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 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 -