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The Development of a Common European Case Law on Liability for Drugs

The Development of a Common European Case Law on Liability for Drugs. Stefan Lenze, BIICL, Lovells. The Case Law on the Directive. European Court of Justice 5 National Courts about 100 relevant decisions UK 7 France 7 Spain 20 Germany 25 Austria over 50 Supreme Court decisions alone

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The Development of a Common European Case Law on Liability for Drugs

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  1. The Development of a Common European Case Law on Liability for Drugs Stefan Lenze, BIICL, Lovells

  2. The Case Law on the Directive • European Court of Justice 5 • National Courts about 100 relevant decisions • UK 7 • France 7 • Spain 20 • Germany 25 • Austria over 50 Supreme Court decisions alone • Decisions on pharmaceuticals 3 • 2 on infected blood (A v National Blood Authority; Scholten) • 1 tranquilizer (Halcion)

  3. Roadmap for courts in shaping the law on liability for drugs • Risk-benefit analysis • Regulatory compliance defence • Development risks defence • Warnings: the role of the learned intermediary • Causation

  4. Risk-benefit analysis and PLD • shortcomings of expectations test • legitimate expectations ≠ not actual expectations • pharmaceuticals - a special case • public perception of risk is inadequate • harmonization with regulatory framework • DTI Explanatory Note 1985 • German Drug Act (r/b) seen to be in line with PLD • Halcion case

  5. Risk-benefit analyis and PLD (2) • Directive: “ … all circumstances … including…” • A v National Blood • All “relevant factors” • Important factors are listed: German Directive: “insbesondere”; French Directive: “notamment” • Risk-benefit would be an important factor but is not listed • Why A v National Blood is wrong: • Misinterpretation of German and French Directive • Only unimportant factors could be considered: are they relevant? • Materials from the legislative process  Listed factors are just examples • A v National Blood concerns manufacturing defect (non-standard product)

  6. Risk-benefit analysis in action The regulatory approach Assessment on basis of pre-marketing knowledge (reviews) Suspected harmful effects v prospective benefits Absolute-risk benefit analysis Possible approach of the Directive Knowledge at time of trial ( Art. 7 e) Regulatory environment at the time of circulation ( Art. 6 (1) c)  Alternative therapies Proven harmful effects v benefits “Good for any class of patients” (US Third Restatement)? Limits of judicial decision-making? not as to pharmaceuticals

  7. Regulatory compliance defence • Debate at EU Level • Suggestions by industry groups • Commission and national governments very sceptical about automatic defence • Discussed before adoption Directive • Part of the defect rule • BIICL database (e.g. German case law)

  8. Causation under the Directive • Causation as an element of the PLD • General causation is part of defect rule in Article 6 PLD • Specific causation • Substantive law: Article 1 PLD • Burden of proof: Article 4 PLD • Standard of proof: national law • Material contribution/increased risk: substantive law concept • Loss of chance: substantive law concept • Uncertainty over producer (Fairchild): substantive law concept • Reversal of burden of proof in new German Drug Act contravenes Article 4

  9. Solution for courts (and lawyers)Comparative Law • European Court of Justice does it • National Courts do it • A v National Blood Authority (PLD) • Fairchild (Negligence) • Austrian and German decisions • BIICL Database has it

  10. “There is law elsewhere!” - Lord Bingham -

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