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NECC: Blames Mold at Framingham Pharmacy on Janitors

Wilmington-based UniFirst issued a statement calling the claims “unfounded” and “without merit.”

New England Compounding Center, the Framingham specialty pharmacy company linked to the deadly nationwide meningitis outbreak is blaming its cleaning contractor.

Lawyers for New England Compounding Center (NECC) sent a letter to UniFirst’s “Uniclean” business demanding that it take legal responsibility for the claims made against NECC, first reported the Boston Globe.

“This demand relates to the limited, once-a-month cleaning services the Company provided to portions of NECC’s cleanroom facilities,” an SEC filing by UniFirst stated.

Wilmington-based UniFirst issued a statement calling the claims “without merit.”

Federal investigators found widespread evidence of mold and other contamination when they visited New England Compounding in October.

“These services were specified by NECC utilizing NECC’s own defined cleansing solutions, and consisted of two UniClean technicians cleaning approximately 1.5 hours each on a monthly basis,” the statement said.” 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.”

A week before Christmas, New England Compounding Center filed for protection under Chapter 11 of the U.S. Bankruptcy Code.

The Framingham pharmacy has closed, surrendered its license, and recalled its products.

Since it was first identified that patients who received a steroid injection linked to New England Compounding Center in Framingham were contracting fungal meninitis, 39 people have died and more than 650-plus have been infected. (None of the cases are in Massachusetts.)

 

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A federal judge has ruled any criminal case against a Framingham specialty pharmacy New England Compounding Center (NECC) would have priority over the numerous civil suits.

Just before Thanksgiving,

Later, NECC recalled every product made and laid off all employees.

Later, CDC and FDA officials confirmed a fungus was found in those recalled steroids and recently, fungus and bacteria were found in other NECC products.

The FDA released a list of customers, who received products from NECC in Framingham on or after May 21.

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Click here to find all of Framingham Patch’s coverage of NECC and the meningitis outbreak.

William LaBarge January 05, 2013 at 12:34 PM
Even if the cleaning company somehow caused the contamination, it was up to NECC management to deal with it early on. Beside, it was not the cleaning company that made the decision to ship the medicine without waiting for the quality control report to come back. If NECC waited for the quality control report to come back, then they would have known that there was a serious problem that needed to be remedied. Beside, it is illegal to ship bad medicine out to the pharmacies and hospitals for consumption by the patients. The buck stop with NECC, only NECC, and nobody but NECC. There should be no such thing as protection under Chapter 11 of the U.S. Bankruptcy Code for cases like this.
TMM January 05, 2013 at 03:00 PM
UniFirst first disclosed the letter from New England Compounding, which it said it received this week, in a filing with the Securities and Exchange Commission on Thursday. To see the filing, go to: http://www.sec.gov/Archives/edgar/data/717954/000128408413000005/form10q-1q2013.htm Contained in the filing reads, "In particular, on December 31, 2012, we received a letter from counsel for New England Compounding Center (“NECC”) demanding, among other things, that we indemnify NECC regarding claims made against NECC, including those related to NECC’s highly-publicized compounding and sale of tainted methylprednisolone acetate. This demand relates to the limited, once-a-month cleaning services we provided to portions of NECC’s clean room facilities. Based on our preliminary review of this matter, we believe that NECC’s claims are without merit. We have notified our insurer of this claim. Based on the information currently available, we are unable to reasonably assess the ultimate outcome of this matter or an estimate or range of estimates of any potential losses. If we are found to be liable with respect to claims brought against us relating to NECC that are not covered by our available insurance, we may incur liabilities that are material to our financial condition and operating results."
Paul Lascari January 05, 2013 at 03:06 PM
Agree, William. This crowd of owners of NECC is a slimy one. They are now trying to shift the blame and responsibility from them. They are the crowd that take no responsibility for what they do. This makes me sick.
Scott Estes January 05, 2013 at 03:08 PM
agree with Willie, I read the FDA's 483 report, it was horrifying. There were so many levels of utter failure to follow basic GMP principles. This was nothing more than complete and utter greed with a shocking level of depravity and disregard for the safety of their patients. Anything less than negligent homicide charges for the Cadden's and Conigliaro would be a gross miscarriage of justice (IMHO)
William LaBarge January 05, 2013 at 05:05 PM
Paul: Unfortunately, the medicine from NECC made too many people sick and made some of them dead. It was NECC and not the cleaning company that made the medicine. It was NECC and not the cleaning company that put the NECC's name on the medicine they shipped out. Shame on the decision makers of NECC who made the decision to ship the poisonous medicine out and shame on the decision makers of NECC for trying to shift the blame on the cleaning company over this scandal which cost several people their lives.
TMM January 05, 2013 at 07:31 PM
Willie - you are absolutely right. Ultimately, the blame remains on the reckless, irresponsible, greedy property and business owners of the New England Compounding Center. Let us not forget their other pharmaceutical-related businesses - Alaunus Pharmaceutical LLC at the same 687 Waverly Street address as New England Compounding Center and Ameridose in Westborough. The attitude of some in Framingham is "make money at whatever cost."
William LaBarge January 06, 2013 at 01:02 AM
George: You and others speak of one of the 7 deadly sins... namely greed. Another deadly sin that comes in mind is sloth. They were too lazy to make sure that what they were doing was proper in every sense of the way. Regardless, what NECC has done was to violate the trust that the patients and medical community has placed in them. Now they are trying to weasel their way out of the full responsibility for their failing by blaming a cleaning company for introduction of the germ that contaminated the medicine they shipped all over this country. If NECC waited for the quality control report before shipping the medicine AND then end up not shipping the medicine because the quality control report said that the medicine was contaminated, then NECC would be within every right and have the responsibility to investigate what caused the contamination, and based on their finding, take whatever appropriate action to correct it. Yes, the owners of NECC had a cash cow. Now it appear that cash cow will be slaughtered and it will be made into hamburger which the victims and their families will be feasting on, as one may say...
GangsterRob January 08, 2013 at 02:21 AM
They were well aware of what they were doing.
Barry Ponzio January 08, 2013 at 04:41 AM
NECC actually put something in writing. As a customer, I could never get a written response back. I am surprised NECC had the conviction to issue a blatent lie in print. Usually they were very secretive and acted suspicious if I asked for things in writing.

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