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
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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
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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
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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 (nonstandard product)
Risk-benefit analysis in action
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The regulatory approach
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Assessment on basis of pre-marketing knowledge (reviews)
Suspected harmful effects v prospective benefits
Absolute-risk benefit analysis
Possible approach of the Directive
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Knowledge at time of trial ( Art. 7 e)
Regulatory environment at the time of circulation ( Art. 6 (1) c)
 Alternative therapies
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Proven harmful effects v benefits
“Good for any class of patients” (US Third Restatement)?
Limits of judicial decision-making?
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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
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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 -