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Imagine that you are engaged in the renovation of a mediaeval convent. The work involves a certain amount of demolition but it concerns only one storey of the building. The design engineer has estimated the costs and has worked on the reliefs and drawings. These show that no buttressing or reinforcement work has ever been carried out on the masonry to be demolished. What should be done Demolish the upper storey Risk a collapse Start the complex installation of temporary support braces Alter the original design Whereas building work has to cope mostly with external constraints (weather, delivery times, the availability of labour), restoration work must also, and especially, cope with internal ones arising from the fact that the building has a history wrought in stone and cannot be treated as a tabula rasa. Constructing a totally new building is a relatively linear activity (though one not without its obstacles and unexpected dif culties). It is easy to follow the architect s drawings in an ordered sequence of actions determined by a set of pre-established canons.The persons involved can therefore act in a more organized manner according to bureaucratic principles, because the work has been organized so that it is compatible with them. Conversely, it is often impossible to plan restoration work beforehand and thereby have time to deal with the unforeseen. The various layers of the building generate constraints which can almost never be predicted when the work begins, but which arise as it proceeds.These constraints raise both operational and economic problems, they rule out some forms of action, they require complicated dodges , and they sometimes con ict with plans and designs, which must be recast in an often non-linear and non-sequential process that instead resembles conversation and continuous negotiation.



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Food and Drug Law Institute (U.S.), Basic outlines on medical device law and regulation: a collective work by top legal and regulatory experts in the food and drug eld. Washington, DC: Food and Drug Law Institute, ii, 490 (1997). Parascandola, J. and Keeney, E., Sources in the History of American Pharmacology. Madison, WI: American Institute of the History of Pharmacy, p. 5 (1983). Young, J.H., The Medical Messiahs: A Social History of Health Quackery in TwentiethCentury America. Princeton, NJ: Princeton University Press, pp. xiii, 498 (1992).





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of physician risk-bene t analysis in prescribing drugs which is what a negligence standards boils down to. Recall that liability for malpractice requires proof that the defendantphysician violated not the jury s standards, but the standards of fellow practitioners when prescribing DES. The allocation of the liability risks in the DES cases between manufacturer and physician is only illustrative rather than prescriptive of the form of allocation that will occur for the products of pharmacogenomics. The main thrust of the DES cases is to illustrate that the standard of care for physicians undergoes a major shift when physicians are operating on the frontiers of medical practice or engaged in clinical research. This allows for the manufacturer s responsibility to be derivative of the physician s duty to deal fairly with patients with regard to the risks.

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