A US woman has received $57 million in damages from Johnson & Johnson for the injuries caused by the company’s vaginal mesh implant.
Gavel
It is the largest pay-out to date for a verdict relating to the mesh devices. Numerous cases have been launched since 2015 in the UK, US and Australia.
The damages were awarded to 51-year-old Ella Ebaugh who had the TVT-Secur device implanted in 2007 after suffering from incontinence. After her condition didn’t improve she had a second TVT device implanted. The devices are made by Johnson & Johnson’s subsidiary Ethicon. Ebaugh suffered from a range of complications due to the TVT device such as pelvic pain and urethral erosion and had to undergo three corrective surgeries.
Ethicon was found liable for causing injury to Ebaugh due to the devices being negligently and defectively designed.
The court case revealed that the TVT-Secur was developed to address the issues seen by Ethicon’s previous mesh products. The product was pushed to market without trial to compete with existing products. By applying for a 510(k)-premarket notification, the TVT-Secur did not have to undergo clinical trials as it was similar to existing products on the market.
French gynaecologist professor Bernard Jacquetin, told The Guardian that Johnson & Johnson acted “irresponsibly” by launching the device without adequate evidence. A study was later done by Jacquetin on the TVT-Secur in 40 patients. The device had success rates of 77% two months after surgery. Ethicon’s original TVT mesh device had success rates of around 85-90%.
Documents provided during the trial show that Ethicon knew about the disappointing results. Ethicon’s director of sales Xavier Buchon suggested the company should withhold the results while it reviewed the patients to be included in the analysis. In an email, Buchon said: “No way to hide the truth but to make sure it has been done correctly in terms of procedure and inclusion.” The TVT-Secur device was withdrawn from market in 2012.
About the verdict an Ethicon spokesperson said the company is planning to appeal. The spokesperson said: “We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems.
Over two and a half million documents have been provided to plaintiff attorneys by Ethicon as part of the pelvic mesh litigation in the United States, and selective disclosure of certain sentences or documents without proper context can be extremely misleading.”
Kila Baldwin, the attorney representing Ebaugh told Law360: “Hopefully they recognise that their conduct was reckless. I hope this sends a clear message that they did something wrong with these products and that they really think, going forward, about what they do.”