First published by The Times on 21 May 2020
Hundreds of Scottish women left in pain by allegedly faulty transvaginal mesh devices are to share £50 million after settling a claim against Johnson & Johnson, the pharmaceutical company.
Their victory comes months after an Australian court found against the US multinational in a similar matter. Dozens of American states issued Johnson & Johnson with penalty notices of several million dollars.
The women had accused the company of leaving them in agony and in some cases having to use a wheelchair after being implanted over the past two decades with the allegedly faulty products.
Mesh is used to treat pelvic prolapse and urinary incontinence, conditions that are common after childbirth. The products have been effectively banned in Scotland since 2018, when they were implicated in the death of Eileen Baxter, 75, who lived in Midlothian.
The Scottish cases had been filed at the Court of Session in Edinburgh and permission had been granted for four lead cases to proceed to a full hearing.
However, in the weeks before the coronavirus lockdown Johnson & Johnson’s legal representatives flew into Edinburgh from the United States to discuss a settlement deal with the women’s lawyers. Although individual awards are being worked out case by case, the size of the overall settlement means the affected women will be in line for an average payment of about £100,000.
A spokeswoman for Johnson & Johnson said that Ethicon, its medical devices subsidiary, had “reached a settlement agreement with several Scottish law firms regarding transvaginal mesh cases”.
She stressed that the company had not admitted liability as part of the deal. “While Ethicon denies any wrongdoing and remains confident in both the performance of its transvaginal mesh devices and how the potential risks were communicated, this settlement will avoid prolonging an uncertain legal process for all parties,” she said. “Ethicon remains focused on meeting the significant surgical care needs of healthcare providers and patients.”
Johnson & Johnson lost a class action brought in Australia’s federal court on behalf of 1,350 women, who claimed to have been left in debilitating pain by its mesh implants. The three lead claimants were awarded collective damages of £1.4 million after the court ruled last November that the company had been negligent, driven by commercial interests and had failed to take action once it knew there were problems with the implants.
That judgment was handed down a month after the company agreed to pay £95.5 million to settle cases brought by 42 attorneys-general in the US. Those cases centred on the claim that the business had deceptively marketed its mesh products. In January Johnson & Johnson was ordered by a court in California to pay $344 million in penalties after the state department of justice brought a case claiming it had “put profits ahead of the health of millions of women”. The company intends to appeal the Californian decision.
In Scotland about 50 Court of Session cases remain outstanding against manufacturers including Astora Women’s Health, Cousin Biotech and CR Bard.
Astora no longer makes mesh products, having been mothballed by its owner, Endo International, in 2016. CR Bard’s parent company, BD, stopped selling implants in European markets last year.
The Scottish government, which in 2017 published a report highlighting the risks in the use of mesh devices, has announced a £1 million fund to help women who have experienced complications after having a mesh product implanted by or on behalf of a Scottish health board.
Applications for one-off payments of £1,000 will open in July with the money being allocated to help women access emotional or practical support.
Jeane Freeman, the Scottish health secretary, said that the fund was expected to “help those who experienced hardship as a result of the complications caused by mesh implants”.
Behind the story
Vaginal mesh products have been used for the surgical management of pelvic organ prolapse and stress urinary incontinence for more than two decades, but they have always been controversial.
Mostly made from polypropylene, a type of plastic, the purpose of such devices is to reinforce vaginal tissue that has been torn or weakened during childbirth. While the majority of women report no ill effects from the implants, others have experienced devastating side effects including chronic pain, bleeding, bowel problems and difficulty having sex.
Campaign groups have formed around the world to fight for justice for these women.
The Scottish Mesh Survivors Group, which is led by Elaine Holmes and Olive McIlroy, has long lobbied the Scottish government on behalf of its members. Although both Ms Holmes and Ms McIlroy quit a government review group in 2017 in protest over what they claimed was a whitewash, the survivors group has played a pivotal role in keeping the issue in the public eye.
As a result no new mesh operations have been performed in Scotland since October 2018. After meeting the group this year, Nicola Sturgeon, the first minister, announced that all affected women would be offered an independent review of their case notes.