A Federal Court judge has awarded combined damages of $2.6 million to the lead applicants in the Johnson & Johnson pelvic mesh class action, following a landmark ruling in November which found that the pharmaceutical giant did not adequately warn of the risks of the implants.
Justice Anna Katzman ruled on Tuesday that lead applicants Katheryn Gill, Diana Dawson and Ann Sanders, who each suffered severe injuries from the devices, be awarded a combined $2.6 million. The judge also ordered J&J to pay the applicants’ costs.
The ruling paves the way for a damages bill in the hundred of millions of dollars for the Shine lawyers-led class action, which, as of November 2019, had around 1,350 group members. Registration for the class action closes on April 9, and the parties must submit a proposal for determining individual claims by June 30 2020.
Shine Lawyers Head of Class Actions Jan Saddler said the judge’s order was encouraging but acknowledged the case still has a way to go.
“We’re pleased with the result and encouraged by the compensation for the three lead applicants ordered today,” Saddler said.
“Today is a significant step forward but there is still a way to go until all Australian women affected by these products receive compensation,” she said.
The future of any payout for group members remains uncertain, with Johnson & Johnson having already flagged a possible appeal.
“Ethicon believes that the company acted ethically and responsibly in the research, development and supply of these products,” the company said.
“I would have thought you would have already drafted your notes,” she remarked.
During the case management hearing on Tuesday, the parties unsuccessfully attempted to agree on a number of other matters, including the parameters of injunctive relief concerning product warnings to be given to doctors and patients. Justice Katzman reserved judgement on these matters until the end of the week. The applicants also requested 90 per cent of their costs on an indemnity basis, which will be determined at a later date.
In her November judgment, Justice Katzmann ruled that all nine devices at the centre of the massive class action, which were manufactured by J&J unit Ethicon, were defective, and that the warnings issued by the companies were deficient.
“All the devices carried risks of complications the respondents admitted were clinically significant, against which no adequate warnings were given, and about which doctors and patients alike could have been misled,” Justice Katzmann said in a summary of her 4,577 paragraph judgment.
“In essence, the Ethicon devices were oversold, that is to say, they were promoted to doctors as suitable for most patients when they had not been adequately evaluated, when they carried significant risks, and when the respondents had not provided sufficient guidance about the nature or extent of the risks, the management of those risks, or the patients who were most at risk.”
Justice Katzmann said J&J Medical Australia and co-respondents, Ethicon Inc and Ethicon Sarl, were aware of the risks of the devices before any of them were supplied to doctors in Australia and the inadequate information they provided “was a problem of their own making”.
“Consequently, I found that the respondents were liable to compensate any applicant and/or group member who suffered an injury because of the defect for the amount of the loss and damage she sustained as a result of that injury,” she said.
J&J and the Ethicon units were also found to be negligent and to have engaged in misleading and deceptive conduct.
“I found that all three respondents were obliged to exercise reasonable care in the supply and marketing of the devices. I held that that duty extended to providing accurate information about the performance and safety of the devices and information that was not apt to mislead, including warnings about all but one of the pleaded complications. I held that the duty was not confined to the period before the devices were made or placed on the market, but was a continuing obligation to evaluate their safety, keep abreast of information about the nature and extent of potential complications, and to convey that information to users of the devices,” Justice Katzmann said.
The lawsuit was filed in October 2012 on behalf of women who were surgically implanted with various pelvic mesh and tape devices, seeking compensation for complications resulting from the implants, such as stress incontinence and pelvic organ prolapse. Group members allege the devices caused catastrophic injuries to their internal organs and ruined their sex lives.
Conservative estimates put the number of women who suffered medical conditions from the implants at just under 5,650. The class is open to all women implanted with the defective devices. More than 90,000 of the devices were supplied in Australia, Justice Katzmann said.
The parties have been in mediation since the trial to negotiate a possible settlement but no agreement has been reached. Given the judgment is likely to be appealed, another round of mediation has been set for May.
Last year, J&J paid $114 million in a settlement of litigation brought by 41 states in the US alleging the company misled patients about the risks of its implants.
That the matter is set to be be listed for further case management hearing on date to be determined.
The class is represented by Tony Bannon SC, Duncan Graham SC, Andrew Naylor and Zoe Hillman, instructed by Shine Lawyers. Ethicon and Johnson & Johnson are represented by Kate Morgan SC and Derek Wong, instructed by Clayton Utz.
The case is Kathryn Gill & Ors v Ethicon Sarl & Ors.