For months we've been following the fungal meningitis outbreak. We've watched this swell from 7 cases to nearly 440 nonfatal cases and 32 fatal cases. The NECC, New England Compounding Center, has surrendered its license and recalled their tainted drugs. Congress has initiated hearings into the outbreak to determine how this could have been prevented. And many families are suffering as a result of this horrific outbreak.
Could this have been prevented? Congress has compiled information on the NECC to answer this question. Where did the NECC go wrong to cause such a frightening outbreak? In a 25 page report released by the House Energy and Commerce Committee, Congress has been able to trace back years of complaints, inadequate safety measures, concerns for hygeine and safety, and regulatory complaints.
The FDA Failed to Act
When it came down to it, the U.S. Food and Drug Administration (FDA) found the NECC lacking in health and safety violations. Instead of taking matters into its own hands, they deferred the decision of what to do with the NECC to their regulatory counterparts in Massachusetts. A deal was likely struck and years later, 32 people have died and 440 people have fallen ill, at risk for death, from this compounding pharmacy's health and safety violations.
On multiple occasions, the NECC failed to uphold health and safety standards. In 2003, the FDA suggested that the NECC be "prohibited from manufacturing" in order to avoid these problems. Based on multiple complaints, including one from Colorado, the NECC was accused of behaving more like a drug manufacturer than a pharmacy. The NECC didn't provide prescriptions like pharmacies did. Instead, they shipped thousands of drugs across the United States without a prescription. Had the NECC been treated like a manufacturer, they would have had much stricter standards in place and the FDA could have shut them down. Ironically, as a pharmacy, the FDA had limited power to act. The grey area of regulatory power over compounding pharmacies has continued to plague FDA efforts.
What Kind of Violations Did the NECC Have
- 2011- Pharmacy Board cited NECC for providing doctors with blank prescription pads with NECC's information
- March 2002 complaints of patient adverse reactions due to steroids led to an FDA investigation, in which NECC felt it did not have to provide records, barring proper inspection.
- October 2002 patients reported symptoms of bacterial meningitis which led to another FDA investigation where the FDA found 4 of 14 infected samples. The FDA let Massachusetts regulators take the lead.
- October 2004 the Pharmacy Board sent the NECC a proposed agreement which would have included formal reprimands publicly available on their license and 3 year probationary periods. The Pharmacy Board ended this without discipline in another 2006 action.
If you have suffered the effects of fungal meningitis as a result of the NECC's tainted steroids, you could be entitled to compensation. You should seek a skilled personal injury and product liability attorney. Call us today so we can help you.