RENOVATIONS NEEDED: THE FDA'S FLOOR/CEILING FRAMEWORK, PREEMPTION, AND THE OPIOID EPIDEMIC.

Author:Abrams, Michael R.
Position:NOTE
 
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The FDA's regulatory framework for pharmaceuticals uses a "floor/ceiling" model: administrative rules set a "floor" of minimum safety, while state tort liability sets a "ceiling" of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law "ceiling" to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA's framework becomes increasingly imbalanced. In the face of a historic prescription-medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note argues that the FDA's administrative design misallocates the costs of the Opioid Epidemic and fails to adequately compensate those injured by it. Part I summarizes the FDA's regulatory framework with respect to opioid medications. Part II explains how that framework creates a compensatory problem that prevents the internalization of negative externalities by pharmaceutical manufacturers. Part III proposes a victims' compensation fund as the best substitute for the functions long performed by state tort liability.

TABLE OF CONTENTS INTRODUCTION I. THE FDA'S "FLOOR/CEILING" SCHEME AND THE PREEMPTION LEVER A. The FDA's Administrative Design B. The Role of Preemption and the Shifting Balance II. THE SUPREME COURT'S NEW STEP IN PREEMPTION'S DOCTRINAL THICKET CREATES A COMPENSATION PROBLEM A. The Court's Embrace of Preemption Minimizes the Crucial Role of Torts B. An Inadequate Regulatory Scheme Remains PostPreemption C. Torts Alone Cannot Adequately Compensate the Victims of the Opioid Epidemic III. CALLING FOR AN OPIOID EPIDEMIC VICTIM'S COMPENSATION FUND A. Nontraditional Torts and Criminal Punishment Cannot Solve This Problem B. The Victim's Compensation Fund Model CONCLUSION INTRODUCTION

In January of 1980, the New England Journal of Medicine published a letter to the editor penned by Boston University medical researcher Dr. Hershel Jick and his assistant Jane Porter. (1) The five-sentence letter was titled "Addiction Rare in Patients Treated with Narcotics." (2) It reported that of 11,882 hospitalized patients who received at least one dose of narcotic pain killers in the researchers' files, "there were only four cases of reasonably well documented addiction in patients who had no history of addiction." (3) Thus, the researchers concluded, "despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction." (4)

The letter, referred to simply as "Porter and Jick," rose to notoriety. (5) Previously, "doctors had long been taught to avoid prescribing highly addictive opioids to patients." (6) But by the 1990s, the letter's conclusory observation about opioid addictiveness "was invoked by doctors, academics, pharmaceutical companies and others as evidence that few users would develop addictions" to prescription narcotic pain killers. (7) An article in Scientific American cited Porter and Jick's one-paragraph letter as an "extensive study." (8) Time magazine referred to their "landmark" research as showing the "exaggerated fear that patients would become addicted" to prescription opioids was "basically unwarranted." (9) Almost forty years later, the Journal published a retrospective "bibliometric analysis" of the letter; this analysis found that the letter was cited at least 608 times and that some of these citations "grossly misrepresented the conclusions of the letter." (10)

Those citations fueled a shift in the healthcare industry's perspective on the treatment of pain. (11) Pharmaceutical and healthcare industry figures "aggressively pushed the concept of pain as the fifth vital sign." (12) With the introduction of subjective measures like the "pain scale" and the linking of pain treatment to patient satisfaction, new incentives pushed doctors to prescribe narcotic pain killers. (13) Concurrently, the pharmaceutical industry ramped up promotion of pain medications. (14) Purdue Pharma introduced OxyContin to the market as a long-term solution to chronic pain. (15) A 1998 OxyContin promotional video featured a doctor referencing the letter's data: "There's no question that our best, strongest pain medicines are the opioids ... in fact, the rate of addiction amongst pain patients who are treated by doctors is much less than one percent." (16) In 2017, Dr. Jick lamented, "I'm essentially mortified that that letter to the editor was used as an excuse to do what these drug companies did." (17)

Exactly what these drug companies did is now the subject of litigation. (18) And unlike previous public health courtroom battles, such as the tobacco litigation of the 1990s, the prescription drugs at the heart of this deadly outbreak are heavily regulated for safety by the federal government. (19) As a result, a diverse array of federal agencies have prioritized responding to the emergency. (20) To understand why, consider the extent of the damage: the Substance Abuse and Mental Health Services Administration's annual survey found that "over 11 million Americans misused prescription opioids" and "2.1 million had an opioid use disorder due to prescription opioids or heroin" in 2016. (21) Drug overdose deaths in 2016 totaled 63,000, which (after adjusting for age) represents a 21 percent increase over the prior year. (22) This is "the largest annual jump ever recorded in the United States," reaching a total greater than any peak number of annual deaths caused by car crashes, HIV, or guns throughout history. (23) Opioids are responsible for 66 percent of those overdose deaths, killing more Americans annually than breast cancer. (24) And 2017 estimates show those numbers rising across all races and nearly all age groups. (25) In 2017, Stanford Professor of Psychiatry Keith Humphreys compared "the amount of standard daily doses of opioids consumed in Japan"--a nation with an "older population than us, you would think more aches and pains"--to that of the United States by saying, "double it. And then double it again. And then double it again. And then double it again. And then double it a fifth time. That would make Japan number two in the world behind the United States." (26) According to one forecast, opioids could kill 500,000 Americans over the next ten years. (27)

Dire as they are, the nationwide numbers mask the extent of the damage in the most heavily impacted localities. The highest-prescribed state sees three times as many opioid prescriptions per person as the lowest-prescribed state, despite "[h]ealth issues that cause people pain ... not vary[ing] much from place to place." (28) Between 2007 and 2012, drug wholesalers shipped 780 million pills of just hydrocodone and oxycodone to West Virginia. (29) In Kermit, West Virginia, a town of 392, drug companies shipped nearly nine million pills of hydrocodone to a single pharmacy. (30) In 2016, Montgomery County, Ohio saw a record 349 opioid deaths, but local officials estimate that 2017 deaths could surpass 800. (31) County coroners are overwhelmed by the influx and struggling to find the physical space necessary to store bodies and conduct autopsies; some coroners have resorted to the use of refrigerated trailers. (32) In New Hampshire, the backlog of autopsies is putting the state medical examiner's office "at risk of losing accreditation." (33) That state has seen a nearly tenfold increase in overdose deaths since 2000. (34)

This human cost, in lost life and welfare, translates to a gargantuan toll on the economy. A 2017 study estimated the societal cost (including lost productivity, healthcare expenses, criminal justice costs, etc.) of the Opioid Epidemic at over $95 billion for 2016 alone. (35) The White House Council of Economic Advisers, additionally placing a value on the loss of human life, estimated the 2015 cost of the crisis at over $500 billion, or 2.8 percent of GDP. (36) These calculations do not incorporate the further costs of patients "initiated" into opioid addiction by prescription medications who then transition to cheaper, more widely available black-market heroin. (37) The damage is sizable enough to cause macroeconomic impact: economists from Princeton University, Goldman Sachs, and the Federal Reserve postulate that the perplexing decline in the labor participation rate is linked to opioids. (38)

This unprecedented rate of addiction and death amounts to the largest drug-related public health emergency in American history. (39) Six states and the White House have declared official emergencies. (40) And, because these drugs are FDA-approved medicines with legitimate applications, the challenge is distinct from past epidemics like the rise of heroin or crack cocaine. According to Scott Gottlieb, the commissioner of the FDA, "Most people who become addicted to opioids become medically addicted. Their first exposure is going to be a clinical prescription that they receive in a clinical setting, and then they'll go on to develop an addiction." (41) Indeed, "many public health experts have traced the roots of the current surge in opioid addiction ... to ... prescription drugs" (42) because "[t]he misuse of prescription opioids is intertwined with that of illicit opioids." (43) Four out of five new heroin users began by misusing a prescription opioid. (44) Between 1996 and 1997, retail sales of hydrocodone increased by 244%, oxycodone by 732%, and methadone by 1,177%, coinciding with the trend of "increased rates of abuse and mortality associated with prescription opioid[s]." (45) Thus, understanding the FDA scheme that regulates the prescription drugs in question is crucial.

This Note argues that the FDA's administrative design misallocates the costs of the Opioid Epidemic and fails to adequately compensate those injured by it. The FDA's regulatory framework emphasizes...

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