Injunction sought to block sale of unlicensed skin product

The Attorney General and the Irish Medicines Board have applied to the High Court for orders to stop the sale and distribution…

The Attorney General and the Irish Medicines Board have applied to the High Court for orders to stop the sale and distribution in Ireland of what was stated to be an unlicensed medicinal product known as "Skin-Cap".

The interlocutory injunctions are being sought against Mr Patrick Bruen, trading as Swiss Laboratories, as Brentford plc, as Skin-Cap Ltd and/or Skin-Cap (Northern Ireland) Ltd.

Yesterday, Mr Justice Kelly adjourned the matter to Monday next after Mr Bruen said he did not "feel equipped" at present to answer some points which had been raised.

The judge told Mr Bruen that his approach to the litigation did not impress. His attitude seemed to be to treat the proceedings somewhat lightly.

READ MORE

Mr Justice Kelly said he was very unsympathetic to the application for a week's adjournment.

He said that an affidavit by Mr John Lynch, director of inspection with the Irish Medicines Board, had demonstrated a lamentable lack of co-operation on the part of Mr Bruen in the past. If that were to continue, he would run a serious risk of "finding yourself in a place other than this court next Monday".

The judge said he was adjourning the case until Monday next on conditions. He required Mr Bruen to disclose in writing by 5 p.m. on Thursday next the location of any of the product which was within this jurisdiction and to identify any persons who had taken delivery of supplies of it.

Mr Eamon Murray, for the Attorney General and IMB, opposing the adjournment application, said that interim orders had been made in the case early last month. In his affidavit, Mr Lynch said the Department of Health and Children was notified in June 1997 of publication in the Sunday World of a mail order advertisement on behalf of Swiss Laboratories which promoted a spray to treat the medical condition, psoriasis.

During July 1997, the Department became aware of publicity material relating to the product, Skin-Cap, which had been issued by Swiss Laboratories. Between August and November 1997, the board received notification from a number of countries that the product had been found to contain clobestasol propionate, a potent steroid which was not declared or disclosed in any marketing or labelling of the product. It became aware of the withdrawal of the product in the UK and Netherlands.

On February 5th last, Mr Lynch said he inspected premises at Lower Pembroke Street, Dublin. He met Mr Bruen, who informed him Swiss Laboratories was the trading name of Brentford plc.

Mr Lynch said the IMB's senior medical assessors had informed him that the risks associated with the unsupervised medical use of "this potent steroid" included risks to persons suffering from untreated bacterial, viral, tuberculosis or fungal infection, risks to sufferers of acne rosacea or perioral dermatoses or plaque psoriasis. The product also posed serious risks to persons suffering from broken and infected skin, including cold sores, acne and athlete's foot. It should not be used during pregnancy or lactation unless considered essential by a physician. A public health warning in relation to the product had been issued in the newspapers early last month. In circumstances where the continued sale of the product was an immediate and serious danger to public health, it was essential that Mr Bruen be restrained from continuing to market, sell and distribute the product.