Claims arising from problems with medical devices and products continue to mount. In the U.S. trial lawyers are pursuing claims arising out of contaminated steroid shots and a subsequent meningitis outbreak that to date has left 23 people dead. Closer to home, Johnson & Johnson faces its third major class action in three years. Shine Lawyers have commenced a class action on behalf of patients implanted with Gynaecare, mesh for the treatment of pelvic organ prolapse (POP), a condition occurring when the tissues holding the pelvic organs in place become weak or stretched.
POP most commonly occurs post pregnancy and childbirth, and mesh implants are used to strengthen the relevant area. Many women have had successful treatment with mesh implants, but some have experienced severe problems as a result of the mesh or scarring associated with the mesh effectively wearing through softer tissues nearby. Johnson & Johnson has withdrawn the mesh from sale, although the company says this was a commercial decision rather than a safety one.
Another prominent plaintiff law firm (Maurice Blackburn) is also reviewing the situation and assessing whether a class action or individual claims will provide the most effective path to compensation.
The U.S steroid cases have given rise to some discussion about the intersection between product liability and medical negligence claims. The same issues may arise in relation to the mesh claims. In a product liability context, it is generally enough to show that the product was not fit for its purpose. Success in a claim for medical negligence requires that a plaintiff must establish personal fault. A product liability claim (where available) would usually represent the easier route, and this may be one factor in Shine’s decision to pursue the manufacturer of the mesh rather than the doctors who implanted it.
However, the line between product liability and medical negligence is not necessarily clear. The Urogynaecological Society of Australia indicated to the TGA that the concerns of its members were with the use of the mesh, rather than the mesh itself. Complication rates were said to be low, and to vary depending upon the skill and experience of the surgeon and ‘patient factors’.
If this is correct, is the mesh unfit for its purpose, or has it instead simply been used inappropriately in certain cases? The Shine Lawyers class action will presumably allege the former, and their website notes that while patients may be angry or disappointed in their doctors, this alone does not amount to negligence. The lack of clarity over this issue may however be one of the reasons Maurice Blackburn is still considering whether it will seek compensation by way of a class action or individual cases.
Time will tell, but the approach ultimately taken may have significant consequences, both for the way claims are managed and how the burden of any liability is ultimately distributed.