Oliver’s investigation of NECC, the supplier of the contaminated drugs in question, led her to carefully examine the history of NECC’s disciplinary actions and enforcement under then Governor Romney’s Health and Human Services Department. Oliver found that NECC had a history of violating accepted pharmaceutical industry standards and that, during Governor Mitt Romney’s tenure, the Massachusetts state government consistently conceded to requests by NECC’s counsel for more lenient treatment rather than the initial requested penalties according to correspondence between NECC and the State of Massachusetts. Oliver, in collaboration with Crivella West Incorporated, an advanced analytics and investigational research company, is providing public access to these important records at www.fungalmeningitis.com.
Massachusetts state records reveal that NECC and its Manager of Record, Barry J. Cadden, were the subject of six complaints between 2003 and 2006. At least one of these complaints alleged that NECC and Cadden failed to comply with accepted pharmaceutical standards in compounding methypredinsolene acetate. Methypredinsolone acetate is the same drug that has been recalled by NECC and linked to the outbreak of fungal meningitis resulting in numerous deaths. The Centers for Disease and Control and Prevention (CDC) and Food and Drug Administration (FDA) earlier this month advised medical professionals to discontinue use of any products manufactured by the New England Compounding Center.
Initially, the Office of Health and Human Services Department of Public Health and Board of Registration in Pharmacy (BRPh) offered to enter into a consent agreement with NECC to resolve the complaints relating to methypredinsolone acetate. The initial proposal required disciplinary action, public reprimand, and a three year probationary period. NECC rejected the proposed consent agreement and, according to the documents of the BRPh, negotiated a more lenient penalty with the Romney administration’s BRPh. Ultimately, the NECC was required to serve one year of probation and pay for a private consultant to monitor compliance. Further, according to these same records, the BRPh agreed that the non-disciplinary agreement would not be reported to the National Association of State Boards of Pharmacy or other outside agencies. Pursuant to the terms of the agreement, NECC could avoid the one year probation if additional conditions were met.
Oliver’s investigation of the public records uncovered little evidence that Governor Romney’s agencies diligently monitored or scrutinized NECC’s compliance activities. Effectively, the BRPh records establish that NECC was left to self-report completion of compliance requirements.
The Oliver Group, P.C. filed the first lawsuit in Michigan involving the meningitis outbreak from the tainted steroids sold by the New England Compounding Center (NECC). Oliver Law Group has also filed a petition before the Joint Panel on Multi District Litigation. This petition seeks consolidation and coordination of the various meningitis lawsuits pending nationally to one court. The Oliver Law Group is an aggressive and effective consumer advocate law firm, currently involved in many of the biggest national cases against pharmaceutical and medical device companies.
- Alyson Oliver (800) 939-7878
- The Oliver Law Group
- 950 West University Drive
- Rochester, MI 48307
Relevant DocumentsThese documents were obtained from The Official Website of the Executive Office of Health and Human Services (EOHHS) of the State of Massachsetts.
- New England Compounding Pharmacy, Inc. - Application for a New Store - date received 2.18.1998
- Barry J. Cadden and NECC - Notice of Resolution of Complaint Comittee - dated - 10.27.1999
- New England Compounding Center - Compounding Pharmacy Inspection Report - dated - 2.20.2004
- Barry Cadden and NECC - Advisory Letter - dated 9.30.2004 - re dkt nos ds-03-036 and ph.03.042
- Barry Cadden and NECC - Advisory Letter - dated 9.30.2004 to Barry Cadden re dkt nos ds-03-060 and ph-03-070
- Barry Cadden and NECC - advisory letter dated - 9.30.2004 re dkt nos ds-04-062 and sa-04-161
- NECC and Barry J Cadden - complaint file ds-03-055 - allegation of complaint
- Barry J Cadden and NECC Staff Assignment and Complaint File DS-05-040 - Allegation of Complaint
- NECC and Barry J Cadden Complaint File PH-03-066 - Allegation of Complaint
- NECC Inspection Report dated 5 24 11