What we do
We have defended the majority of significant pharmaceutical/medical product liability cases in the UK over the last four decades, including Opren, Whooping Cough Vaccine, Benzodiazepines, HIV Haemophilia, Oral Contraceptives, MMR and the Hepatitis C litigation. Our product liability department is top ranked in both of the profession’s leading legal directories, Legal 500 and Chambers.
We act for many of the UK's leading pharmaceutical companies, as well as many medical device and consumer healthcare manufacturers as well as their insurers. We provide specialist advice to the life sciences industry on all aspects of regulatory, liability and product safety issues and have assisted clients with the approval process for medicines, drug pharmacovigilance and compliance issues.
We have a particular speciality in advising on clinical trials and were instructed in the Northwick Park trial of the monoclonal antibody TGN1412 which led to a review of the conduct of all phase 1 clinical trials.
We also have 35 years expertise in defending blood products litigation for the NHS and National Blood Service.
We have been involved in the development of group litigation in the UK, as pharmaceutical and healthcare product liability cases are often, by their nature, repercussive.
We regularly provide coverage advice and have an Intellectual Property specialist with strong experience in pharmaceutical and medical devices patent cases.
We assist our clients throughout the entire lifecycle of their products, providing advice on R&D, clinical trials, approval and licensing, pharmacovigilance, regulatory and compliance issues as well as handling complaints, claims and recalls. We also advise on labelling, advertising and comparative claims for complex healthcare products.
What we are known for
We advise the pharmaceutical, medical device and healthcare sectors in relation to research and development, clinical trials, marketing and regulatory compliance, consumer protection issues, supply chain, contractual and indemnity issues, reputation and brand protection, jurisdictional and cross border issues.
Key cases include:
- Acting for the National Blood Authority and all NHS Trusts, on the instruction of NHS Resolution (formerly the NHS Litigation Authority), in the Hepatitis C litigation. This case is the leading European decision on the interpretation of the Product Liability Directive. We also coordinated the NHS defence in the HIV Haemophilia litigation.
- Acting for clinical trial insurers in respect of claims and issues arising from the clinical trial of monoclonal antibody TGN1412 at Northwick Park Hospital.Acting for GlaxoSmithKline in the MMR Vaccine Litigation.
- Acting for Akzo Nobel in the third generation oral contraceptive pill group action.
- Acting for a US manufacturer in the English Blood Products litigation. Liaison with US attorneys in relation to the coordination of the worldwide defence strategy.
- Acting for a UK captive of AstraZeneca seeking recoveries from reinsurers in respect of legal costs incurred in defending the US Seroquel product liability group action involving 30,000 plaintiffs.
- Advising the manufacturer of an anti-epileptic in actions in respect of Fetal Anti-Convulsant Syndrome.
- Advising two private healthcare organisations in the defence of the group litigation involving allegedly defective PIP silicone breast implants.
- Advising private hospitals on claims arising out of the use of metal on metal hip implants.
- Acting for companies and their insurers in respect of many claims made by patients who allege injuries due to their participation in clinical trials.
- Acting for contact lens manufacturers as regards the safety of their products, advertising and labelling issues and claims.
- Reviewing Patient Information Leaflets and product packaging to determine whether appropriate warnings are given to consumers.
- Advising on off-label issues.
- Advising numerous medical device manufacturers regarding product safety, recall, liaising with regulatory authorities and managing customer communications.
- We are also highly experienced in advising where regulatory action has been taken by the HSE and Trading Standards, and in connection with Coroners' Inquests.