Blinded by the Hype: Shifting the Burden When Manufacturers Engage in Direct to Consumer Advertising of Prescription Drugs

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Vermont Law Review


direct-to-consumer promotions, pharmaceutical industry, prescription drugs, learned intermediary doctrine


This article explores whether direct-to-consumer (DTC) promotions and advertisements create new duties for drug manufacturers under current product liability law. Conversely, is the physician-patient relationship denigrated by advertising which will result in undue pressure on physicians to prescribe medications and possibly induce more iatrogenic injury? Traditionally, a physician acts as a “learned intermediary” and as such, the drug companies are shielded from liability because the physicians are charged with the duties of informing, educating, and treating their patients. This article explains that DTC promotions and advertisements are incompatible with the protective learned intermediary doctrine. The article questions the wisdom of applying undue pressure on physicians to prescribe medication based on media ads. The article then focuses on whether there is ample justification for the courts to carve out a third exception to the learned intermediary doctrine based on the manufacturers' advertising pressure exerted on the ultimate consumer--the patient. The article presents a short discussion of the history of DTC advertisement and promotion of prescription drugs including a balanced look at objections raised by the medical profession as well as the positive benefits that may accrue from DTC advertising. Finally, the article recommends adopting limits on liability, if not impunity, for drug companies from vaccine based suits because of the public interest involved. However, it exhorts the FDA to enact rules which will encourage the dissemination of understandable information while preventing fraud and overreaching in the promotion and advertisement of prescription drugs directly to the consumer. Lastly, in the wake of shifting the burden of causation as done in the Diethylstilbestrol (DES) cases, the article proposes fixing liability according to the drug companies' causal contribution to the risk. This risk theory goes beyond the existing law of causation and includes in its apportionment causal factors such as multi-media advertising. Advertising the product should be considered as a contributing factor. Cases should be decided on a case-by-case basis with the courts assigning liability in a fair and efficient manner.


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