Dr. Bruce M. Hasspieler is internationally-recognized with a background in Forensic, Medical and Environmental Toxicology. His endeavors include alcohol & drug testing, DUI/DWI, personal injury, product liability, addiction treatment, death investigations, environmental forensics, cancer and poisoning.

He is a fully accredited member of the Society of Toxicology and the International Society of Environmental Forensics, a former SAMHSA laboratory director for the transportation industry, formerly a toxicologist with the Ontario Centre of Forensic Sciences and has published numerous scientific articles.

Dr. Hasspieler's services include telephone consultation, affidavits and court testimony across North America.

Dr. William Manion is a Pathologist by training and triple board certified in Anatomic, Clinical and Forensic Pathology. Dr. Manion currently is an assistant Medical Examiner in NewJersey. Dr. Manion is also a licensed attorney in New Jersey and Pennsylvania. With his training and background he can quickly evaluate potential Medical Malpractice Cases, especially involving Delay in Diagnosis or Failure to Diagnose.

Dr. Manion reviews legal cases involving Toxic Tort Litigation, Drug Overdose, Pain and Suffering or matters of a Criminal Nature such as Homicide, Suicide and Accidental Death. Dr. Manion also has experience in Asbestos Litigation, Vioxx and Hormonal Drug Litigation. He can evaluate Dram Shop Cases involving Blood Alcohol Levels where it is claimed that defendants were served alcohol while exhibiting signs of Intoxication. He has a network of experts which he works with in Surgery, Internal Medicine, Infectious Diseases and other specialties. He also evaluates the merits or defensibility of cases.

Dr. Manion can provide Letters of Merit for Medical Malpractice Cases and he works with both plaintiff and defense attorneys. He can also provide Letters of Explanation as an Expert Witness as to why he believes that there is no particular Merit to a Potential Case.

Dr. Kenneth A. Stein is an Attending Staff Physician at St. Anthony's Medical Center, Department of Emergency Medicine and Critical Care, one of the busiest emergency departments in the State of Missouri with approximately 70,000 patient visits per year.

He is an Assistant Clinical Professor at the St. Louis University Health Sciences Center, Department of Surgery/Emergency Medicine Division. 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

Formulation of Case Strategy

Preparation for Opposing Expert Deposition and Cross-Examination

Medical Literature Search

Expert Witness Testimony

Michael H. Anisfeld has over 35 years experience with pharmaceutical and healthcare manufacturing companies in the US and overseas, working in all aspects of Production, Quality Control/Quality Assurance, Regulatory Affairs and Supply Chain Management He provides expert testimony relating to all aspects of compliance to Good Manufacturing Practices (GMPs) impacting the manufacture and testing of pharmaceuticals, biotechnology products, and Active Pharmaceutical Ingredients (APIs).

Mr. Anisfeld has provided articulate "expert" testimony in federal and state courts as well as in international courts/arbitrations on GMP and Supply Chain Management related cases. He has a thorough knowledge of FDA regulatory enforcement activities, and has worked with companies in trouble with FDA and other authorities to strategize quick and cost-effective recovery.

An active member of several key pharmaceutical industry professional groups (FIP, ISPE, PDA, RAPS, TOPRA) in the USA and Europe. Having served on their boards and management committees, he is very well known and respected in the industry and with regulatory agencies worldwide.

Mr. Anisfeld is a regular columnist on GMP-related matters for US and European professional journals, as well as being an author and a frequent lecturer on GMP topics.

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)

Consulting in Toxicology, Carcinogenesis, Pharmacology, and Pharmacy Standard of Care

Dr. Harry Milman is an international authority in Toxicology, Carcinogenesis (e.g., cancer causation), Pharmacology, and Pharmacy Standard of Care with over 40 years experience at the US National Cancer Institute of the National Institutes of Health, the US Environmental Protection Agency, the US Public Health Service, and as a Consulting Toxicologist. ToxNetwork.com is an internationally recognized consulting and expert witness practice serving law firms in the United States and abroad, including Australia. Dr. Milman, a Principal of the firm, assists prestigious law firms (Defense, Plaintiff; 50:50), chemical and pharmaceutical companies, trade associations, national and international organizations, and public relations firms with litigation support, pre-clinical toxicology testing and reporting, cancer and toxicology data evaluation, regulatory submissions (FDA, EPA), and communication of scientific information to lay-, semipprofessional and professional audience. Services provided in the areas of specialization include: Depositions; Jury Trial Testimony; Medical Records Review; Pre-Clinical Toxicology Support; Peer Review.

Issues Evaluated

Carcinogens

Pharmacology

Morphine, Cocaine, Opioids

Benzene

Lithium

Gadolinium

Lead

Trichloroethylene

Product Liability

Drug Overdoses

Medical Malpractice

Pharmacy Errors

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Dr. Michael J. McKenna, is a Toxicologist with over 30 years of experience in the Pharmaceutical and Biotechnology Product Development Industries. His experience extends to Research, Drug Development, Drug Safety, Commercialization, Executive Management and Consulting to companies and investment firms in the Life Sciences Sector.

Strategic Services Include:

Drug Development Strategic Planning

Product Portfolio Evaluations

Due Diligence Support for Product or Company Acquisition

FDA and EU Regulatory Strategy

Advice on Funding and Sponsored Research

Preclinical and Clinical Drug Safety Issue Management

Expert Witness Consulting

Operational Assistance:

Advice on R&D Operations, Structure and Performance

Preclinical and Clinical Product Development Plans

Evaluation and Selection of CRO's

Project Management

Regulatory Submissions and FDA / EMEA Meeting Preparation

Dr. John Budny provides competent opinions based on recognized and accepted medical knowledge to determine if prescriptions, over-the-counter medications, drugs of abuse, and bacterial infections or their treatments are the causes of adverse medical events. With a PhD in basic medical science and a 30-year career as a practicing toxicologist, Dr. Budny combines the science of toxicology with medical knowledge to fully understand all the ramifications of an adverse medical event caused by prescribing errors, faulty medications, or failure in the health care delivery process.

Successfully resolved complex medical issues involving pharmaceuticals and drugs:

Cardiovascular and cerebrovascular toxicology, pharmacology and physiology Drugs affecting the central nervous system Drug receptor agonist and antagonist pharmacology and toxicology Pharmacokinetics Dietary supplements, nutraceuticals and nutrition Opiates Bacterial infections: causes and consequences, including sepsis

Antibiotic, Analgesic and Anesthetic toxicology Over the counter (OTC) product toxicology Gastrointestinal physiology and pharmacology Ototoxicity Drugs of abuse Otic toxicology Animal and plant derived toxins

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Dr. Shannon John Johnson has over ten years of experience as a Licensed Pharmacist in the State of California. Dr. Johnson has experience in Clinical Pharmacy (inpatient acute care), Clinical Information Systems, Safe Medication Practice, Quality Improvement, and Project Management. He has advised and led projects on a number of start-up initiatives in healthcare and information systems marketplaces.

Dr. Johnson offers expert litigation consulting services in areas related to Pharmacy, Medical Legal, Regulatory, Technology Implementation / Strategy, and overall Healthcare Related Issues. He provides expert witness testimony for both Plaintiff and Defense.

Medical and Pharmacy Related Cases, include but are not limited to:

Drug Injury Causation

Pharmacy Standards of Practice

Pharmacy Malpractice

Drug-Related Medical Malpractice

Medication Error Event Reconstruction

Drug Product Liability

Drug-Related Civil Defense