A medical device company discovers that one of their devices is going to be the subject of a public inquiry

A medical device company discovers that one of their devices is going to be the subject of a public inquiry. The device received regulatory approval but its use has resulted in medical complications for patients. The company’s view is that much of these complications were the result of improper training of practitioners in connection with the device and it being used incorrectly and in inappropriate situations. The company have no experience of inquiries and are concerned that negative findings could have a serious impact on their reputation and business.

How much will a public inquiry cost? How long will a public inquiry take?

Kingsley Napley consider the terms of reference for the public inquiry and advise on the timeline of an inquiry, the process, and what resources the company will need to make available to participate in the inquiry. An inquiry like this with limited scope may be able to report in less than a year. If there are a significant number of victims whose views are being heard it may take longer. The company would need to be fully engaged throughout.

Resources that the company would need to make available could include:

• Legal representation in the inquiry and in respect of other related proceedings;
• In-house resource at the company to deal with requests from the inquiry;
• Communications professionals;
• Electronic evidence consultants to assist with evidence requests.

The outlay may be significant but this has to be measured against the damage that would be done to the company’s standing and its future business if an adverse finding was made.

Should I apply for core participant status in a public inquiry?

Kingsley Napley advise on the pros and cons of core participant status. Ultimately it is decided that it is in the company’s best interests to apply for core participant status. Kingsley Napley prepare and submit the application for core participant status on the basis that the company has a significant interest in the events being considered, and could face potential criticism when the inquiry publishes its final report. The application is granted by the inquiry’s chair.

What information has to be disclosed to a public inquiry?

Kingsley Napley advise on how to deal with information requests from the inquiry taking into account data protection considerations and any other restrictions on disclosure. Electronic evidence consultants are engaged as required. Throughout the evidence gathering process Kingsley Napley consider with the company whether any information should be pro-actively disclosed to the inquiry to assist them in their understanding of the matter.

Who will be asked to give a witness statement to a public inquiry?

Kingsley Napley take instructions from the company and liaise with the inquiry to identify potential witnesses for the inquiry. Kingsley Napley provide dedicated support to the witnesses asked to prepare statements. A senior executive of the company has given witness statements on the company’s behalf before but is unfamiliar with the details of the device under scrutiny. An employee from the research and development division is very familiar with the facts surrounding the device’s development but has never prepared a witness statement before. Support from Kingsley Napley is tailored to individual witnesses.

What information will be disclosed by a public inquiry?

The inquiry discloses to core participants documentation received from the company, other core participants, and other evidence providers. Kingsley Napley review and summarise this documentation for the company, identifying any material that alters the company’s understanding of what has unfolded.

Who will be asked to give evidence to a public inquiry?

When the inquiry identifies the witnesses from which it wishes to receive oral evidence Kingsley Napley offers tailored support to those witnesses.  When the timetable for the hearing is published Kingsley Napley advise on issues to raise with key witnesses that are likely to discuss the company’s approach to the medical device.

Will I be criticised by a public inquiry?

Kingsley Napley identify criticisms of the company made by other core participants in the inquiry during the hearing. The inquiry prepare a list of criticisms it is minded to make of the company following the hearing and share this with the company and Kingsley Napley on a confidential basis. Kingsley Napley prepare with the company representations in respect of criticisms and potential criticisms.

Will I get to see the report of a public inquiry in advance of its publication?

Kingsley Napley agree the strategy for report publication in advance of its publication date. The inquiry are only willing to circulate an embargoed report two hours prior to publication. Kingsley Napley liaise as appropriate with communications professionals appointed by the company regarding the publication of the report.

What happens after a public inquiry report is published?

Kingsley Napley liaise with the company to assist them with updates to the inquiry in connection with the recommendations made in the inquiry’s report.

*This is a fictitious case study prepared based on Kingsley Napley’s extensive experience of working with businesses and institutions in respect of public inquiries.