Academic journal article The University of Memphis Law Review

Legal and Quality of Patient Care Issues Arising from Direct-to-Consumer Pharmaceutical Sales

Academic journal article The University of Memphis Law Review

Legal and Quality of Patient Care Issues Arising from Direct-to-Consumer Pharmaceutical Sales

Article excerpt


In the medical world, it is often seen as a paradox that courts may be as powerful as technology in affecting a standard of quality. Accordingly, the courts often serve as a vehicle in which new technology progresses from minimal use at the fringe of medical care to widespread acceptance in mainstream medicine. For example, by updating the legal standard of care to reflect new medical technology, courts have forced the use of new technology in the area of transfusion medicine, thereby supplementing the quality of medical care for patients receiving blood transfusions.' Without the judicial monitoring of scientific and medical advancements, mainstream medicine may never fully appreciate that its sometimes broad variations in the delivery of care can lead to defects in the quality of health care. As such, this note will explore the courts' unique role in health care quality, specifically as it relates to the legal issues surrounding direct-to-consumer pharmaceutical advertising.

A. Historical Introduction

For several decades, courts have monitored quality as it relates to technology. In addition, courts also have used this quality monitoring function to assess liability and update the legal standard of care that civil defendants owe to plaintiffs. For example, when Justice Learned Hand found the tugboat owners of the "Montrose" and "Hooper" liable for the cargo that they lost at sea because they failed to equip their boats with radios, the concept of satisfying one's duty in negligence became more than just complying with the current technological customs of one's industry.2 Justice Hand held that "[c]ourts must in the end say what is required [of one's duty of care]; there are precautions so imperative that even their universal disregard will not excuse their omission."3 In another case, building on the judicial influence that aids in defining the quality of medical care and technology generally, the Supreme Court of New Jersey held the American Association of Blood Banks liable for not recommending HIV testing for the nation's blood supply in the early 1980s.4 The court held that the American Association of Blood Banks had a duty to protect hospital patients from receiving tainted blood during surgery, even though the evidence of infection by HIV from tainted blood was not "conclusive" during that period, because the American Association of Blood Banks, as a trade organization, "sought and cultivated" the responsibility of monitoring and inspecting the nation's blood supply.5

As illustrated by these two cases, the precedent of the courts monitoring the quality of medical and scientific progress is well established. Therefore, it is inevitable that the courts will play a role in ensuring the quality of health care regarding direct-toconsumer advertising of prescription drugs. Curiously, the Food and Drug Administration (FDA) may have facilitated the court's role in drug advertising with its 1997 guidelines, which liberalized broadcast advertising, thereby increasing the use of direct-toconsumer advertising.6

B. Quality Medical Care? You Make the Call

As courts wrestle with the explosion of direct-to-consumer advertising and try to decide whether the physician's duty as a learned intermediary7 remains justified, the question remains whether consumers are able to understand the warnings pharmaceutical manufacturers give them in the advertisements. …

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