15 Million Johnson & Johnson Mesh: 12/14/2017 – Today ended a nearly three-week trial as jurors sided with a woman and her husband who blamed continual debilitating vaginal pain on Johnson & Johnson’s Prolift product, manufactured by their Ethicon unit. She had received the implant to treat pelvic prolapse in 2008.
Elizabeth Hrymoc and her husband were awarded $15 million in damages, which included $10 million in punitive damages. They Hrymoc’s are just one case of thousands who have filed lawsuits against J&J claiming that the company failed to adequately warn the medical community and consumers of the product’s risks.
According to testimony, a doctor working for J&J’s Ethicon unit had proposed adding a warning to the Prolift product prior to launch. In an email sent to an Ethicon employee, he suggested adding the following to the “instructions for use”:
“WARNING: Early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction, which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse. Clinical data suggest the risk of such a complication is increased in case of associated hysterectomy. This must be taken in consideration when the procedure is planned in a sexually active woman.”
The warning was not added, nor was it included in a second version of the product released two years later.
Hrymoc’s attorney called the warning “a description pretty much of what happened to Elizabeth Hrymoc.”
Plaintiff’s attorneys read aloud other email exchanges between Ethicon employees that referenced the proposed warning. One said, “time is precious”, referring to a competitor who was marketing a similar product at the same time, and that Ethicon had “already printed launch stock.” Another read, “I think, all things being equal, being first to market is an advantage. I thought we had a much better product.”
Testimony also revealed that Ethicon had never tested Prolift on live human beings, but that it had only been designed and tested on cadavers.
The case is Elizabeth Hrymoc et al. v. Ethicon et al., case number L-13696-14, in the Superior Court of the New Jersey, County of Bergen.
15 Million Johnson & Johnson Mesh