Download - Medical Devices: Current Liability Issues
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Medical Devices:Current Liability Issues
Anne Ware
Partner
Kennedys
020 7667 9578
BIICL14 June 2012
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Kennedys Law LLP
PIP Implants
• Fraudulent use of non-medical grade silicone gel in breast implants manufactured by Poly Implant Prothese (PIP)
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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
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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
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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
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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
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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
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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
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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?
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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
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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
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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
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QUESTIONS