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 -