September 26, 2016

Traci’s Story: The Human Cost of Corporate Greed and Government Malfeasance in the New England Compounding Center Drug Poisoning Outbreak

Attorney Fred Pritzker, the author of this post, is representing Traci (TM) and over 40 patients harmed in the national fungal meningitis outbreak.  In the weeks since discovery of the massive fungal meningitis outbreak traced to the New England Compounding Center in Massachusetts, much of the news has centered on the company’s long history of corporate malfeasance including its disregard of sterility tests, preparation of medication in unsanitary conditions and systematic violation of its pharmacy license.  The company’s willful (and potentially criminal conduct) was abetted by regulatory inaction of such magnitude that some of the officials charged with overseeing the company have already been fired. As they always do, the lurid details and public ire will fade from memory as the … [Read more...]

Fungal Meningitis Outbreak: Pharmacy Board Chief Fired, Case Count Mounts

The pharmacy board chief in Massachusetts, where tainted injectable steroids that have sickened 424  people in 19 states and caused 31 fatalities were produced, has been fired. James Coffey, director of the Massachusetts Board of Registration in Pharmacy, did not act on a complaint that the New England Compounding Center (NECC) was functioning  like a drug manufacturer. Compounding pharmacies generally custom-mix drugs for a specific geographic area. NECC, based in  Framingham, Mass., prepared the steroid,  preservative-free methylprednisolone acetate, for nationwide distribution. Compounding pharmacies are not regulated like drug manufacturers. So it wasn't until after the outbreak began  that inspectors from the U.S. Food and Drug Administration (FDA) looked inside the  facility where … [Read more...]

Meningitis Outbreak Prompts Ameridose To Recall All Drugs

Ameridose LLC, the sister company to the compounding pharmacy linked to a fungal meningitis outbreak that has sickened 377 in 28 states and killed nine people, announced a recall of all of its products yesterday after federal inspectors discovered inadequacies in its sterility testing procedures. The Westborough, Mass.- based company, which distributes drugs to thousands of hospitals nationwide, notified its customers of the recall in a letter. “During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.  Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or … [Read more...]

NECC Methylprednisolone Acetate Linked to Meningitis Outbreak

The FDA has released a preliminary report of its investigation of the compounding pharmacy facility owned by New England Compounding Center (NECC), the company whose methylprednisolone acetate has been linked to over 300 cases of fungal meningitis and over 20 deaths. Last week, the FDA confirmed that it found a fungus that has sickened outbreak victims, Exserohilum rostratum, in vials of one of three lots of NECC methylprednisolone acetate implicated in the outbreak. As part of its investigation of the NECC facility, FDA obtained documents showing that since January of this year, NECC employees have documented findings of mold and bacteria in rooms that were supposed to be sterile environments, including the main “Clean Room”, the “Gown Room”, and the “Prep Room”. The FDA found “no … [Read more...]

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