Pharmaceutical products giant Johnson and Johnson has been ordered to pay $2.6 million in damages to three Australian women who suffered injuries from one of its products. This opens the door for a massive class action because Johnson and Johnson manufactures the leading mesh product that is widely used to combat urinary stress incontinence or pelvic organ prolapse, both of which can occur after child birth.
The problem is this product carries no warning that it can cause serious complications, and that these include chronic pain, infections and damage to surrounding organs. Because the product carried no warnings a mass of Australian women are involved in a class action and the court having found in their favour there is now the expectation that compensation will be widely awarded.
This week the Federal court followed up on its ruling by ordering Johnson and Johnson and its affiliates to provide patient information leaflets and similar information on promotional material if it continues to sell its products in Australia after March 20.
The terms of this court ordered warning include that the products are " designed to and will " elicit an acute inflammatory response for as long as the implants remain in the patient's body. In some cases, they will cause " adverse effects ".
How adverse the outcome of using this product will be seems to be a matter of luck. Some women find the relief balanced against the discomfort caused, but others have been forced to seek surgical removal. The class action was against nine such products and five of these are no longer available on the Australian market.
This outcome is a timely warning to the entire pharmaceutical industry. All too often the profit motive has induced companies to rush a new product to market before the long term adverse effects of its use have been known. It is usually promoted to the doctors who will prescribe it to their patients as being entirely safe and the adverse effects only become known over a period of time. At the time of release, this seemed a very reasonable response to what was a condition that would seriously restrict a woman's lifestyle.
It seems there is a fortune out there waiting for a company that can find an answer to this debilitating condition and which is virtually free of adverse side effects. They just need to be sure that their product comes with adequate warnings. Leaving the outcome to chance is no longer a viable option.
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