Out-Law News | 06 Jun 2014 | 5:21 pm | 2 min. read
The Medicines and Healthcare Regulatory Agency (MHRA) is carrying out an investigation of pharmaceuticals manufacturer ITH Pharma, in conjunction with Public Health England (PHE), part of the Department of Health (DoH), in relation to the potential contamination of some batches of an intravenous liquid drip feed known as total parenteral nutrition (TPN). Product liability expert Manoj Vaghela of Pinsent Masons, the law firm behind Out-Law.com, said that supply chain management issues would "no doubt be a key focus" in this investigation.
"This is a very saddening incident and the investigation needs to establish the facts in this case as quickly as possible to ensure that it can not and does not happen again," he said.
"The ability to isolate the contamination quickly illustrates the need for careful supply chain management and regulation. Manufacturers and distributors should be diligent in managing this and have recall procedures in place to address such issues when they arise. This incident will cause huge reputational and financial damage to the firms involved; and while the source of the contamination was detected quickly, tragically, it was not quick enough to prevent the loss of life," he said.
PHE and the MHRA are currently investigating 17 cases of septicaemia and one death involving babies in neonatal intensive care units in hospitals in England, caused by a bacterium known as 'bacillus cereus'. This is a fairly common bacterium which is found in dust, soil and vegetation. Although most of the babies, many of whom were premature, are responding to antibiotic treatment, one has died.
Although investigations are ongoing, the cases have been linked with a number of batches of TPN, delivered to the babies intravenously as they were not able to ingest food in the normal way. This product must be manufactured in strictly antiseptic conditions because it is given directly into the bloodstream of vulnerable babies and adults. As part of their initial investigation, manufacturer ITH Pharma found that one "single raw material ingredient" produced by a supplier was common to all the cases. It has not confirmed the ingredient or the name of the supplier.
"Depending on all the facts and circumstances, ITH Pharma may face claims under the Consumer Protection Act, under the law of negligence and potentially criminal prosecution for breach of the General Product Safety Regulation 2005," said Vaghela. "ITH Pharma may have claims against the suppliers of the raw ingredients used in manufacturing the liquid feeds."
According to the MHRA, any stock of the contaminated TPN would have expired on 2 June. It said that there was a possibility that more babies who developed an infection last week or over the weekend would be reported as a result of its investigations.
Editor's note 11/06/14: This story has been updated to remove a reference to the potentially contaminated feed being "withdrawn". We apologise for the error.