A Worldwide Forum Ina Brock and Joe Cyr

Pharmaceutical Product Liability in Europe… • Is increasingly mass torts litigation involving claims brought in the courts of many different Member States • But few European countries provide suitable procedural tools to effectively manage mass torts • So safety of products increasingly regulated by harmonised national laws or at EU level are subject to diverse litigation systems

Collective action • Traditionally, collective action not available • There has been a move across Europe to increase group and class action procedures

Facilitating collective action The move towards facilitating collective action has taken place on two levels: • EU • National level of Member States

Facilitating collective action at the EU level • Legal Aid Directive 2002/8/EC

Facilitating collective action at the EU level • The Brussels Regulation (Council Regulation 44/2001) • Art. 5 No 3: Special jurisdiction: Place the harmful event occurred or may occur • Alternatively: Art. 2: General jurisdiction: Domicile in Member State

Facilitating collective action at the EU level • No forum non conveniens: Owusu v Jackson and others (Case C-281/02) X

Facilitating collective action at the EU level • Recent developments – European Commission Study on "alternative means of consumer redress other than individual redress…" – Background

Facilitating collective action at the national level Mechanisms for group litigation are at various levels of development …

Facilitating collective action at the national level Presently, there are broadly two models of class action style procedures available: • Permitting certain representative organisations to bring a single claim on behalf of a group of individuals or for the benefit of the public at large ("representative actions") • Representation of a specifically defined group of individuals using the concept of a "lead case" or procedural management tools in the form of "group litigation orders"

National measures - United Kingdom 1998 Group Litigation Order enabling coordinated management of individual actions

National measures - Spain 2001 New Civil Procedural Act Consumer Associations can bring collective actions

National measures - Sweden 2003 Act on Class Actions

National measures - Ireland 2003 Consultation Paper on Multiparty Litigation

National measures - Italy 2004 Bill amending Consumer Protection Act

National measures - The Netherlands 2005 New Law on Collective Settlement of Damage Claims

National measures - France 2005 Task force working on a proposal adopting class actions for consumer claims

National measures - Finland 2005 Proposals being discussed, including General Act on Class Actions

National measures - Germany 2005 Law on the Introduction of Investor Representative Proceedings

Implications for Global Pharmaceutical Companies • Increased Product Liability risks in Europe • Cross-fertilisation • Competition of national systems for collective actions / forum shopping • Pan European litigation strategy and management essential

US Discovery In Support of Non-US Proceedings • Letters Rogatory • Hague Evidence Convention • Section 1782 – US Federal license to go fishing?

Section 1782 Applications • The tribunal or any “interested person” can apply directly to US Federal court • In support of a proceeding before a foreign or international tribunal • From a “person who resides or is found in the District” …US style discovery

Factors To Be Considered By Court (Intel) • Aims of Section 1782 • Whether person is a participant in foreign proceeding • Receptivity of foreign court • Whether 1782 is being used to circumvent restrictions on discovery in foreign proceeding • Whether discovery sought is unduly intrusive or broad

Extraterritorial Application of 1782? • Documents located outside the US • Documents in custody of affiliates located outside the US • Depositions of non-US residents

Advice For US Company Opposing 1782 • Obtain objection from foreign tribunal • Intervene to oppose discovery of non-parties • Argue Intel factors • Argue privileges and confidentiality • Seek limitations and obtain quid pro quo

Advice For Non-US Company Sued Outside US By US Residents • Seek 1782 discovery from US plaintiffs • Seek 1782 discovery from non-parties located in the US • Seek 1782 discovery from non-US persons visiting the US

A Worldwide Forum Ina Brock and Joe Cyr