Indiana AG targets pharmaceutical company with petition
Posted: 10/26/2012 at 11:00 am
By: Angelle Barbazon
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This photo provided by the Minnesota Department of Health shows vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak that were being shipped to the CDC from Minneapolis.
AP Photo/Minnesota Department of Health
Zoeller filed an emergency petition Friday asking the Indiana Board of Pharmacy to take a license away from the New England Compounding Center, a drug manufacturer in Framingham, Mass. The company produced contaminated steroid medications used to control back pain. The drugs were recalled Sept. 26 after being distributed to about 75 clinics in 23 states.
The U.S. Centers for Disease Control and Prevention, or CDC, has been tracking the spread of the outbreak for the past three weeks. There have been 328 cases of fungal meningitis confirmed nationwide, including 43 people infected in Indiana. The infection has been blamed for 24 deaths across the country. All three fatalities reported in Indiana have been linked to Elkhart County.
“It is tragically clear that this out-of-state pharmacy presents an immediate danger to public health and safety,” Zoeller said in a news release. “Our office will use all available resources to ensure Indiana patients are protected from any more harm and to pursue a formal administrative action against the company’s ability to operate in our state.”
The Indiana Board of Pharmacy will review Zoeller’s petition at its next meeting on Nov. 5. If the suspension is approved, the New England Compounding Center will not be allowed to operate in Indiana for 90 days. In that time, the Attorney General’s Office would likely file a formal licensing complaint before the pharmacy board. Once the complaint reaches the board, appropriate disciplinary action will be determined.
Roughly 1,500 people in Indiana were exposed to the contaminated medications through epidural and joint injections, according to the state’s health department.
“These are uncharted waters, but we are learning more about these infections every day,” said Joan Duwve, chief medical officer at ISDH. “The State Health Department has been working diligently with the Centers for Disease Control and Prevention to assist Indiana medical providers with the screening, diagnosis and treatment of infections related to use of these contaminated products. We will continue to do so until this outbreak is resolved.”
Six lawsuits have been filed in Elkhart County against the pharmaceutical company. The complaints were filed by patients of OSMC Outpatient Surgery Center in Elkhart where they received tainted medications. OSMC has not been named in any of the lawsuits.
FUNGAL MENINGITIS TIMELINE
• Sept. 26: Health officials recall contaminated steroid medications.
• Oct. 5: OSMC Outpatient Surgery Center reports first cases of fungal meningitis.
• Oct. 10: Pauline Burema, of Cassopolis, Mich., becomes the first person in Indiana to die from the infection.
• Oct. 13: The second Indiana death attributed to fungal meningitis is reported.
• Oct. 15: An Elkhart man files suit against the New England Compounding Center.
• Tuesday: Elkhart General Hospital holds a press conference to address the treatment of patients.
• Wednesday: A third victim in Indiana dies from fungal meningitis.
• Thursday: Five new lawsuits are filed by OSMC patients against the drug manufacturer and its operators.
• Friday: Indiana Attorney General Greg Zoeller files a petition to suspend the license of the drug manufacturer.
NECC Petition SummarySuspension