pharmafileJuly 05, 2017
Tag: Johnson & Johnson , vaginal mesh
Johnson & Johnson will face a lawsuit after 700 Australian women launched a class action suit over the failures of its vaginal mesh implant. The case is potentially serious for the pharma giant, as over 100,000 women are thought to have undergone the procedure worldwide – indicating that there will be many further cases for the company to face.
The case relates to a vaginal mesh that is recommended for women who suffer prolapsed pelvic floors or urinary incontinence, usually after having given birth. The implant has left many women in constant pain, as the device erodes into surrounding tissue and has, in certain cases, been found to shift position causing further damage to the area.
The device is unable to be removed in many cases due to the way in which it is designed – the hooks of the mesh are imbedded into surrounding tissue, which then repair and grow around the device. This has left women in the case living in chronic pain, unable to perform normal activities such as being able to walking or to have sexual intercourse.
J&J stand accused of having aggressively marketing the device as a low-cost solution to the problems previously mentioned and of not thoroughly checking the safety of the device. The mesh itself was designed to cause inflammation, to help the body fix the device in place, but this continued longer than assumed in certain cases, interfering with the function of the device and causing severe pain.
The prosecution argued that J&J had not thoroughly investigated concerns over the device. A consultant was quoted expressing doubts over the device in emails correspondence. "That is one of the transvaginal mesh team members, one of the consultants. His view is that ‘I wouldn’t like my wife to undergo that, and I don’t think I’m alone’," Tony Bannon told the court of the opening day. The company was aware of the comment by the doctor but still did not take further action.
In the UK, as recently as October 2016, it emerged that NHS bosses and the MHRA had discussed ways to minimise press coverage of the implant. This came despite awareness on both sides that the device was likely to cause severe problems in certain individuals and they had actively encouraged women to report problematic side-effects. The assumption is that the faults of the implant were being kept quiet to prevent a large-scale lawsuit against the NHS.
For J&J, it represents another potential lawsuit headache, after a series of cases in the US found the company liable for sums in the hundreds of millions of dollars over its talcum powder product.
Ben Hargreaves
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