Whistleblower Law Blog
Whistleblower Says Meningitis-Linked Pharmacy Ignored His Warnings
Whistleblower Joe Connolly appeared on 60 Minutes to accuse his former employer, the compounding pharmacy linked to 53 deaths from fungus-tainted shots, of ignoring warnings and destroying evidence of contamination at its lab.
Connolly, a lab technician and former employee of the New England Compounding Center (NECC), told the CBS News program that his supervisor literally shrugged when Connolly told him last year that the lab was overextended and likely to start making mistakes. Mold had been found in NECC’s “clean room” about a dozen times over three years, Connolly said.
NECC, which declared bankruptcy in December, faces more than 400 lawsuits for the October 2012 outbreak of fungal meningitis caused by its shots, and it remains under investigation by the Centers for Disease Control and Prevention (CDC) and other government agencies.
According to the CDC, 733 people so far have been sickened with meningitis after injecting themselves with NECC-produced methylprednisolone acetate (MPA), a compounded steroid cocktail used to treat chronic pain in the back, neck, and joints. Between May and September 2012 NECC sent the shots to 23 states, putting more than 13,500 patients at risk.
Connolly said NECC became “sloppy” as production increased in its compounding lab. Federal law requires compounding pharmacies to have an individual prescription for each compounded drug. But NECC began getting a flood of similar orders from dubious sources; Connolly said its output grew a thousand fold.
Since the outbreak started, NECC has recalled all of its products and shut down all operations. A lawyer for Barry Cadden, NECC’s co-founder, said it was “premature and unfair to accuse anybody of causing this contamination.”
Tagged: Enforcement Bodies, Food and Drug Administration (FDA)