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A Worldwide Forum Ina Brock and Joe Cyr

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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

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

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

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

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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

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

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Facilitating collective action at the EU level Recent developments European Commission Study on " alter- native means of consumer redress other than individual redress " Background

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

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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"

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

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

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National measures - Sweden - 2003 Act on Class Actions

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National measures - Ireland - 2003 Consultation Paper on Multiparty Litigation

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National measures - Italy - 2004 Bill amending Consumer Protection Act

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

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

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

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

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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

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

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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

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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

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

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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

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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

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A Worldwide Forum Ina Brock and Joe Cyr