On Tuesday, one of the country’s largest product liability class actions commenced in the Federal Court. More than 700 women joined the class action against Johnson & Johnson Medical Australia and its subsidiary companies Ethicon Inc and Ethicon Sarl for compensation that may run to hundreds of millions. The controversial device is a vaginal mesh implant used to treat prolapsed pelvic floor and poor bladder control arising from childbirth.
Background
The medical device was used by surgeons to treat urogynaecological issues since 2000. What was claimed to be a “quick and easy operation” by Johnson & Johnson has actually left patients to suffer from chronic pain to the point where some have been disfigured and disabled after surgery. According to medical reviews, one in eight patients suffered complications, such as scarring, infection, and bleeding, whereas others argued the mesh eroded their organs and fused them together.
A Quick And Easy Procedure?
One patient said to ABC News she had her mesh removed overseas. She said, “I’ve been through a lot of trauma and recovery that has just been, probably even harder since I’ve had the mesh removed.” Another patient told News.com.au she was forced to retire after developing severe complications. The primary school teacher from NSW Central Coast had the medical device removed in a procedure that costed $20,000. She alleged some parts of the mesh and its hooks remained inside the mother-of-three’s body. An email written by French consultant Dr Bernard Jacquetin who ran a clinical trial for the manufacturer was read to the Federal Court. Dr Jacquetin wrote “I wouldn’t like my wife to undergo this procedure”. Despite Johnson & Johnson knowing about the comment in the past, the company failed to follow it up. Instead, Barrister Tony Bannon SC said the company continued to emphasise the speed and ease with which the devices could be installed. Mr Bannon SC said to the Court surgeons and patients were “overwhelmed by a tidal wave of aggressive promotion” that the operation would be quick with some lasting for only eight minutes and easy to boost profits.
How Did Johnson & Johnson Respond?
On the flip side, Johnson & Johnson rejected claims in its submission to a federal Senate inquiry. The pharmaceutical giant said the use of the implantable mesh was supported by clinical research and was the preferred option to treat pelvic conditions. Critics disputed this claim, and argued clinical trials were not conducted to test the procedure, which made the company negligent. Also, the Court was told patients were not properly advised of the possible risks involved with the surgery or use of the implants. Moreover, some alleged the implants were not fit for purpose, were not of merchantable quality and unsafe. Professor Thierry Vancaillie called for changes to how the Therapeutic Goods Administration (TGA) operates. He said a dynamic process of monitoring all devices is necessary. He said companies should be asked to provide data or information on their product often, such as every two years or three years. By implementing these changes it may be possible to prevent the detrimental impact of complex but quick surgeries on the lives of patients.
Generally, the mesh is designed to cause inflammation once it is surgically inserted. However, the inflammation did not subside. In fact, it caused the mesh to stiffen, which made it incompatible with the human body. Apparently, Johnson & Johnson has stopped selling the medical device in the United States, but the company claimed it was a separate commercial decision. It is unknown whether or not there were other reasons. Maybe it was due to widespread condemnation, and the 100,000 women who have started legal action in the United States, United Kingdom and Canada.
What Will Happen Next?
The trial will continue next Tuesday, and evidence will be presented to the Court. It is expected the number of applicants in the court case may increase as there are a total of 100,000 Johnson & Johnson mesh devices implanted in Australian women. Lawyers for the applicants are hoping the court case will provide justice, accountability and recompense for those affected. Also, a Senate inquiry into transvaginal mesh devices will be conducted, allowing women across the country to speak about their injuries. As for the implants, it is still being sold by Johnson & Johnson.
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