J&J Loses Defective Vaginal Implant Case
Johnson & Johnson (J&J) lost a vaginal implant case from a group of women who claim that they were treated like “guinea pigs.” The women, all from Australia, were all left with chronic pain, according to the lawsuit, which was filed against three medical companies.
Federal Court judges found that J&J was responsible for nine defective implants. Two manufacturers and a supplier from Australia were also found guilty of misleading customers and causing them injuries.
The companies were found guilty of marketing vaginal implants for helping reinforce the pelvic floor, and also for helping with pelvic organ prolapse and stress urinary incontinence. The companies, all part of J&J, falsely marketed their products, which left hundreds of women in chronic or acute pain.
Many women suffered damage to surrounding organs and also acute pain during intercourse.
The implants led to infection, and then extruded and eroded over time.
The class action lawsuit included 1,350 women who had severe implant complications. Multiple surgeries were required to try and remove the implant from the women after it had eroded. One woman had a total of four additional surgeries to try and remove the rest of the implant that was causing her chronic pain.
She is still in chronic pain after the procedures failed.
The judge ruled that nine products went to market without rigorous testing. Some of the products hit the market without clinical trials, while a few of the products had a very small group of tests performed.
Genuine risk analysis was not performed, and the companies failed to comply with the appropriate regulatory requirements.
The Therapeutic Goods Administration was also criticized for allowing eight of the nine devices to go to market without safety or efficacy assessment. The trial took eight months and contained 164,000 pages of evidence. Damages are expected to be awarded in early 2020. Women can still sign up to be a part of the class action lawsuit at this time.