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Meningitis Outbreak Lawsuit and More Questions About New England Compounding Center (update)

8 comments

My partner , Joe Crumley wrote about the issue with the licensing or lack thereof by New England Compounding Center (NECC). The distributor at the heart of the Meningitis outbreak from steroid injections. Beyond the license issue, there are now questions about the distribution itself. It is being reported that there was distribution of the drugs without patient names or prescriptions. This is a violation of Massachusetts law.

Apparently, there is also information that business was referred to a sister company, Ameridose LLC. Ameridose is claiming that the two operated separately. Both companies are owned by engineer, Gregory Conigliaro, and his brother-in-law, Barry Cadden, a pharmacist. Cadden was in charge of pharmacy operations at NECC. Ameridosa is closed and under investigation.

Update: It is now being reported that NECC has also provided drugs to Mayo Clinic, Allina, HealthPartners and other hospitals and clinics — many more than previously disclosed.

In response to the outbreak, a lawsuit has been started here in Minnesota and is reported to be seeking class action status. As fellow Legal Examiner writer, Tracy Finken, pointed out:

The federal lawsuit may be the first in response to the outbreak. The woman claims she experienced headaches and nausea after receiving methylprednisolone acetate injections for chronic back pain. The Minnesota Department of Health later informed her that she may have received a contaminated shot. She has since undergone a painful spinal tap to test for fungal meningitis.

Thousands of people nationwide have been exposed to the tainted steroids, with 119 contracting fungal meningitis including 11 deaths. Over 800 Minnesotans have been notified that they have received the potentially contaminated steroids this summer, as I wrote previously.

8 Comments

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  1. Rich Snyder says:
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    Someone knows EXACTLY what caused this contamination. This is not a simple matter of not washing hands, someone brought normally outdoor fungus into a mixing area – I’ve studied mycology for years, deal with building remediation, have been infected a bit (lungs only), and don’t think Exserophilum is a typical building fungus – as if someone took a smoke break, picked up fungus from an outdoor table on sleeves, then started mixing drugs without proper cleanroom attire (full bunny suit with sleeves tucked into the gloves). There was a major lapse in basic procedure and it should be easy to pinpoint. CDC should be able to find the Exserophilum somewhere around that facility (unless an employee cut their grass then came to work with the mould on clothes, but still… it should have been contained in a clean suit – CSF injections need to be cleaner than mixing dandruff treatments…).

  2. Mike Bryant says:
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    Very interesting, thank you for taking the time to read and comment.

  3. Rich Snyder says:
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    “Fungus has been found in at least 50 vials of an injectable steroid medication made at a specialty compounding pharmacy in Massachusetts, investigators said. Health authorities haven’t yet said how they think the medication was contaminated, but they have ruled out other suspects — other products used in administering the shots — and the focus continues to be on that pharmacy, the New England Compounding Center.”

    THIS is what’s interesting, but I wonder how many vials were tested (were 50 of 50 contaminated? this will indicate if ALL 14000 who got the injections may be infected) and how many contained Aspergillus and/or Exserohilum. The FDA site says the fungus was seen with direct microscopic examination – meaning there was probably a lot of it in the vials (unless examiner was like me who will spend 15 minutes looking at every square mm under the cover slip at 20x mag). I can’t see anyone who was injected with this NOT getting sick. CSF is normally sterile, and never exposed to infectious agents, unless something passes the brain/blood barrier; unlike lungs and digestive tract which are often exposed to fungi, the body was never designed to deal with fungus in the spinal fluid. I hope the best for those exposed.

  4. Mike Bryant says:
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    Maybe, I hope that isn’t the case. My understanding that the testing of people has started of all of those that are being contacted. e should know a lot more very soon.

  5. Rich Snyder says:
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    You’re right that more will come out. “They” should be able to tie those who were affected/died to certain vials, may find out that some vials had more fungus than others, that old/young/immune compromised people were affected more, etc – this is like an experiment carried on my the Nazis to see who would be affected by injected microorganisms. It’s possible the immune system can fight it, as I read the drugs they use only stop the fungus from growing (fungistatic) but don’t kill it (fungicidal), so “it’s left for the victim’s immune system to deal with it” – but this may depend on how much of the drug gets into CSF (enough to slow it or enough to kill it). I know a man who got “cocci meningitis” (resulting from “Valley Fever”) and he’ll have to be on diflucan for the rest of his life – it’s never really cured. This meningitis is worse because the drugs are VERY hard on the body – IV Amphotericin B is real bad (they call it “ampho-terrible”), and voriconazole is hard on the kidneys – dosage matters but so does duration – and the cost is extremely high in any case (even if patients can be put on oral meds afterward). The med community will learn much from this, and the epidemic will be in history books – the only good thing about it is it’s not contagious.

  6. Mike Bryant says:
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    They should be able to pin point all of it.

  7. Rich Snyder says:
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    The FDA report,

    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM325980.pdf

    on page 7, said the “greenish black” and “white filamentous” contamination was “covering the louvers on an HVAC return located behind the [] autoclave”, which will likely be the same as contamination found inside vials/steroid. The paragraph above says NECC’s air intakes are located about 100 feet from a recycling facility where dump trucks/excavators kick up dust. The dust probably clogged filters (no mention of this yet) which usually results in unfiltered air being pulled around them (typical in homes when furnace filters aren’t changed). Shutting off the AC at night would allow condensation from humid air to form on the return duct louvers, which would encourage mould growth (RH should be less than 60% to discourage growth). Hard to say how the contamination from the louvers would get in the mix (still seems only one of three batches was severly contaminated), but it was near the autoclave where ingredients/utensils were to be sterilized. One report said there was evidence NECC had used bleach to clean up some areas, but they missed the louvers. There are records showing NECC knew about contamination problems. I’m no lawyer, but seems like criminal negligent manslaughter. I hope the victims recover and get reimbursed for medical costs (which could go on for a long time) – I’ve read nothing about NECC’s insurance, if they had any, if it will cover this, or what the limit might be – I assume NECC will claim bankruptcy at some point. Bad situation…

  8. Mike Bryant says:
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    Each of the distributing clinics will have coverage also. But doubt NECC has enough.