Fibroblasts 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.
His 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).