Closure for 2012 Meningitis Outbreak: Sentencing Delivered
The Massachusetts man at the center of an infamously deadly 2012 national meningitis outbreak, Barry Cadden, pleaded no contest to 11 counts of involuntary manslaughter in Michigan and was sentenced last month to at least ten years in prison for his part in the deaths of 11 Michigan residents.
Cadden was the co-founder and former owner of the New England Compounding Center (NECC) in Framingham, Massachusetts, which distributed contaminated injectable methylprednisolone, a synthetic corticosteroid used to treat several conditions, including inflammation, severe allergies, adrenal problems, arthritis, blood or bone marrow problems, etc. At least 64 people across the country died, and nearly 800 fell ill. A black mold called Exserohilum rostratum was found in the majority of cases and Aspergillus fumigatus was found in one case. The outbreak eventually became the focus of a CBS News "60 Minutes" investigation in 2013.
He's currently serving a 14-and-a-half-year prison sentence for federal racketeering and fraud convictions. The Michigan sentence will be served concurrently with the federal sentence.
The outbreak could have been avoided had the pharmacy adhered to and enforced chapter <797> of the United States Pharmacopeia. USP <797> establishes best practices and regulations for producing compounded sterile preparations (medications). Last November, USP <797> received its first revision since 2008, increasing the frequency of environmental monitoring activities and aseptic technique verification for compounders. These changes hold pharmacists to stricter standards, ensuring patient safety by reducing the risk of drug contamination, as seen in the New England Compounding Center case.
One of our goals here at Hardy Diagnostics is to help simplify USP <797> compliance. Click HERE to view our USP <797> compliance products suite.
Source: Michigan Department of Attorney General
Written by Joelle Brackeen
Pharmaceutical Product Manager
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