European Trends in Pharmaceutical Litigation and Regulation

1
European Trends in Pharmaceutical Litigation and
Regulation

• Duncan Fairgrieve, BIICL, 1 Crown Office Row.
• Stefan Lenze, BIICL, Lovells

2
Overview

• Causation as an EC law concept
• Update on defect
• Regulatory compliance
• Immunity Pandemic flu vaccines

3
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?

4
Divergent approaches to causation

• Loss of chance
• Presumptions
• Uncertain causation and multiple potential
  tortfeasors
• Failure to warn

5
Loss of a chance

• France broad application
• UK restrictive
• Gregg v Scott 2005 UKHL 2
• Germany/Austria rejected

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.

7
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.

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 http//www.biicl.org/plf/index.a
  sp?contentid700menuid106

9
Update on design defect

• Risk-benefit test
• Germany Yes
• UK
• Design cases Abouzaid v Mothercare, Boogle v
  McDonalds
• 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

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

11
Immunity from liability

• Current regulatory developments with respect to
  the risks of a pandemic flu outbreak

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

13
Pandemic flue vaccines

• Patient Producer
• Government

Product liability
Special legislation
Contractual relations
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?

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

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

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