Data irregularities at lab could have ‘closed down’ generic medicines plant if discovered by regulator, WRC told

An investigator charged with examining data issues at a drug manufacturer’s quality control lab has said its manufacturing licence could have been suspended if they had been uncovered by the State medicines watchdog.

The CIA-trained ex-garda detective – hired in as a consultant by Pinewood Healthcare Laboratories Ltd for a “data integrity” probe – was giving evidence to the Workplace Relations Commission at a hearing into a claim by one of the lab’s analysts.

On Tuesday the Workplace Relations Commission resumed its hearing of Michael Molumby’s complaint under the Unfair Dismissals Act 1977 in which he alleges he was constructively dismissed by the pharma manufacturer.

Mr Molumby accused investigators hired by his employer of subjecting him to “an ambush and an assault on my good name” when they interviewed him in the summer of 2020.

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The company’s former HR director, Ambrose Downey, told the tribunal that “data integrity issues” had already brought about the sacking of one employee.

The company’s aim was to “baseline where we were at” and carry out an investigation on par with Health Protection Regulatory (HPRA) standards.

The firm appointed two pharmaceutical regulatory consultants for a “data integrity” investigation: former garda detective Kevin Sweeney and his associate, Stan O’Neill, a former regulator with the predecessor to the HPRA, the Irish Medicines Board, the tribunal was told.

Giving evidence, Mr Sweeney said that the company “would have been shut down” if the issues had been found out by the national medicines regulator instead of the internal review.

“If it had been a HPRA audit and they had uncovered this the manufacturing licence would have been revoked,” he said.

In a letter later sent to the company’s HR department and opened to the tribunal by his barrister Mr Molumby said he had been led to believe he was going to have a “chat” with the investigators.

Instead he found himself “questioned in an aggressive and judgmental manner in a way that called into question my professional integrity and good character”, the letter read.

“I was offered an ‘amnesty’ – this sounded like blackmail. I got up and walked out without signing the notepad which was pushed under my nose,” Mr Molumby wrote.

“This was the most humiliating experience of my life. It was an ambush and an assault on my good name and character which were dragged through the gutter ... Could it be I was targeted as a quiet type of person who might leak information if I was put under pressure?”

Mr Sweeney denied any “aggression” in his interview of Mr Molumby and said he followed his usual interview format with the complainant, which he said was to start by building rapport, move to general questions and then address specifics.

“Aggression is counterproductive in any interview. Even in a policing context it tends to close people off,” he said.

“Do you deny it?” said the company’s barrister, Mary-Paula Guinness BL.

“I deny it, absolutely, there was no aggression, no need for it to be used,” he said.

“I wasn’t interested in the interviewee’s personal conduct at all. I’d no opinion on his conduct. I was looking at the culture and procedures in his current lab,” he said.

He said that when he showed Mr Molumby a set of test results produced by a machine using his login credentials, the complainant said it was “a failing” which “should have been caught”.

Mr Sweeney said the complainant went on to say: “This is just the tip of the iceberg.”

“This is data used to release this medicine on to the market,” Mr Sweeney told the tribunal.

He said he told Mr Molumby: “I can offer an amnesty if you give me information here and it won’t go any further ... It’s not about individuals, it’s about the system.

The investigator’s evidence was that Mr Molumby became “highly agitated” and stood up and walked around the interview room, said he wanted to speak with his solicitor and left the interview room.

Barbara Ryan BL, who appeared for Mr Molumby, put it to Mr Sweeney that he had “worked for the CIA”.

“My CV does not say that,” he said.

“I’m reading intelligence officer,” Ms Ryan said.

“An Garda Síochána sent me for training,” the witness replied, adding that the US intelligence agency had not trained him in interview techniques.

“Would you have carried out interviews with people accused of crimes?” counsel asked.

“Yes, yes I would have, quite a few,” Mr Sweeney said.

“He [Mr Molumby] said he followed the systems which were in place when he joined the lab,” Ms Ryan said.

“He said he followed the systems in that lab even though he knew it was far lower than his previous lab,” Mr Sweeney said.

Mr Sweeney said a set of readings provided to the investigators in respect of “a number of products” were “egregiously wrong”, among them an item put to Mr Molumby in the interview.

“It was personal at that stage, do you accept that,” Ms Ryan said.

“It would be pointless putting someone else’s work to him,” the witness replied.

Mr Downey, the firm’s former HR manager, said he thought a meeting with Mr Molumby addressing the matter on 20 July that year had been satisfactory but the analyst then submitted a formal grievance three days later and immediately took sick leave on the grounds of work-related stress.

In mid-August, he told the complainant the firm would “hold off on processing” the grievance until he returned to work.

“I feel my health will only return once my grievance has been dealt with,” the complainant replied.

A series of occupational health assessments followed, the tribunal was told, concluding with a finding that Mr Molumby was medically fit to work, but with a doctor noting that it had been the complainant’s third absence due to work stress on record.

Mr Molumby then tendered his resignation in early September, stating that his encounter with Mr Sweeney had left his relationship with the pharma firm “compromised beyond repair”.

Mr Downey told the tribunal the grievance outcome, issued after Mr Molumby’s resignation, did not uphold the complaint – and as he was no longer employed, he had no right of appeal.

“Would you accept that Mr Molumby felt the reason he had to write that email resigning was because he felt his work situation intolerable?” asked Ms Ryan.

“I wouldn’t accept that,” Mr Downey said.

Adjudicating officer Peter O’Brien said he would take the complainant’s legal submissions in writing and closed the hearing to consider his decision, which he said he intended to issue to the parties before Christmas.