Wednesday, December 17, 2014

Criminal Charges Filed In Fungal Meningitis Case



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In early October of 2012 we became aware of a growing medical crisis involving contaminated preservative-free MPA steroid injections distributed by the New England Compounding Center in Framingham, Massachusetts.  In all, more than 700 patients developed infections from these  tainted injections, and more than 60 died.


Among the survivors, many have suffered serious ongoing disability.  I blogged at some length in 2012 and 2013 on this outbreak, including:


CDC Updates On Fungal Meningitis Outbreak
MMWR: Multistate Outbreak Of Fungal Meningitis
CDC/FDA: Multistate Fungal Meningitis Outbreak – Oct 15th
CDC HAN Advisory & Updates On Fungal Meningitis


In late October, in FDA Statement On Conditions Reported At NECC Facility, we saw a report cited the discovery of unopened vials of preservative-free methylprednisolone during an inspection on October 2nd that were observed to have `greenish black foreign matter’ and/or `white filamentous material’ inside.


Additional testing `confirmed the presence of viable microbial growth in 50/50 vials tested’.

On November 2nd, the story grew worse when the CDC released a CDC HAN Advisory: Additional NECC Products Found Contaminated, and again in December the CDC/FDA released a report (see CDC HAN Update On Fungal Meningitis Outbreak )

Laboratory Testing and Results

[12-12-2012] FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis,  Aspergillus fumigatus,  Cladosporium species,and Penicillium species.

While not the first compounding pharmacy-related outbreak, this was certainly the worst. In Revisiting An Earlier Fungal Meningitis Outbreak, we looked at a similar, albeit much smaller, outbreak in 2002 involving a pharmacy in South Carolina.

Today, via Maggie Fox of NBC News, we learn that the Feds have filed a variety of charges (including two with 2nd degree murder) against 14 people involved in the production, distribution, and alleged cover-up of these contaminated products. 

Follow the link to read Maggie’s excellent coverage:

Feds File Murder Charges in Fungal Meningitis Outbreak

By Maggie Fox

The owners and senior officers of a Massachusetts pharmacy that distributed contaminated drugs that killed 64 people have been arrested and two were charged with second degree murder.

Barry Cadden, owner and head pharmacist at the New England Compounding Center (NECC), and other top staffers not only knew their products weren't sterile, but they conspired to cover it up, the U.S. Justice Department says in the indictment.

(Continue . . . )

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