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Pharmaceutical Medicine Expert Witnesses

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Matthew Lee
MD, RPh, MS
5700 Old Richmond Ave.
Suite A-5
Richmond VA 23226
USA
phone: 804-358-1492
fax: 804-358-1491
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Dr. Matthew Lee 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:
  • Criminal and Civil Cases
  • Anaphylactic Reactions
  • Overdosel
  • Wrongful Death
  • Cardiac Arrest
  • Respiratory Arrest
  • Fentanyl Overdose
  • Dilaudid Overdose
  • Pharmacist Mis-Fills
  • Pharmacist Dispensing Errors
  • Pharmacy Standard of Care
  • Medication Adverse Effects
  • Falls Related to Medications (in and out of hospital)
  • Toxicology/Toxic Reactions
  • Medical Marijuana
  • Positive Drug Screens in the Workplace
  • Workplace Safety
  • Fit for Duty Testing
  • Dilaudid is a commonly used opioid narcotic analgesic in hospitals due to its potency and effectiveness in the management of acute pain. On occasion, patients may be administered too much Dilaudid resulting in an overdose.

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    Dr. Kenneth A. Stein
    M.D.
    14312 Aitken Hill Court
    Chesterfield MO 63017
    USA
    phone: 314-495-7009
    fax: 708-585-3348
    Dr. Kenneth A. Stein is an Assistant Clinical Professor at the St. Louis University Health Sciences Center, Department of Surgery/Emergency Medicine Division.He is also a critical care physician at St. Anthony's Medical Center in St. Louis, Missouri.

    Dr. Stein has lectured nationally on Pain Management, and Consults in the area of Pharmaceutical and Bio-Medical Product Development and Marketing.

    In litigation support Dr. Stein furnishes an unbiased opinion on medical malpractice and negligence cases, not guaranteeing a favorable outcome but providing an honest assessment.

    Expert Services Include:
    • Survey of case for merit
    • Medical Chart Review and Analysis
    • Preparation for Opposing Expert Deposition and Cross-Examination
    • Medical Literature Search
    • Expert Witness Testimony
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    Wayne H. Grant, Pharm D
    3655 Rawnsdale Road
    Shaker Heights Ohio 44122
    USA
    phone: 216-339-0183
    Wayne H. Grant, PharmD, is a Clinical Pharmacist with a hospice in Cleveland, Ohio and an adjunct clinical assistant professor with the University of Florida, Gainesville, Florida. As part of an 18 year career, Dr. Grant has an in-depth understanding of various sectors of pharmacy practice. Long-term care, institutional (prison), infusion and retail practice has strengthened the ability to decipher the medical management of patients transitioning through different health care settings.

    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. Dr. Grant 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:
    • Adverse Drug Reactions
    • Chronic Pain
    • Drugs and Narcotics
    • Geriatrics
    • Hospice / Palliative Care
    • Hospital Pharmacy
    • Infusion Pharmacy
  • Long Term Care
  • Medical-Legal Issues
  • Nursing Homes
  • Overdosages
  • Pain Management
  • Pharmaceutical Care
  • Pharmacology
  • View Dr. Grant's Consulting Profile.
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    Esam Z. Dajani, Ph.D., FACG
    Professor
    1549 RFD
    Long Grove IL 60047
    USA
    phone: 847-634-9586; 847-971-7555
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    Professor Esam Z. Dajani, Ph.D., FACG has over 30 years of experience in Pharmaceutical Research & Development with expertise in Clinical Pharmacology, Toxicology, Drug Development, Regulatory Affairs, Pharmaceutical Patents and Contract Research Organizations (CROs). He has directed worldwide clinical research at major pharmaceutical companies and led the research teams that discovered & developed misoprostol (Cytotec), a worldwide anti-ulcer drug. He has 260 publications, pharmaceutical patents and presentations. He is a licensed Pharmacist.

    Professor Dajani is currently the President of IDDC Corporation, a CRO. He holds Adjunct Professor of Medicine appointment at Loyola-Chicago. He is able to evaluate the causal relationships between exposure to drugs or chemicals and the subsequent pharmacological and toxicological actions induced by such exposure. He has the expertise to simplify complex scientific facts to help the jury and the court understand the medical facts of the case. Serving both Plaintiff and Defense attorneys. He has experience in malpractice, criminal cases, pharmaceutical patent litigations, product liability, forensic aspects of alcohol, drug intoxications and administrative cases. Professor Dajani reviews affidavits, depositions, courtroom testimony, medical records, pharmaceutical records and is available for depositions and trial testimony.

    Areas of Expertise:
    • Drug Injury Causation
    • Drug Patent Litigation
    • Pharmacy Malpractice
    • Drug-Related Medical Malpractice
    • Medication Error Event Reconstruction
    • Drug Product Liability - Warnings, Design, Formulation
    • Adverse Effects of Health, Beauty Products, Alcohol and Industrial Chemicals
    View Consulting Profile.
    2/20/2013 · Medical
    It is well established that the use of traditional nonsteroidal anti-inflammatory drugs (NSAIDs) increases the vulnerability of the gastrointestinal (GI) mucosa for the development of peptic lesions and serious ulcer complications. In addition, selective and traditional NSAIDs have also been associated with increased frequency of cardiovascular toxicity, especially in susceptible patients.

    12/14/2012 · Pharmaceuticals
    During the last twenty-five years, a remarkable revolution in the pathophysiology and treatment of gastric (GU) and duodenal (DU) ulcers has occurred. Effective therapies were developed not only to heal ulcers but also to cure most patients.

    Esam Z. Dajani, N.M. Agrawal
    A chapter in the book: NSAIDs - Mechanisms and Clinical Use. Eds. Lewis AJ, Furst D, Marcel Dekker, New York, PP 159-170, 1994.
    Esam Z. Dajani, H. Gallo-Torres
    Chapter in the book: Ulcer Disease: Investigation And Basis For Therapy. Eds. Szabo S, Swabb E, Marcel Dekker, New York, PP 459-485, 1991
    Esam Z. Dajani (ed.), Gabriele Bianchi Porro (ed.)
    Esam Z. Dajani, PhD, FACG
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    Kinsey Partners, LLC
    Sandra K.B. Kinsey, MBA, RPh
    17 Darian Drive
    Bentonville AR 72712
    USA
    phone: 479-381-6522
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    Sandra K.B. Kinsey, MBA, RPh, is a Pharmacist and dedicated Health Care Professional with over 25-years of progressive experience. She provides strategic direction and visionary leadership for high-profile organizations within both the public and private sectors.

    Ms. Kinsey possesses a unique blend of business acumen, clinical expertise, merchandising, operations, teamwork, and corporate experience to establish and deliver exceptional results in a highly-complex and constantly changing environment.

    Background Experience - Ms. Kinsey spent 17 years as Vice President of Merchandising for at Wal-Mart Stores, Inc. With expertise in areas such as pharmacy operations, manufacturing, supply chain, P&L management, and supplier relations, she developed divisional strategies and executed a business model in an integrated network that successfully increased traffic into the stores from multiple marketing segments, exceeding the national growth averages, and delivering more than $15 billion in revenues.

    Ms. Kinsey currently manages a Retail Pharmacy consulting business working with Fortune 500 companies to provide strategic thought leadership, accelerate business development, improve process execution, and enhance relationships in order to grow revenues and improve profitability.

    Litigation Support - During her tenure at Walmart, Sandra Kinsey served as a corporate witness in several pharmacy cases. Recently, she has been retained by two different law firms in the last year to provide expert testimony on both Rx and OTC litigation. Her efforts were highly regarded and the contracts extended to new clients.

    Ms. Kinsey's expertise is available to counsel representing both Plaintiff and Defendant. Her expert guidance is well positioned and communicated, using visual presentations when necessary. She is well-spoken and presents well to both judge and jury.

    Areas of Expertise:
    • Pharmacy Operations
    • Retail Pharmacy
    • Pharmacy Merchandising
    • Specialty Pharmacy
    • Mail Order
    • Central Fulfillment Centers
    • Over the Counter Medications
  • Third Party Payers
  • Legal Compliance
  • Clinical Compliance
  • Quality Assurance / Control
  • Supply Chain
  • Pricing
  • Cost Control / Containment
  • View Sandy Kinsey's Consulting Profile.
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    Alan Schwartz
    Executive VP
    55 Northern Blvd.
    Great Neck NY 11021
    USA
    phone: 516-482-9001
    fax: 516-482-0186
    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)
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    Paul Abato Consulting
    Paul Abato, PhD
    Services Provided Nationally
    Providence RI USA
    phone: 401-487-6594
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    Litigation Support - Most recently, Dr. Abato's services have been retained by Mylan, where he wrote opening and reply expert reports, was deposed by Pfizer's counsel and was involved with federal pre-trial preparation until parties settled.

    Paul Abato, PhD, is a Medicinal Chemist with 11 years of industrial experience at Paratek Pharmaceuticals in the discovery and development of novel human therapeutics in the areas of anti-infective, anti-inflammatory, and neurodegenerative diseases.

    Dr. Abato has been involved in all aspects of drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics) testing, dosing routs, formulation, and the management of CROs to support pre-clinical testing. He has contributed significantly to the development of an antibacterial clinical candidate (Omadacycline) currently in Phase III clinical trials and the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis, and Spinal Muscular Atrophy. In 2013, Dr. Abato co-authored a pre-IND proposal that received a favorable review by the FDA.

    Areas of Expertise:
    • Pharmacology Science
    • Drug Research and Analysis
    • Drug Formulation Development
    • Drugs & Pharmaceutical Testing
    • Drug Effects / Reactions
    • Synthesis / Purification
  • In-vitro /In-vivo (efficacy and pharmacokinetics)
  • Dosing Routs
  • Drug Delivery
  • Drug Dogs
  • Nuclear Magnetic Resonance Patent Infringement
  • Hatch-Waxman ANDA Patent Infringement
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    Harry C. Boghigian
    23850 Via Italia Circle 406
    Bonita Springs FL 34134
    USA
    phone: 973-476-6591
    Harry-Boghigian-Pharmaceutical-Marketing-Expert-Photo.jpg
    Harry C. Boghigian is a Pharmaceutical Executive with over 40 years of industry experience both domestically and internationally. His experience ranges from sales through the ranks into numerous senior positions of responsibility both in the US and abroad.

    Mr. Boghigian's focus and expertise is in:
    • Pharmaceutical Marketing
    • Business Development
    • Product Portfolio Management
    • Product Commercial Viability
    • Product Life Cycle Management
    In 2002, Mr. Boghigian retired from Big Pharma and founded Pharma Consultants LLC, a consulting company catering to entrepreneurs and small start-up companies. He has introduced two over the counter products into the childcare market.

    Litigation Support - Harry Boghigian has a 10 year history of providing testimony in Hatch-Waxman Cases as well as in claims involving Contract Breaches and Marketing Violations. He has worked with some of the country’s best known law firms from coast to coast in providing research, technical advice, research and opening and rebuttal reports on subject matters ranging from commercial success to unmet medical need. Mr. Boghigian has represented both plaintiffs and defendants in not only United States Federal Courts but also Canada and the United Kingdom.

    Patent Litigation Service:
    • Therapeutic Area Analysis
    • Competitive Product Analysis
    • Managed Care Impact on Commercial Success
    • Accessing Data from Industry Sources
    • Expert Reports, Depositions, and Trial Testimony
    • Declarations on Irreparable Harm
    • Opinions on Hatch-Waxman Patent Cases
    • Portfolio Analysis
    • Marketing and Sales Analysis
    • Opinions on Unmet Medical Need from a Business Perspective
    View Mr. Boghigian's Consulting Profile.
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    1500 Walnut St.
    Ste. 902
    Philadelphia PA 19102
    USA
    phone: 215-731-1901
    fax: 215-731-9503
    Richard-Sobel-Psychiatry-Pain-Medicine-Expert-Photo.jpg
    Richard M. Sobel, MD, DFAPA, has over 30 years of experience practicing Adult Psychiatry and Pain Management / Medicine. His specialty focus is in Pain Medicine, for which he has sub-specialty board certification, Psychotherapy, and Psychopharmacology.

    Dr. Sobel is currently a Clinical Assistant Professor in the Department of Psychiatry at Jefferson Medical School. A Distinguished Fellow of the American Psychiatric Association, Dr. Sobel is immediate Past President and continues to serve on the board of the Greater Philadelphia Pain Society, one of six regional chapters of the American Pain Society. He is a Councilor for the Philadelphia Psychiatric Society and Representative of the Pennsylvania Psychiatry Society to the Safe and Effective Prescribing Practices and Pain Management Work Group of the Pennsylvania Department of Drug and Alcohol Programs.

    In 2014, Dr. Sobel was the recipient of the Dean's Award for Excellence in Education at Jefferson Medical College and, in 2013, was nominated Practitioner of the Year by the Philadelphia Psychiatric Society.

    Litigation Support - Dr. Sobel offers expert witness services to counsel representing both plaintiff and defendant. With voice training for public speaking, he is able to effectively communicate with judge and jury. Dr. Sobel's services include Independent Medical Exams (IMEs), medical record review, utilization review, written reports, depositions, and trial testimony as needed.

    Areas of Expertise:
    • Psychopharmacology
    • Worker's Compensation
    • Post Traumatic Stress Disorder (PTSD)
    • Sleep Disorders
    • Depression
    • Anxiety
  • Complex Regional Pain Syndrome
  • Neuropathic Pain
  • Trauma
  • Opioids
  • Addiction
  • Pain Medication
  • View Dr. Sobel's Consulting Profile.
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    The Reading Medical Group- Laureldale
    William Santoro
    MD
    3212 Kutztown Road
    Laureldale PA 19605
    USA
    phone: 610-929-3380
    fax: 610-685-9290
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    Dr. William Santoro, MD is Board Certified in Family Medicine and Addiction Medicine. In addition to being the Medical Director at the Reading Hospital & Medical Center detoxification and rehabilitation program, Dr. Santoro is also the Medical Director for New Directions, Methadone Treatment center where he is responsible for all admission physical examinations and for prescribing methadone to approximately 950 opiate dependant patients.

    Dr. Santoro is the Addictionist on staff at The Reading Hospital & Medical Center in the Department of Psychiatry. He is consulted by the hospitalists to care for patients admitted to the hospital with addiction complicating their condition. Dr. Santoro runs a private Suboxone Outpatient Center treating up to 100 patients with Suboxone maintenance.

    With a special interest in Sports Medicine in 2001, he served as a volunteer physician for the U.S. Olympic Training Team in Lake Placid, New York.

    Dr. Santoro has been deposed approximately 6 times in the past several years. He has testified in two cases, one on behalf of the Plaintiff and the other for the defense.

    Areas of Expertise:
    • Methadone Treatment
    • Suboxone Treatment
    • Dual Diagnosis Pain / Addiction
    View Dr. Santoro's Consulting Profile.
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    Washington State University
    Tracy L. Skaer, PharmD, FC, FABFE, FASHP, FASCP
    College of Pharmacy
    HSB Suite 210 PO Box 1495
    Spokane WA 99210-1495
    USA
    phone: 509-358-7724
    fax: 509-358-7744
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    Tracy L. Skaer, PharmD, FABFE, FASHP, FASCP is a Certified Forensic Consultant and Professor of Pharmacotherapy with over 30 years of pharmaceutical experience; 10 years as an expert witness.

    Dr. Skaer is a Fellow of the American Board of Forensic Examiners Institute, the highest honor ACFEI can bestow upon a member that is reserved for those with outstanding achievements and excellence. She is also 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, comorbid 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 and include record review, written reports, deposition, and trial testimony. Dr. Skaer's cases involve:
    • Chronic Pain
    • Narcotic Use
    • Opioid Pill Mills
    • Illicit Substance Abuse
    • Opioid Overdose
    • Wrongful Death
  • Urine Drug Testing
  • Medication-Related Suicide
  • Medication Reactions and Interactions
  • FDA Controlled Substances Act
  • Opioid Prescribing
  • Opioid Dispensing Regulations
  • View Dr. Skaer's Consulting Profile.