1. European Trends in Pharmaceutical Litigation and Regulation
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European Trends in Pharmaceutical Litigation and Regulation
Duncan Fairgrieve, BIICL, 1 Crown Office Row.
Stefan Lenze, BIICL, Lovells
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2. Overview Causation as an EC law concept Update on defect
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Overview
Causation as an EC law concept
Update on defect
Regulatory compliance
Immunity: Pandemic flu vaccines
Duncan
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3. Causation – EC law concept?
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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
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4. Divergent approaches to causation
Loss of chance
Presumptions
Uncertain causation and multiple potential tortfeasors
Failure to warn
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5. Loss of a chance France: broad application UK: restrictive
Gregg v Scott [2005] UKHL 2
Germany/Austria: rejected
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6. 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.
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7. Uncertain causation and multiple potential tortfeasorsUK
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.”
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8. 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
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9. 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
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10. 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
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11. Immunity from liability
Current regulatory developments with respect to the risks of a pandemic flu outbreak
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12. 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
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13. Pandemic flue vaccines
Patient Producer
Government
Product liability
Special legislation
Contractual relations
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14. 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?
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15. 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
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16. 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
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17. 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
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