Information brochures about pelvic implants that left Australian women with debilitating pain and injuries weren't the be-all-and-end-all of warnings, a lawyer for the manufacturers has told a court.
Three Federal Court judges on Monday began hearing an appeal into a landmark 2019 ruling that Johnson & Johnson Group firms acted negligently and concealed the true extent of complications from the pelvic implants.
Hundreds of the synthetic implants eroded, extruded or caused infection without warning - leaving women in chronic pain and with damage to surrounding organs.
But Johnson & Johnson says the trial judge's ruling had numerous legal errors, including reversing the onus of proof.
A finding that product brochures were deficient - leading surgeons astray - was also wrong, a barrister for the companies, Bret Walker SC, told the appeal hearing on Monday.
Justice Anna Katzmann in 2019 found the "Instructions for Use" handed to surgeons minimised harm and exaggerated the benefits of the devices.
But Mr Walker said it would be "extremely difficult to justify logically" that the brochures were the only source of information and that surgeons could put aside their own knowledge and experiences to rely solely on the document.
"It is sufficiently established that it is simply not right to treat the IFU as the be-all-and-end-all of warnings," he said.
He also took aim at the judge's decision to side with evidence of pathologists, rather than surgeons who were supportive of the innovation
"The clinicians are the people who use this - they are not at the bottom of the totem pole, they're at the top," Mr Walker said.
"(They) did not support the pathologists' view this should not be available."
The judgment did not amount to a finding that surgeons broadly were unaware of the potential complications, he said.
"No one in particular ever came and said 'this happened or if this happened ... that was news to me, a bolt from the blue, it never had occurred to me'," Mr Walker said.
Johnson & Johnson is appealing Justice Katzmann's 1500-page judgment on 15 grounds.
It came after three patients' experiences were examined in an eight-month trial that included 48 witnesses and more than 164,000 pages of written evidence.
But - just as the companies had argued at trial - Mr Walker on Monday said it was significant that the trial lacked evidence from the three patients' surgeons.
"It would be wrong to not regard (the surgeons' knowledge) as highly relevant evidence," he told the Full Court of the Federal Court in Sydney.
Justice Katzman in 2019 dismissed that argument by stating the safety of goods wasn't dependent on the knowledge of individual surgeons.
Since it launched in 2012, more than 1350 Australian women have joined the class action against the manufacturers and marketers of nine pelvic implants.
One of the lead litigants, environmental scientist and mother-of-two Kathryn Gill, was aged 36 when implanted with a device called Prolift Total in 2007 to fix a pelvic organ prolapse.
Side-effects after surgery included bowel issues, pain during sex and constant aching pain that became severe when Ms Gill coughed or moved suddenly.
She and the other two lead litigants were awarded a total of $2.6 million in damages - paving the way for full payout in the hundreds of millions.
The appeal before Justices Jayne Jagot, Bernard Murphy and Michael Lee is expected to run until February 9.
Australian Associated Press
