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Subscribe to RSSThe compounding pharmacy blamed for 620 infections and 39 deaths in an outbreak of fungal meningitis and other infections caused by contaminated drugs filed for bankruptcy Friday, and pledged to establish a fund to compensate victims.
The New England Compounding Center of Framingham, Mass., faces more than 400 lawsuits from patients who received epidural steroid injections later found to be tainted with fungus linked to serious and lethal infections, records showed.
The company filed for Chapter 11 bankruptcy protection in the Massachusetts district bankruptcy court.
In a statement issued late Friday, the company said the goal of the bankruptcy is to provide a "greater, quicker, fairer payout" to creditors than could be achieved through "piecemeal" litigation.
NECC also announced the appointment of Keith D. Lowey as the firm's independent director and chief restructuring officer. He will supervise the restructuring and be responsible for establishing NECC's effort to create a compensation fund. NECC's bankruptcy counsel, Daniel Cohn, said that claimants and their lawyers will be "actively involved" in the compensation process, according to the statement.
"Many families across the U.S. have been impacted by this great tragedy, and it is difficult to comprehend the sense of loss so many people have experienced," Lowey said in a statement. "Everyone associated with the New England Compounding Center shares that sense of loss."
Elizabeth A. Kaveny, a lawyer who represents five clients, all in Michigan, who said they were sickened by contaminated shots, says the company's action is no guarantee of justice for the alleged victims.
"NECC gets no bonus points for establishing a 'victims' compensation fund' after victimizing hundreds of patients in our country," she said in a statement to NBC News. "It is an obvious and necessary step of a bankruptcy proceeding and all victims need to be compensated. While NECC clearly should declare bankruptcy and never be permitted to reopen its doors, we have significant questions as to why this is a Chapter 11 bankruptcy, what funds are available for NECC's victims and how the victims' claims will be evaluated."
Problems with three lots of NECC steroids injected into some 14,000 people in 23 states were first detected in September. The company was shuttered in October after federal inspectors found widespread evidence of contamination throughout the pharmacy, some dating back to January.
The firm was licensed as a compounding pharmacy and was supposed to be mixing medications to order on prescription-by-prescription basis. However, investigations have shown the firm worked on a much larger scale and evaded several run-ins with the Food and Drug Administration and state regulators over the size of its operation and previous cases of contamination.
The illnesses and deaths -- which include not only fungal meningitis, but strokes, joint infections and spinal infections -- have prompted new demands to overhaul the way that compounding pharmacies are regulated in the U.S.
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Besides paying for the deaths and injuries with all this, I sure hope the people in charge of this pharmacy get some prison time for their extremely poor handling of the clean room conditions, as well as breaking the law by not just selling these to people with a specific prescription, but instead for mass producing this and shipping to pharmacies without prescriptions. I also hope this company, nor any related company owned by the same people is never in business again, all these people should be out the the pharmacy business forever.
We seem to be killing ourselves "one shot" at a time because of lack of regulation. One shot at a time would seem to fit other issues of the day because of lack of regulation. I do however sense some major changes coming on the compounding issue . . Stay tuned . .
Steve, I agree and understand your post . . well said !
I dont think this news implies that they will pay much of anything at all. Most companies that go out of business like this and file bankruptcy .. do it to avoid paying lawsuits. They will close up shop and reopen with a new name.. and the same people that let this happen will again be rolling in pools full of their blood money. This statement that they are filing bankruptcy specifically to better facilitate lawsuit payment is the exact opposite of what they are doing. Big corporations do it all the time. Look at the appalacian mountain top removing mine companies that destroy peoples water supplies and then just file bankruptcy and reopen shop under a different name after a big lawsuit comes their way. They rarely pay out. Ha even BP was crying poor and threatening bankruptcy at one point during the gulf spill but they must have realized how ridiculous that sounded.
They will shut down, file bankruptcy, then reopen under another name as they do all the time here in America.
Thrifty, aka Osco in CA did just that when they gave the wrong meds to someone that permanently disabled the little girl. Mom sues, Thrifty Drug filed for bankruptcy, then reopened under the name OSCO.
None of these people should be allowed to file bankruptcy when they have tons of money in their accounts. They need to go belly up and never allowed to work in the drug industry again.
Probably filing bankruptcy now before the lawsuits start coming.
Don't let the culprits escape with just bankcruptcy, pursue and prosecute them to the gates of H*ll.
It's just too common to see these perpetrators of greed, be they Big Pharma, Big banks, NRA, Military-industrial complex, Koch anarchists, Republicans and Teabaggers walk away after they have created chaos and calamity among the people. They only come back after the mess is cleaned up and start their nonsense again.
Enough!
This is life without tight regulations, life without adequate funding to agency watchdogs to oversee what is happening in the medical industry. This company was loose for years in their cost cutting efforts in order to increase profit. That's the name of the game today, bigger profits - collateral damage - that's us. There'll be more deaths for the general public and more money for company owners. That's life with the repub/tparty holding Americans hostage but coddling big money corporations, For ME - not thee.
Some prison time? These guys need LOTS of prison time. Like LIFE+ 50 years.
all drug manufactures have insurance provided by the Federal Government(taxpayers) for any vaccines, immunizations, or new drugs approved, this is not the case here, this was a compound company, it gets drugs in bulk from overseas and repacked in the U.S., (almost all drugs are produced outside of the U.S.; their insurance , if any, may not cover , since this is a criminal violation of the safety standards, injured people may get almost nothing.
Martha Coakley is not going to let these a-holes off either. The Mass Attorney General is fully involved on this case.
As for Osco, they are gone too. A few years ago, they shut down, but you could find them operating Pharmacies in Shaw's Supermarkets in Mass.
Well, people need to get a clue first, and understand how these corporations work, and how they operate within their mindset of "Profit minus ethics".
First off, these companies don't make tragic errors like this. What happens is that the personnel in charge of controlling the quality of the product and regulating safety and product guidelines are ordered directly to do the opposite of their training and jobs, or lose their jobs. When given "unofficial orders" (not written on paper) pertinent personnel figure they can't be held responsible. Its not an error, its a purposeful and direct action that led to these deaths and sickness of innocent patrons of the products issued.
So in all cases, we need legislation that puts executives and management in direct responsibility, because right now such people cannot be held personally financially responsible where they will lose house and home if found to be negligent.
And there's another one for you, criminal negligence. That needs to be redefined for there are far too many loopholes in such laws that allows management and personnel to step aside and have criminal charges directed away from their responsibility. As it stands now, management nor personnel can be held financially responsible for their actions while working as a representative of the company, only the company itself can be held in a civil dispute. So we need new laws that allow persons suffering and damages to be filed against people directly responsible for the decisions and actions that led to the pain and harm suffered by another.
Then again, government sidestepping is a direct action that led to this tragedy. DA warned and cited this company several times, and then became lenient in letting the company slip by in order to not have their doors closed and hundred of people laid off. There are only two reasons why this could happen, Either Washington itself is responsible by directly disabling an inspector's decision in order to keep unemployment rates from rising, or the inspectors themselves are offered bribe jobs (positions for the company in higher paying fields) to offset any trouble they may get into for being so lenient. Then when the tragedy happens as this one has led to death and sickness across the nation, the FDA covers up their complicity in the matter.
Lol...This is a very rare event and people are calling for tight regulations? Don't you think any tighter regulations would yield diminishing returns given how rare this actually does occur? You know there are negative sides to regulation, right? Given the rarity of these events, wouldn't you think it possible that tighter regulations would do more harm than good? If you want to pay more taxes and create slower processes with everything in life for the chance to avoid a .0001% chance of things like this happening, then maybe you need to rethink and actually look at the greater picture instead of spewing rabid hatred and pointing the finger.
FYI...even countries with tight regulations have things like this happen every once in a while. The sky is not falling and we do not live in a bubble. LIVING ALWAYS COMES WITH A RISK and legislation yields diminishing returns after a certain point. Legislation is not the cure to all our problems.
I've learned in the past few years that liberals do want a safer living...but at the cost of having an extremely difficult living. The more you "bubble up," the more difficult it becomes to do basic things.
Yes, I agree with Steve, but wonder if anyone will really go to prison. Afterall, the company is a legal entity, just like a person...however, unlike a person it can't go to prison and it can be "killed" without anyone being convicted of murder. This is another example of how a company is just a one way valve to pay money to the owners, but if there is a problem, the one way valve kicks in and the owners get away scott free.
By declaring bankrupcy, they will assign a certain amount of money to the company and the lawyers will fight over the leavings. But the owners will just get in their Rolls and take their Lear Jet to their Carribbean island for Christmas. You can bet they won't be stripped of their homes and assets even though they were directly involved in this incredibly contaminated pharmaceutical program and profited from it for years.
So, once again, let's think about how companies really aren't entities. They are just pieces of paper that give owners limited liability so that if things go south, the owers bail out and preserve their assets. It's all about knowing how to manipulate the system. To these people, it is a game, to the losers, well in this case, it was death. For once I'd like the owners to be held responsible for what happened, as they are the "real" entities, not this phoney paper company.
.
There is no statute of limitations on murder, which is a criminal offense. Mold was visible in the lab, and any pharmacist knows that mold injected deep into the body can kill.
However, corporations seem to have a license to kill, because where are the arrest warrants?
The death toll goes on and on, and on, and on...
How many times do we see a food industry or a drug company contaminate its products with only a slap on the wrist, after people die? Salmonella in peanut butter or cookie dough. Bacterial contamination in alcohol wipes (a very hardy bacteria) that killed both children and adults. These steroid injections.
Corporations should not have "freedom of speech" as persons. The laws governing corporations allow for them to be sued, including those who are the executives in those corporations. The law also does not protect a corporation from prosecution for murder: that is "organized crime" under the RICOH statute. But all they seem to prosecute is mafia, not the biggest murderers. Try the tobacco industry executives who have said something like their product culls the population over 65. It is beyond disgusting.
Yeah, here we go again. They all bought fancy yachts and dream homes on the shore less than a year before this disaster, so put the company under wraps quick before some lawyer gets after any of that..
Good for them (The New England Compounding Center of Framingham, Mass.)!!!!
Old John the crony capitalist
It's is tragic for the families who lost loved ones. Where are the inspectors or the quality controls in the plant??? Every single person employed there should be sued individually, there was zero oversight and we are worrying about inexpensive drugs coming into the country from overseas!!Give me a break. This should have never happened MOLD WAS VISIBLE !!!!Everyone turned a blind eye. Just disgusting!!
MarilynMD what is your source that mold was visible? It wasn't stated in this article. Why didn't the end user spot it if it was so visible? Not standing up for these creeps but back up your statement with a source!
Most molds are visable that's why one doesn't have to hire a scientist to clear out mold fold in a house.Mold is mold.Highly visable and easily ascertainable by the fewest of tests.Sounds like they were just trying to get a jump on ObamaCare where nothing will be checked but the invoice!
I have not read any information that states whether or not the mold was visible, but either way it could have been 'hidden' in a ventilation duct or something. I work for a regulated pharmaceutical manufacturer, and we're required to perform 'media fill' activities periodically and after maintenance work. The media fill activity produces vials filled with media that promote the growth of contaminants, which are required to not produce any growth for 10 days before the area is 'released'.
If the compounding industry were regulated, they would have been required to perform the same media fill activities. But, as with all regulations, that would interfere with their profits. So where should we draw the line on regulations?
Greed trumps safety, simple. BP has two employees arrested for manslaughter over the Deep Horizon spill, should have been the CEO creep
Rocko 417349, You want more proof search the web yourself. Below is from WebMD citing the FDA inspection after the outbreak.
Among the findings:
Multiple articles noted poor facility cleanliness and failure to address basic maintenance issues that were readily identifiable. They sent out injectible steroids before the contimate testing was completed, thus rendering that process moot.
The CFO ordered the air conditioning to be shut down two or three evenings per week because she stated it would cut costs on electricity bills. Was she totally incompetent and ignorant that air quality/temperature management is a basic cost of doing businness in this industry? Or did she and senior management deliberately decide to push for a higher profit margin and "rolled the dice" on safety hoping they'd be lucky? Wonder how that cost/benefit and Return on Investment analysis looks now?? The corporate board appears to have been criminally negligent in their responsibilities.
The regulatory agencies that did have some authority knew of serious problems for more than 18 months and failed to push the issue on non-compliance with corrective action plans. Their hands are not clean in this mess either.
The govt would have to prove they deliberately sent out contaminated drugs. They probably had some insurance, more than likely with a high deductible. Since they filed for bankruptcy and depending on the amount of insurance there probably won't me much money available. Unless there is some whistle blower that comes forward that proves they knew the drugs were suspect, don't expect any jail time here.
They will reorganize,open the same facilities,give a couple of dimocrap congressmen money for the 2014 elections . They will immediatey get a new $200 million dollar government contract to supply ObamaCare.Of course,those newly infected people will have little of no recourse after Obamacare takes effect.
Dummy, it is Republicans who tell us that regulations are not needed. You ned to listen to your fat leader Rush a little closer you are confused as heck
yeaaaap so they dont have to pay damages ... what a country we live in
Here in Texas, you can't sue your employer if you are injured at work, if you want to sue a doctor and or hospital your claim is limited to 250,000 even if the result of medical malpractice or negligence is death. What are peoples lives worth, literally nothing now days. The repubs and NRA are so set on less government, yet they want to spend a fortune on police in our schools? This country is going madd, there is too much greed and not enough compassion, least of all common sense. These people who were poisoned were someone's wife, husband,mom,dad,brother,sister. Next time you maybe the one suffering because of lack of government.We the people of this country established our constitution and it is we the people who need to take back America. Dont let the corporations dictate what our government officials are doing, and don't let big corporations run our country because in the end we all suffer.
Wow! After reading the headlines,I was convinced the article was about the dimocrap party.They all seem to have "fungi on de brain" syndrome!" It's highly infectuous and dangerous.They recipients immediately find it neccessary to spend all the money they have plus 3000% more.They go to Congress and do the same with my money.As they near the end,they all sound and act like "Harry the Brain" Reid!
You are one sad, silly, misinformed ,brainwashed puppet for the party of lies and hate! Rush and the republican party blesses your misinformed stupid being. Hile Murdock.
Once I read the word, "dimocrap", I knew the rest was just Kool Aid and quit reading. If you want to get your point across, drop the politics and get to the point.
Typical GED grad listening to other GED grads like Hannity and Rush and that drunk Beck
So, mas098, did you graduate summa cum laude from The Laughing Academy? Looks like it to me.
So the real owners of this firm, THE CHINESE, get off scott free and get to start up all over again killing us. Don't be fooled by their token Anglo's names in the articles of thus tragedy.
it's the Chinese folks.
What are you people talking about? We don't need regulations or big government interfering. These people got sick and died because thy did not have enough God in their lives ,schools ,churches ,Uh bathrooms. That's why we need more bibles and more guns! Everyone needs to carry one. (This Message would probably be approved by the republican party.)
Funny, sad but funny and true
Hey, quit repeating the TP mantra.
2014 is coming, vote smart, vote democrat, vote for all of us, not just the rich.
How convenient...
Corporations don't go to jail..they kill all the time. pay a penalty get bonuses, reorganize and go on killing...That's America at it's best.
When these Pharmacists want to own a pharmacy that can compound, it is about making money! 100% money! I guess it is only fair that they suffer the consequences of poor, and unclean procedures. They should pay off the families of the victims and lose their licenses, so they cannot do it again!
Why should they get second chances with peoples lives...
thanks GOV. really got to this quik no arrests what 5 months later bankrupt these guys were well connected
lets talk about the issue of how easy it is for corporations to file bankruptcy while Bush (remember him, dumber than a box of rocks?) made it so much harder for individuals to file for bankruptcy. It should be nearly impossible for a large corporation to file bankruptcy, if not, then they can continue to do things like this with impunity, because they will know there are no real consequences.
I guess not enough died. oh well !
The feds should have seized the companies assets and the executives as well, now a few banks will get theirs and the victims will get nothing while the execs of course maintain their wealth. You know, Romneys kind of business deal.
The first reaction is that this is good news, but the owners will probably just open a new business under a new name and make more huge profits while selling unsafe compound drugs. The owners need to be jailed for life.
Another example of capitalism without personal risk. When a company or corporation goes under, do the people that made millions from it give up anything? The answer is usually not. What happened to: "Corporations are people." The truth is people hide behind capitalism. Until we start charging individuals that run corporations that harm people; until people in corporations have to give up what they gained, including their freedom when harm is done, this will happen over and over again. How much did the bankers get when they ran the economy into the ground? They still made millions. Oh, that's right, they had no control over the day to day operations. And for that, they got filthy rich. That's not capitalism; that's corporate theft.
What about the hospitals who used this "service" instead of paying to compound their own medications for use? They should be identified, investigated, and sued so that administration will think twice when seeking sources from the gray market. R than invest in the necessary equipment, personnel and training, they outsourced to a company operating under the radar across state lines, often when NECC would t have met the requirements of the state boards where the medications were administered. And what about the Board of Pharmacy in Mass's responsibility to regulate these places. Did having one of the company's officers on the Mass board secure a blind eye and deaf ear to what was happening. Especially since she was VP for regulatory compliance for the company. ALL should be held accountable for what happened to these patients. I am a pharmacist, and am ashamed that the profession has not done enough to secure access to safely prepared medications. We, as a profession, have allowed this to happen by valuing $$ over patients. Tragic and so sad for the profession, and most of all for those killed or harmed by these events.
I was afraid this bankruptcy was going to happen and hoped that the courts would freeze their assets. Can't the courts do that? Also, someone asked whether they could be held on criminal charges, I would say at least the pharmacist can because he is a healthcare professional who knowingly sent out bad drugs. In the least, it is negligent homicide. Remember the HIV positive man who spit on the policeman? They sent him to prison.
The owners do have another company called Ameridose....it was also closed because when searched they found it was also unclean. I drive by it every day in Westboro MA. on Flanders road and I still see cars parked out in front. I honestly believe they will be back at it and it makes me feel sick. Please don't forget the victims in all this. I can only hope Ameridose is closed also...and I hope that by writing these words the people reading them will make sure that it legally will be. My heart goes out to all the victims involved....
I read in a report that they also ran a recycling business in the same building as NECC. Is that the same building as Ameridose too? I read that it was extremely unsanitary. The state board slapped them on the wrist a few years ago. If they had sanctioned these creeps, a lot of people would still be alive today.