The announcement this week by plaintiff law firm Tindall Gask Bentley that it was abandoning a class action against the Australian distributors of Poly Implant Prosthese (PIP) breast implants illustrates critical defects in Australia’s regulatory framework for medical devices.
For five of the eight years that Medical Vision Australia Pty Ltd (MVA) was the sole Australian distributor of PIP implants, it apparently had no product liability insurance. The company is now in liquidation. There is no point in pursuing MVA, because there simply won’t be sufficient assets to compensate victims. The French manufacturer is facing criminal prosecution, and is also bankrupt.
These women - over 1,000 of whom had joined the action - have extensive claims for medical care and other costs. Removal of implants is not covered by the public health system, and some women do not have private health insurance.
Regardless of your views on implants, these women were consumers of a regulated product that they reasonably believed was safe. Like consumers of other medical devices including pacemakers, replacement joints, and stents, they put their trust in the Therapeutic Goods Administration (TGA), the regulator responsible for ensuring that medical devices meet quality, safety and efficacy standards. They relied on the TGA to do the job it was entrusted with by legislation - to authorise release of medical devices to the Australian market, and, if necessary, revoke that authorisation. The TGA has let them down.
This is not the first time breast implants have suffered large-scale product failure: the extensive litigation arising from leaking silicone breast implants in the 1990s should have warned the TGA that potential existed for failure of the PIP implants.
Similarly, this is not the first time the TGA has failed to respond appropriately to reports of problems with medical implants. Its response to concerns about DePuy hip and knee joints has been criticised by the Senate, along with its management of the PIP implant failure.
The very fact that the products in question - foreign objects implanted into the human body - required regulatory approval should have provided a clue that the consequences of failure of these devices were significant. After all, if those implants were risk-free, regulation wouldn’t have been required in the first place.
Further compounding this regulatory failure, it appears that the TGA did not perform a basic due diligence check as part of its authorisation to market PIP implants by MVA. It appears that the legislation does not permit them to require marketers to hold product liability insurance. In an era of class action liability, this is simply incomprehensible.
The victims of PIP have been left without a remedy. To add insult to injury, they cannot even sue the TGA for negligence, because the TGA has legislative immunity from the consequences of its regulatory incapacity or indifference.
The TGA is the gatekeeper standing between consumers and suppliers of medical devices. It is responsible for establishing the safety of these goods and to protect consumers from serious harm, the sources of which consumers themselves have no means of identifying.
When it works, that protection directly benefits the Australian economy through minimisation of hospital costs and lost productivity resulting from harm caused by unsafe medical devices and pharmaceuticals. When it doesn’t work, the costs are enormous.
In order to be effective, the TGA must be more assertive in revoking authorisations to market and distribute goods. It is not there to be an industry advocate, and it has to address perceptions of bureaucratic capture by industry.
It should have ensured that PIP’s distributor had sufficient product liability insurance at all times, and if it cannot under law, then this should be a top priority for legislative amendment.
The TGA is funded from the public purse. It is time it decides if it wants to be a real regulator. In the meantime, it would be a very good idea if the Commonwealth got its regulatory house in order, and provided the TGA with legislation that enables it to regulate effectively.