16 May 2012
On 14 May 2012 the health minister Earl Howe published his review
of the actions of the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health in relation to the PIP breast implants scandal. The review found that the MHRA was “fulfilling its obligations in terms of reviewing and responding to the incidents reported to them” and that the MHRA was “active in pursuing PIP about incidents involving its implants.” However, Earl Howe also concluded that “serious lessons must be learned from this scandal”, stating that investigations were “hampered by a lack of reliable and comprehensive information about all the incidents relating to PIP breast implants, as well as uncertainty about comparative data on similar products.”
The current system of adverse incident reporting relies on medical professionals and manufacturers to properly and fully report adverse events. This reporting can be ad hoc, relying on doctors and hospitals to record such information as part of their work systems, and depends on doctors understanding, and taking responsibility for, their part in protecting patient safety.
Earl Howe recommended that evidence of adverse events should be taken from a wider and more detailed set of sources, and that EU countries should become better at information sharing. He argued that the regulatory system could be strengthened, but concluded that “the responsibility for the distress caused to UK women, and indeed many thousands of women worldwide, lies squarely with the fraudulent manufacturer which actively covered up its deceit and showed a complete disregard for the welfare of its customers.”
Specialist product liability solicitors
Leigh Day & Co’s defective medical device
lawyers represent hundreds of patients who have suffered personal injuries and consequential losses following the implantation of medical devices, from metal-on-metal hip components
to heart defibrillator leads
. Jill Paterson
, partner in the product liability
team, welcomes Earl Howe’s recommendations relating to strengthening the reporting of adverse events and improving communication across the EU. However, she believes that the whole system of device regulation needs to be reviewed, and should not just rely on post-marketing surveillance. One particular area of concern, for example, is cases where manufacturers push a device for regulatory approval by presenting it as a modified design, rather than a new product. In some cases, a slight “tweak” to a design can have major ramifications.
The British Medical Journal recently drew attention to the shortfalls in current device regulation. There have been suggestions that regulatory bodies are unable to compete with commercial pressure resulting in patient safety being overlooked. Necessary changes to an arguably outdated system, no longer “fit for purpose”, should ensure appropriate regulation at every stage of the process. Such changes should be implemented in relation to all devices, regardless of how inconsequential the design modification may appear to be. It is possible that such an approach could have prevented the current scenario, which has been described as “one very large uncontrolled experiment”.
To speak to a member of the product liability team please contact Jill Paterson
on 020 7650 1219
for a free and confidential initial consultation.
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