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Subscribe to RSSThe compounding pharmacy at the center of an ongoing outbreak of fungal meningitis and other infections says the cleaning company it hired is also at fault for unsanitary conditions linked to more than 650 infections and 39 deaths in the U.S.
The New England Compounding Center sent a letter Dec. 31 to UniFirst Corp., asking UniFirst officials to indemnify NECC against claims stemming from the compounding and sale of tainted steroid injection drugs, according to a filing with the Securities and Exchange Commission.
“This demand relates to the limited, once-a-month cleaning services the Company provided to portions of NECC’s cleanroom facilities,” UniFirst, of Wilmington, Mass., explained in required filings.
“Based on its preliminary review of this matter, the Company believed that NECC’s claims are without merit.”
Federal health regulators found fungi in three lots of tainted steroids linked to infections and deaths and more fungi and bacteria in other drugs made by NECC.
In addition, Food and Drug Administration inspectors found evidence of contamination documented throughout the NECC facility and dating from January 2012 through September. In some cases, surfaces were overgrown with visible mold, inspectors said.
UniFirst provided services through its UniClean business as specified by NECC and using NECC’s own “defined cleansing solutions,” UniFirst spokesman Adam Soreff told NBC News in a statement. UniClean technicians cleaned approximately 1½ hours each month.
“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,” Soreff said.
NECC filed for Chapter 11 bankruptcy protection on Dec. 21, with officials pledging to establish a fund for victims. NECC faces more than 400 lawsuits from patients who received epidural steroid injections later found to be contaminated with fungus linked to the serious and deadly infections. Some 14,000 people in 23 states received the injections before the problem was discovered in September.
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It was the Match Company who is responsible for the fire that burnt the insured property to the ground.
Perhaps they need a cleaning company to clean after the cleaning company. And then a cleaning company to cleanup after them. Sort of like the NRA idea, armed guards to look after the armed guards who look after the armed guards. Perhaps a good fungus to kill the bad fungus.
Their finger pointing is pathetic! Is anyone going to believe that this inept company was unable to control the environment they compounded their medications in because of a cleaning company? The only thing I would fault the cleaning company for is not having reported the dangerous conditions they must have noticed. Of course, the employees would have more responsibility in reporting this than the cleaning company.
They are kidding, right?
If I come to your house to clean using your specific times and type of cleaner used, then it's MY fault that the kitty litter box stunk up the house between cleanings?
Nice try to pass the buck, but no cigar for you!
Trying to shift the blame to cleaners who worked 1 and 1/2 hours a month at the location is atrocious. The fault lies with NECC becoming a large-scale manufacturer that used local state compounding laws to bypass FDA regulation when compounding was only ever intended for individual patients and small scale production.
You're right and I'd like to elaborate why.
We know of at least the following serious problems:
The A/C was turned off at night, setting up the perfect conditions (warm, moist) for the growth of mold.
A boiler was leaking water onto the floor and into a wall shared by a clean room.
Autoclave sterilizers were not running the minimum 20 minutes recognized by everybody everywhere as the minimum length of time you should sterilize something. (I do 30 minutes at my lab, and I don't inject anything into anybody.)
Lots were being shipped without waiting for results of a sterility test. When the FDA tested 50 random vials, they found contamination in all 50 vials. It is very unlikely that tests performed by the company were coming back clean. This means that once the sterility test results were in (after the lot had shipped), the NECC ignored the findings of the test and didn't issue a product recall.
None of these things are the fault of the cleaning company.
Pragmatic, Willful gross negligence are the words that come to my mind. I hope they hang the people that are responsible. Cleaning company is responsible my a s s ...
Right on Pragmatic...anyone who knows anything about cleanroom/aseptic facilities knows that a once a month regimen is nowhere close to what a company needs to ensure product sterility. NECC should be ashamed of even attempting this.
"Sterility be damned, we're shipping this product!" OMG.
You are supposed to be trained in specialized cleaning of these clean rooms.They should be cleaned every night.I am self employed as a cleaning service and companies,the larger ones,require that you carry 2 million dollars in pl/pd insurance which is laughable considering that they are only having their office cleaned twice to once a week.If you go at night by the banks,insurance companies,beauty shops etc. you will see that slave labor of untrained people abound in the janitorial business.They bring their small children and their spouses with their dirty mops,bagged vacuums missing the paper bags and Windex.I can't compete with their low ball prices but my service is far superior.In business it all comes down to that old adage of,"You get what you pay for."
Gee - the company didn't know its facility was STILL dirty after the cleaning company finished its monthly duty - - try selling that to the jury!!!!!!!!
ha! Nice job trying to pass the buck of blame to the clean up people!
How is it possible for someone to stick a needle into a bottle, pull out so much liquid and then inject it into a smaller bottle and then blame the night cleaning lady or person for the filthy needle? What are they cleaning? I'd like to know the name of this cleaning company and see their employment records. I'd like to know if they like the Court House here in Hamilton, Ohio hires companies to clean their offices that hire illegal's to do the work? Should I remind you that illegals have no medical examination before or after they are hired and handle everything from the food you eat to what I suspect from this story your medication? I want a thorough investigation with names of those responsible going to jail, including those that hired a company that hires illegals!
where the hell are you getting illegas from?? not everything that goes wrong in this country can be blamed on them.
It is the responsibility of the NECC to ensure their environment is clean by doing quality testing. They'd know if the cleaning company was doing a sub-standard or filthy job if they did the environmental monitoring they are required by law to do. And they'd know it within days, the tests aren't complicated.
You're right...EM would have shown the filth...they just didn't do the tests. Closing your eyes and not testing for environmental (and probably personnel) monitoring is the reason they didn't "know" about the unclean facilities. They knew, they just didn't want to prove it to themselves. Daily cleanings with cleaning and sanitizing agents, as well as a rotating sporicidal agent, would have cleaned up the place...monthly janitorial duties do not. Fault NECC for using a poor cleaning strategy, not the people who did what they were contracted to do. Mopping up the bathrooms once a month does not a sterile facility make.
sabine,Illegals are used as slave labor in janitorial jobs,landscaping jobs,housecleaning jobs and nanny services.This is a well known fact in America.
once a month??? you can't do anything cleaning once a month. and in the end, the cleaners don't hold the state license to operate a pharmacy, it was the weasels who owned NECC. next they'll probably blame Obamacare, or Putin, or Lance Armstrong. yeah, that's it, Lance Armstrong. go chase him.
they ought to go after NECC with RICO, and strip everything those weasels have for victims.
Yup> try cleaning our kitchen or bathroom once a month and see what happens...........If you live to tell the story
Mold spores travel through the air. ANY mold and it contaminates the entire environment that air travels in.
I can't even properly clean my own house in 1 1/2 hours a week, how is a cleaning company supposed to clean a medical lab in 1 1/2 hours a month. NECC is just trying to fling mud to see what will stick. Doesn't matter, in the end they are totally responsible and the owners need to do some serious jail time.
Nice try, NECC, but all you'll get is more laughter. Hire a cleaning service for 90 minutes a month, then blame them that the place is filthy - LOL
Lets cut to the chase here. I think the mold spores should be arrested and charged with 1st degree murder. I have no doubt it was premeditated.
90 minutes a month contracted for cleaning just points to the damning pattern that has already emerged. They were more worried about the bottom line than anything else.
Shutting down the A/C at night saves energy and money.
Not fixing a boiler saves maintenance/replacement costs.
Running your sterilizers for less than 20 minutes saves time, energy, and money.
Recalls are costly, so when contaminated test results came back, there were just ignored.
Since these issues span so many departments within a single company, it is clear that this kind of management is coming straight from the top. I hope they do time.
This is disgusting. Think about all the other companies that are doing the same thing and skirting right by the FDA. It is scary. Shouldn't places like this have to be inspected or something? And 1 1/2 hours per month? ... I couldn't imagine what my house would look like if I only cleaned for 1 1/2 hours per month. I think these people are just as disgusting as the facility they have their employees work out of. How dare they put the blame on the cleaning company. I hope the people who were affected by this get heavy compensation for the medical bills they have had to endure due to the ignorance and neglegence of these people. I also hope some sort of inspections are put into place after this...
They are the ones who hired the cleaners, so they are the only ones to blame. Don't pass the buck by placing blame elsewhere.
My fault? Naw. Somebody else did it.
Yep!!! The American way!!! Blame someone else, because absolutely nothing is my fault!!! Hire a greedy dirt bag lawyer and he will convince everyone that you did no wrong; if you have enough money to line his pockets with gold. So can you tell me who hired the cleaning company??? Who paid the cleaning company??? And who could of fired the cleaning company??? No accountability and you blame the cleaning company for all that was totally in your hands to fix. You just have to love lawyers and the American justice system. Anyone can get away with anything as long as they have enough money to pay for their freedom.
Isnt it sad?
I have worked in Food QUality and Sanitation for over 35 years (while not pharmaceutical the same pricipals apply). 1) you have to clean daily if not more frequently; 2) You have to have cleaners who are trained to use the cleaning materials, equipment etc and to know how to clean the surfaces and equipment.; 3) a good cleaning of a single piece of equipment will take more than 90 minutes; 4) Ultimately as the producing company as an owner, operator, manger and quality professional each of these folks is ultimately responsible for the cleaing of the equipment.
I hate pointing a finger at the QUality folks (I assume they had some) but ultimately they are the first line of defense against poor and dangerous products getting loose, if they had a clue that the conditions were so bad they were obligated to take a stand and protest the customer, product safety is ultimately the responsiblity of 3 people THE OWNER, THE PLANT/FACILITY MANAGER and THE QUALITY MANAGER. And as Oregon Vet so simply put it they hired the cleaners, they made the decision, and I will add sounds like they made the decision based on $$ to the bottom line and their pockets.
You gotta be kidding! These people are as slimy as the place they worked in. Why didn't the lazy workers clean up? You can't blame it on the once a month cleaning service.
I hope the ex employees and ex management of NECC are reading this. You are all liable. You will all pay in one way or another. You should be charged with manslaughter, but ruining each one of you financially will just have to do for now. Time to move on? Tell that to the 39 families that lost a loved one due to your complete and total arrogant dismissal of standard cleanliness procedures in a pharmacology prep area. Live your lives but you will meet your maker one day and then you will pay the ultimate price of eternity in hell.
This is NOTHING but a "The dog ate my homework" defense.
Those involved should be sentenced to getting an injection of the drugs they killed people with! It probably won't kill them, but will make them understand what they did to others
No chapter 11....obviously this is not a credible company and they should be put out of business and none of the owners or managers should ever be allowed to work in pharmaceuticals ever again.....of course they blame some under paid workers is there ever going to be a time in big business where the buck stops in the executive offices and they don't get big bonuses and the do go to jail without passing go?
The owners should all be injected with the same contaminated meds as they sent to customers. Nothing less.
When those at the top get in hot water for playing fast and loose with the rules of their industry, they always end up blaming some poor slob making $8 per hour.
The cleaning company should sue for libel.
Relax people, it's only a few dead people, who cares, as long as they made a few extra million dollars. Geeze.
Once-a-month cleaning service. Really said that, didn't it? No daily cleaning by employees who knew the various equipment and how to clean all that effectively Oh, that might have taken money away from buying beachfront homes on the cape and nice boats, right?
If I owned the cleaning company, I'd be investing heavily in Lawyers With Fangs. Because I'd win, and win big.
Sure the maid did it and brought her free flying bird, really.
If UniFirst does not sue NECC for defamation they are IDIOTS.