Women In New Zealand Want To Sue Johnson & Johnson Over Mesh Implants. They Can’t.
Women suffering complications from mesh implants say New Zealand's well intentioned no-fault injury scheme is denying them justice.
Last month more than 1,350 Australian women suffering debilitating pain and complications from transvaginal mesh devices won a landmark class action, but New Zealand patients say they are being denied comparable justice and compensation.
Jan — who asked to use a pseudonym to protect her privacy and that of her husband — is an Australian woman living permanently in New Zealand who has Gynecare TVT, one of the nine products at the centre of the Australian class action against Ethicon, a subsidiary of Johnson & Johnson.
The 59-year-old dual citizen couldn't join the legal fight, as she is entitled to compensation from New Zealand’s Accident Compensation Corporation (ACC), under which the right to take legal action for a personal injury is relinquished.
“[The ACC] was set up as a no-fault scheme for medical misadventure but personally I think this is a faulty product,” Jan told BuzzFeed News.
Australian Federal Court justice Anna Katzmann found patients were "injured because of the defect in the devices", and Jan believes patients in New Zealand should have the right to sue on this ground.
“Yes, your surgeon might have put it in wrong, but he never should have been using it in the first place and we should have the right to sue under consumer law.”
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
Jan’s story follows the same script of countless transvaginal mesh patients: she went to her doctor about urinary incontinence and was referred to a surgeon who implanted her with what she was assured was the “gold standard” in treating poor bladder control. The pain and discomfort she now lives with are more inconvenient and debilitating than the initial incontinence.
“From the moment I had the surgery I had urinary tract infection after urinary tract infection for 14 to 15 months,” she said. “Every now and then I would get a stabbing pain that would stop me in my tracks.”
In 2016 a urologist found the mesh had been implanted through her urethra and he did corrective surgery, covered by the ACC, after which she could urinate in a single stream for the first time in years.
Jan still needs another surgery, also to be covered by the ACC, to cut the mesh out of the side of the urethra where it is currently posing a risk of eroding and causing sepsis.
Her husband is left bleeding after they have sex, but it took years of exploratory surgeries before doctors would confirm the mesh had also eroded through her vaginal wall.
“They will cut the mesh out and repair the urethra using a piece of skin from inside my mouth cheek and then go in and try to deal with the mesh eroding into the vagina,” she said.
Jan joined a class action in the United States after Johnson & Johnson was ordered to pay US$20 million to a New Jersey woman who blamed the company's TVT-Secur mesh for her chronic and unresolved pain.
“I thought ‘I’m going to join this lawsuit, and if I get enough money I could go to the US and have it taken out there’,” she said.
But Jan says she and a handful of other New Zealand mesh patients were dropped from that action because the judge agreed with Ethicon's lawyers, who argued the patients already had access to a remedy in the ACC.
There are a limited number of doctors in the world trained in mesh removal and Jan would prefer, as many women in Australia and New Zealand have, to travel to St. Louis, Missouri, to see obstetrician-gynaecologist Dionysios Veronikis.
“I think you should be able to have the option to go overseas for treatment because there aren’t many doctors trained in this,” she said.
New Zealand's stance on suing for personal injury was upheld in a 2016 High Court decision, when patients with hip implants from another Johnson & Johnson subsidiary DePuy International tried to claim compensation for their injuries.
These patients had "relinquished their right to sue for compensatory damages in respect of their injury" when they accessed ACC payments, the judgement said.
Auckland lawyer Benjamin Hinchcliff specialises in assisting clients pursue ACC claims and said the maximum lump sum payment for permanent impairment in New Zealand is NZ$140,000.
“The lump sum payments, in my opinion, are meagre and don’t reflect the true cost and harm caused by the injuries suffered,” Hinchcliff told BuzzFeed News. “If somebody becomes a quadriplegic or has horrific injuries due to mesh, the most they could hope to receive is $140,000 for the rest of their life.”
Hinchcliff has read the recent decision in Australia, in which the judge made clear the implants generated an inflammatory response, “causing a layer of scar tissue to form through and around the mesh”, and that this “chronic inflammatory response is the primary cause of significant complications” arising from the use of all synthetic meshes.
This is noteworthy because the "biggest hurdle" claimants in New Zealand are facing, Hinchcliff said, is that the ACC has to find that there was a physical injury — a category that does not include "scar tissue, swelling or inflammation".
“I would hope that [the recent decision in Australia] would influence the New Zealand courts when these cases are brought forward, that it shows the mesh causes significant harm," he said.
The ACC published a report last year showing that of the 1,018 claims made between 2005 and 2018 about surgical mesh, 76% were accepted, a higher acceptance rate than those for other treatment injury claims.
Hinchcliff said the ACC did not recognise that pain was “necessarily an indication of a physical injury”. A patient might have chronic debilitating pain but this could be rejected by the ACC on the grounds of "no injury". Around 30% of rejected claims for surgical mesh were rejected on the basis of "no injury".
"ACC in no way seeks to minimise the impact of the pain experienced, and what people are going through," the ACC report reads. "However without clinical evidence of a physical injury the legislative criteria is not met and therefore the claim cannot be covered."
New Zealand woman Carmel Berry was implanted with Gynemesh PS, another of the devices at the centre of the successful Australian class action, and was denied cover by the ACC as her primary symptom was "chronic pain".
"The ACC is helpful if they approve the claim," Berry told BuzzFeed News. "If approved — and treatment injury claims can take up to nine months to decide — then patients can get their entitlements relatively quickly compared to the US where a lawsuit for damages may take many years."
After five years of pain and UTIs, Auckland woman Karen Rogers finally had her Gynecare mesh sling, another of the devices ruled defective by Katzmann, removed last year. In the meantime, Rogers has been on so many different rounds of antibiotics that doctors have told her there are just five types left she is yet to develop resistance to.
"I've lost jobs, lost relationships and became financially in a lot of strife because I couldn't pay my rent," the 53-year-old told BuzzFeed News. "In my case my mesh was too far up my vagina and too tight, causing me to have bowel and urine problems, and then the mesh degraded and came through my vaginal wall."
The ACC paid for Rogers' mesh removal and will cover her next surgery, in which muscle tissue from her thigh will be used to construct a “natural sling” for her bladder. Navigating the scheme has been confusing and Rogers said it isn't always clear what she can claim for.
"I can't claim compensation for all the work I've lost, my sick pay that I lost, all the medications I have had to pay for," she said.
Rogers said she has spent about $5,700 on subsidised medication, $1,400 of that on antibiotics alone, since 2013. She can no longer have sex as it is too painful. She said she would have joined a class action for two reasons, the first as an acknowledgement that Ethicon "fucked up".
"Secondly, for a significant amount of compensation, because I'm still going through this and it completely destroys your life," she said. "No amount of money could actually make up for what has happened."