Publications – Dr James T O'Donnell & Dr James J O'Donnell

Legal brief addressing a ‘Not Guilty’ by reason of insanity in which psychiatric drug non-compliance was a factor

Compliance, or now more recently called adherence, is a topic well known to clinicians. Lack of taking medications results in the loss of any beneficial effects of any type of chronic (or even acute) drug therapy.

The topic was addressed in a recent murder trial in Cook County (Chicago, IL). For those of you who are health care professionals, this may interest you. For the lawyers, and do criminal (and possibly) civil law, the topic of compliance and adherence may be addressed in a variety of cases, not just murder cases.

Cannabis and Dentistry

Pharmaconsultant Partner, James J. O’Donnell PhD recently presented a seminar to the Lake County (IL) Dental (Society) on the topic of Marijuana: Considerations in Dental Practice. The PPT presentation provides a thorough review of marijuana pharmacology and toxicology information in general, and specific information relevant to Dentists. Anyone litigating (or using) marijuana may find this information useful and interesting. (PDF, 55 Slides)

Marijuana Toxicology Presentation

Marijuana usage is ubiquitous and growing, but not without consequences. Whatever your practice, marijuana may be involved. View the presentation delivered at PACDL DUI & Motor

Contrast Media Toxicity Case Reports

We have been consulted in numerous interesting cases that demonstrate that even drugs deemed generally safe for use can show serious side effects if certain factors go wrong.

If the drug dosing is incorrect, if the drug is not administered properly, if too much drug is given (overdose),

The Opioid Crisis and What Has Been Learned

The Opioid Epidemic dominated the news for several years; Covid 19 virus pandemic has quieted the news but not the epidemic. We published a short article on the history and lessons learned for your information. Pharmaconsultant experts have consulted and testified extensively in opiate toxicity cases.

Beyond Medical Cannabis: Considerations for Updates to Hospital Policies and Procedures

Cannabis (marijuana) is classified as a schedule-I controlled substance, currently not accepted for medical use and with a high potential for abuse. As stated in a previous P&T article, although marijuana remains illegal at the federal level, 33 states have legalized its medical use for certain indications and 10 have legalized its recreational use.

Among those states are differing laws that regulate the possession or supply of usable marijuana, with certain states providing more flexibility than others when it comes to using medical marijuana.

Regulatory and Legislative Disparities With Cannabis Present Challenges to P&T Committees and Health Care Providers

Over the past several years, the legal status of cannabis has been determined by regulatory changes affecting its use, as well as the use of cannabidiol (CBD). Prior to 2018, CBD, along with all forms of marijuana, was considered a Schedule I controlled substance (CI), indicating that these drugs had no medical use and presented a high potential for abuse. On June 25, 2018, the Food and Drug Administration (FDA) approved Epidiolex (cannabidiol) for the treatment of Lennox-Gastaut and Dravet syndromes. Upon approval, …

Use of Regulations, Laws, Standards, and Best Practices When Prosecuting and Defending Hospitals in Drug Injury Lawsuits

During their professional training, health care practitioners take courses in medical law and regulation. And today, many states require practitioners, particularly high-risk professionals like physicians, to take some form of continuing education for risk management, to reduce the possibility of an error leading to a lawsuit.

Also, such education is often necessary for purposes of renewing state licenses or registration. Risk in this context refers to the legal liability or malpractice cases that may be brought by a patient or family member against the practitioner (physician, nurse, pharmacist, etc.) along with the entity (for example, the hospital) that employs the practitioner. Frequently, this includes a lawsuit against many practitioners as well as the entity

Forensic Analysis in Drug Litigation Finds Most Errors Occur with Commonly Used Therapies and Practices

In previous columns, we have explored various ways in which the historical basis for pharmacy and therapeutics (P&T) committees’ accreditation requirements and litigation matters have driven the need for sound P&T committees within health care entities. The importance of rational drug-use policy was covered in this column in 20172 and the topic has gained additional exposure as a result of recent Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) initiatives. FDA Commissioner Scott Gottlieb accelerated

Marijuana in Injury Litigation: The New Alcohol

Medical Marijuana is legal in at least 2 dozen states and the approved indications are increasing. Recreational marijuana is legal in only a few, but more are to follow. Even without legal status, marijuana use is widespread, and with legalization, use will increase.

As forensic consultants, we have consulted on marijuana matters in a wide variety of civil and criminal matters, similar to our consultations in alcohol. Legal or not, if an event occurs, or a person is injured and marijuana use is suggested or detected, part of the focus will be on marijuana.

The attached lecture PPT addresses this matter and provides some case examples that may be useful or interesting.

Forensic analysis of adverse drug events and litigation claims in ob/gyn

Injury is a risk/complication of any drug therapy, and more damaging to the patient and the caregiver if the drug was selected, administered, dispensed, or monitored negligently, contributing greatly to the injury. Obstetrical patients are at even greater risk, given the little known teratologic and embryo-fetal toxicity of drugs given during pregnancy and the perinatal period.

The facts and outcomes of the following Obstetric litigation cases will be presented and discussed:

Fatal electrolyte disturbance in hyperemesis gravidum

Pharmacy & Therapeutics Article $20 Million Verdict in Drug interaction case

People v. Corlett – Drug Impaired driving conviction reversed – Issue of laboratory test integrity

Selected Opiates Toxicity – A Modern Day Epidemic

Learning Objectives:
1. Identify the names and reasons/circumstances for additional toxicity of SELECTED OPIATES

Hydromorphone DILAUDID
Methadone
Fentanyl/DURAGESIC
Criteria for these selected opiates
2. Identify and discuss

education,
potency,
tolerance,
safety,
kinetics,
dosing
Opiates Toxicity Workshop-12-2013 (PDF of presentation)

Forensic Pharmacist Report in a Coumadin Death Case

THIS ARTICLE. AS part of the Forensic Pharmacist issue, presents a series of reports of opinions, case summary, citations to standards of practice, and pharmacy rules and regulations, as applied and utilized in a forensic evaluation by this author in a death caused hy a Coumadin dispensing error; Cogentin had been prescribed. An interesting part of the case was the deception by the defendant pharmacist, who denied knowledge of the error when the death was investigated by the hospital treating the patient as well as by the Board of Pharmacy investigators.

The case is made interesting further because, in Pennsylvania, the state in which the error occurred and the suit was brought, experts must express complete reports, and depositions of experts are, by custom, not taken. All of the experts’ opinions must be fully expressed in reports, or they will be precluded in trial. Because Coumadin errors are the mosr frequent cause of lawsuits against pharmacists …

Alcohol: Gastrointestinal and Other Toxicities

This article will focus on the two areas of alcohol injury: first, the gastrointestinal system, primarily liver toxicity and cirrhosis, and second, the human toll in injury, examining injury epidemiology information that estimates alcohol’s involvement in trauma. Any pharmacist consulting in any capacity, especially related to gastrointestinal disorders, will need to understand the significant sociological, pathological, pharmacological, and psychological impact of alcohol.

Pharmacists providing care, including dispensing many different drugs to patients, should be cognizant of the interacting effects of alcohol and the need to warn patients. Finally, the reader will Jearn of a case in which a pharmacist was sued for not warning about the use of alcohol with a central nervous system depressant, and the resultant litigation after that lawsuit.

Forensic Drug Testing and Drug Testing in the Workplace

xcerpted Chapters from Drug Injury: Liability, Analysis and Prevention – Chapter 43 – Forensic Drug Testing — Chapter 44 – Drug Testing in the Workplace (PDF – Full chapters)

43.1 Introduction
Review of this chapter will assist counsel in understanding
the tests, in communicating with their own experts, and also
in cross-examining opposing experts.

In order for a scientist, toxicologist, pharmacologist,
pharmacist, or pathologist to correlate drug action or effects
with the drug found in the body, the concentration found in
the body must be sufficient to cause the adverse reaction or
be beyond the expected therapeutic dose. In addition, the
type of specimen collected must

Policies and Procedures – Enhancing Pharmacy Practice and Limiting Risk

Let’s face it—health care settings, including pharmacies, can be legal land mines because patients and the public can and do get hurt. As a policy-recommending body to the medical and administrative staff in health care organizations, P&T committees have a primary
role of maintaining a limited list (formulary) of medications approved for use that meet the needs of clinicians and their patients as well as those of the organization. 1 Because most members of P&T committees are not pharmacists, a primer on policies and procedures (P&Ps), including an emphasis on their importance for pharmacists, may be helpful for P&T
committees in executing their duties.

Drug Shortages Pose Problems for P&T Committees in Accountable Care Organizations

For more than a decade, drug short¬ages have made headlines. Shortages also have forced P&T committees in many hospitals and health care delivery organizations to make contingency plans for providing safe and effective therapies when conventional and preferred drugs are not available. An article published in P&T in 2011 described several concerns associated with drug shortages and substitutions, including safety risks, cost implications, and the domino effect that shortages can have when the inability to acquire one agent leads to unexpected demand for another.

The passage of health care reform legislation

Preface to “Drug Injury, Liability, Analysis and Prevention. Third Edition.”

Drug Injury, Liability, Analysis, and Prevention, Third Edition (2012) was designed to serve as a reference for attorneys, pharmacists, physicians, risk managers, nurses, drug manufacturers, and regulators—as well as anyone with any interest in drug use and drug injury. It summarizes the FDA’s responsibility in monitoring dr ug development and safety. It reviews current drug-product-related liability issues that focus on the manufacturer’s role in providing for drug safety. The book identifies important roles that pharmacists play in enhancing medication safety and effectiveness, and demonstrates what can happen when pharmacists and other practitioners and healthcare institutions do not perform adequately. By focusing on the most dangerous drugs, the reader can learn from the tragedies and mistakes of others, look at their own practice settings, and avoid making similar mistakes.

Transitions of Care. Pitfalls and Recommendations

Transitions of CareBy James O’Donnell, PharmD, MS; and F. Randy Vogenberg, RPh, PhD.P&T 2012;37(12):679-682.Discusses the risk of prescription transcription errors resulting from the transition of patients

Dr James T O'Donnell & Dr James J O'Donnell

Pharmaconsultant Inc.