PUBLIC POLICY, DOCTRINAL ORTHODOXY AND THE FUTURE OF MEDICINAL PRODUCT LIABILITY Dr Richard Goldberg Director, Institute of Medical Law School of Law University of Birmingham

1. Introduction Doctrinal orthodoxy Case C-183/00 Gonzalez Sanchez v. Medicinia Asturiana [2002] ECR I-3901 Public policy, particularly in the context of causal uncertainty, but also in the context of development risks. But use of such public policy must be constrained within defined limits. Future of pharmaceutical product liability

2. Doctrinal Orthodoxy (a) Proof that the product was defective Foster v Biosil (2001) 59 BMLR 178 Richardson v LRC Products Ltd. [2000] Lloyd’s Rep Med 280.

2. Doctrinal Orthodoxy (b) Determination of defectiveness itself Richardson v LRC Products Ltd. [2000] Lloyd’s Rep Med 28 A v National Blood Authority [2001] 3 All ER 289 Risk-utility or risk-benefit approach is accommodated for within the framework of the Directive and the 1987 Act. Restatement, Third, Torts: Products Liability § 6(c) Freeman v Hoffman – La Roche Inc 618 NW 2d 827 (Neb 2000), J A Henderson Jr and A D Twerski, ‘Drug Designs Are Different’ 111 Yale LJ 151 (2001)

2. Doctrinal Orthodoxy (c) Development risk defence (see public policy)

3. Public Policy Liability for Defective products (Law Com No 82, Scot Law Com No 45), (Cmnd 6831, 1977) Commission Green Paper on Liability for Defective Products, Brussels, COM (1999) 396 final (28 July 1999) American pharmaceutical product liability litigation. Product Liability Directive, Recital 7

3. Public Policy (a) Causal uncertainty Fairchild v. Glenhaven Funeral Services Ltd [2003] 1 AC 32; [2002] 3 WLR 89 Gregg v. Scott [2005] 2 WLR 268 HL Chester v. Afshar [2004] 3 WLR 927

3. Public Policy (b) Development risk defence A v National Blood Authority [2001] 3 All ER 289 Graham Barclay Oysters Pty Limited v Ryan (2000) 102 FCR 307 Scholten v Foundation Sanquin of Blood Supply H (3 February 1999, County Court of Amsterdam) Kobe ter Neuzen v Korn [1995] 3 SCR 674, (1995) 127 DLR (4th) 577.

4. Conclusion: The Future of Medicinal Product Liability Lawyers and judges must grasp the distinctive problems of medicinal product liability. Consumer expectations approach to allegedly defective drugs over-simplistic and unlikely to succeed in practice Class Actions Fairness Act Restatement, Third, Torts: Products Liability § 6(c) EC regulation of medicinal products