WEANING DRUG MANUFACTURERS OFF THEIR PAINKILLER: CREATING AN EXCEPTION TO THE LEARNED INTERMEDIARY DOCTRINE IN LIGHT OF THE OPIOID CRISIS.

• Author: Roberts, Max

Introduction 684 I. The Opioid Crisis and the Learned Intermediary Doctrine 686 A. The Opioid Crisis 686 B. The Learned Intermediary Doctrine 691 II. Fashioning an Opioid Exception to the Learned Intermediary Doctrine 694 A. Drug Manufacturers Engaged in an Industry-Wide Practice of Failing to Adequately Warn Physicians About Opioid Dangers, and Rendered Warnings Were Made Moot Through Over-Promotion of Opioids 694 1. Drug Manufacturers Failed to Warn Physicians about the Risks of Opioids 694 2. Drug Manufacturers Over-Promoted Opioid Painkillers, Rendering any Warnings Meaningless 695 3. Drug Manufacturers' Engagement in Industry-Wide Marketing Practices Justifies the Creation of an Opioid Exception to the Learned Intermediary Doctrine 701 B. Prescription Opioids Are Not "Unavoidably Unsafe" for Treating Chronic, Non-Cancer Pain 704 III. The Effects of Creating the Opioid Exception to the Learned Intermediary Doctrine 708 A. The Problem of Pre-Existing Chronic, Non-Cancer Pain Patients 709 1. Despite the Impediments to Multi-Disciplinary Approaches to Pain Treatment, It Still Represents an Effective Alternative to Opioids 711 B. The Problem of Cancer Patients and Other Similarly Situated Patients 713 Conclusion 714 INTRODUCTION

Beginning in the twentieth century, a shift in tort law allowed consumers to hold manufacturers of goods, rather than just sellers, liable for injuries caused by said goods. (1) However, a notable exception to this rule still exists for pharmaceuticals through the "learned intermediary" doctrine. The learned intermediary doctrine provides that a drug manufacturer may evade liability for injuries caused to a patient when the manufacturer warns the prescribing physician of the dangers associated with the drug. (2) For many years, drug manufacturers have relied on this doctrine as a shield from liability. But should manufacturers continue to be allowed to do so?

Since the 1990s, an epidemic has been brewing in the United States: the opioid crisis. In 2017 alone, opioid overdoses--either caused by prescription opioids or illicit opioids such as heroin--caused 47,600 deaths in the United States, (3) and the opioid crisis has cost the United States over $1 trillion from 2001 to 2017, according to estimates. (4) In light of these alarming figures, President Trump declared the opioid crisis a "national emergency." (5)

As with any crisis, a question of liability arises and becomes especially relevant to any legal action taken by aggrieved parties. (6) Yet, when the spotlight has been pointed at pharmaceutical manufacturers--already under fire in a number of lawsuits (7)--these companies have attempted to shield themselves from liability using the aforementioned learned intermediary doctrine. (8) This Note argues that opioid drug manufacturers should not be able to hide behind the learned intermediary doctrine.

This Note does not intend to place the burden of the opioid crisis solely on the shoulders of drug manufacturers. "Pill mill" doctors and heroin dealers also contributed to the opioid crisis, and doctors, government regulators, law enforcement, and insurance companies, in addition to drug manufacturers, all have a role to play in curbing the epidemic. Rather, this Note proposes that deterring drug manufacturers by removing a barrier to liability will create the ripple effects necessary to help alleviate the crisis.

Part I of this Note chronicles the scale and tragedy of the opioid crisis in the United States, and how opioid manufacturers were a direct cause of the problem. Part I then explains the learned intermediary doctrine, which drug manufacturers are currently able to rely on to avoid liability for harm caused by opioids. Part II proposes that an exception to the learned intermediary doctrine should be carved out for prescription opioids. This exception is based on the collective practices of drug manufacturers in over-marketing opioids, which helped create the crisis. The exception is also based on opioids not being "unavoidably unsafe," as the learned intermediary doctrine relies upon, in their most common use. Finally, Part III assesses the effects of creating this exception on the health care industry. Although exposing drug manufacturers to increased liability will carry some negative ramifications, this Note argues that the exception should still be instituted because those negative effects can be alleviated by realistic changes to the treatment of pain.

1. THE OPIOID CRISIS AND THE LEARNED INTERMEDIARY DOCTRINE

   In providing an overview of the opioid crisis and the learned intermediary doctrine, this Part discusses how the opioid crisis transpired, specifically examining the role of prescription opioids and drug manufacturers in causing the crisis. Next, this Part discusses the application of the learned intermediary doctrine, the policy underlying the doctrine, and certain exceptions to the doctrine that have been carved out previously.

   1. The Opioid Crisis

      Opioids are a class of drugs derived from the opium poppy that are typically used to treat pain. (9) These drugs also react strongly with pleasure receptors in humans and can be very addictive with debilitating withdrawal effects. (10) Opioids come in a number of forms, with three in particular contributing to the opioid crisis. The first and most recent contributor is fentanyl. Fentanyl is a synthetic opioid most often used for treating severe pain (such as advanced cancer pain) that is fifty times more potent than morphine. (11) In many cases, fentanyl is being laced into heroin and into counterfeit pills without the user's knowledge, causing users to intake far stronger opioids than intended, leading to overdoses. (12) The second contributor is heroin, a Schedule I drug. (13) While heroin has been around for over a century, (14) more potent forms sold more cheaply and conveniently by dealers from Xalisco, Mexico have led to an increase in usage. (15)

      The third contributor, and most relevant for this Note, is prescription opioids. For much of the twentieth century, doctors were hesitant to prescribe opioids to patients because of the fear of addiction. (16) This attitude gradually changed in the 1970s as doctors began prescribing opioids for cancer and terminally ill patients. (17) By the 1980s, however, the floodgates began to open. In 1980, The New England Journal of Medicine published a letter to the editor authored by Jane Porter and Dr. Hershel Jick. (18) The letter claimed that of the nearly 12,000 patients treated with opioids at a hospital, only four had become addicted. (19) The letter did not provide any data on which opioids were given or the dosages prescribed, (20) and the fact that these patients were carefully overseen by their treating doctors was overlooked. (21) The letter was not even a formal scientific study. (22) Nevertheless, the letter was cited in a number of influential scientific studies on pain treatment, (23) which helped reinforce by the 1990s the claim that opioids were non-addictive. (24) In fact, this "pain revolution" helped swing the pendulum far to the other side, suggesting to physicians the idea that not only might opioids be safe to treat chronic pain patients, but also that doctors had been previously "undertreating" pain patients. (25) This shift in thinking led to the emergence of blockbuster painkillers like OxyContin, which was heavily promoted and prescribed (26) chiefly because it was thought to not be addictive. (27)

      From these origins, the opioid crisis was born. Backed by the aforementioned research, drug manufacturers such as Purdue Pharma ("Purdue"), Cephalon, Inc. ("Cephalon"), Janssen Pharmaceuticals ("Janssen"), Endo Health Solutions ("Endo"), and Insys Therapeutics ("Insys") began heavily manufacturing opioids. (28) To foster sales of these drugs, manufacturers contributed substantial funds to patient advocacy groups and professional societies including the Academy of Integrative Pain Management and the National Pain Foundation, groups which focused on chronic pain and opioid-related issues. (29) For instance, from 2012 to 2017, Purdue, Janssen, Mylan N.V., Depomed, Inc., and Insys contributed $9 million in total to opioid-related advocacy groups. (30) In turn, these advocacy organizations heavily promoted the use of prescription opioids. (31) Manufacturers also relied on large pharmaceutical distributors, including McKesson Corporation, Amerisource Bergen Corporation, and Cardinal Health, Inc. to distribute their drugs. (32) As a result of these marketing and distribution efforts by manufacturers, by 2015, the number of opioids prescribed was enough for every American to be medicated around the clock for three weeks. (33)

      Concurrently, because opioids were addictive despite "studies" to the contrary, this surge in use was coupled with an increase in misuse and tragedy. (34) Of the 97.5 million people who used painkillers in 2015, 12.5 million people misused them. (35) Further, drug distributors often failed to meet their reporting obligations under the Controlled Substances Act to "monitor and report suspicious orders under the controlled substances act to the Drug Enforcement Agency." (36) This resulted in massive amounts of opioids being diverted--given from the person to whom it was prescribed or from the pharmacy it was sold to another person for illicit use--contributing to the crisis. (37) Other users simply switched from prescription opioids to heroin because heroin was cheaper. (38) Regardless of the form, this misuse of opioids exacted both a human and financial toll. Over 47,000 people died from an opioid overdose in 2017, (39) and the opioid crisis could claim a projected one million lives by 2020. (40) The crisis has cost the United States over $500 billion per year attributable to criminal justice measures, treating patients in intensive care wards in hospitals, and lost productivity in businesses. (41)

      Although the opioid crisis has hit...