Hugs and Drugs: Research Ethics, Conflict of Interest, and Why the FDA's Attempt to Preempt Pharma Failure-to-Warn Claims Is a Dangerous Prescription

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INTRODUCTION

One of the most common claims brought by patients against drug manufacturers involves the failure to warn consumers of the risks associated with taking a drug. The Food and Drug Administration ("FDA") recently adopted labeling rules and issued an accompanying advisory opinion to preempt all failure-to-warn claims brought against compliant drug manufacturers. (1) The actions taken by the FDA, however, ultimately jeopardize the rights of injured patients to recover damages when real injury has occurred.

The purpose of this Note is to discuss the effects that the conflicting interests in drug research should have in a court's deference to the recent FDA advisory opinion. Specifically, it exposes the faulty premises upon which the FDA opinion is based and argues that the opinion can and should be disregarded. Part I sets the scene and explains how the pharmaceutical industry ("pharma") influences the process that led to the adoption of the recent advisory opinion. Next, Part II discusses the doctrine of preemption, the FDA's most recent attempt to undermine failure-to-warn claims, and courts' varied reactions. Part III examines the serious ethical problems pervading pharmaceutical research and the detrimental effect these problems are having on the accuracy of research and, consequently, the safety of drugs and their warnings. Moving to the crux of the issue, Part W argues that federal preemption of failure-to-warn claims is a dangerous policy and, in light of the problems pervading drug research, it would be unwise to give the FDA little, if any, deference in this regard.

I. BACKGROUND

The pharmaceutical industry's influence reaches further than most people realize. Its influence is perhaps most apparent on television where prescription and over-the-counter drug advertisements occupy an estimated 8% of commercial airtime. (2) The $2.5 billion that pharma spends annually on direct-to-consumer advertising has undoubtedly purchased not only the interest of consumers, but also goodwill from the media who sell various forms of advertising. (3) The advent of many innovative and life-saving drugs has also won pharma the admiration of the American public. (4) Pharma exerts another more subtle influence by earmarking $14 billion annually to promote drugs directly to physicians, amounting to about $30,000 per physician. (5) This expense typically manifests itself in the form of free seminars and educational funding that generate goodwill toward pharma and commonly "sell" doctors on the drug. (6)

Of course, pharma's influence extends far beyond the obvious realm of advertising; it reaches into government, (7) politics, (8) front groups, (9) regulatory agencies like the FDA, (10) advisory committees, (11) associations responsible for creating medical guidelines, (12) research labs and clinics, (13) medical journals, (14) and even classrooms. (15) In 2004 alone, pharma's efforts generated the industry more than $500 billion worldwide, $248 billion of which came from the United States. (16) Furthermore, pharma's pervasive influence has significantly increased prescription drug use, even among the healthy. (17) Over the last ten years, "the number of prescriptions issued annually has increased approximately 67%." (18) Today, nearly half of Americans take at least one prescription drug, (19) and in 2004 the average person had approximately twelve prescriptions each year. (20)

While drugs have saved the lives of many patients, increased drug use has demonstrated many harmful consequences. Independent research suggests that adverse reactions to even properly prescribed and administered medication is between the fourth and the sixth leading cause of death in the United States, killing more than 106,000 people annually. (21) Additionally, more than two million serious adverse reactions to properly taken prescription drugs occur annually. (22) This amounts to 6.7% of hospitalized patients sustaining drug-related injuries. …