A Massachusetts pharmacy has agreed to pay a $100 million settlement after being held accountable for the 2012 deadly meningitis outbreak from tainted steroid injections traced back to the company. New England Compounding Pharmacy Inc. (NECC) of Framingham was at the center of the fungal meningitis outbreak last year causing more than 700 illnesses and 64 deaths in 20 states, the Centers for Disease Control and Prevention (CDC) reports.
All the infections stemmed from an NECC-made steroid injection sealed with vials of methylprednisolone acetate in which additional testing confirmed the species of the fungus. The drug frequently used to treat back pain was tainted before it ever left NECC. The Food and Drug Administration (FDA) says these tainted vials were shipped around the country and administered to patients who suffered from chronic back pain.
The first case linked to the fungal meningitis outbreak was reported in Tennessee in late September 2012, which lead to the Massachusetts Board of Pharmacy to initiate an inspection of NECC. The board was later joined by the FDA the following week. Since the inspection, NECC voluntarily gave its pharmacy registration to the state and no product has been produced at the facility. The steroid found in the injections is frequently used to treat back and joint pain.
Despite the numerous cases linked back to the pharmacy, NECC owners have denied any liability or wrongdoing, but they claim they want to play a major role in establishing a fund for those who died or suffered "as a result of this tragic outbreak," according to a statement announcing the settlement. Paul Moore, a trustee of NECC, showed support for the preliminary settlement agreement. "We are pleased that a significant amount of funds will become available for distribution to victims and their families as compensation for the deaths, injuries, and suffering they endured as a result of this tragic meningitis outbreak," Moore said, CNN reports.
Fungal meningitis is considered to be rare and usually occurs as the result of spread of a fungus through the bloodstream from somewhere else in the body due to the fungus being introduced directly into the central nervous system or from an infected body site infection that is next to the central nervous system. It is possible to contract the disease after taking medications that weaken the immune system such as steroids, as per the NECC fungal meningitis outbreak. The treatment of fungal meningitis is contingent on the status of the immune system and the type of fungus that caused the infection. Patients who have other conditions like AIDS, diabetes, or cancer, will most likely endure longer treatment.
In the wake of the fungal meningitis outbreak, Massachusetts health officials ordered 11 compounding pharmacies to completely or partially shut down after conducting unannounced inspections to prevent further contamination. The outbreak prompted Massachusetts Gov. Deval Patrick's administration to launch initiatives to prevent a reoccurrence. The MA Health and Human Services website says these moves included the requirement of sterile compounding pharmacies to report volume and distribution to the state for the first time and hiring additional inspectors.
Now just before Christmas, NECC will compensate victims, families, and creditors who were greatly affected by the deadly meningitis outbreak linked to the now-bankrupt MA pharmacy. The accord will require final documentation and does not cover the claims against the various clinics that sold the tainted steroid or the various vendors used by the pharmacy.
The case is In re: New England Compounding Pharmacy Inc, U.S. Bankruptcy Court, District of Massachusetts, No. 12-19882.