Company allegedly knew devices posed added risk for patients with compromised immune systems
The pharmaceutical giant Johnson & Johnson allegedly failed to warn women that its vaginal mesh devices posed a particular risk for patients with compromised immune systems, despite it being well known before they were first sold in Australia.
The mesh was surgically implanted to treat stress urinary incontinence and pelvic organ prolapse, common complications of childbirth. It was marketed to surgeons as a simple, safe and affordable implant, which would boost their profits and speed up operations considerably.
But the devices left many women in debilitating pain and unable to have sex, ruining lives and causing long-term impairment.
Over a six-month hearing, the federal court heard allegations that Johnson & Johnson either knew of the risks or failed to properly test the devices before launching them on the Australian market.
On Monday, the women won the right to add a new allegation to its case: that Johnson & Johnson knew the devices posed an added risk for patients with compromised immune systems but failed to warn women.
Kathryn Gill, the lead applicant in the case, was among those who were not warned, the court heard.
Gill suffered from psoriasis but says she was not told of the added risk she faced in undergoing the surgery. She said she never would have gone ahead with the procedure had she known.
It was not until after Gills operation that warnings about immune problems were added to the instructions for a number of the mesh devices.
The warning read: In patients with compromised immune systems or other conditions that would compromise healing, the risks and benefits should be carefully weighed.
The court was also told that US regulators wrote to the manager of regulator affairs at Ethicon, Johnson & Johnsons product development arm, in October 1990, well before the products were first sold in Australia. The letter adverted to potentially delayed wound healing in patients with compromised health due to a number of factors, according to the federal court.
The court also heard from a biomaterials expert, Prof Paul Santerre, who said it was well known that immune system problems made it more difficult for biomaterials to integrate with tissue. Santerre cited a 1997 report on the issue.
Mesh was not sold in Australia until after 1997.
The allegations about the immune system response were not initially included in the class action against Johnson & Johnson. But lawyers for the women launched a late bid to have them included in their formal pleadings, which was opposed by the company.
Federal court justice Anna Katzmann allowed the pleading to be changed in a judgment handed down on Monday afternoon. She rejected the arguments that doing so would put the company in an unfair position, having already argued its case.
Having given careful consideration to the points raised by both parties, I am not satisfied that the amendments would cause any injustice to the respondents, she said.
Katzmann has also allowed the women to seek an injunction that would prevent the mesh devices being sold or marketed in Australia without a comprehensive warning about the risks.
The company had attempted to argue that was a role best left to the Therapeutic Goods Administration (TGA), an argument Katzmann rejected.
Katzmann has reserved her full judgment in the case and it will be handed down at a later date.