PUBLIC POLICY, DOCTRINAL ORTHODOXY AND THE FUTURE OF MEDICINAL

PRODUCT LIABILITYDr Richard Goldberg

Director, Institute of Medical LawSchool 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 itselfRichardson v LRC Products Ltd. [2000] Lloyd’s Rep Med 28A v National Blood Authority [2001] 3 All ER 289Risk-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 289Graham Barclay Oysters Pty Limited v Ryan (2000) 102 FCR 307 Scholten v Foundation Sanquin of Blood Supply H 98.0896 (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