New England Compounding Center blames cleaning company UniFirst for meningitis outbreak
The New England Compounding Center, the specialty pharmacy tied to a nationwide outbreak of fungal meningitis and other infections traced back to contaminated steroid injections made by the firm, is pinning the outbreak on its cleaning contractor.
The Boston Globe reports that attorneys for NECC sent a letter to UniFirst Corp. demanding that it take legal responsibility for claims against the pharmacy. The outbreak linked to injectable steroids made by the NECC have sickened more than 650 people, including 372 meningitis infections, and has killed 39 people.
UniFirst acknowledged that a subsidiary helped clean portions of the pharmacy's cleanroom facility in Framingham, Mass., but maintained its cleaning services were limited and it was not responsible for the contaminated drugs. A spokesman called the claims "unfounded and without merit."
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"UniClean was not in any way responsible for NECC's day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced," UniFirst spokesman Adam Soreff told the Globe.
Soreff said his company sent two technicians to NECC monthly for 90 minutes each, and they used the NECC's own cleaning solution.
The letter was referenced in a Thursday filing by UniFirst to the Securities and Exchange Commission.
Federal investigators foundwidespread evidence of mold and other contamination when they visited the pharmacy in October.
The agency found that some vials of preservative-free methylprednisolone acetate -- the injectable steroid tied to the outbreak -- contained "greenish black foreign matter" while others had "white filamentous material." The FDA report also detailed contamination in "clean" areas where drugs were meant to be prepared, such as discoloration on surfaces, nearby standing water from a leaky boiler, and condensation buildup on devices meant to be sterile.
When House lawmakers had planned to ask owner and director of the pharmacy, Barry Cadden, to explain the FDA's findings at a November hearing, but he exercised his Fifth Amendment rights.
Last month, the company declared Chapter 11 bankruptcy and said it was seeking to set up a fund to pay victims.