‘Weakness’ revealed by NECC
Experts: Owner documents show mistakes
Investigators searching a Framingham compounding pharmacy amid a deadly fungal meningitis outbreak uncovered a memo by owner Barry Cadden citing “lack of end product testing” as a company weakness, according to testimony yesterday at his federal murder trial.
Frank Lombardo, a special agent with the Food and Drug Administration, testified Cadden’s January 2012 “agenda for brainstorming opportunities,” an outline for a meeting to rally and re-energize staff at the New England Compounding Center, was but one of several potentially incriminating documents search warrants enabled him to seize from Cadden’s office. Another that Lombardo showed jurors, dated just two months later, suggests Cadden knew lab tests showed anesthesia NECC sold to Massachusetts Eye and Ear to numb eyeballs for surgery was likely ineffective.
Lombardo returns to the witness stand today. He helped lead the law enforcement team that conducted searches of NECC on Oct. 16 and Oct. 31, 2012, as patients around the country who had received mold-tainted steroid injections for back and joint pain began suffering massive strokes and dying. Besides mold, prosecutors have said NECC was infested with mice and insects. It also shared an office park with a recycling center — another “weakness” Cadden wrote that he wanted addressed, Lombardo testified.
Dr. Benjamin Park, a Centers for Disease Control outbreak specialist, compared it to the 2014 Ebola epidemic in West Africa.
“But this one,” Park said, “was here in our country — and entirely preventable.”
Park testified the majority of deaths were linked to Exserohilum, a pathogenic fungus that typically thrives in dirt, but which he said will aggressively “burrow through” a body’s natural defenses.
On Oct. 4, 2012, after 35 cases of fungal meningitis emerged in six states and five people were dead, Park said the FDA informed the CDC the mold in one unopened vial of NECC’s tainted methylprednisolone acetate medication was visible to the naked eye. Park said the CDC was also aware at least 14,000 people had received the shots.
“We were very scared,” Park said. “I felt like I was at the edge of a cliff and I couldn’t really see where the bottom was.”