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POTENTIAL RISKS FOR MANUFACTURERS, HEALTHCARE PROVIDERS AND THOSE UNDERTAKING CLINICAL TRIALS

Introduction. Kennedys:-International law firm

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POTENTIAL RISKS FOR MANUFACTURERS, HEALTHCARE PROVIDERS AND THOSE UNDERTAKING CLINICAL TRIALS

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    1. POTENTIAL RISKS FOR MANUFACTURERS, HEALTHCARE PROVIDERS AND THOSE UNDERTAKING CLINICAL TRIALS Shane Sayers Head of Product Liability Department Kennedys 25 Fenchurch Avenue London EC3M 5DA Tel: +44-207-667-9127 Email: s.sayers@kennedys-law.com

    2. Introduction Kennedys:- International law firm – offices and associated offices in countries including England, Ireland, Spain, Dubai, India, Hong Kong, Australia, New Zealand Over 120 partners Law Firm of the Year in England 2010 Specialist in International Litigation and Dispute Resolution Established relationship with US Manufacturers, Healthcare Providers and Insurers.

    3. Legal System in England and EU England – common law system like U.S No juries, except liable, (professional judges) No punitive damages. Brain damaged child, including care and full life expectancy = Ł3m to Ł6m Loser pays winner’s legal fees (joint fees often exceed claim value) No depositions….exchange of witness statements Damages highly predictable

    4. Rest of EU (France, Spain, Germany, Holland etc) Generally codified system (Code Napoleon) Judge Prosecutor – Investigate claim – series of submissions and findings – no final trial or cross examination of witnesses or experts No depositions and generally no punitive damages Court appointed expert’s investigation and report before proceedings (possibly before proceedings are issued) Need to be proactive during expert’s investigation – Monitoring claims But Spain Party Experts Hearing since 2000

    5. Rest of E.U Cont…. Often criminal investigation of executives and employees if death has occurred Criminal investigation by Prosecutor (Judge) Findings based on court appointed expert Companies legally liable to compensate for civil claims based upon criminal prosecution of executives employees Criminal sentences and damages may be lower if compensation paid before trial (e.g railway and aviation claims) Limited payment by defendant of successful claimant’s legal costs.

    6. EU Directives The EU issues Directives EU countries bound by Directives – must issue enforcing laws Recent Directives in Product Liability and Regulation of Clinical Trials Cross border co-ordination – RAPEX…

    7. Determining the Strength of Local clinical Trials Experience Difficult to find objective analysis FDA produces various studies Part of their Bio Research Monitoring Programme Based on clinical studies

    8. FDA Results - 2004 Countries analysed included UK, Belgium, France, Hong Kong, Italy, Spain, Sweden, Germany and Israel For 6 countries inspections took place for more than 10 years.

    9. Top countries % of inspections requiring no action Italy – 57% Belgium – 44% Spain – 36% Countries with highest % requiring action France – 80% Germany- 79% Hong Kong/Israel – 75%

    10. Most Common Failings Inadequate patient consent form Inadequate drug accountability Failure to adhere to protocols Inadequate and incorrect records

    11. Damages Overall continental Europe 10-25% difference partly representing differences in level of income Italy: (a) Introduction of Milan Tables in 2000 – injuries assessed on tables of extent of invalidity and age (predictable) (b) No structural settlement (c) Social Security may recover medical and nursing care cost from wrongdoer

    12. Sweden (a) Damages assessed under Damage Insurance Law (predictable) (b) Compensation for disability assessed under Traffic injuries (c) Pharmaceutical no fault scheme since 1988

    13. Germany (a) Pharmaceutical claims covered by German Pharmaceutical Act (strict Liability). (b) Liability cap for death of 1 person (was Ł511,292(,. A maximum for injury from 1 drug was Ł102,258,376 (c) History of state compensation. Thalidomide victims’ and Hepatitis C victims/ funds shared by State and pharmaceutical companies.

    14. Legal Aid and Funding Critically important Germany – Conditional and contingency fees illegal but some companies now offer claims financing. Legal Advice scheme is limited France – Legal aid system may provide all or part of legal costs. Italy – Conditional fees illegal, limited legal aid, Consumer Associations can act as representatives and recover damages for injured parties

    15. Using the “Virtual Law Firm” Co-ordinate response across jurisdictions Co-ordinating information and expertise Common approach – potential use of Protocols/Guidelines Local firms (not just associated offices)

    16. Case Study – Recent Clinical Trials Example Various regions were not properly pooling information Failure to appreciate difference in handling claims in Denmark/New Zealand Need for one on one between Pharma company and lead lawyer Agreed approach to claims/tightening local protocols

    17. Exchange of Information Member States whose territory the clinical trial takes place shall enter into a European database, accessible only to the competent authorities of the Member States, the Agency and the Commission: (a) extracts from the request for authorisation referred to in Article 9(2) (b) Any amendments made to the request as provided for in Article 9.3 (c) Favourable opinion of the Ethics Committee (d) Declaration of the end of the clinical trail (e) Reference to the inspections carried out on conformity with good clinical practice.

    18. The Law The EU position stems from the thalidomide disaster in 50’s The Product Liability Directive imposes strict liab8ility - No need for a Claimant to prove negligence - Implemented in the UK by the Consumer Protection Act 1987 The General Product Safety Directive - Product placed on the market must meet the “general safety requirement”

    19. The U.K. Position The Consumer Protection Act - Strict liability on Producers Defect will arise if “the safety of the product is not such as persons are generally entitled to expect” - Defences are available Common Law - Negligence Criminal Law - General Product Safety Regulations (“GPSR”)

    20. Product Recall Regulations General Product Safety Directive (“GPSD”)(2001) Imposes obligations on producers, suppliers, and distributors Specialist Directives for cosmetics, toys and electrical appliances Products must be “Safe” – normal use does not represent any risk or nominal risk compatible with the products’ use All other products are dangerous

    21. Need for Speed Producers/distributors must immediately notify enforcement agency where product is known to pose a risk that is incompatible with the general safety requirement If risk is “serious” (requiring rapid intervention) authority must notify Commission and they notify other members through RAPEX (Rapid Alert System) If voluntary action is unsatisfactory authorities may order actions including recall

    22. MHRA Medicines and Healthcare Products Regulatory Agency Hazard warning notices Request for withdrawal of products The need to dovetail with GPSR

    23. Protocols Agreement between manufacturer and claimants to resolve claims under agreed procedure with no admissions Manufacturer settles if criteria met Can include offer of future monitoring and medical treatment (revision operations) Limited use of experts and agreed legal costs

    24. Protocol Example Potentially thousands of claimants Potential for parties to litigate Early identification of risk of claim Avoided Litigation Protocol set up Protocol Solicitors No admission of liability Cont...

    25. Protocol Example Participation in claimant press releases Co-operating with hospitals Benefits of fixed fee Law & expert evidence Not binding Protocol banding – examples

    26. THE END

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