Just three women started a class action against one of the biggest pharmaceutical companies in the world to seek redress when it marketed a medical device without adequate warning of the risks involved. Very quickly this trio were joined by 1350 other women suffering the pain and discomfort from medical failure and this week a Federal Court judge delivered a finding in their favour.
The company defending the action was Johnson and Johnson and two of its subsidiaries. This week Justice Anna Katzmann brought to a close this trial which started in July, 2017 with a finding that Johnson and Johnson and its attending companies engaged in misleading conduct and each was negligent as the risks for the devices were " known and not insignificant ".
All the devices carried risks of complications - against which no adequate warnings were given. The case will now proceed to the compensation stage and there is the expectation that this could run to many hundreds of thousands in damages.
The mesh products involved were supposed to treat stress urinary incontinence or uterus prolapse after childbirth. In finding the companies liable for damages, Justice Katzmann said risks of the nine mesh or tape devices included in the case were minimised " or not mentioned at all ." She also found that all three companies had been negligent as they knew the risks of the devices and knew these risks could " cause significant and serious harm ".
There was also criticism of the Therapeutic Goods Administration which approved most of the devices for use on the basis that they had been approved for use in the European Union without doing their own checks.
It is suspected that the women involved in this class action are only the tip of an iceberg. It is unfortunate that the condition this mesh is supposed to treat makes its appearance in various degrees of severity associated with childbirth and is fairly widespread. It is evident that no reliable relief is yet available.
One of the women involved in the class action commented that Johnson and Johnson still had the opportunity to appeal against this ruling, but it was an " incredibly pleasing result. " For all us women who have had to stand and be heard, we can all start to heal a little bit " she said.
This finding will send shock waves through the entire Therapeutic industry. The devices used in medical surgery are an important income earner for the companies that develop them and this case brings home the need for adequate testing and a frank revelation of the risks involved before they are released on the market.
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