Duty to warn

A recently filed case in Pennsylvania illustrates a possible new face for liability (Cassidy v. SmithKline Beecham, 1999). The plaintiff claims that the manufacturer of a vaccine for Lyme disease should have warned physicians and patients in its advertisements that 30% of the population ran the risk of developing "treatment-resistant Lyme arthritis" because their particular genotype interacted adversely with the vaccine. This duty to warn is based not in product liability doctrine, but on negligence. 

McCormick, R., "Pharmaceutical Manufacturer s Duty to Warn of Adverse Drug Interactions," Defense Counsel J., 66, 59-68 (1999). ... 

What is the best way to balance a patient s right to privacy with a duty to warn (465)... 

Classe JG. Optometrist s duty to warn of vision impairment. SouthJ Optom 1986 4 66-69. 

Traditionally, the learned intermediary doctrine, shielded drug manufacturers and pharmacists from liability by imposing on the physician the duty to explain and to warn the patient about the effects of specific medications. Courts have remained reluctant to impose a duty to warn on pharmacists dispensing prescriptions, unless... 

Termini, R.B. The pharmacist duty to warn revisited The changing role of pharmacy in health care and the resultant impact on the obligation of a pharmacist to warn. Ohio N.U. Law Rev. 1998, 4, 551 566. 

The legal burden for vaccine manufacturers also rests on somewhat different grounds than it does for drug manufacturers. While courts have found in most drug and contraceptive cases that companies have fulfilled their duty to warn of adverse reactions by adequately informing physicians of risks,16 some courts have ruled that because there is no personalized relationship between physician and patient in mass immunization programs manufacturers must provide warn-... 

Tarasoff Decision Duty to Warn and Duty to Protect... 

A manufacturer must look beyond the product liability statutes and regulations to determine the full scope of his duty to warn others of the potential risks his products may pose. He must also look at one of the most dynamic areas of law-those decisions of judges and juries which comprise the manufacturer s common law duty to warn others of the risks involved in using his product. 

The common law duty to warn is an area of the law where a court decision which was first thought to be an aberration is later seen as the start of a new trend. It can be a costly arena for the unwary manufacturer—in adverse damage awards, adverse publicity, and damaged reputation. Product liability in general is one of the fastest growing areas of the law, with an estimated... 

The manufacturer searching for a definition of his particular responsibilities must carefully scrutinize his own factual situation. Consequently, neither this nor any own published treatment of the duty to warn should be presumed to provide definitive answers to his questions. As an aid to the manufacturer, this chapter ... 

C. Offers a duty to warn check list to assist the manufacturer in identifying, implementing and maintaining his own duty to warn ... 

THE SOCIAL PHILOSOPHY AND PRINCIPLES OF THE COMMON LAW DUTY TO WARN... 

Why do court decisions turn out the way they do A brief review of the social philosophy and principles of the common law duty to warn may assist a manufacturer in answering that question. 

There are certain causes of action within the field of torts which are relevant to a manufacturer s duty to warn of the risks of his products. " One of these was developed shortly after the turn of the 19th century, as accidents in-... 

One area of the law which has been subject to a great deal of controversy and expansion recently is the efforts of courts to deal with duty to warn situations in which a number of manufacturers might be involved. The courts have over time developed philosophies eind procedures for dealing with such situations. For instance, where a plaintiff can not identify which of two or more defendants caused an injury, the burden of proof in some cases may be shifted to the defendants for them to prove they were not responsible. The assumption here is that the defendants may be in a better position to provide the needed evidence than the plaintiff. ... 

What is important to recognize for the purposes of this chapter is the flexibility of the judicial system in providing relief for injured plaintiffs as against corporations which are deemed to have fallen short of their duty to warn. 

The duty to warn is a multifaceted obligation imposed on manufacturers who, because they obtain benefits from the products they create and place into commerce, must bear the responsibility of informing users of their products and the public at large about the dangers those products may pose. Society believes those manufacturers are in a better position than users and the public to identify those dangers, to minimize them, and to bear the associated costs. 

Society s shaping of the nature and scope of a manufacturer s common law duty to warn has been strongly influenced by the consumer and environmental movement and initiatives of the 1960s and 1970s. The prudent manufacturer will take into consideration the fact that not only... 

The number of product liability suits is increasing. The prudent manufacturer will initiate an ongoing preventative program to assure that he adequately fulfills his duty to warn. 

The litigated cases which are discussed in the next section have been selected to illustrate particular aspects of the manufacturer s duty to warn and how that particular aspect was treated in the reported case. The manufacturer should note, however, that nearly all product liability cases involve a basic pattern of analysis. In order for the manufacturer to have been found liable there must have been, in fact, a duty to warn, a breach of that duty, and (except in Sindell) a causal relationship established between the manufacturer s breach and the plaintiffs iiyury. In conducting this analysis, regardless of the legal theory being employed, the courts will consider ... 

The warning must be appropriate implicit in the duty to warn is the duty to warn with a degree of intensity that would cause a reasonable man to exercise for his own safety the caution commensurate with the potential danger. From this it follows that the likelihood of an accident taking place and the seriousness of the consequences are always pertinent matters to be considered with respect to the duty to provide a sufficient warning label, and that there is a particular need for a sufficient warning where there is a representation that the product in question is not dangerous. ... 

Where there is good evidence that a plaintiff was well aware of the risks in using a product-as in the case of Daniels v. The Atlantic Refining Co.f involving a herbicide, the manufacturer will not be held liable regarding his duty to warn. On the other hand, in some situations, no amount of warning will suffice, such as where a product is inherently unsafe for a particular use. 

Finally, compliance with federal or state labeling requirements will not alone be sufficient to fulfill the common law duty to warn. Violation of such mandatory requirements may establish negligence per se. ... 

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