Common law damages claim over vaginal mesh product to proceed to full hearing

A judge in the Court of Session allowed a proof before answer after ruling that the pursuer, who alleges that the manufacturer breach its duty of care, had pled a relevant case.

Lord Boyd of Duncansby heard that the action brought by the pursuer “GR” against Greater Glasgow and Clyde Health Board and Johnson and Johnson Medical Limited was one of a large number of cases relating to vaginal mesh implants.

In four related actions heard by the same judge, AH v Greater Glasgow Health Board [2017] CSOH 57, two of the cases against Johnson & Johnson were based on an alleged breach of the Consumer Protection Act 1987 and a breach of their common law duty of care, but the common law case was subsequently dropped.

However, there remain a number of cases based only on an alleged breach of common law duty, and the judge allowed a legal debate in the present case on the issue of whether or not the pursuer had pled a relevant case at common law against the second defenders, and to give guidance on those cases which relied solely on the common law.

The court was told that the pursuer, 72, was referred by her GP to a consultant at the Southern General Hospital in Glasgow in 2002, having experienced long-standing problems with stress urinary incontinence (SUI) and urge incontinence.

Initial treatment involving physiotherapy and anticholinergic medicine did not assist and following surgery in 2003 she was advised to undergo a new procedure to address her SUI.

In February 2004 she underwent surgery involving insertion of a pelvic mesh product, which was a Gynecare TVT manufactured by the second defender and supplied by them to the Southern General.

But the pursuer claims that immediately after surgery she suffered in a number of ways.

The product is made from polypropylene, which the pursuer claims is “not a suitable substance” for a permanent prosthetic implant in the pelvic region because is “degrades over time” and causes “foreign body reactions”.

She raised an action alleging that the first defenders were “vicariously liable” for the acts and omissions of the doctor who carried out the surgery, and that the second defenders were “negligent” at common law for the injuries she suffered as a result, having failed in their duty to exercise “reasonable care” in the design, manufacture, marketing and supply of their products.

The pursuer claims that the second defenders failed to “adequately test” the TVT product before supplying, distributing marketing or promoting them in the UK, and that had she been made aware of the lack of testing and the number of complaints about the product, she would not have permitted it to be included in her surgical procedure.

Had the second defender not failed in their duty of care to the pursuer, she would not have suffered the loss, injury and damage.

On the issue of relevancy and specification, on behalf of the pursuer it was submitted that the common law case was very similar to the statutory case and proceeds on the same factual hypothesis.

At common law, a manufacturer has a duty to ensure that its product is safe for the intended use and will not cause “further” damage to the recipient or consumer of the product.

However, the second defenders argued that the pursuer could not rely upon a general duty of care, and must particularise the specific way in which it is said to have been breached, but the pleadings did not identify the way in which the TVT product was said to be defective.

It was argued that the pleadings also failed to address causation.

The pursuer failed to identify the respect in which the product was unsafe, by what means the second defenders in exercise of their duty of care could have eliminated the risk and how the duty was breached, it was submitted.

However, the judge ruled that the pursuer’s pleading were sufficient for a proof before answer.

In a written judgment, Lord Boyd said: “Where a manufacturer having developed, manufactured and put on the market a product which he intends should be used by an end user he has a duty to take reasonable care in the developing, manufacturing and marketing of the product not to cause injury to the user. The fact that the product in question is one which could only be used by means of invasive surgery does not alter the duty of care but emphasises its importance.

“In condescendence 4 the pursuer sets out something of the history of the use of synthetic mesh. I reject the submission that this is irrelevant as it does not relate to the actual product used in this case. As I understand these pleadings they relate to the use of polypropylene which the pursuer says is not a suitable substance for use in vaginal mesh products.

“The averments continue that the pelvic mesh products were placed on the market with little or no clinical data from randomised studies and that there was little evidence in relation to mid and long term safety and efficacy. She then particularises the injuries, conditions and complications suffered due to Gynecare TVT insertion with a list of such injuries.

“The pursuer has thus set the ground for the averments of breaches of duty of care…The specific duties averred relate to the ‘design, manufacture, marketing and supply of their products’; ‘that the product was safe for surgical use and would not cause further (sic) injury to patients such as the pursuer’; and ‘not to supply to hospitals a product they knew or ought to have known was untested for efficacy and safety’. Later the pursuer avers that having become aware of adverse events and failure they failed in their duty either to withdraw the product from the market or to take reasonable steps to ensure that patients were made aware of the risks.”

He added: “In any proof before answer the pursuer will first have to prove that the product which was implanted in her caused her injury; that the second defenders were aware or ought to have been aware (for example by testing of the product) of the risks; despite that the second defenders put the product on the market or did so without adequate warnings; or, having later become aware of the risks failed to withdraw the product or warn of risks. That may be a difficult goal to achieve but I am not persuaded that the pursuer has not pled a relevant case.

“So far as causation is concerned the pursuer has set out the injuries which she says she suffered. At this stage I am not entirely clear what more is required of the pursuer. Both parties will no doubt have the pursuer medically examined and the question of causation of damage is then a matter for proof.”