A group action legal claim is being pursued by more than 700 women in Australia against Johnson & Johnson over claims its vaginal mesh implants have left them suffering chronic pain. Thousands of patients in the UK, Canada and the United States have launched similar cases against Johnson & Johnson and other pelvic mesh manufacturers over the devices, which are used to treat urinary incontinence and repair pelvic organ prolapse.
The Australian trial began on 4 July and is expected to last six months. The claimants are alleging that the US based company was negligent in not properly warning doctors and patients about the risks associated with the devices. It is also contended that the products were not fit for the purposes for which they were designed, and the testing prior to the devices being sold was inadequate.
The main issue with the devices is that they erode into surrounding tissue and organs, causing a chronic inflammatory response. A majority of the women affected suffer chronic pain. Many are no longer able to have any sort of sexual relationship, and those who are suffer a lot of pain as a consequence.
Johnson & Johnson says it has sold over 100,000 mesh products in Australia. The action singles out nine separate devices and of those, the company has taken five off the market. None of the devices have been subject to a recall by Australian regulators. In the US last year, the Food and Drug Administration reclassified all pelvic mesh implants as ‘high risk’ instead of moderate, making them subject to extra regulatory requirements, but the devices were not recalled.
Johnson & Johnson has defended the claims on the basis that the mesh has successfully helped millions of women worldwide and the majority of women who undergo the surgery have experienced positive results. The pharmaceutical company argues that the mesh products are developed in close consultation with specialist surgeons and ‘backed by years of clinical research’.
Last week, the federal court in Australia heard that Johnson & Johnson had tried to stop French health authorities publishing a report warning against the use of the pelvic mesh devices, two years after they started being used in Australia. The claimants in the Australian action claim they were used as ‘guinea pigs’ by Johnson & Johnson and that the devices were not properly tested before they were approved by the Therapeutic Goods Administration and placed on the Australian market in 2005.
It is further claimed that Johnson & Johnson instead conducted an aggressive marketing campaign aimed at convincing surgeons the devices were inexpensive, simple to implant and therefore a lucrative alternative to other treatment options. The court heard that no proper trials were conducted and the testing that was available was insufficient. It is claimed that had such trials been conducted, it would have been discovered that the devices posed an unacceptable risk to women.
The court was shown internal documents which suggested that the company knew proper testing had not been carried out. In the 2007 report prepared by the French health authority, Haute Autorité de Santé, it was found that a proper randomised and controlled trial was needed before the devices could be approved. It was concluded that the devices should only be used in clinical research until such a trial was complete. Investigations have revealed that Johnson & Johnson was aware of the report before its release. Minutes of a meeting were shown to the court last week which revealed the company feared the report ‘could have a major impact on our business if made public’ and that work was needed to ‘stop the publication of the report’.
Elise Bevan, a solicitor in the product liability team at Penningtons Manches, said: “The claims being presented against Johnson & Johnson in Australia mirror those being brought in the UK and the US. At least 92,000 women had a vaginal mesh implant in England in the eight years up to March 2015, with almost 10 per cent experiencing problems. Patients have reported being left unable to walk, work or enjoy a sex life as a result of the pain. Many of our clients have also had to undergo complex revision surgery.
“The Medicines and Healthcare products Regulatory Agency (MHRA) has said it ‘sympathises’ with the women affected, but so far, not a single mesh model has been recalled in the UK. The model is still being used in the NHS, despite the regulator receiving more than 1,000 complaints in the last five years. Hundreds of affected women in the UK are bringing claims against Johnson & Johnson and the specialist product liability team at Penningtons Manches is investigating a number of claims.”