Drug Injury: Liability, Analysis and Prevention

drug injuryThird edition

James T. O’Donnell,
Pharm.D., MS

1000 pages, 8.5″ x 11″, casebound
2012, Lawyers and Judges

Price: $149.00



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Essential for the attorney in understanding forensic drug cases

If you are involved with the healthcare system as a practitioner or attorney, you know that cases involving drug-induced injury 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.

Whether prosecuting or defending, you will want to be sure that the case has merit or can be successfully defended. To accomplish this, you need the knowledge of the drug development, regulation, pharmacists practice, and which drugs cause the most injuries. This is all carefully detailed in this new third edition by a medley of well-accomplished authors.

Easy for the non-medical professional to follow, the book is divided into four useful sections. Part I deals with the pharmaceutical process, covering the liability of pharmaceutical companies, warning labels and clinical trials. Part II examines high-risk drug therapies that result in pharmaceutical litigation. You’ll read about important litigation regarding drugs like opiates and pain medications, anticoagulants, steroids, insulin and oral diabetic drugs, as well as allergic reactions, and liver/kidney injuries caused by drugs. 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. Part III looks at the professional pharmacist and malpractice claims. Finally, Part IV covers forensic and toxicological issues, particularly recreational drugs, drug testing, and pain equipotency.

You’ll find this text indispensable for the comprehensive information it provides for all those affiliated with the use of drugs in healthcare, in the community, and in the pharmaceutical industry.

New chapters:

  • The Pharmaceutical Revolution: Drug Discovery and Development
  • Counterfeit Drugs
  • General Principles of Pharmacology
  • Search and Analysis of the Food and Drug Administration’s Adverse Event Reporting System
  • Liability, Litigation, and Lessons in New Drug Development
  • Anticoagulants: Therapeutics, Risks, and Toxicity-Special Focus on Heparin-Induced Thrombocytopenia Dangers of Opioids
  • Acute Adverse Drug Events in Critical Care: Emergency Department and Intensive Care Units
  • HIV Pharmacotherapy and Its Complications
  • Fetal Drug Exposure
  • Nonscientific Uses and Illegal Marketing of Drugs and Dietary Supplements
  • Regulation of Pharmacy Practice
  • Pharmacist Malpractice and Liability
  • After-Hours Pharmacy Services, Medication Use and Safety in U.S. Hospitals
  • Postmortem Redistribution and Interpretation of Drug Levels

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
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 Drug-Approval Process
by Justina A. Molzon, M.S. Pharm., J.D., and Mary E. Kremzner, Pharm.D.

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

Chapter 3: The Pharmaceutical Revolution: Drug Discovery and Development
by John C. Somberg, M.D.

Chapter 4: The Failed System of Drug Warnings in the United States
by Kip A. Petroff, Esq.

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

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

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

Chapter 8: Identification of Regulated Solid-Dosage Forms

by Francis J. Muno, Jr., B.S., Pharm., R.Ph., MBA

Chapter 9: Counterfeit Drugs
by Kimberly O’Donnell, MBA

Chapter 10: General Principles of Pharmacology
by James J. O’Donnell III, M.S., Ph.D., James T. O’Donnell, Pharm.D., MS, FCP, and Vanessa M. Vullmahn M.S.

Chapter 11: Important Code of Federal Regulations Applicable to Drug Product Liability Suits Compiled by S. Albert Edwards, Pharm.D., RAC, FRAPS

Chapter 12: Search and Analysis of the Food and Drug Administration’s Adverse Event Reporting System
by Paul N. Danese, Ph.D.

Chapter 13: Liability, Litigation, and Lessons in New Drug Development
by James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Part II: High Risk Drug Therapies Resulting in Injury and Litigation

Chapter 14: Adverse Drug Reactions: Focus on Drug Allergy
by James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Chapter 15: Evaluation of Medical Causation
by Donald H. Marks, M.D., Ph.D.

Chapter 16: The Role of Pharmacoepidemiology and Expert Testimony
by William N. Kelly, Pharm.D., FISPE

Chapter 17: Medication Errors
by James T. O’Donnell Pharm.D., M.S., FCP, ABCP, FACN, R.Ph., Patricia Iyer MSN, RN, LNCC, CLNI, and David Benjamin PhD, FCP, FCLM

Chapter 18: Physician and Hospital Liability in Drug and Medical-Device Litigation
by Ramune E. Barkus, Esq. and Armand Derian, Esq.

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

Chapter 20: Antidepressants: Clinical Use and Litigation
by Henry Cohen, B.S., M.S., Pharm.D., FCCM, BCPP, CGP and Antonia Alafris, B.S., Pharm.D., CGP

Chapter 21: Drugs for Asthma, Allergies, and Anaphylaxis: Harm from Use, Misuse, and Non-Use
by Constantine John Falliers, M.D.

Chapter 22: Adverse Effects of Diabetic Drugs
by Gourang Patel, B.S. Chem, Pharm.D., MSc, BCPS and James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Chapter 23: Nephrotoxic Drugs
by Domenic A. Sica, M.D. and Todd W.B. Gehr, M.D.

Chapter 24: DrugInduced Liver Disease
by Donald H. Marks, M.D., Ph.D. and James T. O’Donnell, Pharm.D., MS, FCP

Chapter 25: Anticoagulants: Therapeutics, Risks, and Toxicity—Special Focus on Heparin-Induced Thrombocytopenia
by James T. O’Donnell, Pharm.D., MS, FCP

Chapter 26: Drug-Induced Movement Disorders
by Jadwiga Najib, Pharm.D.

Chapter 27: Dangers of Opioids
by James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Chapter 28: Acute Adverse Drug Events in Critical Care: Emergency Department and Intensive Care Units
by Gourang Patel, B.S. Chem, Pharm.D., MSc, BCPS

Chapter 29: Hemophilia Holocaust Litigation Related to Blood Factor VIII and IX Products and AIDS Transmission
by Charles R. Kozak, J.D.

Chapter 30: HIV Pharmacotherapy and Its Complications
by Vincent Idemyor, Pharm.D.

Chapter 31: Fetal Drug Exposure
by Damani Parran, Ph.D., DABT

Chapter 32: Nonscientific Uses and Illegal Marketing of Drugs and Dietary Supplements

by Stephen Barrett, M.D. and Robert S. Baratz, M.D., DDS, Ph.D.

Part III: Pharmacists, Pharmacy and Pharmacy Practice

Chapter 33: Regulation of Pharmacy Practice
by Ned Milenkovich, Pharm.D., J.D.

Chapter 34: Pharmacy Case Law Update: October 2009 through October 2010
by Roger Morris, R.Ph., J.D. and William J. Stilling, R.Ph., M.S., J.D.

Chapter 35: Pharmacist Malpractice and Liability
by James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph. and David M. Benjamin, Ph.D., FCLM, FCP

Chapter 36: Specialized Services: A Full-Service Community Pharmacy Practice: Is this Feasible, Beneficial, and Risk-Free?
by Roger S. Klotz, R.Ph., BCNSP, FASCP, FACA, CDM

Chapter 37: Pharmacy Compounding Regulations

by Loyd V. Allen, Jr., B.S., M.S., Ph.D.

Chapter 38: After-Hours Pharmacy Services, Medication Use and Safety in U.S. Hospitals

by Christopher A. Keeys, B.S., Pharm.D., BCPS, RPh

Chapter 39: The Emergency Department Pharmacist
by Victor Cohen, B.S., Pharm.D. and Megan Musselman, B.S., Pharm.D.

Chapter 40: The NABP Model Act and Rules Initiative toward Pharmacy Technicians
by Ed Sweeney, Esq. and James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Part IV: Forensic and Toxicology Issues: Recreational Drugs, Drug Testing, and Pain Equipotency

Chapter 41: The Forensic Pharmacist
by Peter D. Anderson, Pharm.D. and James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Chapter 42: Forensic Drug Testing
by Anne D. ImObersteg, M.S., J.D., MBA, B.A., and James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Chapter 43: Drug Testing in the Workplace
by Anne D. ImObersteg, M.S., J.D., MBA, B.A., and James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Chapter 44: Forensic Issues in Recreational Drugs: Alcohol, Cocaine and Marijuana

by James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Chapter 45: Pain Equipotency
by James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.

Chapter 46: Postmortem Redistribution and Interpretation of Drug Levels

by Gourang Patel, B.S. Chem, Pharm.D., MSc, BCPS

Chapter 47: Guideline for Injectable Medications
by Saifi Vohra, Pharm.D., RPh, MBA, FASHP, FASCP

Chapter 48: Managed Care in Pharmacy and the Pharmaceutical Industry
by F. Randy Vogenberg, R.Ph., Ph.D. and Rita Marcoux, R.Ph., MBA

Appendices on CD-ROM

Detailed Table of Contents