Medical Devices: Current Liability Issues

1. Medical Devices:Current Liability Issues Anne Ware Partner Kennedys a.ware@kennedys-law.com 020 7667 9578 BIICL 14 June 2012

2. PIP Implants • Fraudulent use of non-medical grade silicone gel in breast implants manufactured by Poly Implant Prothese (PIP)

3. 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

4. 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

5. 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

6. 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

7. 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

8. Product Liability Claims • Product Liability Directive (85/374/EEC) • UK Consumer Protection Act 1987 • Tort • Contract

9. 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

10. 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?

11. 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

12. 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

13. 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

14. QUESTIONS