European Trends in Pharmaceutical Litigation and Regulation 4/28/2019 European Trends in Pharmaceutical Litigation and Regulation Duncan Fairgrieve, BIICL, 1 Crown Office Row. Stefan Lenze, BIICL, Lovells 4/28/2019

Overview Causation as an EC law concept Update on defect 4/28/2019 Overview Causation as an EC law concept Update on defect Regulatory compliance Immunity: Pandemic flu vaccines Duncan 4/28/2019

Causation – EC law concept? 4/28/2019 Causation – EC law concept? Article 4 Directive 85/374/EEC (PLD) “The injured person shall be required to prove the damage, the defect and the causal relationship between the defect and damage” Burden of proof: EC law Standard of proof: national law Test of causation: courts apply national law  Consistent with maximum harmonisation goal? Duncan 4/28/2019

Divergent approaches to causation Loss of chance Presumptions Uncertain causation and multiple potential tortfeasors Failure to warn 4/28/2019

Loss of a chance France: broad application UK: restrictive Gregg v Scott [2005] UKHL 2 Germany/Austria: rejected 4/28/2019

Presumptions Germany: Drug Act 2002 Presumption of causation if the drug is, in the individual case, capable of causing the damage No presumption if other circumstances are also capable of causing the damage France: Where concordant factors indicate causal link, presumption applies. 4/28/2019

Uncertain causation and multiple potential tortfeasors UK Fairchild v Glenhaven Funeral Services [2002] All ER 305 Comparative law approach Germany: Negligence: Joint liability where co-defendants are “participants” of a tort Drug Act: Joint liability where two or more defective drugs are capable of causing the damage France Cass civ 5 June 1957 – “whole group created a risk through negligent conduct.” 4/28/2019

European approach to causation? Maximum harmonisation directive ECJ, C-52/00, Commission v France Divergence in key areas of causation Lack of consistency in PL cases Common principles? Codifcation projects Comparative law by the Courts ECJ: state liability national courts: Fairchild BIICL PL Database http://www.biicl.org/plf/index.asp?contentid=700&menuid=106 4/28/2019

Update on design defect Risk-benefit test Germany: Yes UK: Design cases: Abouzaid v Mothercare, Boogle v McDonald’s Non-standard product: A v NBA France: traditional test of defect Shift in recent pharma cases? (Cass civ 26 Jan 2006) European guidance Article 1 (28, 28a) Directive 2001/83/EC Eudralex Guidelines 4/28/2019

Regulatory compliance Defence where defect is due to compliance with mandatory regulations Art. 7 d PLD Otherwise, compliance with regulations indicates absence of defect Recent case law (Germany, Austria, France) Comparison with US law (s 4 Restatement Third) Pre-emption defence US Federal pre-emption Community pre-emption Maximum harmonisation Common Market 4/28/2019

Immunity from liability Current regulatory developments with respect to the risks of a pandemic flu outbreak 4/28/2019

Pandemic flue vaccines Public need Design of virus and vaccine typically unclear until shortly before the vaccination period Not suitable for normal authorisation procedure No authorisation Mock-up authorisation procedure 4/28/2019

Pandemic flue vaccines Patient Producer Government Product liability Special legislation Contractual relations 4/28/2019

Directive 2001/83/EC (amended in 2004) Article 5 (3): Marketing authorisation holders/ manufacturers shall not be subject to civil liability if damage is the consequence of medicinal product no marketing authorisation off-label use the use of the product is recommended or required by authority in response to spread of pathogenic agents Article 5 (4): Liability for defective products, as provided for by Directive 85/374/EEC, shall not be affected by Article 5 (3)  Contradiction? 4/28/2019

UK Regulation: SI 2005 No. 2759 3B. (2) Marketing authorisation holders/manufacturers shall not be subject to any civil liability if damage is the consequence of medicinal product no marketing authorisation/off-label use licensing authority recommend or required use of the product in response to spread of pathogenic agents the use of the product in accordance with recommendation or requirement 3B. (3) Paragraph 2 shall not apply in relation to liability under section 2 of the Consumer Protection Act 1987(a)  In line with EC law 4/28/2019

German Regulation of 7 April 2006 Marketing authorisation holders/ manufacturers shall not be subject to civil liability if damage is the consequence of medicinal product no marketing authorisation/off-label use licensing authority recommend or required use of the product in response to spread of pathogenic agents lack of authorisation procedure is probable cause of the damage Compliance with EC law questionable Marketing authorisation holders/manufacturers shall be subject to liability in cases of gross negligence or intentional harm  Not in compliance with EC law 4/28/2019

Pandemic flu vaccines Product liability risks Claims in negligence excluded  No “failure to test” cause of action Claims under strict liability provisions possible Defect Development risks defence no “failure to test” claims Contractual risk management 4/28/2019