Portrait of development risk as a young defence.

• Author: Arbour, Marie-Eve
• Position: Product liability - Technological Innovation and Civil Responsibility

Since its (recent) insertion into the vocabulary of jurists, development risk has piqued the curiosity of experts in defective products liability. An investigation into development risk's scope and reach, however, requires a comparative analysis that brings out the issues it raises and the ambiguities it has occasioned. In this light, this article draws support from abundant doctrine, and, perhaps paradoxically, scant jurisprudence on the subject, in an effort to sketch, in broad strokes, a contemporary portrait of development risk.

Depuis son insertion (recente) dans la langue des juristes, le risque de developpement suscite la curiosite des experts de la responsabilite du fait des produits defectueux. Pourtant, une reconstruction de sa portee et de son etendue ne semble pouvoir s'effectuer qu'au prix d'une analyse comparative destinee a mettre en relief les enjeux qu'il souleve et les ambiguites qu'il fait naitre. Dans cette optique, la presente contribution prend appui sur l'abondante doctrine a son sujet, et, peut-etre paradoxalement, la rare jurisprudence l'ayant aborde, afin d'esquisser, a grands traits, un portrait contemporain du risque de developpement.

Introduction I. The Territories of the Development Risk Defence A. Supranational Moulds and Pathways B. Of National Clones, Mutants, and Hybrids II. Knowledge or Uncertainty? The Methodology Maze A. The Domain of Knowledge: Existing Data and Accessibility B. The "Whom" Question C. "Enabling", Discovery, and Business Ethics D. Eppur si muove ... (Thou Shall Dissent) Conclusion Introduction

It is no secret to anyone familiar with tort law that product liability has become an extensive, globally recognized area of private law. (1) The same can be said of the (in)famous development risk defence (DRD), (2) which precludes product liability whenever "the inherent risk of a defective product [is] undiscoverable at the time of supply by a manufacturer." (3) Fuelled by the desire to enhance the "long-term social good" (4), the DRD is said to foster innovation by shielding industries from liability stemming from defective products born of research and development (R&D) in cases where the risk was not discoverable in light of accessible scientific knowledge at the time the product was put onto the market. (5) Conceptually distinct from the state-of-the-art defence (6) (which speaks the language of negligence), (7) the extension of such immunity from liability to producers amounts to a state in which victims of this type of defective product are, at best, dependent on other legal categories and causes of action in order to obtain compensation (contractual warranty, vice cache, negligence, faute, culpa, dangerous activity, etc.) or, at worst, left to themselves in a situation perhaps reminiscent of the pre-industrial caveat emptor paradigm fiercely criticized by PL scholars. (8) Despised and glorified, adopted and rejected, transplanted, transposed, and altered, much has been said--mostly in Europe (9) but also in Quebec (10)--about this immunity from liability that polarizes commentators along a left-right divide.

Beyond the civil law and common law divide, the exemption clause crystallizes the link between some conceptions of justice and our contemporary economy, as it suggests that too much liability chills innovation. Its features have been extensively documented, to the point that the aim of the present contribution may appear methodologically modest, as it merely seeks to provide a comparative overview of recent developments regarding the DRD, driven by expanding case law on the issue. (11) In which legal systems is the DRD to be found? A classical, horizontal comparative exercise (beyond mainstream EU/USA'corresponding endeavours) allows us to map properly the territories it occupies after testifying of its projection, through vertical comparison, at the supranational level (Part I). Despite widespread adoption of the DRD, interpretations vary respecting its elements, including knowledge and its counterpart, uncertainty, which are at the very core of the defence (Part II). A comparative legal analysis provides the ability to highlight methodological and ethical concerns and ambiguity present in the DRD, while raising the delicate practice of melding law and science within the courtroom, which has long stimulated debate among evidence and causation experts. (12) Ultimately, indeed, the DRD's boundaries are set by the judiciary, although "the courtroom is not the place for scientific guesswork, even of the inspired sort," as Justice Posner once warned. (13)

1. The Territories of the Development Risk Defence

   As product liability spread to many of the industrial world's legal systems, the DRD, too, marked both national and international levels. Transported by circulating policy reasons and, possibly, path dependencies, the model spread rapidly beginning in the 1960s. Intertwining legal roots make it difficult to determine whether it originated in national laws (Section B) or supranational endeavours (Section A). The following section is, therefore, merely intended to offer greater clarity.

   1. Supranational Moulds and Pathways

      The 1960s were characterized by the spread of product liability maximodels throughout the industrialized world, including those established in the Vienna Convention on Civil Liability for Nuclear Damage (1963); (14) the European Convention on Products Liability in regard to Personal Injury and Death (1977), adopted under the auspices of the European Council; (15) and the later, famous European Union PL Directive. In light of the general principles of monism and dualism that structure the law of treaties, some models are mandatory, while others are persuasive guidelines that emerge from academic or technocratic experiences (e.g., the Principles of European Tort Law (PETL) (16) or the Uniform Law Conference of Canada (17)); finally, some are of a hybrid nature, such as the American Restatement of Torts (Second)(18) and (Third) (19), as they may, through time, penetrate states' legislation or case law. This last model has largely forged a field of law of its own.

      In 1965, section 402A, entitled "Special Liability of Seller of Product for Physical Harm to User or Consumer," gave birth to this new field known as product liability. Under this section, any professional vendor who sells a product in a defective condition unreasonably dangerous to its user or consumer is held liable even if he has "exercised all possible care in the preparation and sale of his product." (20) This rule is also applied in civil law jurisdictions, mutatis mutandis, through either an extension of the contractual sphere to third parties, special consumer laws, or both (whereas common law product liability stems from an extension of the duty of care in tort law, applying Donoghue v. Stevenson (21)). The general rule in section 402A was tempered by an exception, which was added to the Restatement (Second) as a reporter's comment--comment k--that explicitly addressed dangerous products. (22) This famous comment recognized that the market might include "some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use." (23) American Law Institute reporters were then undoubtedly particularly concerned with drugs and vaccines, as 1965 also marked the infamous thalidomide scandal. (24) After laying the foundation for proper risk-benefit analysis, the comment goes on to state that "[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous." (25) In this context, the comment argued that because "there [was] no assurance of safety," economic actors should not be held liable for "unfortunate consequences." (26) The model has been widely adopted in US case law and re. mains good law in many American states. The economic wind changed from sociodemocratic ideas to neoliberal ones, however, and the time came to update the rule, which had been designed, quite ironically, the same year John F. Kennedy asserted that "[consumers, by definition, include us all." (27) In 1997, a new version, although criticized by some commentators, was proposed by ALI members. Section 2, comment d, of the Restatement (Third) provides instead that

      [t]he term "state of the art" has been variously defined to mean that the product design conforms to industry custom, that it reflects the safest and most advanced technology developed and in commercial use, or that it reflects technology at the cutting edge of scientific knowledge. (28) Prima facie, this new rule bears little resemblance to its predecessor. Not only does it apply exclusively to certain products (drugs and medical devices), it also crystallizes the learned intermediary doctrine (29) while it states that

      [a] prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients. (30) Simply stated, neoliberal conceptions of the economy suggest that such a drug shall not be prescribed by any doctor (and should not, to begin with, ever be on the market).

      The European Economic Community had earlier adopted the PL Directive, which defined product defect based on consumer expectations. It provides that a "product is defective when it does not provide the safety which a person is entitled to expect." (31) It draws partly on the American experience, and article 7(e) states that a producer will not be liable if "the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be...