Drug Injury—Liability, Analysis and Prevention Second edition James T. O'Donnell,  Pharm.D., MS 1000 pages, 8.5" x 11", casebound 2005, Lawyers and Judges Price: $149.00 Quantity: Questions about shipping?

Contributors: Patricia W. Iyer, Lloyd V. Allen, Jr., Peter D. Anderson, Henry Cohen, S.A. Edwards, Ronald W. Gottrich, Justina A. Molzon, Tzarina Middlekoop, Jadwiga Najib, Lori A. Nesbitt, John M. Restaino, Linda S. Robinson, Dori Stehlin, F. Randy Vogenberg, Steven Zlotnick, Anne D. ImOberstig, Roger S. Klotz, John Salemi, Gopi Ahuja, Antonia Alafris, Ramune Barkus, Rainey Booth, Laura Carpenter, David Clark, I. Larry Cohen, Victor Cohen, Kathleen Dahle, Armand Derian, Constantine Falliers, Joel Kauffman, William Kelly, Delbert Konnor, Charles Kozak, John Lehmann, Zoe Littlepage, Donald Marks, Dennis Miller, Roger Morris, James Morris, Francis Muno, Kip Petroff, Domenic Sica, Ed Sweeney, Saifi Vohra, James Walters

Table of Contents

Essential for the attorney in understanding forensic drug cases

If you have an involvement with the health care system, you know that drug-induced injury cases are as complex as they are common. While the injury to the patient might seem obvious, in reality that has very little effect on the course that the litigation will take. This makes it especially important to accurately evaluate the case. You'll want to be sure that the case you take on has merit and will prove economically sound for both you and your client. To successfully accomplish this, you need the knowledge of pharmacy and the drug manufacturing industry that the authors have carefully detailed in this book.

Easy for the nonmedical professional to follow, the book is divided into three useful sections. The first section deals with the pharmaceutical process, covering the liability of pharmaceutical companies, warning labels and clinical trials. The second section examines high-risk drug therapies that result in pharmaceutical litigation. You'll read about important litigation regarding drugs like Prozac, Accutane and Rezulin, as well as anabolic steroids, insulin and oral diabetic drugs, and more. Whether or not your case involves the drug cited you'll find that the theories applicable to one pharmaceutical case are often applicable to another. The third section of the book looks at the professional pharmacist and malpractice claims. It also includes appendices of FDA regulations relating to drug product liability, guidance for industry, use of risk minimization plans, and FDA pregnancy classifications.

You'll find this text indispensable because it provides comprehensive information for all those affiliated with the pharmaceutical industry.

New chapters:
• The failed system of drug warnings in America
• Clinical research: Testing treatments in humans
• FDA regulation of clinical investigations
• Identification of regulated solid dosage forms
• Evaluation of Causation in drug injury cases
• The role of pharmacoepidemiology and expert testimony in drug injury
• E-ferol disaster
• Drugs for asthma, allergies and anaphylaxis: Harm from use, misuse and non-use
• Nephrotoxic drugs
• Statins and Baycol-Questionable cholesterol
• The Rezulin litigation
• Drug-induced movement disorders
• Ephedra
• The emergency department pharmacist
• Drug testing in the workplace

Reviews for the first edition:

"Investigators love having one volume that answers all of their questions on a particular subject. It saves time, makes us look really smart, and usually leads us to an expert witness for the case at hand. Drug Injury does all this, and more.... A professional investigation office must have a good library of reference materials, and that library must contain this new book!" -Cluesonline

"O'Donnell...presents 28 contributions of value for any professional affiliated with the pharmaceutical industry who has to take a case to trial." -SciTech Book News

"Drug Injury is an excellent resource for those involved in product liability suits. This book is a must read for health care professionals who recommend, prescribe, counsel, and administer drug products...." Victor Cohen, Journal of Pharmacy Practice

"Essential reading for lawyers and forensic physicians . . . Fully recommended reading!" Anil Aggrawal’s Internet Journal of Forensic Medicine and Toxicology

Table of Contents

Related products:

Drug and Medical Device Product Liability Deskbook

The Forensic Evaluation of Traumatic Brain Injury

Legal Nurse Consultant's Handbook

Medical Legal Aspects of Alcohol

Medication Errors DVD or Videotape

Nursing Home Liability DVD/Videotape

Nursing Malpractice

Preparation and Trial of Medical Malpractice Cases

Product Liability

Product Liability: Winning Strategies and Techniques

Structured Settlements and Periodic Payment Judgments

Table of Contents

Detailed Table of Contents

Drug Injury: Liability, Analysis and Prevention
James T. O'Donnell, Pharm.D., M.S., D.A.B.C.P, F.A.C.N, C.N.S.

Part I: The Pharmaceutical Process
Chapter 1: The FDA and the Drug-Approval Process
Edited by Justina A. Molzon, M.S. Pharm., J.D.

Chapter 2: The Dietary Supplement and Health Education Act of 1994 (DSHEA) and Related FDA Activities
Justina A. Molzon, M.S. Pharm., J.D.

Chapter 3: The Pharmaceutical Industry
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 4: The Failed System of Drug Warnings in America
Kip A. Petroff, Esq.

Chapter 5: Clinical Research: Testing Treatments in Humans
Lori A. Nesbitt, Pharm.D., MBA and Karen L. Pellegrin, Ph.D., MBA

Chapter 6: FDA Compliance and Inspection Programs Governing Clinical Investigations
James P. Walters, J.D., M.S.

Chapter 7: The Protection of Subjects in Clinical Research
Gopi Doctor Ahuja, MPH and David C. Clark, Ph.D.

Chapter 8: Identification of Regulated Solid-Dosage Forms
Francis J. Muno, Jr., B.S. Pharm., R.Ph., MBA

Part II: High-Risk Drug Therapies Resulting in Injury and Litigation
Chapter 9: Adverse Drug Reactions: The Extent of the Problem
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 10: Evaluation of Medical Causation
Donald H. Marks, M.D., Ph.D.

Chapter 11: The Role of Pharmacoepidemiology and Expert Testimony
William N. Kelly, Pharm.D., FISPE

Chapter 12: Medications Errors and Adverse Drug Reactions in Hospitalized Patients: How Common are They, and Why do They Occur?
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph., Larry Cohen, M.D., FCCP and Patricia Iyer, M.S.N., RN, LNCC

Chapter 13: Medical-Legal Aspects of Medication Errors
Patricia Iyer, M.S.N, RN, LNCC, I. Larry Cohen, M.D., FCCP and James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 14: Preventing Medication Errors
I. Larry Cohen, M.D., FCCP, Patricia Iyer, M.S.N, RN, LNCC and James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 15: Pharmacists' Errors
Dennis Miller, B.S. Pharm.

Chapter 16: Danger at the Drugstore: Some Practical Comments on Pondimin and Redux Litigation
Kip Petroff, Esq. and James A. Morris, Jr., J.D.

Chapter 17: Diet-Pill Litigation: The Fen-Phen-Redux Debacle: A Medical-Legal Perspective
John M. Restaino, D.P.M., J.D.

Chapter 18: Diet Drugs: Pharmacology/Interactions/Cautions
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 19: The Story of E-Ferol: Adding Insult to Injury
Kathleen M. Dahle, RN, B.S.N.

Chapter 20: Accutane: Focus on Psychiatric Toxicity and Suicide
Donald H. Marks, M.D., Ph.D. and Tzarina Middlekoop, Ph.D.

Chapter 21: Antidepressants: Clinical Use and Litigation
Henry Cohen, B.S., M.S., Pharm.D., BCPP, CGP and Antonia Alafris, B.S., Pharm.D., CGP

Chapter 22: Drugs for Asthma, Allergies, and Anaphylaxis: Harm from Use, Misuse, and Non-Use
Constantine John Falliers, M.D.

Chapter 23: Corticosteroids
James T. O'Donnell, Pharm.D., M.S.,FCP, ABCP, FACN, CNS, R.Ph., and Linda S. Robinson, Esq.

Chapter 24: Adverse Effects of Diabetic Drugs
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 25: Nephrotoxic Drugs
Domenic A. Sica, M.D. and Todd W.B. Gehr, M.D.

Chapter 26: Drug-Induced Hepatotoxicity
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 27: Statins Including Baycol: Questionable Cholesterol Control
John Lehmann, Ph.D. and Joel M. Kauffman, Ph.D.

Chapter 28: The Rezulin Litigation
Zoe Littlepage, J.D. and Rainey C. Booth, J.D.

Chapter 29: Drug-Induced Movement Disorders
Jadwiga S. Najib, Pharm.D., B.S.

Chapter 30: Pain Medications and OxyContin
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 31: Performance-Enhancing Substances: Ephedrine, Anabolic Steroids, Herbals and Dietary Supplements
John Salemi, B.S. and James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 32: Ephedra
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 33: Recreational Drugs: Alcohol, Cocaine and Marijuana: Forensic Issues
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 34: Hemophilia Holocaust Litigation Related to Blood Factor VIII and IX Products and AIDS Transmission
Charles R. Kozak, J.D.

Part III: Pharmacists, Pharmacy, and Pharmacy Practice
Chapter 35: Regulation of Pharmacy Practice
Ronald W. Gottrich, R.Ph., M.S.

Chapter 36: Pharmacist Malpractice and the Infamous Courtney Case
James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 37: Guidelines for Injectable Medications: 2004
Saifi Vohra, Pharm.D., R.Ph., MBA, FASHP, FASCP

Chapter 38: Specialized Services: A Full-Service Community Pharmacy Practice: Is this Feasible, Beneficial, and Risk-Free?
Roger S. Klotz, R.Ph., BCNSP, FASCP, FACA, CDM

Chapter 39: Nursing Home Pharmacy: Pharmacology and the Elderly
Steven Zlotnick, Pharm.D., CCP, FASCP

Chapter 40: The Emergency Department Pharmacist
Victor Cohen, B.S., Pharm. D., BCPS

Chapter 41: Pharmacy Compounding Regulations
Lloyd V. Allen, Jr., B.S., M.S., Ph.D.

Chapter 42: The Forensic Pharmacist
Peter D. Anderson, Pharm.D., BCPP, FASCP and James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 43: Forensic Drug Testing
Anne D. ImOberstig, M.S., J.D., MBA, B.A.

Chapter 44: Drug Testing in the Workplace
Anne D. ImOberstig, M.S., J.D., MBA, B.A.

Chapter 45: Managed Care in Pharmacy and the Pharmaceutical Industry
F. Randy Vogenberg, R.Ph., Ph.D.

Chapter 46: The Evolution of Pharmacy-Benefits Managers (PBMs): An Overview
Delbert D. Konnor, Pharm.B.S., Pharm.M.S.

Chapter 47: The NABP Model Act and Rules Initiative toward Pharmacy Technicians
Ed Sweeney, Esq. and James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.

Chapter 48: Physician and Hospital Liability in Drug and Medical-Device Litigation
Ramune E. Barkus, Esq., J.D., B.A. and Armen Derian, J.D.

Appendices on CD-ROM

Detailed Table of Contents