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 Johnson & Johnson has withdrawn the mesh from sale,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
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
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
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.
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What happens if a patient, particularly a mental health patient,.
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