Tuesday, March 26, 2013

Schuette seeks grand jury for meningitis outbreak probe

This is Schuette's press release issued today:
LANSING- Attorney General Bill Schuette today announced the he has filed a petition with the Michigan Court of Appeals requesting a multi-county grand jury be convened to investigate whether New England Compounding Center (NECC), a Massachusetts company linked to the recent meningitis outbreak, broke any state laws when it distributed tainted steroid injections to patients at clinics in four Michigan counties. 
Michigan leads the nation in patients affected by the outbreak, with 259 infections and 14 deaths recorded by the Centers for Disease Control and Prevention.
“Hundreds of Michigan citizens and their families have endured terrible pain and deaths of loved ones suffering from illnesses caused by these tainted steroid injections,” said Schuette.  “This investigation is necessary uncover the truth as to how this unspeakable tragedy happened and to restore public faith in our healthcare system.” 
“We will discover what went wrong, bring bad actors to justice, and then work to implement new protections to ensure tragedies like this never happen again.”
Today Schuette filed a formal petition to request a grand jury investigation of NECC with the Michigan Court of Appeals.  The Court will review the petition and determine whether to appoint a Circuit Court Judge to lead a confidential grand jury investigation.  Following a review of the evidence, the grand jury can decide whether to issue criminal indictments.  Grand juries are one of the strongest investigative entities in state law, holding the power to compel testimony under oath.
On October 12, 2012, following verified reports that NECC was responsible for the meningitis outbreak, Schuette acted to suspend the company’s pharmacy license in the State of Michigan.  In a formal Complaint and Order of Summary Suspension filed with the Department of Licensing and Regulatory Affairs, Schuette alleged that NECC acted as a “drug manufacturer” – not a compounding facility – by distributing large amounts of medication to various hospitals and clinics in Michigan.  The company had only been licensed to fill individual prescriptions for Michigan patients as a compounding facility.  NECC’s license was suspended and the company was forced to cease operations in Michigan. 
On December 12, 2013, the Michigan Board of Pharmacy Disciplinary Subcommittee formally agreed to the surrender and NECC voluntarily surrendered their Michigan pharmacy and controlled substance licenses.  As a result, NECC can no longer do business in the State of Michigan, and its surrender will be reported as a disciplinary surrender to other states.  Because the order provides that the surrender is based on a breach of Michigan’s Public Health Code, the State of Michigan can deny licensure to any individual who had a financial interest in NECC and applies for a new pharmacy license in the future. 
As of March 25, 2013, the Centers for Disease Control and Prevention (CDC) report 259 Michigan citizens have been infected and 14 have died. Michigan leads the nation in number of infections, and ties one other state for the highest number of patient deaths.   The CDC records Tennessee with 150 infections and 14 deaths.  The latest CDC reports can be viewed online: http://www.cdc.gov/hai/outbreaks/meningitis-map.html
On October 6, 2012, NECC issued a recall of all its products currently in circulation that were produced and distributed from its facility in Framingham, Massachusetts.  More information about the recall, including a list of affected medications can be found here: http://www.neccrx.com.


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