the development of a common european case law on liability for drugs stefan lenze, biicl, lovells
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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
• Decisions on pharmaceuticals 3– 2 on infected blood (A v National Blood Authority; Scholten)– 1 tranquilizer (Halcion)
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
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
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)
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
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)
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
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
“There is law elsewhere!”
- Lord Bingham -
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