Pharmacy / Pharmacology / Pharmaceuticals Expert Witnesses: 13

Dr. Matthew Lee, MD, RPh, MS. is a Physician, Pharmacist, Pharmacologist and Toxicologist who also practices as an Expert Witness and Legal Strategy Consultant. Specific Benefits Include:

• Increased quality and integrity of written expert reports, based on an expanded knowledge base
• Time savings by only having to coordinate and discuss a case with one expert as opposed to two or more
• Since there is so much overlap between fields in the medical profession it is often hard to determine where one scope ends and another begins. This ambiguity is dramatically decreased , and scope increased by combining physician, pharmacist, and pharmacologist into one
• Communication skills of a pharmacist and experience dealing directly with the lay-public, in addition to the knowledge and background of a physician is extremely beneficial describing technical details to a jury
• Practicing in different realms within the healthcare field has allowed Dr. Lee to integrate the multiple facets giving him a unique and distinct perspective that no other expert has.

Case Experience Includes:

Merrill S. Wise, MD, is Board-Certified in Psychiatry and Neurology with special qualifications in Child Neurology, and he is certified by the American Board of Sleep Medicine. Involved in the full-time practice of sleep medicine, Dr. Wise has evaluated and managed the full range of Sleep Disorders since 1991.

Dr. Wise evaluates children, adolescents, and adults with the full range of sleep problems and disorders. He is involved with supervision and interpretation of polysomnography (sleep studies), Multiple Sleep Latency Tests (MSLT), Maintenance of Wakefulness Tests (MWT), and integration of these findings with the clinical history in order to develop a diagnosis and treatment plan.

Because of the population served in Memphis, Dr. Wise evaluates a large number of pilots (FedEx world hub), air traffic controllers, commercial drivers and barge pilots, rail engineers, and shift workers. He is experienced in the treatment of obstructive sleep apnea (OSA), narcolepsy, and other disorders of excessive sleepiness, insomnia, circadian rhythm sleep disorders, restless legs syndrome, and parasomnias.  This expertise and experience allows him to analyse and provide valuable opinions on a wide range of sleep-related legal issues.

Litigation Support - Dr. Wise has reviewed a wide variety of cases involving both neurology and sleep medicine for greater than 20 years including report generation, testimony at deposition, and at trial. He has served on numerous national task forces and committees, as well as the Board of Directors of the American Academy of Sleep Medicine (AASM). These experiences have exposed him to the full range of sleep disorders, as well as healthcare systems, best practices and evidence-based standards of care, policies, and the legal aspects of sleep problems and disorders. 

Special Interest and Expertise:  

• Individuals with Excessive Daytime Sleepiness
• Downstream Effects of Sleepiness on
  • Cognitive Function
  • Driving
  • Safety
  • Work
  • Behavioral Regulation

Tracy L. Skaer, PharmD, FASHP, FASCP is a Professor Emeritus of Pharmacotherapy with over 30 years of pharmaceutical experience; 10 years as an expert witness. She is a licensed pharmacist in California, Idaho, and Washington. Dr. Skaer is a Fellow of the American Society of Health-Systems Pharmacists, the American Society of Consultant Pharmacist, and a Member of the American College of Clinical Pharmacist's (ACCP) Pain and Palliative Care Practice and Research Network (PRN).

Dr. Skaer's research interests include chronic pain, co-morbid mental illness in chronic disease, depression, anxiety disorders, insomnia, mindfulness, complementary and alternative medicine, and pharamcoeconomics and pharmacoepidemiology. Her research has been supported by over $3.2 million in grants from foundations and pharmaceutical industry.

Litigation Support - Dr. Skaer has completed several expert cases across the United States. Her services are available to attorneys representing plaintiff and defendant, including record review, written reports, deposition, and trial testimony. Dr. Skaer's cases involve:

View Dr. Skaer's Consulting Profile.

Dr. Michael L. Dourson has a PhD in Toxicology from the University of Cincinnati, College of Medicine, and is a board-certified toxicologist (i.e., DABT) with over 40 years of experience in Environmental Risk Assessment. 

Dr. Dourson serves as President/Director of the 501c3 nonprofit organization Toxicology Excellence for Risk Assessment (TERA). Prior to this, he was Senior Advisor in the Office of the Administrator at the US EPA. Before this, he was a Professor in the Risk Science Center at the University of Cincinnati, College of Medicine and also worked at TERA and US EPA. 

Litigation Support - Dr. Dourson's specialized knowledge of the issues and pitfalls involved in the research and development of human health risk assessments along with his cutting-edge toxicology expertise allows him to provide state-of-the-art science assessments for attorneys representing plaintiff and defense. 

Services:

• Review toxicity data to assist in determining whether an exposure was the proximate cause of health effects;
• Perform literature searches and providing written critical analysis of literature;
• Provide services related to expert witness opinions and testimony;
• Review and analyzing environmental monitoring data;
• Assist with the development of exposure and medical monitoring programs; and
• Plan and manage peer review and peer consultation programs.

Areas of Expertise:

Dr. Dourson has been awarded the Arnold J. Lehman award from the Society of Toxicology, the International Achievement Award by the International Society of Regulatory Toxicology and Pharmacology, and 4 bronze medals from the U.S. Environmental Protection Agency. He has been elected as a Fellow of the Academy of Toxicological Sciences (i.e., FATS) and as a Fellow for the Society for Risk Analysis (i.e., FSRA).

He is the co-author of 3 Patty’s Toxicology chapters on PFAS chemistries and the co-author of 6 research papers on PFOA, two of which have won paper of the year awards from the Society of Toxicology’s Regulatory and Safety Evaluation Specialty Section.

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.

Dr. Pia Quimson-Guevarra is Board-Certified in Psychiatry and Forensic Psychiatry by the American Board of Psychiatry and Neurology. She opines about psychiatric issues in civil litigation, employment matters, and criminal cases. She has extensive experience with diagnosis and treatment of depression, anxiety, bipolar disorder, PTSD and other factors of emotional distress, both as a treating physician and in medical-legal cases. She serves as a forensic consultant, and/or disclosed Expert Witness. She assesses competency and undue influence,  standard of care, and mental status re judgment and clarity of thinking. Applies to civil, probate and CTST criminal matters including criminal responsibility. She is also experienced in treatment of psychotic disorders,  hallucinations, and delusions.

She opines about medication or drug impact on behavior.

Dr. Quimson-Guevarra conducts IMEs and review of medical and legal records. Her assessments are thorough and inform thoughtful and objective expert opinions issued by verbal and written report and testimony. She conducts Independent Medical Evaluations face-to-face in person and by video.

She is a Certified Forensic Evaluator in Oregon.

Dr. Quimson-Guevarra's clinical practice in Portland is Quimson Behavioral Health, providing psychiatric patient care, medication management, and psychotherapy, for patients who suffer from mental disorders, e.g., Anxiety, Depression, Bipolar Disord & PTSD and medication management. She continues to use her expertise in psychopharmacology to treat mental health conditions in the context of medicolegal medically complex cases.

Prior to expanding her private practice, she was a psychiatrist at Cascadia Behavioral Healthcare, in an Assertive Community Treatment (ACT) team, a method to deliver an intensive level of services to patients in the local community. Her patients consisted of individuals who suffer from severe and persistent mental illness.  At Cascadia, she also treated patients with a history that includes forensic medical-legal issues.

Previously, Dr. Quimson-Guevarra treated patients who suffered from anxiety, mood, and psychotic disorders at Cedar Hills Hospital, Multnomah County Detention Center, Washington County Jail, Snake River Correctional Institute, and the Portland Veteran's Administration. 

Dr. Quimson-Guevarra has served as a forensic consultant for the Washington County Mental Health Court in Oregon. She also has worked in the forensic evaluation service department at the Oregon State Hospital where she performed forensic evaluations.

John Budny, PhD, provides expert Toxicology opinions based on recognized and accepted medical knowledge to determine if prescriptions, over-the-counter medications, and drugs of abuse that cause adverse medical events. With a PhD in basic medical science and a 40-year career as a practicing toxicologist, Dr. Budny combines the science of toxicology with medical knowledge to fully understand the ramifications of an adverse medical event caused by prescribing errors, faulty medications, or failure in the health care delivery process.

Dr. Budny has conducted scientific investigations in toxicology and has published the results of his research. In addition to being as an expert witness, Dr. Budny provides scientific contributions by writing book reviews of relevant topics related to toxicology and forensics. He is also on the Editorial Board of the International Journal of Toxicology. In his position on the Editorial Board, Dr. Budny reviews manuscripts on general toxicology and forensic topics that are submitted and proposed for publication in the journal. He also writes book reviews that cover the entire breadth of toxicology. 

Litigation Support - Dr. Budny has over 25 years of experience as an expert witness. He has been retained in over 300 cases in which he has opined in reports, depositions, and in court testimony about cause and effect relationships between chemicals and adverse reactions and toxicities. While his forensic toxicology practice is not limited to any specific type of chemical, most of his retention as an expert has been for prescription drugs, illicit drugs, dietary supplements and nutritional products.  

Successfully resolved complex medical issues involving pharmaceuticals and drugs:

Nancy M. McClellan, MPH, CIH, CHMM, is an award winning, Industrial Hygiene and Safety expert with over 25 years of broad international experience practicing, teaching and authoring to anticipate, recognize, evaluate, control and prevent workplace health and safety hazards in high hazard industries.

 Prior to her independent expert and consulting practice, Ms. McClellan practiced industrial hygiene management as a Board Certified Industrial Hygienist on a global scale for both AbbVie, a major producer of highly potent biopharmaceuticals and LafargeHolcim, the world’s largest building materials corporation.

She currently provides industrial hygiene and safety legal expert, management, training, and select field services to sectors such as the pharmaceutical, automotive, military, hospital, electronic, food, chemical, and commercial real estate industries. 

She is the Chair of the University of Michigan Graduate School of Public Health COHSE External Advisory Board and an international AIHA Distinguished expert lecturer.

Ms. McClellan is domestically and internationally recognized for leadership service to the IH profession for the American Industrial Hygiene Association (AIHA), the American Board of Industrial Hygiene (ABIH), the Occupational Hygiene Training Association (OHTA) and the Joint Industrial Hygiene Ethics Education (JIHEEC) Boards of Directors and Committees. She currently serves on the AIHA Executive Board of Directors.

As a result of her well-practiced ability to describe science in lay terms, Ms. McClellan was interviewed in October 2020 on the ABC Network’s Good Morning America program regarding Covid pandemic controls, as well as a number of ABC News and professional journal articles regarding the association between HVAC systems, Indoor Air Quality and the Covid pandemic to advance public and worker health protections.

Ms. McClellan has extensive expertise in Pandemic, Covid-19 Response Management, including chemical and non-chemical disinfectant exposure evaluation and real estate/facility controls.

Good Morning America Pandemic / Indoor Air Interview 

Litigation Support Goal - Nancy McClellan seeks to continue a 50/50 defense/plaintiff practice that presents challenging cases determining worker and/or public exposure to chemical, biological, physical or ergonomic hazards. Her services include thorough review, reporting, depositions, and trial testimony.

Areas of Expertise:

• Chemical and biological airborne and dermal exposure assessment and modeling
• Bioaerosol Assessment and Pandemic Control Programs 
• Indoor Air Quality and Air disinfection Technologies Evaluation
• H&S Policy and Program Development and Audits
• Highly Potent Compound Containment 
• Workplace Hazard Risk and Exposure Assessment 
• USP 800 Safe Hazardous Drug Handling Conformance
• Hearing Conservation Program Development and Controls
• Respiratory Protection Evaluation and Program Development
• Worksite Ergonomic Evaluation and Controls

View Nancy McClellan's Consulting Profile.

Dr. James C. Norris, Ph.D., DABT, EURT is an Expert Witness in Toxicology and Pharmacology. He has Litigation and Arbitration experience in the United States, United Kingdom and Hong Kong. Dr. Norris has given testimony to government agencies, has acted as a consultant for the media (BBC) and is an Industrial Site Crisis Team Member. He is avaliable for both Plaintiff and Defense.

Areas Of Expertise:

• Carcinogenicity and Chemicals
• Combustion or Fire Toxicolog
• General and Inhalation Toxicology
• Pesticides, and Pharmaceuticals (pharmacology)

Professional Affiliations:

• American Association of Pharmaceutical Scientists
• British Toxicology Society
• Society of Toxicology
• Editorial Boards of Inhalation Toxicology and Journal of Fire Sciences

Milliman’s Tampa Office provides a variety of Health Insurance, Health Care services, and Pharma consulting services to law firms, health plans, insurance companies, HMO’s, Blue Cross/Blue Shield plans, hospitals and other providers, employers and government agencies. Stuart Rachlin and other staff are experienced actuaries and related consultants.  

We provide support to our clients with all types of health related services including Medicare Advantage and Prescription Drug plans (MAPD), Part D plans (PDP), ACA plans, medical, dental, long-term care, Medicare supplement & critical illness.

We assist clients nationwide with forensic actuarial work, rate filings, regulatory compliance, reserve projections, valuations, employee benefit analysis and design, mergers and acquisitions, claim cost analysis, and fee schedule analysis.

These health care services are used in litigation relating to:

• Life care planning
• Contract development and fee schedule analysis
• Pricing & Underwriting
• Senior Services
• New benefit plan design

Jeffrey A. Sugar, MD has been a practicing Psychiatrist for over 20 years. Dr. Sugar is board certified both in Child and General Psychiatry. He is Past President of the Southern California Society of Child and Adolescent Psychiatry.

Dr. Sugar  is an Assistant Professor of Clinical Psychiatry at USC, and has been an Assistant Clinical Professor of Psychiatry at UCLA. Dr. Sugar is the Director of the Child and Adolescent Psychiatry Trauma Program at the University of Southern California, Keck School of Medicine in Los Angeles, CA where he sees patients, teaches psychiatry, and performs research. He is Attending Psychiatrist in both Child and Adolescent Psychiatry and Adult Psychiatry Outpatient Clinics at USC. He teaches child and general psychiatrists-in-training and medical students on topics ranging from Trauma, Adversity, and Dissociation to Psychotherapy theory and methods.

Dr. Sugar was the founding director of the Hathaway Children’s Clinical Research Institute where he performed funded research on the effects of interpersonal child trauma. Dr. Sugar has presented at national and international meetings on child and adolescent Trauma and Dissociation. Director, Child Psychiatry Trauma Program at the University of Southern California, Keck School of Medicine .. Dr. Sugar has been worked with the legal industry since 1988. Qualified in Superior court, he has been retained over 40 times as an expert in a broad range of child and general psychiatric cases, for both Plaintiff and Defense. His services include:

• Consultation Regarding Psychiatric Injury, Diagnosis, Treatment
• Record Review and Opinion
• Psychiatric Interview and Mental Status Evaluation
• Expert testimony

Dr. Sugar's litigation support is available to attorneys for both Plaintiff and Defense. His Areas of Expertise include:

Professional Training:

• MD: University of California, San Francisco
• General Psychiatry: Harbor-UCLA, Torrance, California
• Child Psychiatry: UCLA-Neuropsychiatric Institute
• Chief Fellow: UCLA

View Dr. Sugar's Consulting Profile.

Wayne H. Grant, PharmD, is a Clinical Pharmacist with over 30 years of pharmacy experience working in or within various practice settings—retail, long-term care, home infusion, sterile products, corrections, hospice, specialty, and hospitals.  

Dr. Grant has prepared and delivered educational programs to physicians, nurses, and other healthcare professionals based on his extensive experience in multiple disease states. Programs include topics such as Pain Management, COPD, and Motor Neuron Diseases.

Serving as an integral member of multiple pharmacy and therapeutics committees, he has promoted evidence-based interventions while driving quality initiatives and building a highly collaborative consortium among healthcare professionals.  

Earning his Doctor of Pharmacy from the University of Florida, his Master of Business Administration for Kent State University, and his Bachelor of Science from Ohio Northern University highlights Dr. Grant's drive for education, understanding, and application of pharmacy services.  

Dr. Wayne Grant on Consulting with Attorneys

Litigation Support - Dr. Grant is an expert in pharmacy practice. His expertise in long-term, institutional, infusion, and retail practice allow for an extensive understanding of the various pharmacy sectors. He is responsible for pharmacotherapeutic management, medication safety and efficacy and drug information all which follow federal, state, and local laws. He has provided a variety of expert witness services on behalf of legal professionals, including attorney consultation, case review, case opinion, and written case opinion. 

Areas of Medication Expertise:

View Dr. Grant's Consulting Profile.

Dr. Glenn Prestwich  is a National Academy of Inventors fellow with over 45 years of experience as a professor, entrepreneur, and biotech startup C-suite executive. Dr. Prestwich specializes in Biomedical Intellectual Property. He has been a prolific inventor since 1977, and an expert witness in IP law cases since 2007. He is an inventor on over 95 patents and patent applications, including 48 issued patents.

Litigation Support - Dr. Prestwich brings to all legal and technical cases a deep appreciation for how chemistry informs the invention and development of products that offer solutions to problems in the life sciences and medicine, ranging from disease detection and treatment to tissue healing and regeneration. He’s been involved in intellectual property litigation that concern medical devices, diagnostics, new pharmaceuticals, drug delivery, agrochemicals, and consumer products.

As an expert witness, Dr. Prestwich enjoys the challenges of dissecting the validity (or invalidity) of patents in litigation. He appreciates the subtleties of claim construction and works collaboratively with attorneys to identify successful arguments based on sound science and legal principles. He has drafted over 40 expert reports, declarations, and affidavits in support of his attorney clients.  He has been deposed 18 times and testified in Court four times.

Glenn D. Prestwich on Accessible and Experienced Expert Witnesses

Areas of Expertise:

Publications - Dr. Prestwich is an organized, clear, and effective writer. He has co-authored  over 610 additional peer-reviewed articles in the scientific literature, and written over 50 single-author scientific publications, reviews and book chapters. His publications encompass areas such diverse topics as anti-cancer drugs, gels for wound repair, cell therapy, and regenerative medicine, insect and pest control agents, cholesterol-lowering agents, lipids and cell signaling tools, and anti-inflammatory agents.