Health Ministry ordered to reconsider drug case in which 8 lose eyesight

The Court of Appeal has ruled in favour of former minister Devant Maharaj in his legal battle against the Ministry of Health over access to information regarding the illegal importation of a drug that caused several individuals to lose their eyesight in 2019.

In a unanimous decision, Justices of Appeal Prakash Moosai, Mira Dean-Armorer, and Eleanor Donaldson-Honeywell quashed the ministry’s refusal to disclose certain details requested under the Freedom of Information Act (FOIA), ordering the ministry to reconsider its decision within 42 days.

Maharaj filed an FOIA request in December 2019 seeking information about the seizure of the unregistered drug N-Cort Triamcinolone Acetonide Injection, which led to cases of permanent blindness.

The ministry refused access to several key details, including the names of suppliers, the number of affected people, investigative reports, and information on those involved in its distribution. The ministry cited Section 28(1)(a) of the FOIA, arguing that disclosure would prejudice an ongoing police investigation.

However, the Court of Appeal found that while an investigation was ongoing, the ministry failed to conduct the necessary balancing exercise under Section 35 of the FOIA, which allows disclosure in cases of public interest, potential abuse of authority or risk to public health. The judges ruled that this failure constituted a breach of statutory duty and ordered the matter be sent back to the ministry for reconsideration.

The ministry is also expected to include in its reasons the status of the police’s investigation.

Dean-Armorer, who delivered the ruling, acknowledged that a significant amount of time had passed and recognised the devastating impact on those who lost their vision and their families. She also noted the serious public health risk involved.

Anand Ramlogan, SC, Kent Samlal, Candice Ramkhelawan, Aasha Ramlal and Ganesh Saroop represented Maharaj.

Roger Kawalsingh and Savitri Marajh represented the ministry.

In support of his lawsuit, Maharaj said several people contacted him in early August 2019 about relatives who developed infections after treatment by a doctor in June 2019.

“Specifically, five families have complained to me that their elderly relatives have developed infections in one or both of their eyes after treatment by this doctor…”

“The infections were so bad they all had to remove the infected eye.

“The prevalence of such a drastic outcome, by the same doctor, raised serious concern.”

Maharaj said his investigations led him to the public recall of the drug. In a notice, the ministry warned that the drug was not registered in TT, and was illegally imported. The ministry’s notice also said the drug – N- CORT 40 mg/mL., Ml Intravitreal/ Intraocular Use (Triamcinolone Acetonide Injection Bp), Batch No NC-O2 with expiry date March 2022 – was recalled due to possible bacterial contamination.

Maharaj said he was concerned that the drug reached the shelves of reputable doctors while many lost their eyesight.

One of the affected patients, who admitted he contacted Maharaj, said he received the drug via an injection after eye surgery and immediately began to experience blurry vision, after which he became blind. He was referred for an infection, his eye flushed with antibiotics, but the problem persisted. He was examined by a team of specialists who told him the eye would have to be removed to prevent further infection, which could turn fatal.

A sergeant at the Port of Spain CID said in December 2020, he received an investigative file referred by the office of the Director of Public Prosecutions on a complaint made by the Health Ministry of an alleged breach of the Food and Drugs Act. He said several people had to be interviewed but covid19 slowed the investigation. He advised against disclosure of the information since the investigation was at a sensitive stage.

Director of the Food and Drug Division and chief chemist Farz Khan said the division received an anonymous letter in 2019, which indicated that the unregistered drug N-Cort Triamcinolone Acetonide Injection had been imported by a company and distributed to ophthalmologists. He noted that the drug had caused permanent blindness in eight people.

Khan explained that after becoming aware of the letter, the chief medical officer was notified, and in July 2019, one of the division’s inspectors visited the importer.

According to the investigator’s memorandum, the drug had been requested by local ophthalmologists, with ten boxes imported and distributed. He said seven vials were used by two doctors, after which patients reported adverse reactions, including permanent blindness. The doctors then informed the importer, who initiated a recall of the product. A total of 93 vials were recalled and received, with a sample sent for testing.

Khan said the drug was not imported by the ministry and that, under normal circumstances, a drug must be registered before it can be legally imported. He explained that the division examines drugs to ensure compliance before they are released for sale. However, he confirmed there was no evidence of approval or registration for the drug in question, nor had any notices been issued regarding its legal status.

He further noted that if a drug is not registered, its importation for sale or advertising is considered illegal. He also said there was no clear evidence how the drug had been released to the importer after it was brought into the country.

As far as he was aware, Khan said, the matter remained under active investigation.