Meningitis Outbreak: NECC Blames Cleaners
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Credit: Minnesota Department of Health/AP Photo
The pharmacy at the heart of the fungal meningitis outbreak says a cleaning company it hired should share the blame for the tainted steroid injections that caused more than 600 illnesses in 19 states, killing 39 people.
Click here to read about the road to recovery for fungal meningitis victims.
The New England Compounding Pharmacy, which made the fungus-tainted drugs, sent a letter to UniFirst Corp., which provided once-a month cleaning services to the Framingham, Mass., lab, “demanding” it indemnify NECC for the meningitis outbreak, according to a UniFirst filing with the Securities and Exchange Commission.
“Based on its preliminary review of this matter, the company believes that NECC’s claims are without merit,” UniFirst wrote in its quarterly filing.
The New England Compounding Center recalled 17,000 vials of tainted steroid injections on Sept. 26 before recalling all drugs and shutting down on Oct. 6.
The Food and Drug Administration investigated NECC’s lab and found that a quarter of the steroid injections in one bin contained “greenish black foreign matter,” according to the report. The FDA also identified several cleanrooms that had bacterial or mold overgrowths.
UniFirst’s UniClean business cleaned portions of the NECC cleanrooms to NECC’s specifications and using NECC’s cleansing solutions, UniFirst spokesman Adam Soreoff said in a statement. It provided two technicians once a month for about an hour and a half.
“UniClean was not in any way responsible for NECC’s day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced,” Soreoff said. “Therefore, based on what we know, we believe any NECC claims against UniFirst or UniClean are unfounded and without merit. ”
Click here for our fungal meningitis outbreak timeline, “Anatomy of an Outbreak.”
NECC was not immediately available for comment.
The House of Representatives subpoenaed Barry Cadden, who owns NECC, to a hearing in Washington, D.C. on Nov. 14. He declined to testify when members of Congress pressed him on his role in ensuring that the drugs his company produced were safe and sterile.
“On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges including the Fifth Amendment of the Constitution of the United States,” he said at the hearing.
Members of Congress also questioned whether the FDA could have prevented the outbreak.
Compounding pharmacies, which are intended to tailor drugs to individuals with a single prescription from a single doctor, are typically overseen by state pharmacy boards rather than the FDA because they are so small. However, in 2006, the FDA issued a warning letter to NECC, accusing it of mass-producing a topical anesthetic cream, and jeopardizing another drug’s sterility by repackaging it.
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They are really trying to blame the “once-a-month” cleaning company. Wow, does anyone take responsibility anymore and quit blaming others????
Posted by: Seriously | January 4, 2013 January 4, 2013, 12:15 pm
WHOA! That takes the cake. The cleaning company is there for 1 1/2 hours and it is THEIR fault that the company has substandard practices!
Posted by: pksk531 | January 4, 2013 January 4, 2013, 12:20 pm
A pharmaceutical company outsources their cleaning? And it is only done once a month? What are they, nuts?
Posted by: BSWW | January 4, 2013 January 4, 2013, 12:32 pm
Their labs were only cleaned once a month?! That is just GROSS.
Posted by: yesiteach | January 4, 2013 January 4, 2013, 12:33 pm
It is the FDA’s fault several times they told them that there were problems but let them continue.
I can no longer trust anyone to do what they are suppose to.
We need a better punishment than we file for bankruptcy someone needs to go to prison for this.
Posted by: thecrud | January 4, 2013 January 4, 2013, 12:33 pm
Rich weasels thrashing about for any hole to crawl into.
Posted by: MARC BAUDER | January 4, 2013 January 4, 2013, 12:46 pm
Any company, any where should be aware of a huge underground of persons corrupting their manufactured products and services. I know there is extensive issues in the chicagoland area with poor quality Pharmaceuticals coming into local pharmacies. I myself have had NIGERIAN MADE meds distributed over the counter that I found were NOT FDA approved. My insurance provides for name brand and or generic. What is with the local pharmcies NOT CARRYING USA MADE PHARMECUTICALS when we have some of the best companies here in the world. I do not EVER WANT TO SEE NIGERIAN MADE drugs again. I FOund that product had a whitening agent that is used to TINT WHITE PAINT IN IT. I made an FDA complaint and the whole world started stalking me and hararssing me for TELLING THE TRUTH.
THERE IS SOMETHING WAY BIGGER GOING ON HERE. And everyone needs to be vigilant and NOT DO WHAT An underground tells them too. People are training to BE TERRRORISTS NOT TO STOP THEM.
Posted by: Pam Toll | January 4, 2013 January 4, 2013, 12:55 pm
once a month?
Posted by: tom | January 4, 2013 January 4, 2013, 1:17 pm
Unless the cleaning company was subcontracted to develop the cleaning standards, this charge is ridiculous. Although, I can’t believe the cleaning company didn’t see the problems. While they may not have a legal responsibility to report this, they certainly have a moral responsibility.
Posted by: Bill | January 4, 2013 January 4, 2013, 1:18 pm
The Crud–it is not the FDA’s fault. It is the fault of Congresspeople who blocked FDA oversight of supplements. Compounding pharmacies started as supplement compounders and our brilliant lawmakers said ‘hands off’ to the FDA and left regulation of these entities to the states. Then they moved into more traditional medicine compounding and were able to operate in a no man’s land where it was entirely unclear who had oversight. It is still unclear, although legally compounding pharmacies are still regulated by the states and not by the FDA. If you have an issue with FDA oversight, stop electing people who insist on interfering with it every chance they get.
Posted by: Mickey | January 4, 2013 January 4, 2013, 1:51 pm
So, the company puts that in their little book of CYA excuses. Never know, may have to use that one again sometime.
Posted by: howdymo1 | January 4, 2013 January 4, 2013, 1:53 pm
Perhaps they should have had the company clean more than once a month. Seriously, in a large company, that’s ridiculous. They should clean at least once a week.
Posted by: Willow | January 4, 2013 January 4, 2013, 1:58 pm
What does quality control of the product have to do with cleaning company. A simple quality control procedure would have detected the contaminating mold. Every batch should be tested for sterility and that is what failed. Sure cleaning company could take a miniscule fraction of the blame but ultimately the responsibility lies with the company owners.
Posted by: Girish | January 4, 2013 January 4, 2013, 2:07 pm
They can’t expect a once a month cleaner or supervisor to keep up with standards of performance or even know the current one, only to quality assure their own work. Standards must be set and enforced by regulators who hold the producers accountable.
Posted by: David | January 4, 2013 January 4, 2013, 2:09 pm
They are doing the same thing the Feds. are doing – blame someone else. The only difference between the two is no one will be able to file suit against the Government. Isn’t it great to have someone say they’ve got your back only to find out they are the one’s that have the knife. Big Government – doesn’t work, never has, never will, it gets keeps taking more and giving a whole lot less.
Posted by: Wha !!! | January 4, 2013 January 4, 2013, 2:11 pm
ONCE A MONTH !?! They clean their luxury cars more frequently than that !!!!!!!!
Posted by: michael | January 4, 2013 January 4, 2013, 2:28 pm
so, how did the mold spores get past the hepa durring compounding that is suposed to be done in a bological control cabinet? Are they going to sue the cabinet maker? i doubt that would work, i still suspect this was murder as payback and not an accident.
Posted by: bobby | January 4, 2013 January 4, 2013, 2:35 pm
Well that’s the way things are today……blame someone else instead of taking responsibility!
Posted by: pagrow | January 4, 2013 January 4, 2013, 2:44 pm
I think the interesting thing here is: 1) the cleaners only came in once a month for a thorough cleaning? Restraunts are supposed to be fumigated once a month for cleanliness, 2) no one in the company saw something that the FDA inspectors saw with their eyes. 3) the cleaning company used NECC supplied cleaning agents, Maybe those cleaning agents weren’t up to the job. The cleaning company should have been allowed to use THEIR OWN products. They may know of stronger more effective agents. IF the cleaning company had full control over the cleaning process they may have a case
Posted by: D Mayeda | January 4, 2013 January 4, 2013, 2:49 pm
Man, that’s like trying to blame guns for killing people…..opps forgot we did that one.
Posted by: Dan | January 4, 2013 January 4, 2013, 2:58 pm
Blame the butler.
Posted by: Charley B. | January 4, 2013 January 4, 2013, 3:22 pm
Anyway, if there is so much danger involved, why would you hire someone else to perform such a task. The company is at fault, and if they hired someone else to perform tasks or duties, it’s still their fault. Scapegoating, that’s all it is. Now their harm and hurtfulness continues in other ways. And so it goes.
Posted by: Charley B. | January 4, 2013 January 4, 2013, 3:26 pm
First response – find someone to blame. Then get the lawyers involved. The American way.
Posted by: ArghONaught | January 4, 2013 January 4, 2013, 3:47 pm
“If you blame others for your failures, do you credit them with your success?”
Posted by: Ananay | January 4, 2013 January 4, 2013, 4:56 pm
Companies should not be able to file for bankrupcy during incidents like this. My brother was killed at work. As soon as it happened, the company filled for bankrupcy. My family received nada! The owners of hte company opened another company under another name….back in business. They dont care who they hurt/kill in order to keep up their lifestyle……and uncle sam is allowing this to continue.
Posted by: Beverly | January 4, 2013 January 4, 2013, 5:51 pm
I blame te Gov. & FDA because the Big G simply doses not fire people like they should. Everyone in Gov just points to some OTHER Gov agency and nothing ever get done.
Posted by: netstarr77 | January 5, 2013 January 5, 2013, 4:49 am
People attacking the FDA are likely the very same people attacking regulation as inhibiting the “free market” and “costing jobs”. You can’t have it both ways. You can’t attack government agencies and at the same time do everything possible to defund, discredit and obstruct their work. Government is ineffective because the voting population makes it that way.
Posted by: dan | January 6, 2013 January 6, 2013, 1:41 pm
They’re taking the BP approach… blame the contractor. Nice!
Posted by: ScroogeYou | January 6, 2013 January 6, 2013, 11:23 pm