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.

AuthorMartin, Christina Marie


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.


    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. (23) Many researchers suggest that even these shocking figures are low, (24) particularly since prescription drug use has significantly escalated since those estimates were made.

    Despite such statistical research, most people do not realize the serious health risks that even over-the-counter and common prescription drugs pose. Drugs are often viewed as a safe and acceptable way to maintain a comfortable but unhealthy lifestyle. (25) Regardless of whether there are apparent side effects, every drug has toxic effects. (26) The United States has decided to weigh these toxic effects against potentially beneficial uses. (27) Congress created the FDA in order to establish minimum safety requirements for products like prescription drugs. (28) The FDA balances the reported benefits and risks associated with a drug and must find that the benefits appear to outweigh the risks in order for the drug to be legally sold in the United States. (29) Additionally, the manufacturer must adequately warn consumers of potential risks and side effects associated with the drug. (30)

    Unfortunately, the information that the FDA uses to approve drugs is frequently skewed by conflicting interests. Institutions, researchers, practicing physicians, and even FDA employees commonly have financial ties to pharma. (31) Even prestigious academic institutions such as Harvard Medical School are not immune from financial conflicts of interest. (32) The prevalence of these ties is a serious obstacle to the integrity of research and the practice of medicine, and has triggered a growing outcry. Medical journals commonly lament the serious problems created by these conflicting interests, and with good cause: such conflicts of interest undermine the objective study and evaluation of new medications. (33) Accordingly, drugs frequently enter the market with exuberant approval, only to cause a rash of severe and unexpected side effects. (34)

    In the meantime, alleged victims of adverse drug reactions are suing pharma en masse. The most prevalent claim is that the manufacturer failed to properly warn of the damaging side effects. (35) For example, Merck, the manufacturer of Vioxx, faced more than 1357 product liability claims within the first year of the drug's withdrawal from the market. (36) Since many claims result in multi-million dollar awards, they can pose a significant threat to pharma's financial viability. (37) Consequently, some scholars support the creation of a fortress around pharma to protect it from allegedly frivolous claims that supposedly threaten to keep life-saving drugs from suffering patients. (38)

    Naturally, pharma is not taking its litigation and settlement costs lightly. Pharma has made great strides to protect its interests by hiring more than 600 well-connected, full-time lobbyists (including many former members of Congress) and drawing in millions of dollars in campaign contributions. (39) A prime example of pharma's influence in Washington, D.C., is the rewritten Medicare drug law, which forbids the government from negotiating lower drug prices. (40) Shortly after the amended bill was passed, the congressman who promoted the bill was appointed as the President of the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's trade association. (41) Most recently, in January 2006, pharma's efforts were rewarded by new FDA labeling rules and an influential advisory opinion that clearly attempts to block all failure-to-warn claims against the industry. (42) This opinion specifically states that the FDA intends to preempt all failure-to-warn claims against drug manufacturers where the manufacturer complied with FDA regulations. (43)

    While some dismiss these developments as mere politics inside the Beltway, the FDA's latest actions in favor of pharma jeopardize the legal remedies of every American patient. If courts follow the FDA's recommendation to treat failure-to-warn claims as preempted, it would substantially hinder or even destroy a plaintiff's ability to recover against a manufacturer for inadequate and unsafe warnings. (44) It may also undermine other claims since "most civil actions brought against a pharmaceutical manufacturer for liability from a defective drug hinge on the company's failure to warn of a known risk." (45) Furthermore, the advisory opinion may be extended to protect pharma from a variety of other products liability claims since it states that FDA approval should preempt at least any failure-to-warn claims. (46)

    In addition to leaving plaintiffs uncompensated for corporate wrongs, the FDA's recommendation has a number of substantive flaws. It raises issues of federalism and arguably may interfere with constitutional rights. This Note does not address those issues since they have been amply commented on with relation to preemption. (47) Instead, this Note discusses the effect that the conflicting interests dominating drug research should have on the deference afforded to the FDA's advisory opinion. The conflicting interests haunting drug research destroy the premises on which the reasoning of the FDA's advisory opinion is based. Therefore, the FDA's opinion is outweighed by other factors and accordingly should not be followed.


    Proponents of greater protection for pharma have long argued that FDA approval should preempt failure-to-warn claims. (48) The doctrine of preemption is rooted in the Supremacy Clause of the U.S. Constitution, which states that federal law is the supreme law of the land. (49) Under the doctrine of preemption, "state law that conflicts with federal law is 'without effect.'" (50)

    As a general rule, there is a presumption against the preemption of state law. Recognizing that states are "independent sovereigns," some courts have been wary of applying the preemption doctrine. (51) For a federal statute to displace state law, congressional intent must be readily apparent in either the statute's language or its structure and purpose. (52)...

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