, the descriptions below have been generalized and do not identify clients or disclose confidential information. They are intended to demonstrate the diversity of technologies and litigation issues on which I have been retained.
Cardiovascular Devices
Transcatheter Aortic Valve Replacement (TAVR) Delivery System
Evaluation of catastrophic balloon delivery system failure during transcatheter aortic valve replacement resulting in fatal vascular injury. Responsibilities included engineering failure analysis, FDA PMA review, post-market surveillance, MAUDE evaluation, clinical evidence review, and causation assessment.
Inferior Vena Cava (IVC) Filter
Evaluation of fractured stainless-steel Greenfield inferior vena cava filter requiring open-heart surgery for device retrieval. Included engineering failure analysis, FDA regulatory history, adverse event review, metallurgy, and long-term implant performance.
Implantable Cardioverter Defibrillator (ICD)
Evaluation of Medtronic implantable cardioverter defibrillator performance following inappropriate shock delivery and device replacement. Included review of device performance, engineering issues, clinical evidence, and regulatory considerations.
PULS Cardiac Diagnostic Test
Evaluation of regulatory and scientific issues involving a novel cardiovascular risk prediction assay utilizing proprietary biomarker algorithms. Responsibilities included assessment of FDA regulatory status, clinical utility, and commercialization issues.
General Surgery
Surgical Staplers
Evaluation of circular surgical stapler malfunction involving incomplete staple formation during colorectal surgery. Responsibilities included engineering failure analysis, FDA regulatory history, product recalls, manufacturer notices, quality system issues, and post-market surveillance.
Ambulatory Pain Pumps (Multiple Matters)
Retained in multiple litigation matters involving ambulatory pain pumps manufactured by several companies. Responsibilities included engineering failure analysis, FDA regulatory compliance, product design, expert reports, depositions, and trial testimony.
Intrathecal Baclofen Infusion Pump
Evaluation involving implantable baclofen infusion pump technology, including device performance, refill procedures, withdrawal risks, and engineering issues associated with long-term implanted infusion systems.
Extracorporeal Shock Wave Lithotripsy (ESWL)
Evaluation involving extracorporeal shock wave lithotripsy technology and device performance.
Orthopedic & Spine
Cervical Spine Fixation Systems
Multiple matters involving cervical plating systems, spinal fixation devices, and cervical intervertebral body fixation orthoses. Responsibilities included evaluation of engineering performance, biomechanical considerations, FDA regulatory history, and product design.
Bone Morphogenetic Protein (Infuse®)
Evaluation involving recombinant bone morphogenetic protein technology, FDA PMA requirements, product labeling, off-label use, and clinical evidence.
Knee Joint Implant
Evaluation involving orthopedic knee implant technology and engineering performance.
Women’s Health
Silicone Breast Implants — Mass Tort
Retained in mass tort litigation involving silicone breast implants. Responsibilities included evaluation of implant design, manufacturing, FDA regulatory history, scientific literature, and clinical safety issues.
Transvaginal Mesh
Evaluation involving transvaginal mesh technology with emphasis on product design, FDA regulatory history, adverse events, clinical complications, and product performance.
Ophthalmology
LASIK Systems
Evaluation involving laser vision correction systems, including device technology, FDA regulation, labeling, warnings, clinical performance, and standards of care.
Diagnostics & Molecular Medicine
Novel Molecular Diagnostic Technology (RPA)
Retained to evaluate whether Recombinase Polymerase Amplification (RPA) technology had a realistic and achievable pathway to FDA clearance and commercialization. Responsibilities included comparison with FDA-cleared PCR and other molecular diagnostic technologies, evaluation of applicable FDA regulatory pathways (510(k) and De Novo), assessment of analytical and clinical development requirements, and preparation of expert opinions regarding commercialization potential.
BRCA Companion Diagnostic
Evaluation involving BRCA molecular diagnostic testing used to guide targeted ovarian cancer therapy. Included FDA regulatory requirements, companion diagnostic strategy, PMA issues, and clinical application.
Regenerative Medicine & Biologics
Adipose-Derived Regenerative Cell (ADRC) Technology
Evaluation involving adipose-derived regenerative cell technology, FDA biologics regulation, minimal manipulation, regenerative medicine, and commercialization issues.
Human Tissue Allografts & Bone Matrix Products
Evaluation involving human tissue allografts, dermal matrices, and bone matrix implants, including FDA tissue regulations, biologics considerations, manufacturing, and clinical applications.
Pharmaceuticals
Vioxx® — Mass Tort
Retained in Vioxx mass tort litigation to evaluate preclinical laboratory studies, clinical trial data, and internal corporate communications relating to the generation, analysis, and interpretation of cardiovascular safety data. Responsibilities included scientific evaluation of research findings, product safety, risk communication, regulatory issues, and corporate decision-making.
Avandia® (Rosiglitazone) — Mass Tort
Retained in pharmaceutical mass tort litigation involving the alleged association between rosiglitazone therapy and cardiovascular events. Responsibilities included review of scientific literature, clinical evidence, FDA regulatory history, and pharmaceutical safety issues.
FDA Regulatory & Manufacturing
OTC Hand Sanitizers
Preparation of FDA expert opinions involving over-the-counter hand sanitizer regulation, manufacturing quality, analytical testing, FDA monograph compliance, and regulatory enforcement.
Additional representative matters are available upon request. Because many engagements remain confidential or are subject to protective orders, only a representative selection is presented here.
Ready for Case Evaluation
Full CV, detailed case history, and testimony record available upon request for qualified engagements.
Contact Alan Donald directly at (619) 208-5624 or adonald@matrixmedcorp.com to discuss your matter.