McGill Law Journal Revue de droit de McGill
PORTRAIT OF DEVELOPMENT RISK
AS A YOUNG DEFENCE
Marie-ve Arbour*
Since its (recent) insertion into the vocab-
ulary of jurists, development risk has piqued
the curiosity of experts in defective products li-
ability. An investigation into development risks
scope and reach, however, requires a compara-
tive 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 ju-
risprudence on the subject, in an effort to
sketch, in broad strokes, a contemporary por-
trait of development risk.
Depuis son insertion (rcente) dans la
langue des juristes, le risque de dveloppement
suscite la curiosit des experts de la responsabi-
lit du fait des produits dfectueux. Pourtant,
une reconstruction de sa porte et de son ten-
due ne semble pouvoir seffectuer quau prix
dune analyse comparative destine mettre en
relief les enjeux quil soulve et les ambiguts
quil fait natre. Dans cette optique, la prsente
contribution prend appui sur labondante doc-
trine son sujet, et, peut-tre paradoxalement,
la rare
layant abord, afin
desquisser, grands traits, un portrait contem-
porain du risque de dveloppement.
jurisprudence
* Professor of civil law, Laval University (Qubec). I am particularly thankful to Lara
Khoury and Etienne Vergs for their outstanding endeavour and to my peer reviewers
for their thorough and helpful comments. I would also like to acknowledge the stimulat-
ing hospitality I encountered amidst the books and shelves of the Institute of Advanced
Legal Studies (University of London) and the European University Institute (Florence).
This article builds upon ideas expressed by the author in Itinraire du risque de d-
veloppement travers des codes et des constitutions in Benot Moore, ed, Mlanges:
Jean-Louis Baudouin (Cowansville, Que: Yvon Blais, 2012) 677 and Rischi da svilup-
po in Elio Sgreccia & Antonio Tarantino, eds, Enciclopedia di Bioetica e Scienza giu-
ridica (Naples: Edizioni Scientifiche Italiane) [in press]. Only in occasion of proofread-
ing was I capable of referring to Richard Goldbergs outstanding monograph Medicinal
Product Liability and Regulation (Oxford: Hart, 2013) (especially Chapter 8, The De-
velopment Risk Defence and Medicinal Products). The overall relevancy of this piece
is therefore largely underestimated.
Citation: (2014) 59:4 McGill LJ 913 Rfrence : (2014) 59 : 4 RD McGill 913
Marie-Eve Arbour 2014
914 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
Introduction
I.
II.
The Territories of the Development Risk Defence
A. Supranational Moulds and Pathways
B. Of National Clones, Mutants, and Hybrids
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
915
917
917
924
927
927
929
930
936
940
THE DEVELOPMENT RISK DEFENCE
915
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 defec-
tive product [is] undiscoverable at the time of supply by a manufacturer.3
Fuelled by the desire to enhance the long-term social good4, 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 Conceptual-
ly distinct from the state-of-the-art defence6 (which speaks the language of
negligence),7 the extension of such immunity from liability to producers
1 See Mathias Reimann, Liability for Defective Products at the Beginning of the Twenty-
First Century: Emergence of a Worldwide Standard? (2003) 51:4 Am J Comp L 751;
Marie-Eve Arbour, Fragments de droit qubcois et canadien (Cowansville, Que: Yvon
Blais, 2012) at 238.
2 Albeit relevant in the world of common law, this concept does not properly fit in the ci-
vilian tradition, where defences are unknown and are instead embedded in the dialec-
tic of fault and its variations. I nonetheless refer to the DRD as a defence because it is
a legal transplant that intervenes after a defect has been established, and as such this
appears to be the least confusing approach.
3 Richard Goldberg, Causation and Risk in the Law of Torts: Scientific Evidence and Me-
dicinal Product Liability (Oxford: Hart, 1999) at 224 [Goldberg, Causation and Risk].
See also Richard Goldberg, The Development Risk Defence and Medicinal Products in
Medicinal Product Liability and Regulation (Oxford: Hart, 2013) 168.
4 Jane Stapleton, Product Liability (London: Butterworth, 1994) at 225 [Stapleton, Prod-
uct Liability].
5 The EU-style exoneration clause is defined in EC, Council Directive 85/374/EEC of 25
July 1985 on the approximation of the laws, regulations and administrative provisions
of the Member States concerning liability for defective products, [1985] OJ L 210/29, art
7(e) [PL Directive].
6 The defence emerged in the US at the dawn of the 1970s. Although the landmark case
on this issue was Beshada v Johns-Manville Products Corp (447 A (2d) 539, 90 NJ 191
(1982)), a stream of cases had already set the stage for it to be considered by courts. See
e.g. Suter v San Angelo Foundry & Machine, 406 A (2d) 140, 81 NJ 150 (1979) (observ-
ing that the state of the art refers not only to the common practice and standards in
the industry but also to other design alternatives within practical and technological lim-
its at the time of distribution at 151 [cited to A (2d)]).
7 Although similar in effect, the state-of-the-art defence is linked to the subjective fore-
seeability of risk by the producers, while the DRD revolves around objectively evaluated
knowledge. As such, the EU-style defence relates more to the type of risk than to the
producers behaviour. See Stapleton, Product Liability, supra note 4 at 225. The DRD
therefore shifts away from the economic dimension embedded within the state-of-the-
art defence, as total lack of experience makes it impossible to foresee such risks and to
make estimates regarding the probability of accidents (Gran Skogh, Development
916 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
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 cach, negligence,
faute, culpa, dangerous activity, etc.) or, at worst, left to themselves in a
situation perhaps reminiscent of the pre-industrial caveat emptor para-
digm fiercely criticized by PL scholars.8 Despised and glorified, adopted
and rejected, transplanted, transposed, and altered, much has been said
mostly in Europe9 but also in Quebec10about this immunity from liabil-
ity that polarizes commentators along a left-right divide.
Risks, Strict Liability, and the Insurability of Industrial Hazards (1998) 23:87 The Ge-
neva Papers on Risk and Insurance 247 at 248).
8 The economic analysis of law (EAL) has greatly contributed to the idea that personal in-
jury damages must be borne by the enterprises responsible for putting the product on
the market. See e.g. Guido Calabresi, Some Thoughts on Risk Distribution and the
Law of Torts (1961) 70:4 Yale LJ 499 ([n]ot charging an enterprise with a cost which
arises from it leads to an understatement of the true cost of producing its goods; the re-
sult is that people purchase more of those goods than they would want if their true cost
were reflected in price at 514).
9 In the civilian world, see Pascal Oudot, Le risque de dveloppement: Contribution au
maintien du droit rparation (Dijon: ditions Universitaires de Dijon, 2005); Michel
Cannarsa, La responsabilit du fait des produits dfectueux (Milan: Giuffr, 2005); Yvan
Markovits, La directive C.E.E. du 25 juillet sur la responsabilit du fait des produits d-
fectueux (Paris: Librairie gnrale de droit et de jurisprudence, 1990) at para 226ff;
Jean-Sbastien Borghetti, La responsabilit du fait des produits (Paris: Librairie gn-
rale de droit et de jurisprudence, 2004) at 397ff; Agnese Querci, Il rischio da sviluppo:
Origini ed evoluzioni nella moderna societ del rischio [Development Risk: Origins
and Evolutions in Modern Risk Society] (2012) Danno e responsabilit (Special Issue: I
25 anni di products liability) 31; Pablo Salvador Coderch & Antoni Rub Puig, Riesgos
del desarrollo y demarcacin judicial de la buena ciencia [Development Risks and Ju-
dicial Delimitation of Good Science] (UC Berkeley: Berkeley Program in Law and
Economics, Latin American and Caribbean Law and Economics Association (ALACDE)
Annual Papers, 2008). In the common law tradition, see Mark Mildred, The Develop-
ment Risks Defence in Duncan Fairgrieve, ed, Product Liability in Comparative Per-
spective (New York: Cambridge University Press, 2005) 167; Christopher Hodges, De-
velopment Risks: Unanswered Questions (1998) 61:4 Mod L Rev 560; Simon Whit-
taker, Liability for Products: English Law, French Law, and European Harmonization
(Oxford: Oxford University Press, 2005); Stapleton, Product Liability, supra note 4. In
comparative law, see Cees van Dam, European Tort Law (Oxford: Oxford University
Press, 2006) at art 1410.
10 See Nathalie Vzina, Lexonration fonde sur ltat des connaissances scientifiques et
techniques, dite du risque de dveloppement: Regard sur un lment perturbateur
dans le droit qubcois de la responsabilit du fait des produits in Pierre-Claude La-
fond, ed, Mlanges Claude Masse: En qute de justice et dquit (Cowansville, Que:
Yvon Blais, 2003) 433. C.f. Pierre-Gabriel Jobin & Michelle Cumyn, La vente, 3d ed
(Cowansville, Que: Yvon Blais, 2007) at 296300; Claude Masse, La responsabilit ci-
vile (Droit des Obligations III) in Barreau du Qubec & Chambre des notaires du Qu-
bec, La rforme du Code civil, t 2 (Qubec: Les Presses de lUniversit Laval, 1993) 241
at 301ff.
THE DEVELOPMENT RISK DEFENCE
917
Beyond the civil law and common law divide, the exemption clause
crystallizes the link between some conceptions of justice and our contem-
porary 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 projec-
tion, through vertical comparison, at the supranational level (Part I). De-
spite 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 meld-
ing law and science within the courtroom, which has long stimulated de-
bate among evidence and causation experts. 12 Ultimately, indeed, the
DRDs 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
I. The Territories of the Development Risk Defence
As product liability spread to many of the industrial worlds legal sys-
tems, the DRD, too, marked both national and international levels.
Transported by circulating policy reasons and, possibly, path dependen-
cies, 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.
A. Supranational Moulds and Pathways
The 1960s were characterized by the spread of product liability maxi-
models throughout the industrialized world, including those established
11 See also Geraint Howells, Product Liability in Jan M Smits, ed, Elgar Encyclopedia of
Comparative Law (Cheltenham, UK: Edward Elgar, 2006) 578 at 583.
12 The defence might be useful in furthering scientific knowledge and testing. See John
Murphy & Christian Witting, Street on Torts, 13th ed (Oxford: Oxford University Press,
2012) (self-interest impels manufacturers to disclose all reports of tests on a product as
well as the expert opinion made available to them at 433).
13 Rosen v Ciba-Geigy Corp, 78 F (3d) 316 at 319, 64 USLW 2612 (7th Cir 1996).
918 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
in the Vienna Convention on Civil Liability for Nuclear Damage (1963);14
the European Convention on Products Liability in regard to Personal In-
jury and Death (1977), adopted under the auspices of the European Coun-
cil;15 and the later, famous European Union PL Directive. In light of the
general principles of monism and dualism that structure the law of trea-
ties, some models are mandatory, while others are persuasive guidelines
that emerge from academic or technocratic experiences (e.g., the Princi-
ples of European Tort Law (PETL)16 or the Uniform Law Conference of
Canada17); finally, some are of a hybrid nature, such as the American Re-
statement 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
14 Vienna Convention on Civil Liability for Nuclear Damage, 21 May 1963, 1063 UNTS
265, 2 ILM 727 (entered into force 12 November 1977). See also Convention on Third
Party Liability in the Field of Nuclear Energy of 29th July 1960, as amended by the Ad-
ditional Protocol of 28th January 1964 and by the Protocol of 16th November 1982, 29
July 1960, 956 UNTS 251 (entered into force 1 April 1968); Protocol to Amend the Vien-
na Convention on Civil Liability for Nuclear Damage, 29 September 1997, 36 ILM 1454;
Convention on Supplementary Compensation for Nuclear Damage, 29 September 1997,
36 ILM 1473.
15 European Convention on Products Liability in regard to Personal Injury and Death, 27
January 1977, Eur TS 91.
16 See e.g. The European Group on Tort Law, European Principles on Tort Law (New
York: SpringerWienNewYork, 2005). See generally Miquel Martn Casals, Una pano-
ramica sui Principles on European Tort Law (dalla prospettiva spagnola) [An Over-
view of Principles on European Tort Law (From the Spanish Perspective)] (2005) 70:6
Responsabilit civile e previdenza 1277.
17 See e.g. Uniform Product Liability Act adopted by the Uniform Law Conference of Can-
ada, online: Uniform Law Conference of Canada
defective if it falls short of the standard that may reasonably be expected of it in all the
circumstances (ibid, s 3(1)).
18 Restatement (Second) of Torts 402(A) (1965) [Restatement (Second)].
19 Restatement (Third) of Torts: Products Liability (1997) [Restatement (Third)]. See also
David Owen, Products Liability Law Restated (1998) 49:2 SCL Rev 273; Jane Staple-
ton, Restatement (Third) of Torts: Products Liability, an Anglo-Australian Perspective
(2000) 39:3 Washburn LJ 363 at 37374.
20 Restatement (Second), supra note 18 at 348.
THE DEVELOPMENT RISK DEFENCE
919
(whereas common law product liability stems from an extension of the du-
ty of care in tort law, applying Donoghue v. Stevenson21). The general rule
in section 402A was tempered by an exception, which was added to the
Restatement (Second) as a reporters commentcomment kthat explicit-
ly 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 in-
tended 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 con-
text, the comment argued that because there [was] no assurance of safe-
ty, economic actors should not be held liable for unfortunate conse-
quences.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 [c]onsumers, by definition, include
us all.27 In 1997, a new version, although criticized by some commenta-
tors, was proposed by ALI members. Section 2, comment d, of the Re-
statement (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
21 Donoghue v Stevenson, [1932] AC 562 HL (Scot), [1932] All ER Rep 1 (which removed
privity of contract as an obstacle to recovery).
22 Restatement (Second), supra note 18 at 353.
23 Ibid.
24 Nonetheless, the shift toward strict liability is a more complex confluence of events. See
Michael D Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substanc-
es Litigation (Philadelphia: University of Pennsylvania Press, 1996) at 813.
25 Restatement (Second), supra note 18 at 35354 [emphasis in the original].
26 Ibid at 354.
27 John F Kennedy, Address (Special Message to the Congress on Protecting the Consum-
er Interest, delivered 15 March 1962), online: The American Presidency Project
28 Restatement (Third), supra note 19 [emphasis added].
920 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
devices), it also crystallizes the learned intermediary doctrine29 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 pre-
scribe 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 Di-
rective, 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 ex-
perience, 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 de-
fect to be discovered.32 Commenting on the PL Directive in a European
Court of Justice (ECJ) case, Advocate General Tesauro stated that
the Council opted for a system of strict liability which was no longer
absolute, but limited, in deference to a principle of the fair appor-
tionment of risk between the injured person and the producer, the
latter having to bear only quantifiable risks, but not development
risks which are, by their nature, unquantifiable.33
Bolstered by the Thatcherism then in vogue, the DRD had success in
Brussels and other world capitals as well as academic endeavours.34 The
29 Concisely, the American-born doctrine states that manufacturers of prescription drugs
have a duty to warn prescribing physicians of the drugs known dangerous propensities,
and the physicians, in turn, using their medical judgment, have a duty to convey the
warnings to their patients (Kirk v Michael Reese Hospital and Medical Center, 513 NE
2d 387 at 392, 117 Ill 2d 507 (Sup Ct 1987)). See also Leesley v West, 518 NE 2d 758,
165 Ill App 3d 135 (App Ct 1988); Laws v Johnson, 799 SW 2d 249 (Tenn App Ct 1990);
Reyes v Wyeth Laboratories, 498 F 2d 1264 (5th Cir 1974). For a Canadian illustration,
see Buchan v Ortho Pharmaceutical (Canada) Ltd (1986), 25 DLR (4th) 658, 54 OR (2d)
92 (Ont CA) [Buchan (CA) cited to OR]; Hollis v Dow Corning Corp, [1995] 4 SCR 634 at
paras 2829, 129 DLR (4th) 609.
30 Restatement (Third), supra note 19 at 6(c) [emphasis added].
31 PL Directive, supra note 5, art 6.1 [emphasis added].
32 Ibid.
33 Commission v UK, C-300/95, [1997] ECR I-2651 at I-2658, Tesauro AG.
34 Among them is the Restatement of a single man: see Gert Brggemeier, Modernising
Civil Liability Law in Europe, China, Brazil and Russia (Cambridge: Cambridge Uni-
THE DEVELOPMENT RISK DEFENCE
921
culturally neutral language of economic sciences unsurprisingly bloomed
and flourished throughout the field of product liability, justifying just
about any of the forms it took, be they closer to negligence-based models
or risk-distribution anchored rationales.
Although in both the EU and the US harmonization of the DRD re-
mains optional,35 a fundamental difference exists between the two legal
systems: the rule is merely persuasive authority in the latter but becomes
truly normative in the former whenever a member state avails itself of
the option to adopt the DRD.36 The EU-style DRD harmonization process
requires further explanation. The integration of the DRD in the PL Di-
rective was so controversial that the European Council was politically
forced in 1985 to leave member states a discretionary margin to either
adopt or reject certain features of the directive including the DRD. For
example, article 15(1)(b) provides that
by way of derogation [each member state may] maintain or provide
in [its] legislation that the producer shall be liable even if he proves
that the state of scientific and technical knowledge at the time when
he put the product into circulation was not such as to enable the ex-
istence of a defect to be discovered.37
This discretionary freedom does not, however, allow member states to al-
ter the wording of the DRD as they see fit, as the degree of harmonization
versity Press, 2011) at 86 art 3:204, who proposes the following exclusion cause of liabil-
ity: A producer is particularly not liable where he can prove that the products defect,
at the point when it was marketed, did not exist or that the defect was not recognisable
through the current state of science and technology at this point [emphasis added]. The
adverb particularly and the adjective recognisable reflect the novelty of Brggemei-
ers reflection.
35 For a historical account, see Lori M Linger, The Products Liability Directive: A Manda-
tory Development Risks Defense (1991) 14 Fordham Intl LJ 478.
36 At first sight, the ECJs interpretation may appear confusing, as total harmonization is
the goal of regulations rather than directives.
37 The compromise is described as follows: Whereas … the [DRD] may be felt in certain
Member States to restrict unduly the protection of the consumer; whereas it should
therefore be possible for a Member State to maintain in its legislation or to provide by
new legislation that this exonerating circumstance is not admitted (PL Directive, supra
note 5 at 30). According to Van den Bergh and Visscher, [t]he goal to create a level
playing field for industry seems to be in contradiction with the essence of international
trade itself. Exploiting differences in legal systems may be objected on distributional
grounds, but it is not necessarily in conflict with the goal of allocative efficiency (Roger
Van den Bergh & Louis Visscher, The Principles of European Tort Law: The Right
Path to Harmonisation? (2006) 8 German Working Papers in Law and Economics 1 at
4 [emphasis added]).
922 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
sought is quite total given the sui generis, federal-inspired structure that
now characterizes the EU.38
The EU learned its lesson after France subordinated the application of
the DRD to a post-market duty of safety (obligation de scurit).39 The
ECJ came to the conclusion that the wording of this national measure de-
parted from the harmonized provision in article 7(e).40 To summarize, the
ECJ held 41 that the EU Council unanimity procedure that underlies
market-driven directives42 erected upon article 100 of the (former) Trea-
ty Establishing the European Economic Community43 (among them, the
PL Directive), is incompatible with a bottom-up, minimum approach, be-
cause they seek to eliminate legal divergences that may distort competi-
38 For a deeper analysis of the constitutional dimensions of liability rules, see Marie-Eve
Arbour, Scurit des produits, sant des consommateurs, responsabilits et constitu-
tions: Synergies compares (2013) 7:2 McGill JL & Health 169 at 191ff [Arbour, Scu-
rit des produits].
39 The producer cannot invoke the grounds of exemption from liability [such as the DRD]
if … he has failed to take appropriate measures to avert the harmful consequences
thereof (art 138612(2) C civ, modified by Loi No 2004-1343 du 9 dcembre 2004, JO,
10 December 2004, art 29 [translated by author]).
40 See Commission v France, C-52/00, [2002] ECR I-3856 at I-3874.
41 See ibid at I-386569.
42 The first recital of the PL Directive states:
Whereas approximation of the laws of the Member States concerning the liability of
the producer for damage caused by the defectiveness of his products is necessary
because the existing divergences may distort competition and affect the movement of
goods within the common market and entail a differing degree of protection of the
consumer against damage caused by a defective product to his health or property
(supra note 5 [emphasis added]).
As Howells rightly points out, [p]roduct liability does not directly impose barriers to
trade as it makes no specific requirement of products other than they are not defective.
Thus the justification must rest upon the distortion of competition ground (Geraint
Howells, Product Liability: A History of Harmonisation in Fairgrieve, supra note 9,
202 at 203). The rationale laying down the DRD is even more unsatisfactory, as it sug-
gests that a fair apportionment of risk between the injured person and the producer im-
plies that the producer should be able to free himself from liability if he furnishes proof
as to the existence of certain exonerating circumstances (PL Directive, supra note 5,
7th recital [emphasis added]). I have expressed doubts as to the relevancy of this as-
sumption: Sur le terrain de lempirisme … ltablissement dun rapport de cause effet
entre la svrit des normes de responsabilit civile et la vivacit de la recherche et du
dveloppement est taye de preuves contradictoires. Et il nest pas certain que la tche
qui consiste tablir cette corrlation choit aux
juristes (Marie-Eve Ar-
bour, Itinraire du risque de dveloppement travers des codes et des constitutions in
Benot Moore, ed, Mlanges: Jean-Louis Baudouin (Cowansville, Que: Yvon Blais, 2012)
677 at 684 [Arbour, Itinraire du risque).
43 25 March 1957, Eur TS 1 (Cmd 5179), amended by EC, Treaty of Lisbon Amending the
Treaty on European Union and the Treaty Establishing the European Economic Com-
munity, [2007] OJ C 306/1.
THE DEVELOPMENT RISK DEFENCE
923
tion and affect the movement of goods within the common market and en-
tail a differing degree of protection of the consumer against damage
caused by a defective product to his health or property.44 Rather, the ECJ
concluded that the margin of discretion available to the Member States
in order to make provision for product liability is entirely determined by
the Directive itself and must be inferred from its wording, purpose and
structure.45 Hence, it held that the discrepancies in the provisions of
French transposition laws were contrary to the spirit of the directive, and
although France aimed to increase protection for victims,46 this nonethe-
less violated EU law, as establishing a level playing field47 was the ra-
tionale underlying the PL Directive.48 Therefore, EU harmonization law
holds that inclusion of the DRD in a national legal panorama is optional,
but that whenever a member state chooses to do so, adherence to its spirit
(and conditions) must be quite total although interpretative flexibility is a
tool explicitly recognized by national courts. Disharmony in the law ad-
dressing tainted blood, for example,49 may well be explained by the diver-
gent approaches of the civil and common law to judicial discourse.50 None-
theless, the limits of such flexibility remain to be defined.
44 PL Directive, supra note 5 at 29.
45 Commission v France, supra note 40 at I-3867.
46 See Whittaker, supra note 9 at 450ff.
47 The paradigm is widely referred to in product liability scholarship: see e.g. van Dam,
supra note 9 at art 1505; Van den Bergh & Visscher, supra note 37. Nonetheless, the
various options left to member states rather seem to impede harmonization: see e.g.
Stephen Weatherill, EU Consumer Law and Policy (Cheltenham, UK: Edward Elgar,
2005) at 184.
48 PL Directive, supra note 5, 1st recital.
49 See especially Geraint Howells & Mark Mildred, Infected Blood: Defect and Discovera-
bility: A First Exposition of the EC Product Liability Directive (2002) 65:1 Mod L Rev
95; Shanti Williamson, Compensation for Infected Blood Products: A and others v Na-
tional Blood Authority and Another, online: (2003) 7:5 EJCL 5
France, see e.g. Yvonne Lambert-Faivre, Laffaire du sang contamin: Le risque de d-
veloppement, le principe indemnitaire face la pluralit dactions et les limitations de
garantis dassurance responsabilit civile (1996) D Jur 610. The relevant Italian law is
based instead on a provision for dangerous activities (art 2050 Codice civile). See gener-
ally Umberto Izzo, La precauzione nella responsabilit civile: Analisi di un concetto sul
tema del danno da contagio per via trasfusionale [Precaution in Civil Liability: Analysis
of a Concept on the Theme of Damage from Infection by Transfusion] (Trent: Universit
degli Studi di Trento, 2007), online: UNITN
50 This idea was expressed in Geraint Howells, Consumer Concepts for a European
Code? in Reiner Schulze, ed, New Features in Contract Law (Munich: Sellier European
Law Publishers, 2007) 119 at 131.
924 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
B. Of National Clones, Mutants, and Hybrids
In a German case that addressed personal injury caused by an explod-
ing glass bottle (the Mineralwasserflasche case),51 for example, the Bun-
desgerichtshof held that the DRD does not apply to manufacturing de-
fects, as
[w]hen the EC Directive on product liability was being fashioned it
was agreed that the defence under art. 7 (e) should apply not to
manufacturing defects, but only to defects of design and construction
… and the only dangers emanating from a product which the Ger-
man legislator wished to exempt from the scope of the Product Lia-
bility Law were dangers, undetectable even with the exercise of all
possible care, arising at the stage of design and construction.52
The court observed that the companys bottle control system was inade-
quate despite that it may well have been the best possible machinery.53
In fact, the court held that increased quality control by visual inspection
could contribute to preventing the harm caused by ausreisser (isolated de-
fective goods in the production line) and therefore insisted that the defect
is specific to the individual product.54 The judgment ultimately ruled in
favour of the plaintiffs, anchoring its conclusion on the general principle
of defect-based liability.55
Other member states availed themselves of the PL Directives discre-
tionary window (a compromise clearly designed to satisfy public opinion),
thereby depicting dissimilar scenarios in light of the very nature of the in-
51 See Bundesgerichtshof (Sixth Civil Senate), 9 May 1995, (1995) NJW 2162, translated
by Tony Weir, online:
serflasche].
52 Ibid at para 1 [emphasis added].
53 Ibid at para 2.
54 See ibid. The courts reasoning relies upon the technical explanation of the cause of the
defect. Be it attributable to a hairline crack, the defence would apply as the risk was
undiscoverable; be it a chipped area, conversely, it was discoverable and as such would
not trigger the defence: see Mildred, supra note 9 at 171. However, the court further
seems to merge these issues, as it indistinctively concludes that [t]he evidence shows
that the explosion which damaged the plaintiff was due either to a chip or to a hairline
crack, both of which are defects under 3 of the Product Liability Law (Mineralwas-
serflasche, supra note 51 at para 2 [emphasis added]).
55 See ibid. At the time Justice Burton was deliberating on A and others v National Blood
Authority and another ([2001] EWHC 446 (QB), [2001] 3 All ER 289 (QBD) [A and oth-
ers]), he was well aware of the German Mineralwasserflasche case, and to some degree
borrowed the narrow interpretation of the DRD that the Bundesgerichtshof had pro-
posed. Using slightly different vocabulary, Justice Burton established a dichotomy be-
tween standard and non-standard products in order to distinguish those that are manu-
factured according to their specifications from others (i.e., lemons or defective prod-
ucts) to which the DRD does not apply (see ibid at para 36).
THE DEVELOPMENT RISK DEFENCE
925
volved products. Because of these ad hoc responses to national
sometimes highly localizedconsumer product crises (thalidomide, wine,
oil, etc.), some products remain outside the DRDs field of application to-
day, including medicines in Germany; 56 foodstuffs in Spain; 57 or, in
France, blood products and body parts.58 The result is an unappealing,
compartmentalized structure within liability law, which has shrunk, ex-
panded, twirled, and been eradicated to the rhythm of political and moral
sentiments, often oblivious to a principle that shouldin my opinion59
always guide compensation law: that of equal treatment among victims
(galit horizontale). Despite this anti-aesthetic configuration, the model
has rapidly spread beyond the EU to many other countries, including
Australia,60 Switzerland,61 and Japan.62
Quebec, on the other hand, has adopted a dual product liability archi-
tecture rooted in both the Civil Code of Quebec63 and the Consumer Pro-
tection Act.64 Article 1473 of the 1991 reform of the CCQ mimics the EUs
DRD approach:
The manufacturer, distributor or supplier of a movable property is
not liable to reparation for injury caused by a safety defect in the
property … if he proves that, according to the state of knowledge at
the time that he manufactured, distributed or supplied the property,
the existence of the defect could not have been known, and that he
56 See Gesetz ber den Verkehr mit Arzneimitteln [Medicinal Products Act (The Drug
Law)], BGBl, 12 December 2005, 3394, s 84.
57 See Real Decreto Legislativo, de 16 de noviembre, 1/2007 por el que se aprueba el texto
refundido de la Ley General para la Defensa de los Consumidores y Usuarios y otras
leyes complementarias, BOE 287, 16 November 2007, 49181, art 140(3): En el caso de
medicamentos, alimentos o productos alimentarios destinados al consumo humano, los
sujetos responsables … no podrn invocar la causa de exoneracin.
58 Art 1386-12 C civ.
59 I have argued elsewhere that the suppression of a right of action in some legal systems
may even be unconstitutional. See Arbour, Itinraire du risque, supra note 42 at 682.
60 See Australian Consumer Law, s 142, being Schedule 2 to the Competition and Con-
sumer Act 2010 (Cth).
61 See Franz Werro, La jurisprudence et le droit compar: La rception des concepts juri-
diques trangers in Publications de lInstitut suisse de droit compar, ed, Permabilit
des ordres juridiques (Zurich: Schulthess, 1992) 165 at 166ff.
62 See Product Liability Act 1994 (Act No 85 of 1994, Japan), art 4; Hiroyuki Hirano, La
scurit du consommateur au Japon in lAssociation Henri Capitant des amis de la cul-
ture juridique franaise, ed, Le consommateur, t 57 (Brussels, Paris; Bruylant, LB2V,
2007) 407 at 407; Luke Nottage, Comparing Product Safety and Liability Law in Ja-
pan: From Minamata to Mad Cowsand Mitsubishi in Fairgrieve, supra note 9, 334
at 335.
63 LRQ, c C-1991 [CCQ].
64 RSQ, c P-40.1 [CPA].
926 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
was not neglectful of his duty to provide information when he became
aware of the defect.65
Much uncertainty remains regarding the application of the defence,66
and it is still unclear whether it applies to contractual liability.67 The de-
fence has clearly not been adopted in section 53 of Quebecs Consumer
Protection Act, which allows victims to recover based on strict liability, as
[t]he merchant or the manufacturer shall not plead that he was unaware
of the defect or lack of instructions.68
Finally, some states never seriously considered adopting the DRD
(e.g., Finland and Luxembourg); others have been unenthusiastic about
judge-made product liability schemes to begin with (such as most Canadi-
an common law provinces,69 which tend to opt for the state-of-the-art
standard that is better suited to the catch-all tort of negligence70). Moreo-
ver and by reason of a constitutional interference (pre-emption71), Ameri-
can victims are prevented altogether from initiating actions based on fail-
65 Art 1473 CCQ [emphasis added].
66 See ABB Inc v Domtar Inc, 2007 SCC 50, [2007] 3 SCR 461. At least in Quebec, case-
law seems to be reluctant to it, but see Berthiaume c Val Royal Lasalle Lte, [1992] RJQ
76, JE 92-71. For a similar observation in France, see Borghetti, supra note 9 at 555
60.
67 See Vzina, supra note 10 at 45354.
68 CPA, supra note 69, s 53, para 3. See Marie-Eve Arbour, Garantie de qualit: Droit de
la consommation in Pierre-Claude Lafond & Grald Goldstein, eds, Contrats nomms I
(Montreal: LexisNexis, 2001) fasc 8. Similarly, the new Civil Code of the Peoples Repub-
lic of China, Book VIII: Law of Delict/Act on Liability Law (2009), is silent on the mat-
ter: see Brggemeier, supra note 34 at 190.
69 See Denis W Boivin, Strict Products Liability Revisited (1995) 33:3 Osgoode Hall LJ
487; Andersen v St Jude Medical Inc, [2002] OTC 53, 111 ACWS (3d) 234 (Ont Sup Ct):
There is good reason to leave to the legislatures the decision on whether to impose
strict liability on manufacturers, and whether that should be done in all industries
(Dambrot J at para 38).
70 See e.g. Privest Properties Ltd v Foundation Co of Canada Ltd, 128 DLR (4th) 577, 11
BCLR (3d) 1.
71 See e.g. Cipollone v Liggett Group, 505 US 504, 112 S Ct 2608 (1992); Medtronic v Lohr,
518 US 470 at 485, 116 S Ct 2240 (1996); Geier v American Honda Motor Co, 529 US
861, 120 S Ct 1913 (2000); Altria Group, Inc v Good, 555 US 70, 129 S Ct 538 (2008);
Riegel v Medtronic, 552 US 312, 128 S Ct 999 (2008). See also Robert RM Verchick &
Nina Mendelson, Preemption and Theories of Federalism in William W Buzbee, ed,
Preemption Choice: The Theory, Law, and Reality of Federalisms Core Question (New
York: Cambridge University Press, 2009) 13 at 1519; Catherine M Sharkey, Federalism
in Action: FDA Regulatory Preemption in Pharmaceutical Cases in State Versus Federal
Courts (2007) 15:3 JL & Poly 1013; Peter H Schuck, FDA Preemption of State Tort Law
in Drug Regulation: Finding the Sweet Spot (2008) 13:1 Roger Williams U L Rev 73. For
an account of the subject in French, see Arbour, Scurit des produits, supra note 38
at 178ff.
ure to warn (information defect) when it comes to certain products (e.g.,
medical devices and tobacco products).72
THE DEVELOPMENT RISK DEFENCE
927
II. Knowledge or Uncertainty? The Methodology Maze
As already mentioned, the premise underlying the DRD is surprising-
ly simple. Overly broad liability chills innovation, threatens to make cer-
tain products entirely unavailable, and increases insurance premiums. To
avoid these negative effects, the DRD aims to strike an acceptable com-
promise. It reintroduces the knowledge variable that is usually excluded
by strict product liability schemes, which focus on product defects, evoking
common law dialectics between foreseeable and unforeseeable, avoidable
and unavoidable. Accordingly, producers of defective goods are legally ex-
cused if insufficient scientific knowledge was available at the time the
product was commercialized. Recent product liability scholarship has dis-
tilled a two-prong DRD test out of the knowledge element and the discov-
ery variables, which gives rise to a sui generis, EU-style product liability
regime, distinct from the American approach.73 Although helpful, this
framework raises four difficult questions that will undoubtedly require
judicial clarifications. First (Subsection A), how accessible must the
knowledge be? Second (Subsection B), who must it be available to, and
what criteria should be used to evaluate it? Third (Subsection C), how
should the ethical questions be addressed that arise whenever producers
of goods generate knowledge regarding the very products they put on the
market? Finally (Subsection D), how should novel or marginal scientific
opinions be evaluated?
A. The Domain of Knowledge: Existing Data and Accessibility
Although still scarce, recent comparative case law analysis has shed
light on a possibility to avoid liability rooted in scientific and technical
knowledge, and, by implication, the producers capacity to avoid risks.
Knowledge entails two conditions: that relevant data indeed exists, and
that it be accessible to the producer. The least worrying concern is acces-
sibility, which may now be moot due to the proliferation of online data-
bases and search engines (e.g., open access services, Google Scholar, etc.)
and the hegemony of the English language within academia and the sci-
entific community. Accessibility refers to the potential to identify the re-
sults of technical and R&D studies. By 1997, a well-known ECJ case74 had
72 See ibid.
73 See Lucas Bergkamp & Rod Hunter, Product Liability Litigation in the US and Eu-
rope: Diverging Procedure and Damage Awards (1996) 3 MJECL 399.
74 See Commission v UK, supra note 33.
928 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
already provided valuable insight as to the reach of the DRD. The ECJs
case, coupled with Advocate General Tesauros opinion, began to establish
the parameters of the knowledge element embedded in the DRD.75 Indeed,
the former had set the table for establishing the parameters of the
knowledge element of the DRD with the predictable, academic Manchu-
rian hypothesis: Does a tiny publication in the Mandarin language con-
stitute accessible knowledge? Probably not. Is knowledge coterminous
with peer-reviewed articles written in English? Probably not. Scientific
and technical knowledge remains, reasonably enough, a factual question
that is left to courts discretion.
Existing data refers to scientific information surrounding a given risk,
founded on sources such as trials or experiments whose results are ex-
posed and discussed in scholarly publications. A wide interpretation of the
text of article 7(e) suggests that producers ought to know every scientific
result, in every relevant technical or scientific field, that could enable
them to discover the defect. This heavy informational burden has been
criticized by invoking a hypothetical lucky plaintiff who turn[s] up in-
formation from a totally unexpected field76 which precludes the defend-
ant from availing himself of the DRD.
At least in Germany, the impossibility of improving a product due to
lack of scientific knowledge is no defence to liability when, though una-
voidable, a risk is known to the producer. This conclusion was reached by
the Bundesgerichtshof in a seminal German case77 that held that the ex-
plosion of a glass bottle containing mineral water does not fall within the
scope of the development risk exemption, as such risk is known to produc-
ers. The court seemingly shifted its focus away from the defect toward the
risk of harm itself. Although there were no technical means available to
prevent the (rare) occurrence of this risk, the court stuck to a narrow in-
terpretation of the knowledge element and discarded the arguments the
defendant had put forward to exclude himself from liability. These
thoughts echoed in London when Justice Burton, apparently seduced by
the Germanic argument, held in the context of contaminated blood litiga-
tion that
[i]t would, in my judgment, be inconsistent with the purpose of the
directive if a producer, in the case of a known risk, continues to sup-
ply products simply because, and despite the fact that, he is unable
75 See ibid at I-2659. See also A and others, supra note 55 at paras 4749.
76 Christopher Newdick, Risk, Uncertainty and Knowledge in the Development Risk De-
fence (1991) 20 Anglo-Am L Rev 309 at 310.
77 Mineralwasserflasche, supra note 51. More recently, see OLG Munich, 11 January
2011, (2011) Az 5 U 3158/10 (available on openJur). In a similar context in Belgium, see
Civ Namur, 5e Ch, Riboux v SA Schweppes Belgium (21 November 1996).
THE DEVELOPMENT RISK DEFENCE
929
to identify in which if any of his products that defect will occur or re-
cur.78
Seemingly, the boundaries of the DRD are interpreted narrowly, thereby
confining the scope of an exoneration clause that seems at odds with the
risk distribution rationale that underlies product liability.
B. The Whom Question
Another of the most critical issues was articulated by Newdick: [T]o
whom ought that information be available before it may be described as
discoverable?79 Is knowledge to be evaluated in light of subjective or ob-
jective criteria? The whose knowledge? question was at the core of
Commission v UK.80 In their transplant of the PL Directive, English legis-
lators adopted a formulation of the supranational instrument that reject-
ed key features of the DRD. In their place, the UK substituted an assess-
ment of scientific knowledge from the standpoint of a producer of prod-
ucts of the same description as the product in question81 (i.e., the produc-
ers perspective). The UK provision uses the language of negligence: refer-
ence to classes of producers suggests reasonableness, objective standards,
and other porous terms well known to common lawyers.82 Despite this
clear disparity in the wording of the provisions, the ECJ came to the con-
clusion that the action introduced by the Commission was premature,
given that UK courts might still interpret the PL Directives section 7(e)
national clone in conformity with EU law. According to Attorney General
Tesauro, however, this knowledge standard is not concerned with the
practices and safety standards in use in the industrial sector in which the
producer is operating.83
As a result of the above-mentioned criterion, knowledge needs to be
apprehended in light of a twin notion: that of discoverability, which in
turn leads to the labyrinth of causation.84
78 A and others, supra note 55 at para 74.
79 Newdick, supra note 76 at 310.
80 Commission v UK, supra note 33.
81 Consumer Protection Act 1987 (UK), c 43, s 4(1)(e).
82 See Mildred, supra note 9 at 168.
83 Commission v UK, supra note 33 at I-2658.
84 Although highly relevant, much of the debate surrounding causation will be left aside
here. For a thorough analysis, see Goldberg, Causation and Risk, supra note 3; Richard
Goldberg, ed, Perspectives on Causation (Portland, Or: Hart, 2011); Lara Khoury, Cau-
sation and Health in Medical, Environmental and Product Liability (2007) 25:1 Wind-
sor YB Access Just 135. See also Christophe Quzel-Ambrunaz, Essai sur la causalit
930 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
C. Enabling, Discovery, and Business Ethics
Discoverability purports to establish the elusive link between
knowledge and proof of a defectthe trail of breadcrumbsallowing an
inference that an improper R&D process caused the defect. While
knowledge may be described as a bundle of objective information, discov-
erability refers to a manufacturers intellectual capacity to assemble the
pieces of the puzzle to enable the existence of the defect to be discov-
ered.85 The key word is likely the verb enablemeaning permit86
which, despite lending itself to varying interpretations, clearly introduces
a subjective element into the evaluation of the DRD. The question be-
comes whether, aside from dissenting or isolated opinions (discussed be-
low), the knowledge available was such as to allow, scientifically speak-
ing, the producer to discover the defect. Did he have the benefit of the in-
terdisciplinary knowledge of a scientific, technical team87 or rather con-
sciously handpick from available information in a teleological fashion? In
this context, evaluation of a producers behaviour may discover a partial
merging of the DRD and the state-of-the-art defence.
Evaluation of the safety of everyday products usually calls for
knowledge of technical standards (e.g., ISO, CEN, DIN). Assessing prod-
ucts with significant R&D cycles often entails the difficult task of combin-
ing two or more data sources. Airplanes may today be faster, safer, and
ever more comfortable due to advances in metal alloys, physics, thermal
radiation, electronic devices, meteorological science, etc. Would all this
knowledge preclude the DRD, say, in the context of the Air France flight
447 accident over Brazil? Was Airbus capable of anticipating the risk of
data distortion due to the presence of ice crystals in its airspeed meas-
urement device, despite the fact that [t]he obstruction of the Pitot probes
by ice crystals during cruise was a phenomenon that was known but mis-
understood by the aviation community at the time of the accident?88 In
the case of experimental productsexcepting GMOs, drugs, and medical
devicesthere might be little, contradicting, or no knowledge at all. Of-
en droit de la responsabilit civile (Paris: Dalloz, 2010); other contributions in the ins-
tant volume.
85 PL Directive, supra note 5, art 7(e).
86 See A and others, supra note 55 at paras 51, 183.
87 See Oudot, supra note 9 at 40.
88 See Bureau dEnqutes et dAnalyses pour la scurit de laviation civile (BEA), Final
Report on the accident on 1st June 2009 to the Airbus A330-203 registered F-GZCP op-
erated by Air France flight AF 447 Rio de JaneiroParis (July 2012), online:
ed]. The causes of this tragedy were, however, even more complex, as human error also
contributed.
THE DEVELOPMENT RISK DEFENCE
931
ten, producers generate their own knowledge through the R&D they di-
rectly carry on or sponsor. They might know that a particular molecule
cures a pathology, but remain unaware of its effects when combined with
another. In such cases, does the enabling factor refer to the methodolog-
ical capacity of the producer to gather sufficient knowledge (and if so, to
what extent?), or is discoverability to be ascertained through existing
knowledge stemming, say, from clinical trials? There is evidence of the
discoverability loop in the thalidomide story, as the trials conducted on
animals had failed to prove the drugs toxicity. Rats did not metabolize
the drug, and it was assumed the same would be true for humans, but
this was ultimately true of many tests in which extrapolation of animal to
human response is impossible.89 In such circumstances the producer did
not have knowledge, and thus, the DRD appears to apply, leaving victims
without compensation. An alternative approach is to suggest that the
producer was in fact able to discover the defect, had it combined the result
of these trials (knowledge) with proper human clinical trials (discoverabil-
ity).
the discoverability variable? Barker et al. ask the right question:
[W]hat if there is some evidence that the product may have been de-
fective but the causal connection has not been established according
to the usual scientific methods used to determine whether use of a
product can cause a particular side effect (and hence be defective as
not being as safe as persons generally are entitled to expect)?90
In other words, what are the effects of traces or partial knowledge on
They add: Can the [DRD] apply to a supply of the drug at the time the
potential risk was discovered but before it had been established whether
the risk was a real risk? It appears that it can.91 Until now, case law has
remained focused on knowledge, neglecting discoverability. Nonetheless, a
Dutch case handed down in the sensitive context of contaminated blood
concluded that the DRD applied in the following context.92 The plaintiff
contracted HIV during the famous window period in which detection is
impossible (that is, the period between the moment of infection and the
89 See Carl F Cranor, Toxic Torts: Science, Law, and the Possibility of Justice (New York:
Cambridge University Press, 2006) at 10.
90 Kit Barker et al, The Law of Torts in Australia, 5th ed (South Melbourne: Oxford Uni-
versity Press, 2012) at 65455 [first emphasis in original, second emphasis added]. The
authors provide a further example: Initial testing on a drug, say, may reveal that it is
possible that it could cause certain side effects but further testing is required to estab-
lish whether it does so (ibid at 655).
91 Ibid at 655.
92 RB Amsterdam, 3 February 1999, Scholten v The Foundation Sanquin of Blood Supply
(1999) NJ 1999 621. See also Goldberg, Medicinal Product Liability and Regulation, su-
pra note 3 at 2223.
932 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
actual development of HIV detectable antibodies); so that the risk, hence,
was unavoidable. The court of first instance held that the blood supplier
had acted in light of technological and scientific knowledge at the time of
the transfusion. Was the defect discoverable with the help of proper re-
search and development (and funding)? The court never really asked that
question, as it rather relied on the consumer expectation test: the general
public is entitled to expect that blood products in the Netherlands have
been 100% HIV-free for some time.93 Moving away from the prevailing
objective criteria that the landmark case A and others had advocated, the
Dutch case, precisely through the door left open by the discoverability el-
ement, seems to reintroduce the possibility of American-inspired interpre-
tations.
Discoverability gains further force when the producer is capable of set-
ting its own development risk boundaries through corporate strategies.
Bureaucracies do not repeat R&D already carried out in laboratories and
universities. Once invited to release a market authorization, for example,
national regulators (e.g., Health Canada) and supranational agencies
(e.g., European Medicines Agency, the Food and Drug Administration)
evaluate the methodology that underlies scientific knowledge. Techno-
crats analyze the exactitude of scientific correlations between variables to
assess the risks and potential benefits. However, the formulation of hy-
potheses and even the very selection of appropriate variables, through
protocols, are among the prerogatives of the researchers, who will de-
cidewhenever economically feasible94what will be studied95 in order to
meet the regulators requirements. Ironically enough, it may not be in a
producers best interest to know too muchincluding pharmacogenomic
effects96as too much knowledge could lead to the exclusion of the DRD,
and, consequently, expose producers to liability. A group of Australian au-
93 Daily Wuyts, The Product Liability Directive: More Than Two Decades of Defective
Products in Europe (2014) 5:1 Journal of European Tort Law 1 at 9.
94 See Goldberg, Causation and Risk, supra note 3 at 230.
95 The producer is not alone in this task, as ethics committees and international standards
exist to help carry out the research ethically. Nonetheless, the standards (best prac-
tices) and approval processes have more to do with the research materials and subjects
than the parameters. See e.g. US, National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for
the Protection of Human Subjects of Research (The Belmont Report) (18 April 1979), now
embedded in Basic HHS Policy for Protection of Human Research Subjects, 45 CFR
46.10146.124 (1991).
96 For an explanation of pharmacogenomics, see Richard Weinshilboum, Inheritance and
Drug Response (2003) 348:6 New Eng J Med 529 (explaining that [a]s our knowledge
of genetic variations in proteins involved in the uptake, distribution, metabolism, and
action of various drugs improves, our ability to test for that variation and, as a result, to
select the best drug at the optimal dose for each patient should also increase at 536).
THE DEVELOPMENT RISK DEFENCE
933
thors accordingly note this incentive for a defendant not to conduct the
necessary further testing to establish the causal connection, although the
failure to do so may well amount to common law negligence.97
Commenting on the UK blood contamination case A and others,98 an-
other author formulated similar comments, emphasizing that
[o]ne issue which was left unclear by Burton Js judgment is whether
the conduct of the producer, particularly in relation to efforts to dis-
cover the relative safety of a product by comparing it with another, is
to be taken into account when assessing the discoverability of the de-
fect.99
Although this would have properly addressed the discoverability issue,
scrutinizing safety testing amounts to reintroducing fault into the product
liability dialectic, and would certainly expand the length and complexity
of trials, which strict liability sought, in the wake of the 1970s, precisely
to circumvent.
A single example will suffice to illustrate these difficulties. In the re-
cent 222-page Canadian common law negligence case Andersen v. St.
Jude Medical,100 the safety of heart valves coated with Silzone was the ob-
ject of a class action after some patients suffered thromboembolic compli-
cations. Designed and manufactured by the defendant, the medical device
had been authorized for distribution and sale in Canada in 1997.101 After
being regularly implanted in patients beginning in September 1997, a
voluntary recall of the valves was issued on 21 January 2000. A clinical
trial carried on while the device was on the marketunder the name
AVERT102had brought to light a small, but statistically significant in-
97 Barker et al, supra note 90 at 655, n 121. Conversely, Australian courts have held the
defendant liable although there were no means to test for the defect at time of the sale.
See e.g. Ryan v Great Lakes Council, [1999] FCA 177, 102 LGERA 123, affd [2000] FCA
1099, 177 ALR 18. See also Claudia Newman-Martin, Manufacturers Liability for Un-
discoverable Design Flaws in Prescription Drugs: A Merck-Y Area of the Law (2011) 19
Torts Law Journal 26.
98 See A and others, supra note 55.
99 Leigh-Ann Mulcahy, Civil Law Liability in Peter Feldschreiber, ed, The Law and
Regulation of Medicines (New York: Oxford University Press, 2008) 181 at 201 [empha-
sis added].
100 Andersen v St Jude Medical, 2012 ONSC 3660 (available on QL), Lax J [Andersen].
101 It was only approved by the FDA in March 1998.
102 AVERT was a randomized control trial (RCT) sponsored and funded by St. Jude and is
an acronym for Artificial Valve Endocarditis Reduction Trial. Its purpose was to study
whether Silzone was clinically effective in reducing prosthetic valve endocarditis, but its
protocol included the collection of data on adverse events that are complications of valve
surgery. The protocol specified that the study would take four years to complete (An-
dersen, supra note 100 at para 26).
934 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
crease in explants due to a medical complication known as paravalvular
leak (PVL).103 The AVERT study, hence, ended prematurely in 1999. As
36,000 devices had already been sold, national regulators took varying ac-
tion to manage the risk.104
defective products:
The decision captured the spirit of manyif not allactions involving
While it would be nave to think that the company was unconcerned
about profits or protecting its intellectual property, no valve manu-
facturer would be in business very long if it neglected patient safety
and marketed products that didnt work.105
The crux of the case materializes in the key issue surrounding the allega-
tion of a design defect, which the court summarizes by asking whether a
Silzone coating on a mechanical heart valve [put] patients at a materially
increased risk of experiencing one or more … complications.106 The court
answered this question negatively, holding that
the plaintiffs did not establish that the defendants failed to exercise
a reasonable degree of care in the pre-market design and testing or
in the post-market surveillance of Silzone-coated products that
would be expected of a reasonable and prudent prosthetic heart
valve manufacturer in similar circumstances.107
More specifically, the plaintiffs had argued that although the defendant
St. Jude complied with the FDAs Draft Heart Valve Guidance, ISO
5840108 and ISO 10993109 standards,110 more testing should nonetheless
103 Ibid at para 1. Silzone is a proprietary term for a coating comprising layers of titanium,
palladium and an outer layer of metallic silver. This was applied to the polyester (Da-
cron) sewing cuff that surgeons use to attach a prosthetic heart valve to heart tissue
(ibid at para 2).
104 By way of an advice notice, the United Kingdom Medical Devices Agency (MDA)
warned physicians about these safety concerns; regulators in Australia and New Zea-
land immediately withdrew market approval, while Health Canada and the FDA,
though informed by the Data Safety Monitoring Board (DSMB) of the risk uncovered in
the AVERT clinical trial, took no action.
105 Andersen, supra note 100 at para 73. The court added that [e]vidence that a business is
motivated by profit cannot, without more, be treated as evidence that it fell below the
standard of care. At most, the evidence demonstrates that St. Jude behaved as would be
expected of a commercially-motivated party (ibid at para 74).
106 Ibid at para 5 [emphasis in original].
107 Ibid at para 6.
108 See International Organization for Standardization, ISO 5840: Cardiovascular im-
plantsCardiac valve prostheses, 4th ed (Geneva: ISO, 2005). The abstract states that
ISO 5840
outlines an approach for qualifying the design and manufacture of a heart
valve substitute through risk management. The selection of appropriate
qualification tests and methods are derived from the risk assessment. The
THE DEVELOPMENT RISK DEFENCE
935
have been done following pre-clinical (in vitro) and animal trials,111 there-
by contesting the American-style risk utility assessment112 advocated by
the defendant.113
St. Jude appears to have sought regulatory approval of its Silzone-
coated valve despite gaps in knowledge about its clinical effectiveness:114
cautionary labelling reflected the strategic step-by-step approach taken by
the defendant. The plaintiff believed the coated valve offered no greater
benefit than another one already marketed by the same defendant. On
this issue, the court held that the risk utility test does not require defend-
ants to assess
whether the benefits of the Silzone valve outweighed the benefits of
the conventional valve relative to their risks. Rather, it was required
to consider whether the potential benefits associated with the addi-
tion of Silzone outweighed the potential risks of Silzone.115
Methodologically, the court confined the analysis to the device itself, shift-
ing away from the American idea suggesting that product comparison and
tests may include those to assess the physical, chemical, biological and me-
chanical properties of heart valve substitutes and of their materials and
components [in addition to] those for pre-clinical in vivo evaluation and clini-
cal evaluation of the finished heart valve substitute.
109 See International Organization for Standardization, ISO 10993: Biological evaluation
of medical devices, parts 120 & Supp (Geneva: ISO, [nd]) (sets standards in order to
assess the biocompatibility of a medical device at the preclinical stage).
110 The Ontario court stated that [t]he plaintiffs led no evidence at trial of Canada-specific
industry standards and they acknowledge that the FDAs Guidance document and ISO
standards are relevant in determining whether St. Jude met industry standards (An-
dersen, supra note 100 at para 103).
111 Ibid at para 58.
112 This requires a balancing or weighing of foreseeable risk against the foreseeable utility
of the product based on information available to the manufacturer at the time of distri-
bution of the product and without the benefit of hindsight (ibid at para 61). The Court
relies on Rentway Canada Ltd v Laidlaw Transport Ltd, 49 CCLT 150 at paras 4346,
16 MVR (2d) 86 (Ont SC (H Ct J)), affd 45 ACWS (3d) 373 (available on QL) (Ont CA);
Ragoonanan Estate v Imperial Tobacco Canada Ltd, (2000) 51 OR (3d) 603 at paras
10304, 4 CCLT (3d) 132 (Ont Sup Ct (Civ Div)).
113 The court stated that they disagreed on
(i) the degree of certainty the defendants were required to have about the
benefits of Silzone before distributing the product, (ii) the reasonableness of
the product development process including the testing undertaken and the
manner in which the testing results were interpreted and, (iii) the role and
impact of industry and regulatory standards and practices and regulatory
approval (Andersen, supra note 100 at para 60).
114 See ibid at para 94.
115 Ibid at para 95 [emphasis added].
936 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
safer alternatives be at the heart of asserting defectiveness. Accordingly,
in the eyes of the court the conventional valve did not meet the same need
as the Silzone valve because it did not address the risk of [prosthetic valve
endocarditis].116 Through these lenses, the coated valve brought about
distinct risks, and different benefits, as PVE was a known risk with the
conventional valve that the Silzone valve had the potential to address.117
The case was therefore dismissed.
In the UK, scholarship suggests that industry practice is less relevant
than industry capability, or the potential for greater safety, in judging
whether a state of the art defence is made out.118 Albeit stringent, the
hybrid nature of such a position appears more satisfactory, as some objec-
tiveness in the criteria allows judges to leave aside dubious corporate
choices designed to avoid specific risk testing.119 From a conceptual point
of view, though, asserting the centrality of such a paradigm may well
amount to merging, as was already mentioned, the DRD with the distinct
state-of-the-art defence and vocabulary.
D. Eppur si muove … (Thou Shall Dissent)
This raises a final question, as R&D is largely advanced by initially
marginal scientific voices: Were Galileo and Copernicus aware of the close
intimacy between dissent and heresy? What are the weight and rele-
vance of dissent and isolated scientific opinions? In his submission to the
ECJ in Commission v. UK, Attorney General Tesauro rightly pointed out
that the progress of scientific culture does not develop linearly in so far as
new studies and new discoveries may initially be criticized and regarded
as unreliable by most of the scientific community, yethe added
subsequently after the passage of time undergo an opposite process of
beatification whereby they are virtually unanimously endorsed. 120 He
then tackled the issue directly: [W]here there is a risk that is not certain
116 Ibid at para 96 [emphasis added].
117 Ibid at para 95.
118 Simon Deakin, Angus Johnston & Basil Markesinis, Markesinis and Deakins Tort
Law, 6th ed (New York: Oxford University Press, 2008) at 739 [emphasis in original].
119 Say, for example, that a drug manufacturer knows the effect of A (molecule) + B (pa-
thology-1) + C (posology) on human health, but suspects that A (molecule) + B (patholo-
gy-2) + C (posology) might produce significant side effects, so the drug manufacturer
does not proceed with drug testing for pathology-2, fearing disastrous scientific and
commercial results. How would a similar situation be handled by the DRD?
120 Commission v UK, supra note 33 at I-2659 [emphasis added].
THE DEVELOPMENT RISK DEFENCE
937
and will be agreed to exist by all only ex post, [may] the producer … still
rely on the [DRD]?121 In answer to his own query,122 he stated that
the state of scientific knowledge cannot be identified with the views
expressed by the majority of learned opinion, but with the most ad-
vanced level of research which has been carried out at a given time.123
The scientific community recently provided an interesting example, by
investigating whether eating genetically modified maize causes health
problems in laboratory rats. The answer suggested in a scholarly article
published in Food and Chemical Toxicology by G.-E. Sralini et al. is that
it does, as their research results
demonstrate that lower levels of complete agricultural glyphosate
herbicide formulations, at concentrations well below officially set
safety limits, induce severe hormone-dependent mammary, hepatic
and kidney disturbances. Similarly, disruption of biosynthetic path-
ways that may result from overexpression of the EPSPS transgene
in the GM NK603 maize can give rise to comparable pathologies that
may be linked to abnormal or unbalanced phenolic acids metabolites,
or related compounds.124
In sum, the significant biochemical disturbances and physiological fail-
ures documented in this work confirm the pathological effects of these
GMO and R treatments in both sexes, with different amplitudes.125 Many
scientists fiercely opposed these results, arguing that the type of rats used
in the study was predisposed to tumours, and that the statistical evidence
presented was inconclusive.126 These methodological gaps therefore alleg-
edly contaminated the experiment and gave rise to results thatdespite
being subjected to appropriate peer reviewwere not scientifically
sound.127 Is Sralinis article credible? When a reliable answer cannot be
121 Ibid.
122 The relevance of the isolated opinion seems to be unclear. See Goldberg, Causation
and Risk, supra note 3 at 225.
123 Commission v UK, supra note 33 at I-2659 [emphasis added].
124 Gilles-Eric Sralini et al, Long Term Toxicity of a Roundup Herbicide and a Roundup-
Tolerant Genetically Modified Maize (2012) 50 Food and Chemical Toxicology 4221 at
4230 [emphasis added].
125 Ibid.
126 See e.g. Alexander Y Panchin, Letter to the Editor, Toxicity of roundup-tolerant genet-
ically modified maize is not supported by statistical tests (2013) 53 Food and Chemical
Toxicology 475. Critics abound; these are but random examples found in a foray into
pure science databases.
127 Sralinis study was later removed from Food and Chemical Toxicologys pages. Indeed,
the editors held that
[u]ltimately, the results presented (while not incorrect) are inconclusive, and there-
fore do not reach the threshold of publication for Food and Chemical Toxicology. The
938 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
found within the scientific community, it is even more elusive to legal ex-
perts, who are intellectually ill equipped to second-guess scientists meth-
odological choices and tactics. In such matters, speculation is always at
best tentative and at worst empty rhetoric.
From a legal standpoint, then, what can possibly be done in the face of
such scientific polemics? Coderch and Puig anticipated the problem trig-
gered by uncertain science that may nonetheless influence the amount
and quality of knowledge128 for the purpose of making findings on a bal-
ance of probabilities.129 Quite predictably, the debate leads to the junk sci-
encegood science dialectic, which underlies the landmark American case
of Daubert,130 as the criteria embedded in the DRD invite analysis of the
scientific evidence presented by expert witnesses (whether appointed by
the court or hired by the parties).131 In a different context, the Australian
decision in Peterson v. Merck Sharp & Dohme132 was a pharmaceutical
consumer class action involving the drug Vioxx. The court held in that
case that the drugs side effects were not sufficiently known to the produc-
er so as to constitute scientific knowledge. The drug had been approved
around 1999 by regulators but was withdrawn from the market in the fall
of 2004 after a study revealed that its side effects included doubling the
risk of adverse cardiovascular events.133 A year later, the federal appeals
peer review process is not perfect, but it does work. The journal is committed to get-
ting the peer-review process right, and at times, expediency might be sacrificed for
being as thorough as possible (Elsevier, Press Release, Elsevier Announces Article
Retraction from Journal Food and Chemical Toxicology (28 November 2013) online:
Elsevier
128 See Coderch & Puig, supra note 9 at 2327.
129 In this regard, scientific philosophical schools of thought (Popper, Kuhn, Galileo, etc.)
may not be of the utmost relevance to lawyers. Newdick (supra note 76) and Coderch &
Puig (supra note 9) have summarized these debates.
130 Daubert v Merrell Dow Pharmaceuticals, 509 US 579, 113 S Ct 2786 (1993). The criteria
adopted by the US Supreme Court were echoed in Ottawa. See e.g. R v JLJ, [2000] 2
SCR 600 at para 32, 192 DLR (4th) 416; R v Trochym, 2007 SCC 6 at para 36, [2007] 1
SCR 239. Similar issues have been raised in an environmental context. See Spieser v
Canada (PG), 2012 QCCS 2801 at paras 2021 (available on CanLII).
131 See Jean-Louis Baudouin & Patrice Deslauriers, La responsabilit civile, Volume II:
Responsabilit professionnelle, 7th ed (Cowansville, Que: Yvon Blais, 2007). Baudouin
and Deslauriers suggest that theoretical disparity might lead to confusion between
legal causality and scientific causality: Devant une seule thorie propose par le de-
mandeur, et plusieurs souleves par la dfense, la jurisprudence, bien souvent, estime
que le premier ne sest pas adquatement dcharg du fardeau probatoire qui est le
sien (ibid at para 2-107).
132 Merck Sharp & Dohme v Peterson, [2011] FCAFC 128 at paras 20608, 196 FCR 145
[Merck Sharp].
133 The door was wide open for the defence, although, according to commentators, this
conclusion is surprising as it had earlier been held that the drug was defective because
THE DEVELOPMENT RISK DEFENCE
939
division, known as the Full Court, rejected the imposition of a duty to
warn on the defendant Merck toward the plaintiff of risks of heart dis-
ease, as scientific and technical knowledge was inconclusive.134 Indeed,
the result of one study made available in March 2000 named VIGOR was
held insufficient to establish scientific knowledge, hence allowing recourse
to the DRD, in force in section 142 of the Australian Consumer Law.135
Can this debate on the place of dissenting science be further nourished
by scholarship in international trade law? The temptation is great, as mi-
nority opinions have caught the attention of WTO arbitrators in their in-
terpretation of the Sanitary and Phytosanitary (SPS) Agreement,136 and
specifically determining the quality of scientific expertise underlying SPS
measures adopted or maintained by member states. Article 2(1) of the
SPS Agreement provides that such measures may be undertaken if nec-
essary for the protection of human, animal or plant life or health. All
such SPS measures must be based on scientific principles and [shall not
be] maintained without sufficient scientific evidence.137 In interpreting
this provision, the WTO appellate body has mentioned that risk assess-
ment is not bound by any monolithic conclusion of majoritarian scientific
opinion, as these may hide the uncertainty within the community.138
Nonetheless, SPS measures still must meet the sufficiency criterion139
by demonstrating the existence of a sufficient or adequate relationship
no warnings had been given that the drug may cause the side effect (Barker et al, supra
note 90 at 655 [emphasis added]). If knowledge was lacking, how could the producer
have disclosed the unknown risks to consumers through proper warnings? Liability,
though, had instead been found on the basis of contractual warranty, as the court of
first instance had held that Vioxx was not reasonably fit for its purpose and was not of
merchantable quality as it did not meet consumers expectations that arthritic pain
medication should not double the risk of heart attack. Insights might also be gleaned,
mutatis mutandis, from the duty to warn, as the underlying problem is similar: where a
producer acquires knowledge of a risk of harm to consumers, that producer must take
action to inform consumers of the risk (by modifying the product, recalling it, or with-
drawing it from the market). Though this obligation may not always be statutory, it
undoubtedly influences the distinction between negligence and strict liability.
134 Merck Sharp, supra note 132 at paras 20608, special leave to appeal to HCA on the
causation issue refused, [2012] HCATrans 105 (11 May 2012).
135 Supra note 60.
136 Agreement on the Application of Sanitary and Phytosanitary Measures, 15 April 1994,
1867 UNTS 493, art 2(2) [SPS Agreement].
137 Ibid [emphasis added].
138 EC Measures Concerning Meat and Meat Products (Hormones): Report of the Appellate
Body, WTO Doc WT/DS26/AB/R; WT/DS48/AB/R (1998) at para 194, online: WTO
139 Panels are not to substitute their own opinion for that of competent national authori-
ties. Their task is rather to examine the compliance of the risk assessment carried out
by a member with the requirements of the SPS Agreement (see ibid at para 117).
940 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
between two elements, in casu, between the SPS measure and the scien-
tific evidence.140
The wording of the DRD probably opens the door to similar questions
that flow from the definition of scientific and technical knowledge con-
tained at article 7(e) of the PL Directive. A last, intriguing question will be
left unexplored: To what extent does science include the humanities, ep-
idemiology, or metaphysics?
Conclusion
The effects of the DRD on product liability are twofold. First, it pre-
dictably sends victims back to the labyrinth of fault-based liability (or
other relevant causes of action) and invites them to search out other de-
fendants. Focusing on different elements of the DRD may result in a more
or less subjective analysis. Insisting that efforts could have been made by
an industry to discover a defect, to carry on further research, etc., saddles
plaintiffs with a burden that the directive seemingly sought to lift. As
Howells and Mildred suggest, this situation is explained by the political
compromise that was reached in the PL Directive. Even if it comes at the
cost of further fractioning the interior market, flexibility as to the strict-
ness of liability may well be available to member states willing to exercise
their discretion. In this regard, strict liability and fault-based liability ad-
vocates will each long persist within the world of product liability, accom-
panied by third-way141 proponents of hybrid solutions.
Second, the policy reasons underlying the exoneration clause have al-
ways been economic in nature: too much liability is said to chill innova-
tion. However, little tangible proof of the correlation has been presented
in empirical research. Ironically enough, although this aspect of the DRD
merits further study, its proponents have never really been bothered by
the lack of evidence surrounding the arguments foundation in the alleged
chilling effect. Indeed, one study conducted at the European Commis-
sions request remains utterly prudent in establishing such a cause-effect
relationship.142 A qualitative analysis was also carried out by the Fonda-
zione Rosselli to illustrate the impact of the DRD on product liability.
Published in 2004, the study cautiously concluded that
140 JapanMeasures Affecting Agricultural Products: Report of the Appellate Body, WTO
Doc WT/DS76/AB/R (1999) at para 73, online: WTO
141 See e.g. art 2050 Codice civile (which encompasses liability for dangerous activities).
142 See John Meltzer, Rod Freeman & Siobhan Thomas, Product Liability in the European
Union: A Report for the European Commission (Lovells: London, 2003), online: Europe-
an Commission
THE DEVELOPMENT RISK DEFENCE
941
it can be said that the [DRD] has had the merit of providing industry
with a clear-cut reference for evaluating product safety. At the same
time, there is no evidence that the absence of the [DRD] in specific coun-
tries and/or industries have significantly hindered innovation.143
Indeed, participating companies144 expressed the sentiment that if the
DRD were to disappear, they would simply invest in more comprehensive
insurance coverage or would deploy additional efforts to better assess the
safety of their products.145 There is a clear contradiction between this in-
difference toward the DRD on the part of economic actors and alarmism
about its demise.146 The shallowness of the rationale of chilling innovation
probably explains the polarized positions found in contemporary scholar-
ship and case law.
However, antibodies are present in most states veins that may allow
them to ward off the DRD by allowing plaintiffs to institute their action
on other grounds.147 Somewhat by default, negligence, faute, and all of
143 Alessandra Alaimo et al, Analysis of the Economic Impact of the Development Risk
Clause as provided by Directive 85/374/EEC on Liability for Defective Products (Turin:
Fondazione Rosselli, 2004) at 4041, online: European Commission
[emphasis added]. Another study released in 2003 showed that 94 per cent of a sample
of manufacturers responded negatively to the question, Do any disparities in product
liability risks as between Member States discourage the marketing of products? See
Meltzer, Freeman & Thomas, supra note 142 at 27, fig 6. On these reports, see Duncan
Fairgrieve & Geraint Howells, Rethinking Product Liability: A Missing Element in the
European Commissions Third Review of the European Product Liability Directive
(2007) 7:6 Mod L Rev 962.
144 291 questionnaires were distributed to economic operators, and 75 telephone interviews
were conducted.
145 See Alaimo et al, supra note 143 at 46, fig 3.
146 The main weakness of the report seems to have been in identifying a priori the variable
under studyhere, the DRDwithout formulating an open question that would have
allowed it to properly isolate a variety of factors that ultimately determine whether cor-
porations will choose to engage in a particular commercial field or to settle in a given
country. Such a question would have clarified the overall importance given to the DRD
in light, inter alia, of what are likely more relevant variables, such as the cost of labour,
tax issues, regulatory compliance, etc. By contrast, pinpointing a specific variable at the
outset may grant it de facto overimportance. This flaw might explain why some re-
spondents became interested in the DRD while participating in the study.
147 This choice is allowed by article 13 of the PL Directive, supra note 5. C.f. Mara Victoria
Gonzlez Snchez v Medicina Asturiana SA, C-183/00, [2002] ECR I-3905 (and similar
cases). See also Marie-Eve Arbour, Corte di giustizia e protezione delle tradizioni giu-
ridiche nellinterpretazione della Direttiva CEE/374/85 [Court of Justice and the Pro-
tection of Legal Traditions in the Interpretation of Directive CEE/374/85] (2003) 4 Dan-
no e responsabilit 375. Surprisingly, the commission held that [t]he coexistence of dif-
ferent product liability rules … is considered positive because the range of rules allows
consumer protection to be improved (EC, Commission, Report from the Commission to
the European Parliament, the Council and the European Economic and Social Commit-
tee: Fourth report on the application of Council Directive 85/374/EEC of 25 July 1985
942 (2014) 59:4 MCGILL LAW JOURNAL REVUE DE DROIT DE MCGILL
their variations have historically formed the basis of personal injury law,
but have long been considered inadequate bases on which to ground com-
pensation for damage caused by innovative products.148 Nonetheless, it is
to be anticipated that the costs and the uncertainty associated with such
actions will render them decreasingly effective, as proof of negligence re-
quires scientific evidence that is often outside the reach of plaintiffs.
Pharmaceutical litigation, for example, revolves around a two-part strate-
gy, which consists of proving a failure in product safety evaluation before
the products introduction into the market and establishing a further fail-
ure to warn health professionals (in case of prescription drugs) or con-
sumers (for over-the-counter medicines) of a risk. Proof of causation can
also turn cases into fora for scientific debate,149 as the waltz of variables
endlessly shifts according to new hypotheses, theorems, deductions, and
assumptions. Such an endeavour requires expert examination of the
methodology and protocols underlying clinical trials and often involves a
level of complexity that materializes in extended hearings.
Ultimately the benefit of the DRD lies not so much in its actual results
for producers, but rather in the enrichment of judicial discourse through
the use of comparative legal approaches that increase the circulation of
ideas and solutions available within courtrooms.150
on the approximation of the laws, regulations and administrative provisions of the
Member States concerning liability for defective products amended by Directive
1999/34/EC of the European Parliament and of the Council of 10 May 1999 (Brussels:
EC, 2011) at 4 [emphasis added]). Furthermore, this issue raises the problem of deter-
mining the respective boundaries of contract and tort. See Franz Werro & Vernon Val-
entine Palmer, eds, The Boundaries of Strict Liability in European Tort Law (Durham:
Carolina Academic Press, 2004).
148 Contra James Gordley, Foundations of Private Law: Property, Tort, Contract, Unjust
Enrichment (Oxford: Oxford University Press, 2006) at 15981.
149 Its centrality is reflected by the choice of some courts to address it first. See Buchan v
Ortho Pharmaceutical (Canada) Ltd (1984), 8 DLR (4th) 373 at 37677, 46 OR (2d) 113
(Ont H Ct J), affd Buchan (CA), supra note 29.
150 Justice Burton professed,
I would of course pay particular attention to any European decisions, not because
they are binding upon me, but because not only does respect have to be paid, on the
usual principles of comity, to reasoned decisions of competent foreign courts consid-
ering the same or similar issues, whatever the nature of the legislation, but particu-
larly so where Community courts are applying the directive (A and others, supra
note 55 at para 44).
