A congressional memo issued in anticipation of a hearing on the national meningitis outbreak, points to Barry Cadden, co-owner of New England Compounding Center (NECC), as one of the parties at fault for the outbreak. Barry Cadden, a pharmacist, is supposed to live by a code of ethics that places patient care as the primary concern. The following “Oath of a Pharmacist” has been approved by the American Pharmacists Association:
I promise to devote myself to a lifetime of service to others through the profession of
pharmacy. In fulfilling this vow:
- I will consider the welfare of humanity and relief of suffering my primary concerns.
- I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.
- I will respect and protect all personal and health information entrusted to me.
- I will accept the lifelong obligation to improve my professional knowledge and competence.
- I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.
- I will embrace and advocate changes that improve patient care.
- I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.
Mr. Cadden, whatever oath you took upon graduation, the evidence suggests that you have violated it egregiously. Thousands of people have suffered and over 30 people have died because you chose to put something else before patient care.
One of those people is TM, one of eleven people in Minnesota with NECC fungal meningitis and a client of Attorney Fred Pritzker, who is also representing over 40 other patients from several states. TM was hospitalized twice and has not fully recovered, and may never. She told the St. Paul Pioneer Press that she is upset with NECC and the clinic where she had her NECC epidural injection for pain, Medical Advanced Pain Specialists (MAPS) in Maple Grove, MN. She has become the voice of many victims of this outbreak. They want justice, and they want measures put in place to make sure this never happens again.
TM was also featured in an article in The Guardian.
There are many parties to blame, and the most obvious wrongdoer is Cadden, the evidence suggests. According to the FDA, for years Cadden has denied FDA authority over NECC and failed to cooperate with FDA inspectors. As early as 2003, the FDA recommended in an inspection report that “the firm be prohibited from manufacturing until they can demonstrate ability to make product reproducibly and dependably.”
In a foreshadowing of the current outbreak, the FDA concluded a meeting with state officials on Feb. 5, 2003, by “emphasizing the potential for serious public health consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.” Sterile products include injectable drugs and intravenous solutions.
Cadden later responded to the FDA in writing, saying that he had improved his compounding procedures but that his company was not subject to good manufacturing practices because it was a compounding pharmacy not a manufacturer. A compounding pharmacy is supposed to prepare drugs customized for individual patients, such as in doses or forms unavailable from manufacturers. The FDA apparently conceded this point, saying during a meeting that month that it considered the company a compounding pharmacy at that time, leaving ultimate regulatory authority to the state.
The state, however, never took action to stop the company from making drugs, even though it later produced drugs in batches and shipped them to most states — like a manufacturer. In 2004, the state Board of Registration in Pharmacy voted to reprimand Cadden and the company and place both on three years probation, but for reasons that remain unexplained, these actions were not included in a final consent agreement reached with the company in 2006. (Quote from an article in The Boston Globe)
The congressional finger was also pointed at the FDA and the Massachusetts Board of Pharmacy. Both knew about the sanitation issues, patient illnesses associated with NECC products and NECC’s bulk sales of drugs in violation of state and federal law. Nothing was done to stop the company and prevent the outbreak that now has 438 CDC-confirmed cases of fungal meningitis (Aspergillus and Exserohilum), stroke, epidural abscess and septic arthritis. The 32 CDC-confirmed deaths were from Exserohilum meningitis and stroke, in most cases related to the meningitis. In addition, thousands of others had to have spinal taps, a painful procedure, to determine if they had meningitis.
Pritzker Hageman attorneys are representing over 40 patients harmed by this outbreak. They have won money for clients in meningitis personal injury and wrongful death cases. They are providing free consultations for all patients who had injections of NECC methylprednisolone acetate and the families of patients who died of fungal meningitis and/or stroke. You can contact Fred and Ryan for a free consultation here regarding an NECC meningitis lawsuit.
Fred and Ryan are representing patients throughout the United States and in the following Minnesota locations: Twin Cities, Minneapolis, St. Paul, Blaine, Bloomington, Brooklyn Park, Chaska, Columbia Heights, Coon Rapids, Crystal, Eden Prairie, Edina, Fridley, Golden Valley, Hopkins, Maple Grove, Minnetonka, Mounds View, New Brighton, Plymouth, Richfield, Shakopee, St. Louis Park, Wayzata, Anoka County, Carver County, Hennepin County and Ramsey County.