Clinicians responsible for manufacturer misrepresentations in product literature

Between 2003 and 2006 Isolagen therapy was available in the UK for the treatment of facial lines and wrinkles. The treatment involved the extraction of a patient’s own fibroblasts from a small skin biopsy and culturing them in foetal calf serum, before re-injecting in to the treatment site.

Isolagen FDA Report download as a pdfFibroblasts synthesise collagen and cause some re-modelling of the extracellular matrix at the site of injection. The treatment aimed to achieve long-lasting facial rejuvenation through an augmentation of the soft tissues, filling out facial lines and nasolabial folds.

However, the manufacturer of Isolagen (Isolagen Europe Ltd) ceased trading in the UK in 2006 amidst financial losses and complaints from dissatisfied patients. The treatment was expensive and failed to deliver the clinical results it promised.

In February 2013 a group action was brought against a number of clinicians in relation to Isolagen treatment. It was argued that the clinicians were responsible for the information they provided to patients in product literature. At issue was the small amount of residual foetal calf serum, retained in the fibroblast suspension after washing, which was injected in to the patient. The claimants pointed to the product literature which stated that only autologous cells would be transferred.

Webster vs Liddington Judgement download report as a pdfHis Honour Judge Platts concluded that if product literature is given to a patient, the doctor or nurse who provides that literature intends the patient to rely upon the information it contains. The patient reasonably looks to the practitioner as having expertise in, and knowledge of, the proposed treatment. The clinicians were, therefore, responsible for any misrepresentations contained within the literature.

The defendants appealed, but the judgement was upheld in the Court of Appeal last week (Webster v Liddington [2014] EWCA Civ 560).

The message to cosmetic clinics is now clear; a disclaimer for the accuracy of a manufacturer’s information must be issued if a clinic or practitioner is to avoid facing costs for misrepresentation (Read news article on The Lawyer website).

The Lawyer Article website news item on Webster v Liddington

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