No doctor present when Botox like treatment given, court hears
THREE women have told a court that there was no doctor present when anti-wrinkle botox like treatments were administered on them at a hair and beauty clinic in Dublin.
Anne Rossi, who runs the Anne Rossi Clinic, at Vernon Avenue, Clontarf, Dublin 3, is being prosecuted by the Health Products Regulatory Authority (HPRA) on 18 counts under the Irish Medicines Board Act. The HPRA is the regulatory body for prescription medicines in Ireland.
She has pleaded not guilty to all the charges and has gone on trial before Judge John Brennan at Dublin District Court. The court heard that the term botox, was a brand and trademarked but not a product featured in the charges, however, it was used as a generic term for similar products which contain the same active ingredient Botulinum Toxin A.
Opening the case for the prosecution, Ronan Kennedy BL told the court that the case relates to the a botox-like product called Dysport which contains the prescription only substance Botulinum Toxin A.
It was the prosecution case that it was imported into the State without permission and administered to customers by injection at Ms Rossi’s clinic. Mr Kennedy said it must be done by a doctor or a pharmacist.
Defence counsel Breffni Gordon BL said that there is not a shred of scientific evidence to support the charges.
The first witness Bronwyn Molloy told the court that on Oct. 30, 2014, she received a botox treatment to her forehead.
She said it was done by Ms Rossi who cleaned the area with an anti-sceptic swap and then administered an injection with a needle into to her forehead.
She said Ms Rossi would have explained it would eliminate creases and she paid €300 for the treatment.
She said she returned on Nov. 20, 2014 and Ms Rossi administered what she assumed was botox to eliminate a crease on her forehead and she assumed it was authentic.
She said there was no doctor present and she was not asked to complete a medical history form.
In cross examination she told the defence counsel that she did not know if it was specifically botox but she went there to get botox.
She said that she did not have any scientific training when asked that if she had been shown the vial or saw details indicating its contents. However, she agreed she trusted that it was botox.
The court heard the effects of the treatment lasted for about three months.
Denise Johnson told the court that she went to the clinic in January 2015 and she assumed it was botox which had been injected into her forehead by Anne Rossi.
She said she came back for a “top up” treatment 17 days later and this was done by the defendant. Afterwards she had an abscess on her forehead and stinging around her eyes, she said.
Witness Karen Harmon agreed with the prosecution that she went to the clinic on seven occasions in 2014 and she had requested a botox treatment which she said was injected into her forehead.
She agreed with Mr Gordon that she was aware of terms like Dysport but she did not know anything about it.
Dr Muckesh Lalloo a skin surgeon specialist, who works out of a HSE clinic at Blanchardstown Primary Care Centre in Dublin said he reported the Anne Rossi clinic to the HPRA after a patient came to him with “one brow lower than the other” which he said was consistent with “inexpert administration” of Botulinum Toxin A which has a freezing effect.
He said it was a “very powerful substance”.
Dr Katherine Mulrooney told the court from 2008 to 2012 she had an arrangement with the Anne Rossi Clinic where she would see a number of patients on a given day and administer Botulinum Toxin A, in either Dysport or Botox.
She said she brought the substances with her and they have to be administered by a medicinal practitioner such as a doctor.
She also provided after care if necessary at her main clinic but she had not done any work for Anne Rossie since 2012.
The court heard that Ms Rossi is a qualified nurse.
Dr Mulrooney was shown six copies of orders allegedly emailed from the Anne Rossi Clinic in 2014 to a UK based supplier of health care cosmetic products with orders for boxes of Dysport.
She agreed with Mr Kennedy that in the attachments to the email were copies of prescriptions with her medical registration number and a signature in her name.
However, she said that it was not her signature and she had not done any work for the Anne Rossi Clinic since 2012.
She had also not given any permission for the use of her medical registration number, she said.
The trial will continue in October.
It is alleged that from Nov. 20, 2014 until Jan. 27, 2015 while not being a pharmacist Ms Rossi supplied a medicinal product without a prescription.
The product named Dysport contains the prescription only substance Botulinum Toxin A.
It is also alleged that on the same dates she unlawfully placed the product on the market without authorisation.
It is also alleged that on or about Nov. 25, 2014 and Feb. 10, 2015, she imported the medicinal product into the State without the HPRA's authorisation.
Dysport is a Botox-like product used in various treatments but most popular for its anti-wrinkle and anti-ageing signs effects.
A district court conviction for the charges can result in a fine and, or a jail sentence of up to one year.