Drug company fined after supplying dangerously weak medicine to Milton Keynes toddler

The little girl ended up seriously ill in hospital as a result

By Sally Murrer
Thursday, 3rd March 2022, 9:29 am
Updated Thursday, 3rd March 2022, 9:30 am

A drugs company which made and sold a dangerously weak medicine that left a young Milton Keynes child seriously ill in hospital, was today fined more than £50,000 by a judge.

The Middlesex-based drug company Syri Ltd supplied medicine which was under-strength for almost five years.

A court was told that a two-year-old girl - known only as "MK" as she cannot be named for legal reasons - had been relying on the bottles of magnesium supplement made by Syri to make her better but the liquid was so weak, it failed to help with her chemical deficiency and she suffered multiple seizures.

In the courts

Judge Catherine Tulk heard that Hilltops Pharmacy in Great Holm asked Syri to produce a special batch of a medicine called magnesium glycerophosphate for two-year-old "MK", who was suffering from a rare genetic disease.

Prosecution counsel Paul Ozin QC told the court that the pharmacy sent the order to a large conglomerate of companies, headed by Syri, which would manufacture the special prescription.

The prosecutor revealed that the firm then proceeded to make up the two bottles of medicine. However, they were each made up to different specifications. The court heard that the first bottle was made to a formula used since 2011 while the second bottle was made to a new recipe.

Mr Ozin said: "The medicine was administered orally. Within three weeks of taking the medicine MK started becoming unstable, she was crying constantly and could not sleep.

"MK had seizures on the night of April 12 and 13, 2016. During the course of that night MK suffered seven seizures each lasting between 30 and 90 seconds."

In a harrowing victim impact statement, MK's father said: "As I look back on the night that she spent in hospital I remember the numerous blood tests causing pain.

"I thought that she was going to die. That night she had 10 fits and the nurses had to hold her down.

"I wish that the drugs company had been at the hospital to watch her suffering. I hope that no other family has to go through what my wife and I went through that night."

The court was told that blood tests revealed MK was suffering from severe magnesium deficiency, despite the fact that she had been taking her medicine as prescribed.

Judge Tulk heard that medicines regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) swiftly swung into action to try to get to the bottom of what had gone wrong.

The court heard that the first batch had only 12 per cent of the required strength, meaning that it did not provide MK with the nutrients she needed to overcome her condition.

Mr Ozin also revealed that Syri changed the formula of the medicine between the production of the two prescriptions to increase the concentration of magnesium, claiming that they wanted to increase the shelf life and improve the taste.

However, he said: "Neither of those two aims is the rationale behind the changes to the formulation from a medically useless 12 per cent to a 100 per cent useful medicine."

Syri admitted a charge of supplying a medical product that did not meet with the standards demanded by the prescription under the Medicines Act 1968.

Defence counsel Ben Close explained that despite 268 doses of the medicine being produced to the wrong formulation since 2011, there were no other known incidents of anyone coming to harm.

He added that Syri accepted their procedures had been lax but they had since been reformed to make sure this error could not happen again.

After a five-month delay in the hearing, Judge Tulk today handed the firm a fine of £51,000 after concluding that the company's management had been negligent.

Syri was also ordered to pay £104,898.40 in protection costs.

The child's parents will be able to apply for compensation through the civil courts.