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    Murder and other criminal charges filed against NECC executives

    Ned MilenkovichIn December 2014, the United States Attorney’s Office charged 14 New England Compounding Center (NECC) employees, among them the owner and seven other pharmacists, with crimes that included murder, racketeering, and mail fraud. The charges stem from the NECC’s compounding and distribution of thousands of doses of contaminated injectable steroid medications that were ultimately linked to a fungal meningitis outbreak, first reported in 2012, that resulted in 76 patient deaths and 778 cases of illness.

    The federal government has also seized $18.3 million held in various bank accounts associated with the company's principals.

    See also: NECC pharmacist-owner charged with second-degree murder

    Racketeering and murder

    The NECC pharmacy executives face a 131-count indictment, including 25 counts of second-degree murder. Although the requirements for second-degree murder charges vary by state, second-degree murder generally requires willful or extreme disregard for life or awareness that such wrongful conduct would cause death.

    The indictment also lists 78 acts of racketeering, in which the defendants shipped the drugs interstate as part of a scheme to defraud their customers and the patients of those customers by making materially false representations of compliance with Massachusetts pharmacy laws. For instance, one pharmacy technician had voluntarily surrendered his Massachusetts license in a disciplinary action a year before he was employed by NECC.

    The NECC sold its compounded drugs through a sales force and marketing materials that asserted the pharmacy’s compliance with USP-797’s standards for sterile compounded drugs. However, the indictment demonstrates multiple instances of noncompliance with USP-797.

    For example, company pharmacists did not verify the effectiveness of NECC’s sterilization process and routinely attempted to sterilize drug lots in the autoclave for approximately five minutes less than the minimum time stipulated by USP-797.

    The sales force also provided quality assurance report cards with false environmental monitoring results. In reality, the NECC had actionable environmental deficiencies but did not remediate the issues.

    See also: Feds seize $18 million from NECC owners

    Nonsterile ingredients

    The NECC’s high-risk compounding business allegedly used nonsterile ingredients to make sterile drugs. According to the indictment, the pharmacy used expired and expiring ingredients, created fake expiration dates, mixed lots to conceal expiring or untested lots, and changed lot numbers. If the company received a notification from an independent laboratory that a drug was nonsterile, the NECC did not notify its customers or recall the drugs.

    NECC employees also falsified cleaning records and sent samples from stock solutions for sterility testing, as opposed to filled vials of drugs.

    See also: FDA observed filthy "clean rooms" at NECC facility associated with meningitis outbreak

    See also: Mass. DPH, FDA find violations at NECC

    Ned Milenkovich, PharmD, JD
    This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with ...

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