Massive victory in class action

THREE women representing thousands of patients given defective vaginal mesh implants have won a landmark class action against an international medical giant.

The Federal Court yesterday found the nine implants were defective and that two Johnson & Johnson group manufacturers and its Australian supplier misled customers and were liable for the injuries caused.

Damages will be awarded early next year.

More than 90,000 devices were inserted into those wanting structural support to treat stress urinary incontinence and pelvic organ prolapse. But hundreds, if not thousands, who elected to undergo surgery suffered chronic and debilitating acute pain as the supposedly permanent implants eroded and extruded.

One of those in the class action, Victoria’s Diane Dawson, remains beset by pain despite five additional surgeries to address her complications, Justice Anna Katzmann SC said.

“She is understandably angry, frustrated and distressed by her plight,” the judge said yesterday.

Reading a 24-page summary of a 1500-page judgment, Justice Katzmann said she found the applicants had shown all devices by manufacturer Ethicon were defective, weren’t fit for purpose and were supplied with misleading instructions.

Further the Johnson & Johnson companies failed to take “reasonable care to evaluate the safety” of the devices before and after they were first marketed and that the applicants were entitled to compensation.

Some of the devices went to market without clinical trials. Ethicon’s post-market surveillance was also deficient on multiple fronts, Justice Katzmann said.

Essentially passive, the surveillance was conducted primarily

FOR THE MOST PART, THESE REPORTS COULD SCARCELY BE DESCRIBED AS EVALUATIONS AT ALL, LET ALONE CRITICAL ANALYSES JUSTICE ANNA KATZMANN

for marketing purposes, lacked genuine risk analysis and didn’t comply with regulatory requirements.

“For the most part, these reports could scarcely be described as evaluations at all, let alone critical analyses,” Justice Katzmann said.

In instructions for use supplied with all the Ethicon devices, the company knowingly falsely represented that the mesh elicited a minimal to a slight inflammatory reaction.

Some 1350 women have already signed up to the class action but Shine Lawyers says there is still time for other affected women to register.

The case will return to the Federal Court in February.