The Drug Expert: A Practical Guide to the Impact of Drug Use in Legal Proceedings

By Craig W. Stevens

The Drug Expert: A Practical Guide to the Impact of Drug Use in Legal Proceedings targets academic and industry pharmacologists, pharmacology graduate students, and professionals and students of affiliated disciplines, such as pharmacy and toxicology. Users will find it to be an invaluable reference for those involved in the field. In addition, pharmacists and others who increasingly serve as expert witnesses and toxicologists will find an array of very useful information.

• Focuses on important topics for the consulting pharmacologist, including prescription, over-the-counter and illegal drugs and their effects on criminal and civil proceedings
• Details the “how-to aspects of being an expert witness in pharmacology by presenting real-life cases and effective tips and experiences
• Includes several appendices, such as a sample letter of engagement and fee schedule, a litigation report, a consulting invoice and valuable resources

• Language: English
• Publisher: Academic Press
• Release date: Jan 8, 2020
• ISBN: 9780128005828

Craig W. Stevens

Craig W. Stevens, Ph.D. is a professor of Pharmacology at Oklahoma State University and is co-author of Brenner and Stevens’ Pharmacology, a popular pharmacology textbook now in its 5th Edition. He also wrote and edited two books on G-protein coupled receptors entitled Methods for the Discovery and Characterization of G Protein-Coupled Receptors (Springer Protocols, 2011) and G Protein-Coupled Receptor Genetics: Research and Methods in the Post-Genomic Era (Springer Methods in Pharmacology and Toxicology, 2014). He has just finished working on a new book for the Science and Technology Pharmacology list called The Drug Expert: A Practical Guide to the Impact of Drug Use in Legal Proceedings which is a guide for pharmacologists aiming to be successful as drug litigation consultants and a helpful book for the lawyers that hire them. Dr. Stevens maintains a second career as an expert witness in Pharmacology (Drug Expert) and has consulted for lawyers on over 80 cases in both criminal and civil proceedings.

Book preview

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Chapter 1

What a Long Strange Trip It’s Been: Our drugged society

Drug Use by Americans—Drugs and Mental Illness—Drugs and Crimes Drug Effects on Brain and Behavior—Drug Use and the Legal System

We live in a drugged society. There are drugs all around us and inside us. In the last 40 years we’ve witnessed the meteoric rise of the medical-pharmaceutical complex. Drug companies made more drugs. Physicians prescribed more drugs. Patients took more drugs.¹ Witness the emergence of celebrity drugs; those drugs marketed so well and used by so many that they achieve widespread name recognition, like Lipitor®, Ambien®, and Viagra®.

The growth in the mass media marketing of prescription drugs began when the Food and Drug Administration (FDA) clarified its rules on drug advertising in 1997.² This government action gave the green light for Big Pharma to launch highly successful direct-to-consumer TV commercials and magazine ad campaigns. It is now commonplace for Viagra® or Cialis® commercials appear when families are gathered around the TV, giving rise to the unique juxtaposition of erectile dysfunction and grandma in the room. There is the veterinary drug market with numerous canine and feline versions of human-approved drugs.³ This includes many canine psychotherapeutic drugs, like antidepressants and antianxiety drugs, commonly called doggie downers. The picture comes to mind of an overmedicated American man walking an overmedicated dog, stopping a little too long at each fire hydrant.

This introductory chapter will present recent data on overall drug use in America, drugs and mental illness, the linkage between drugs and crime, and the effects of drugs on brain and behavior. The chapter ends with an overview of the pharmacolegal issues of drug use and an introduction to the increasing role of the drug expert in legal matters. Chapters following this introductory text provide guidance to pharmacologists and attorneys working to incorporate testimony by drug experts into the court record and highlight actual pharmacolegal issues from real-life, drug expert cases. The final chapter of the book outlines the pharmacology of lethal injection, a sordid tale of clinical drugs misused for the lethal injection of condemned inmates. The involvement of the author in lethal injection litigation on behalf of the State and the inmates is the foundation for this closing chapter.

Drug Use by Americans

Americans love drugs. It is probable that the reader has at least one drug in his or her body at this very moment. Most likely it is caffeine, a brain stimulant, delivered in a convenient dosing form such as a cup of coffee, or tea, or an energy drink or soda pop. Eighty percent of the America’s population voluntarily use caffeine daily, many others unknowingly ingest caffeine in their diets.⁴ Or perhaps you have the stimulant nicotine in your blood, efficiently delivered by numerous devices ranging from a hand-rolled cigarette to a rechargeable electronic cigarette (e-cig), or chewing tobacco, or chewing gum (Nicorette®). Maybe you have a medical condition, like chronic pain, or diabetes, or hypertension, or all three, and take drugs as prescribed by your physician. Most of the drugs used to treat these chronic conditions remain in your bloodstream around the clock, 24-7. Or you have a headache and recently took ibuprofen (Advil®) or acetaminophen (Tylenol®) which remains in your system for the rest of the day. Some of you may have gone to a bar last night, leaving remnants of ethanol in your blood from having one, or two, or three drinks too many. Readers in Colorado, Washington state, or practically everywhere, may have smoked marijuana earlier today or in the last day or two.⁵ Your pothead bodies contain the active ingredient of marijuana, tetrahydrocannabinol (THC), sequestered in fat cells and being slowly released back into the bloodstream, metabolized by the liver, and excreted out in the urine. A few of you are chipping away on illegal drugs like cocaine or methamphetamine, leaving long-lasting metabolites detectable in your bloodstream and urine. A larger number of you are abusing prescription drugs, not taken under any doctor’s orders, and obtained illegally from a friend or relative or a dealer or someone else’s medicine cabinet. These legal drugs used illegally leave the tell-tale signs of the parent drug molecules or drug metabolites in your bloodstream as well.

The following first section presents the results of new research studies, and industry and government reports that detail the use of drugs in America. The overall thrust of this section is to show that all kinds of different drugs are used at inordinately high frequencies and among an unusually large number of people in America. The focus in this section is on four sectors of societal drug use, namely, prescription drugs, nonprescription drugs, alcohol, and illegal drugs.

Prescription drug use

No other country in the world comes close to the United States in the volume of drug consumption. Americans are the number one among all peoples, cultures, and countries in drug use per capita, measured as drug consumption per person, for both legal and illegal drug substances.⁶ The Kaiser Family Foundation reports that for the year 2018, the total number of prescriptions filled at retail pharmacies across the United States was 3,787,398,033.⁷ Divide this number into the estimated U.S. population in 2018⁸ (327,167,434) and you get 11.6 prescriptions per capita. That is enough prescriptions written for each newborn, child, and adult in the United States to get a prescription drug filled each month for about a year.

In the United States, retail sales of prescription drugs in the year 2018 brought in a total of $378 billion and some change.⁹ With about 3.78 billion prescriptions filled, we get an average prescription price of about $100, which seems a little high, but may represent the skewing of the price curve by newer, higher-priced medications.¹⁰ Additionally, with health insurance or Medicare paying for some or all of the cost of our medicine, and various levels of co-pays contributed by the consumer, we really have no idea of the true price of each prescription filled. Retail prescription drugs are subsidized products, made cheaper to the consumer by third-party health insurance or government subsidies. The profits from the $378 billion in sales of prescription drugs are divvied up between the retailer/wholesaler, like Walgreens¹¹ or CVS Health, and drug companies, like Pfizer. Headquartered in New York City, Pfizer is one of the world’s most profitable pharmaceuticals firm with revenues of $53.6 billion dollars in 2018.¹²

While the numbers of prescription drugs filled in the United States is enough for everyone to get one prescription filled each month, a recent study by the Mayo Clinic gives us an idea of who is getting all these prescriptions filled, and what types of prescription drugs are taken.¹³ Using nearly all men, women, and children residing in a single county in Minnesota, the Mayo researchers were able to examine the electronic prescription records of 142,377 people. This is such a large sample size that, to a first approximation, the conclusions of the study have general validity for the whole nation. Nearly 7 out of 10 people were prescribed at least one drug in the year 2009. It is no wonder that the pharmaceutical industry is called Big Pharma with 70% of Americans buying and using their products. Even more telling, about half of these drug users were prescribed two or more drugs, and another fifth are taking as many as five or more prescription drugs. Overall, women and the elderly received more prescriptions than males and other age groups.

As expected, the most commonly prescribed class of drugs was antibiotics, with 17% of the population written a script for a Z-Pak® or another antibiotic. The second-most common type of drugs were antidepressants, like Prozac® and Zooloft®, prescribed to 13% of the population. The third most common drug class prescribed to 12% of the population was opioid analgesics (painkillers), with the well-known examples being hydrocodone (in Lortab® and Vicodin®) and oxycodone (OxyContin®).

Americans love all drugs but they really, truly love opioid drugs. This love has gotten totally out of hand, with Americans consuming 80% of the global opioid drug supply while making up only about 5% of the world’s population.¹⁴ Focusing on the opioid analgesic drug, hydrocodone, we use and abuse hydrocodone to such an extent that 99% of the global hydrocodone supply is consumed by Americans (5% of the world population). That is enough hydrocodone so that every adult in America could be medicated with the standard dose of hydrocodone every 4 h for 1 month.¹⁵

Prescription opioids are analgesic drugs, used to treat moderate to severe pain.¹⁶ Opioids are abused for their euphoric effects, targeting the same brain receptors as heroin. Unfortunately, opioid analgesics are extremely dangerous drugs that can easily lead to addiction and death from respiratory depression. Unintentional death from prescription opioids is at epidemic levels, far outnumbering the combined death toll from heroin and cocaine overdose deaths.¹⁷ The deaths of celebrities Heath Ledger, Philip Seymour Hoffman, Prince, and Whitney Houston are just four of the overdose deaths attributed to prescription opioid abuse in recent years. In spite of all the public information and media coverage of prescription opioid abuse and overdose death, some physicians prescribe opioids to their patients without full realization of the dangers of opioid addiction and overdose. We will see a civil case later in the book where death from prescription opioid overdose led to a physician charged with improper prescribing practices and medical negligence. Other types of drugs that are prescribed to millions of Americans include sleep medications, like Ambien®, and antianxiety agents, like Xanax®. In the chapters ahead, the use of legal prescription drugs, including antidepressants, opioid analgesics, sleep medications, antianxiety drugs, antiseizure agents, and others, will be examined in the context of civil and criminal proceedings.

Nonprescription drug use

There are two types of pharmaceutical drugs available in the United States and most countries: prescription drugs and nonprescription or over-the-counter (OTC) drugs. Prescription drugs require a physician’s written, FAXed, or computer-transmitted prescription (e-script) written for a particular individual. Nonprescription or OTC drugs don’t require a doctor’s prescription and are widely available to all individuals in drugstores, grocery stores, mass merchandizers (like Walmart or Target), gas stations, and convenience stores. In the United States, both prescription and nonprescription drugs are approved and regulated by the FDA.

Some OTC drugs, like celebrity or blockbuster prescription drugs, are household names. Most people are familiar with the trade names of Advil®, Nyquil®, Robitussin DM®, Mucinex®, and Tylenol®.¹⁸ Nonprescription or OTC drugs are sold in numerous formulations and products that present the buyer with a dizzying array of choices, much like going down the breakfast cereal aisle in the supermarket. In the popular OTC pain reliever category, the neighborhood Walgreens store carries 70 aspirin-containing products and 198 nonaspirin drug products.¹⁹ There are 204 OTC drug products in the adult cold and cough medicine category. Many of these cold and flu products contain mixtures of various drugs including nonopioid pain relievers, cough suppressants, decongestants, and antihistamines. OTC combination medicines increase total drug exposure compared with prescription drugs, which are mostly single drug products. For example, the combination OTC product, Nyquil® Severe Cold & Flu Nighttime Relief®, contains four active ingredients: acetaminophen, for pain and fever; dextromethorphan, for cough suppression; doxylamine, an antihistamine; and phenylephrine, a decongestant.

Many nonprescription or OTC drugs started off as prescription drugs. When a drug is available as an OTC medicine, it was usually approved and marketed as a prescription medicine first.²⁰ After years or decades on the prescription drug market, prescription drugs with a good safety profile may be switched to OTC status by the drug company working with the FDA to gain approval. Even though the OTC drug market as a whole is < 10% of the prescription drug markets, an Rx-to-OTC switch can mitigate declining sales due to a generic competitor and extend the life cycle of a drug.²¹ The FDA reviews the safety data and proposed OTC drug labeling and if all goes well, there quickly appears a new, heavily advertised box or bottle in the pharmacy section. Some drugs remain marketed as both prescription drugs and nonprescription drugs, with the OTC version of the drug available in a different formulation or with a lowered dosage strength. The movement of drugs from prescription-only to nonprescription OTC drugs is a continual process, with monthly announcements by the FDA of the drugs making this switch on the FDA website.

Americans love taking drugs that they can buy without a prescription more than drugs that need a prescription. Whereas the Mayo study before showed that 70% of the population had at least one prescription filled in a year, a 2012 report from the Consumer Healthcare Products Association found that 81% of the American population bought at least one OTC drug product in a year.²² Retail sales of OTC drug products reached about $34 billion in 2017.²³ Although the OTC drug market is more fragmented than the prescription drug market, many of the OTC branded products are from drug companies which are owned by a Big Pharma company. Case in point, NyQuil® is branded as a Vicks® product, from the original Vick Chemical Company established in 1809, and later acquired by Proctor and Gamble in 1985.²⁴

Like prescription drugs, many nonprescription OTC drugs are abused and taken for nonmedical purposes, that is, to get high. OTC drug abuse is easier, and easier on the wallet, than abusing prescription drugs. Additionally, it is not a crime to possess Benadryl® tablets or Robitussin DM® cough syrup or any OTC drug. There is no need to go to the doctor and get a prescription for an OTC drug. Anyone, including teenagers and children, can buy OTC drugs which are widely available in almost any type of store or gas station. As a result, there is a great deal of OTC drug abuse in America, especially among the youth and adolescent.²⁵ The next chapter introduces our first drug expert case, which centers on abuse of an OTC drug product containing an antihistamine. Excessive doses of this antihistamine-containing product were taken by a teenager who survived the drug doses, but because of the psychotic effect of the OTC medication did not make it through the night.

Alcohol use

Alcohol remains the true over-the-counter drug. In some cases, especially when purchasing the pocket-sized half-pints kept behind the cashier, alcohol is literally passed over the counter to the customer. Most OTC drugs today are not actually passed over-the-counter but thrown into a shopping basket by the consumer directly off the shelf in the supermarket or drugstore. The over-the-counter term for nonprescription drugs is from the early days when there were no prescription-only medications and all drugs were passed over the pharmacist’s counter.

The active ingredient in all alcoholic beverages is ethanol. Ethanol is a simple molecule, with only two carbon backbone atoms. It is the excretion product of yeast, which is actually a type of microorganism in the fungus Kingdom. Ethanol is produced by fermentation. Fermentation is the biological process in yeast and other microorganisms whereby sugars are converted into energy for the yeast cell. The yeast cells then release ethanol and carbon dioxide as metabolic waste product. Essentially, ethanol is yeast piss.²⁶

Alcohol and drugs is a common phrase that makes a drug expert cringe. Alcohol is a drug; there is no way around it. But historically, alcohol got mixed up with prohibition and La Cosa Nostra, and ended up being regulated by a federal agency called the Bureau of Alcohol, Tobacco, Firearms and Explosives, known commonly as the ATF, housed in the Department of Justice. The ATF’s mission with regard to alcohol is to reduce smuggling and trafficking activity, decreasing funds derived from illegal alcohol trafficking available to criminal and terrorist organizations, and significantly reduce alcohol tax revenue losses to the States.²⁷ Since January 1, 2003, the Alcohol and Tobacco Tax and Trade Bureau in the Department of the Treasury became responsible for regulating the alcohol and tobacco industries, removing the tax and industry regulation burden from the ATF. Now, alcohol production, importation, wholesale distribution, advertising, and labeling is regulated by the Alcohol and Tobacco Tax and Trade Bureau.

Alcohol remains the only legal and most commonly used drug in the United States that is not regulated as a drug. Perhaps following the path of tobacco regulation, alcohol will become a drug by new laws, and included under FDA regulation.²⁸ Or maybe there will be a legal recognition of alcohol as a food, or more specifically a beverage. After all, alcoholic beverages are nothing but fermented forms of foodstuffs that can be taken in their original forms; it is grape juice that becomes wine, grain slurries that transform into beer, and molasses that turns to rum. But alcohol is not a food, although some people seem to live on beer. If alcohol was a food it would already be regulated by the Food and Drug Administration, the FDA. Neither is alcohol an illegal drug like heroin, but alcohol has exceedingly more detrimental effects on society than all illegal drugs combined.²⁹ So because alcohol is not regulated like legal drugs by the FDA, and alcohol is not an illegal drug like heroin and hounded by the DEA, there is some credence to using the phrase drugs and alcohol. Alcohol is a different drug than any other drug in our society. This does not mean that our repugnant view of the phrase drugs and alcohol is relaxing, just that alcohol is a very special nondrug drug.

The contribution of alcohol to our drugged society cannot be overstated. As a single agent, ethanol is the number one legal drug used and abused by Americans. Slightly more than half (52.2%) of Americans age 12 or older report regular use of alcohol, with about half of those reporting binge drinking in the last month.³⁰ In comparison, the number one illegal drug, marijuana, is used regularly by about 7.5% of the American population that are 12 or older. More people using alcohol does not mean that alcohol is more addicting than marijuana, although it may be. It’s just that alcohol products are so widely available, heavily advertised, and socially acceptable. If the trend continues toward state and perhaps federal legalization of marijuana, it is possible that the number of marijuana users would increase and approach the level of alcohol users.

The volume of beer, wine, and liquor sold in 2016 was enough for every man, woman, and child in America to consume 2.35 gallons of pure ethanol (200 proof alcohol).³¹ The alcoholic beverage industry in the United States drank in about $234 billion in retail sales in 2017.³² In comparison, prescription drugs bring in retail sales of $378 billion a year, and nonprescription or OTC drugs ring up $34 billion in sales.

Tobacco use delivers nicotine to the brain. Nicotine is a stimulant drug that acts on the brain and is addictive, but may be more addictive when delivered in the form of tobacco than by itself.³³ However, nicotine effects on brain and behavior are mild and not associated with major changes in behavior or psychomotor effects. Nicotine, for example, does not affect one’s ability to drive a motor vehicle. No legal cases are found where being under the influence of nicotine is linked to criminal or civil proceedings. Yet nicotine in tobacco products is a common legal drug that in 2012 was currently used by 27.3% of all Americans aged 18 or older.³⁴ The U.S. tobacco industry had sales of nearly $96 billion in 2010.³⁵ So while tobacco drug use is the leading cause of preventable death in the United States, killing more than 480,000 people annually,³⁶ tobacco use per se does not impact the legal system directly as do other drugs. In contrast, alcohol use has a tremendous impact on criminal and civil proceedings. There are three examples in this book where different aspects of alcohol use were factors in civil or criminal cases.

Illegal drug use

The use of illegal drugs by individuals occurs in every society that has illegal drugs. The legality of a drug, whether as a medicine or socially used drug, is entirely dependent on where the drug user is located. For example, a marijuana user that takes one step in any direction from the iconic Four Corners Memorial at the southwestern corner of Colorado changes the legal status of the marijuana joint in the user’s pocket. One step northwest, into Utah, or one step southwest into Arizona, or southeast into New Mexico, and the user is committing a state crime in possessing that particular plant product. One step back to the Rocky Mountain High state and the marijuana joint is legal again, at least according to state law. The feds, in the form of DEA agents, could arrest anyone in the United States, in any state, for marijuana possession as it remains a Schedule I Controlled Substance under Federal Law. Federal Drug Law trumps state drug law.³⁷ Taking a broader worldview, federal and state laws in the United States allow the unabated use of alcohol. Hop a flight to Saudi Arabia and one arrives in a country where alcohol is illegal, with draconian punishment for its sale and use. The punishment for getting caught for alcohol offenses in Saudi Arabia is a public whipping.³⁸ Like in the real estate business, when it comes to drug use and drug laws, it’s all about location, location, location.

When the location is America, bring your party hat. Recent studies by the World Health Organization (WHO) show that Americans have the highest incidence of lifetime use of cocaine and marijuana, compared to seventeen countries around the world.³⁹ Americans were also among the top users of tobacco. The 17 countries in the study were Colombia, Mexico, United States, Belgium, France, Germany, Italy, Netherlands, Spain, Ukraine, Israel, Lebanon, Nigeria, South Africa, Japan, People’s Republic of China, and New Zealand. According to the Office of National Drug Control Policy, Americans spend more than any other country on illicit drugs, buying more than 100 billion dollars’ worth of cocaine, marijuana, heroin, and methamphetamine annually.⁴⁰ The biggest illegal drug marketplace in the world is on the streets of America.

The illegal use of drugs in America over the last five decades followed the availability and development of specific drugs and formulations. As shown in Table 1.1, each decade is noted for a particular illicit drug in vogue during that decade. The first wave of baby-boomers in the 1960s that rocked the boat were the hippies, fueled by an illegal drug diet of marijuana and LSD. The 1970s saw the return of opioid-addicted Vietnam vets who first tasted the rich heroin produced in the Golden Triangle.⁴¹ In the 1980s there was the disco craze, powered by powder cocaine. The 1990s saw the full bloom of the crack cocaine epidemic, a cheaper, smokable form of cocaine. The new millennium and following decade swelled with the internet-enabled manufacture of methamphetamine. The decade of the 2010s, so far, looks like the decade of the synthetic and designer drugs.

Table 1.1