Medical Devices:Current Liability Issues

Anne Ware

Partner

Kennedys

a.ware@kennedys-law.com

020 7667 9578

BIICL14 June 2012

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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

QUESTIONS