As Johnson & Johnson this week lost a bid in the US Supreme Court to overturn a $302m judgment in a case brought by the state of California accusing the company of concealing the risks of its pelvic mesh products, a planned legal suit in South Africa was gaining momentum, writes Chris Bateman for MedicalBrief.
The court, following its usual practice, did not give any reason for refusing to hear J&J's appeal, reports Reuters. J&J had argued to the Supreme Court that state consumer protection laws like California's are too vague, exposing companies to unpredictable state lawsuits. Business groups including the US Chamber of Commerce backed the company.
California Attorney-General Rob Bonta in a statement called the court's decision "a definitive win in our fight for justice." J&J said in a statement that the Supreme Court's rejection of the case will lead to continued "uneven, unclear and unfair enforcement that harms both consumers and businesses."
California sued New Jersey-based J&J in 2016 in San Diego Superior Court. The case stemmed from a multistate investigation into J&J subsidiary Ethicon Inc's marketing of pelvic mesh devices, which are surgical implants that were used to treat incontinence and other conditions.
J&J and other mesh makers were already facing numerous private lawsuits by women who said they suffered pain, urinary problems, bleeding and other serious injuries from the devices. The lawsuits have resulted in more than $8bn in settlements.
J&J, which stopped selling pelvic mesh in 2012, has denied wrongdoing. In 2019, the US Food and Drug Administration ordered all pelvic mesh devices off the market.
California did not take part in that settlement, and its lawsuit resulted in a $344m judgment in January 2020 following a non-jury trial.
A judge found that Ethicon's marketing materials about the mesh devices, and its instructions for using them, deceived doctors and patients by failing to disclose serious risks, violating the state's unfair competition and false advertising laws. A California appellate court last year cut $42m off the award.
In South Africa, meanwhile, scores more women have joined a planned class action against companies that supplied their surgeons with a polypropylene mesh device used to repair vaginal prolapse and urinary incontinence – but face a frustratingly long wait.
Papers were filed in the Gauteng High Court last October and lawyers representing the women this month received notice that the companies which produced the products, Johnson & Johnson, Coloplast and Ethicon, intend to oppose the suit. Their international parent companies, based in New Jersey, USA and Switzerland, have yet to respond.
From a handful of women using Facebook to support one another through what is described as “agonising” injuries inflicted by their bodies’ rejection of the polypropylene mesh, there are now some 140 women who have come forward, following some initial publicity.
They are awaiting court certification, expected towards early next year, enabling a possible major class action in which probably hundreds more litigants will join.
This was confirmed yesterday by Richard Spoor Inc Attorney’s Sonam Mansingh, who said the victims were suffering vascular, nerve and organ damage, dyspareunia, chronic pain, inflammation, infections and/or urinary incontinence after their bodies rejected the mesh implant.
The devices were introduced to complement biomedical mesh versions in the US in the early 2000s, but within a few years serious adverse effects were being reported. An FDA warning, issued in 2008, prompted thousands of transvaginal mesh lawsuits which spread to Australia, resulting in settlements approaching a billion dollars so far.
Mansingh said: “We realised that Johnson and Johnson and others were distributing a lot of medical devices in SA and that we could have the issue here as well. We started research and it wasn’t long before we found a few Facebook groups, with women supporting each other.”
She said the problem was the polypropylene material that the body recognised as foreign and began attacking, resulting in scar tissue and inflammation, and the mesh breaking up and often piercing surrounding organs.
“It was used successfully for abdominal hernias, but the female genital area is rich in blood vessels and nerve endings and far too susceptible to eliciting a foreign body response,” she explained.
Clients tend to be in the middle-to-upper income brackets and confined to the private healthcare sector. However, Mansingh said the device was also distributed to public hospitals.
“We are investigating the extent to which mesh implants were used in the public sector and whether similar complications have arisen,” she added.
There will be an interlocutory motion before the Gauteng High Court based on the parent companies allegedly being aware of the sale of mesh products by their local subsidiaries, despite the global awareness of the dangers associated with polypropylene mesh. Once the court determines the jurisdictional issue, the certification application will be heard, allowing the class action to proceed, probably by early 2024 – unless a settlement is reached out of court beforehand.
Mansingh said it was hard to “guestimate a quantum”, as each individual case differed, some significantly, with a sub claim filed for psychological injury and associated family suffering.
In Australia, the first three of 1 000 litigants were paid out 1.7m Australian dollars in March 2020 after a seven year long court battle.
The worst of the local cases involves excessive blood loss, organs being pierced by various pieces of the mesh, vascular damage, permanent nerve injuries and recurring operations to remove the mesh device. No deaths have been reported locally, though one woman reportedly died of infection in the US.
Said Mansingh. “The body keeps reacting to the polypropylene mesh device by creating scar tissue that ultimately never heals. It causes tissue damage, which often leads to death of the body tissue, great pain, not to mention the accompanying social distress caused by incontinence and inability to engage in intercourse.”
If the mesh can be removed early enough, some relief is possible but by the time symptoms emerge it’s often too late for corrective surgery.
“We’ve had one client who had quite a large piece of mesh removed, two further corrective surgeries had to be performed and this client still suffers from debilitating incontinence,” Mansingh added.
She said the tragedy was that even if the women received hefty compensation, they still had to live with conditions that severely reduced their quality of life.
She claims the device is still being distributed in South Africa, in spite of its reported history of inflicting damage and distress. The South African Health Products Regulatory Authority, however, has received no complaints so far, according to Deon Poovan, Sahpra’s senior manager, Inspectorate and Regulatory Compliance.
He said that after the overseas litigation, many companies distributing the polypropylene mesh locally had recalled it, but was unable to say unequivocally that all such products had been recalled.
“No adverse events have been reported to us in the past couple of years except for one person who could not provide sufficient data for us to reach any conclusion; There’s been nothing that required market action by us,” he said.
He said medical product companies were obliged by law to conduct post market surveillance and report any adverse events to them.
“Yes we can effect a recall, but we haven’t – the companies did it themselves. The other legal sanction we can use it to declare a product undesirable, which hasn’t happened in this case.”
When Spoor Inc Attorneys notified the respondent companies of the class action last year, the manufacturers “asked for the pre-implant and post-implant medical history of our clients, pharmacy record, medical bills, the relevant implant identification sticker etc., but it’s not our job to educate the respondents on their risks associated with their products, it’s theirs”, asserts Mansingh.
She stressed that Spoor’s class action does not involve any physician who either recommended or performed the implants. She says there are no plans by her company to set up any medical, surgical or psychological support for the victims at this stage.
“We unfortunately cannot provide interim relief at this stage. We will pursue the class action, which will entail performing medical assessments and developing treatment protocols,” she said.
See more from MedicalBrief archives:
SA vaginal mesh class action following landmark judgment
SA group plans vaginal mesh class action
FDA halts sale of all surgical mesh products in the US
Law firms kickstart class action over J&J pelvic mesh devices