Medical Devices:
Current Liability Issues
BIICL
14 June 2012
Anne Ware
Partner
Kennedys
a.ware@kennedys-law.com
020 7667 9578
PIP Implants
• Fraudulent use of non-medical grade
silicone gel in breast implants manufactured
by Poly Implant Prothese (PIP)
Kennedys Law LLP
PIP Chronology
• October 1997 – TUV Rheinland certifies PIP
silicone implants as Class IIb device
• July 2002 – TUV Rheinland carry out
notification audit of PIP – issue second
certificate of comprehensive quality
assurance on 17 October 2002
• February 2003 – Breast implants reclassified
as class III medical devices – PIP recertified
as class III medical devices in 2004
Kennedys Law LLP
PIP Chronology
• 2005 - UK Breast Implant Registry closed: issues of consent
from women for further research
• 17 March 2010 – On inspecting PIP’s manufacturing site
Agence Française de Śecurité Sanitaire des Produits de Santé
(AFSSAPS) discover PIP are using an unapproved silicone gel
• 29 March 2010 – AFSSAPS suspended marketing, distribution,
export and use of silicone filled breast implants manufactured
by PIP
• Implants manufactured since 2001 had contained the
unapproved silicone gel
• The shell may not have conformed to the approved
specification
• PIP went into liquidation with losses of approximately 9
million Euros
Kennedys Law LLP
PIP Chronology
• 31 March 2010 – Medicines and Healthcare products
Regulatory Agency (MHRA) issues Medical Device
Alert (MDA) to cease implantation of PIP implants
• Estimated 40,000 women in UK have PIP implants
• 6 July 2010 – MHRA commissions UK testing of PIP
implants
• 26 July 2010 – MHRA receive preliminary results
that show no evidence of toxicity
• 4 October 2010 – MHRA issues MDA to advise that
there is currently no evidence of health risk with
the filler and routine action in the form of
explantation or ultrasound is not necessary
Kennedys Law LLP
PIP Chronology
23 December 2011 – MHRA Press Statement
• Does not recommend routine removal in UK
• No evidence of increased incidence of
cancer
• No evidence of disproportionate rupture
rates other than in France
• March 2012 – MHRA issued MDA that
implants manufactured before 2001 are
implicated
Kennedys Law LLP
Types of Claims
• Clinics
• Contractual claims
• Implants not of satisfactory quality
• Surgeons
• Distributors
• Consumer Credit Providers – patient
purchased implants and/or surgery on a
credit card
• Insurance cover may be triggered
Kennedys Law LLP
Product Liability Claims
• Product Liability Directive (85/374/EEC)
• UK Consumer Protection Act 1987
• Tort
• Contract
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Consumer Protection Legislation
• Sale of Goods Act 1979
• Supply of Goods and Services Act 1982
• Supply of Goods and Associated Guarantees
Directive (1999/44/EC)
• Misrepresentation Act 1967
• Consumer Credit Act 1974
Kennedys Law LLP
Claims - Germany
Brenntag
• Potential allegations of negligence against German
chemical supplier, Brenntag, who sold silicone to
PIP
• PIP presented themselves to Brenntag as a
diversified healthcare provider
• No evidence that the silicone they provided was
used in breast implants
• The silicone they supplied was labelled as not
suitable for use in implants
TUV Rheinland
• Claims for “CE” certification?
Kennedys Law LLP
Claims - France
Insurers
• Claims made against Allianz France as
insurer of PIP between 2005 and 2010
• Allianz allege misrepresentation and are
challenging policy coverage
• The Court’s decision is expected June 2012
Kennedys Law LLP
Product Liability Insurance
• Purpose - to provide cover for third party
bodily injury claims and damage claims
arising from defects in products designed,
manufactured or supplied by the Insured
• Sold as a separate policy or with Public
Liability (PL) insurance or as part of another
commercial insurance package e.g. a
Commercial Combined Policy
Kennedys Law LLP
Common Exclusions to Product Liability Cover
• Damage due to a deliberate act/omission
• Contractual Liability
• Professional Indemnity
• Anything covered by a more specific policy
in place
• E.g. Employer’s Liability
Kennedys Law LLP
QUESTIONS