In July of this year, the Colorado Board of Pharmacy filed a complaint against New England Compounding Center (NECC) stating that NECC had distributed “manufactured” drugs in bulk and without patient-specific prescriptions to many hospitals in Colorado between 2010 and 2012. The complaint state accurately that this was done in violation of NECC’s Colorado and Massachusetts licenses. It was also in violation of federal law because NECC was not a licensed manufacturer of drugs, according to the FDA.
It appears that, in an attempt to avoid FDA regulations and oversight, NECC claimed to be a pharmacy and was licensed as such by the State of Massachusetts and other states. However, compounding pharmacies are not supposed to sell drugs in bulk without patient-specific prescriptions. Only drug manufacturers licensed by the FDA can do that.
NECC had been investigated by the Massachusetts Board of Pharmacy and Massachusetts Department of Public Health for doing this in 2006, but the company agreed to make changes and was allowed to keep its pharmacy license and continue to sell compounded drugs. Because NECC had been in trouble for selling in bulk before, the Massachusetts Board of Pharmacy should have taken immediate action whey it received the complaint from the Colorado Board of Pharmacy.
Instead, the Massachusetts Board of Pharmacy did nothing. The Colorado Board of Pharmacy complaint against NECC was forwarded to James D. Coffey, Director of the Massachusetts Board of Pharmacy, on July 26, 2012, which he then forwarded to Board attorney Susan Manning and Board inspectors. The director of the Board is responsible for ordering investigations. Mr. Coffey failed to order an investigation or take any other action on the Colorado complaint.
This week, Mr. Coffey was fired, and Ms. Manning was placed on administrative leave. According to Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren Smith:
It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado complaint given NECC’s past, and their responsibility to investigate complaints. Following the outbreak, staff also failed to disclose the existence of Colorado’s complaint to leadership at DPH. . . . I find the actions of NECC reprehensible. We have the righ t to expect that all companies producing medication for use in delivering health care to comply with laws designed to protect patient safety. But I also expect the staff charged with oversight to perform their duties to the highest standards. That failed to happen here.
Can Patients Injured by NECC Medications Sue the State of Massachusetts?
Our attorneys are representing over 40 patients injured by NECC medications connected to the national fungal meningitis outbreak. They are looking at all possible parties legally responsible for the outbreak. The reason this is important is that they anticipate that NECC will declare bankruptcy in the near future. At least for patients injected with the tainted NECC steroid medication after July 26, the State of Massachusetts should be held accountable and provide financial help. There are a number of legal issues that need to be investigated and analyzed by our lead attorneys for these cases, Fred Pritzker and Ryan Osterholm. If you would like to speak Fred or Ryan, call our law firm at 1-888-377-8900 (toll free) or submit our free consultation form. If you call after business hours, you should leave a message with our on-call attorney, Ryan Osterholm, and he will get back to you as soon as possible, usually within a few hours at most.
All patients who received injections of the NECC steroids implicated in the fungal meningitis outbreak (methylprednisolone acetate) are welcome to contact Fred and Ryan for a free consultation regarding a steroid meningitis lawsuit against NECC. This includes patients diagnosed with meningitis or NECC epidural abscess, families who lost loved ones (wrongful death), and patients who had spinal taps but do not have meningitis.