September 20, 2018

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 news cycle shifts to the next debacle. But for the 483 people sickened by this poisoned medication and the families of the 32 dead, the memories will not fade, the physical damage will not vanish and the emotional scars will not heal.  TM is one of those victims. Steroid medication produced by the now closed company was injected directly in the 22 year-old woman’s spine for treatment of a rare neurologic disorder. Within five days of the injection, she began experiencing neurologic symptoms . Tests at a local hospital (including a painful spinal tap) revealed that she had a rare form of fungal meningitis. Further analysis revealed that the fungus found in her cerebrospinal fluid matched samples from other outbreak victims and from unopened vials of steroids produced by NECC.

Fungal meningitis is a rare and potentially lethal illness that requires a long course of high dose antifungal medications, usually given through an IV line in the hospital. The doctors fighting to save TM’s life had only one medication option – a rarely used and not very well understood drug that’s known to cause irreversible liver damage and hallucinations. In TM’s case, her hallucinations were so severe that she thought she was involved in murders and other grotesque violence.  Four weeks after she first took sick, TM is still receiving the toxic brew of antifungal medication. Her realistic fear of long-term major organ damage remains as palpable as her ongoing symptoms which include transient visual disturbances, fever, rash, nausea, diarrhea, headache, peripheral edema, and abdominal pain.

The neurologic condition that required TM’s steroid injection in the first place is called Reflex Sympathetic Dystrophy (RSD) also known as Complex Regional Pain Syndrome (CRPS). The disease is characterized by intense pain that gets worse, rather than better over time. In TM’s case, the pain was so severe and so debilitating that she required implantation of a nerve stimulation device in which an electrode is positioned in the spinal cord. Electrical current from the electrode brings about an abnormal sensation, typically tingling or pricking, that suppresses the pain. It was only through this device that TM could live a relatively normal life.

Not long before her fungal meningitis, TM required replacement of her nerve stimulator. The first step of that process involved surgical removal of the old stimulator and repair of her spine to accept the new one. That repair included implantation of a device called a “spacer” to which the new stimulator would be attached in a later surgery. In fact, TM received the poisoned steroid injections during the time between the surgeries to help her deal with the pain that the absent nerve stimulator would have later brought back under control.

When TM’s doctors discovered her fungal meningitis, they knew that in order to have any chance to successfully treat it, any foreign body in the spine (that could possibly harbor the pathogen and make it more difficult to eradicate) needed to be removed. Thus, TM underwent yet another spinal surgery consisting of removal of the recently implanted spacer.

The problem – indeed the tragedy – with this cavalcade of events triggered by the NECC drug poisoning is that scar tissue in TM’s spine now and permanently prevents her from undergoing another procedure to implant a spacer. Without a spacer, her doctors have told her it’s impossible to anchor a nerve stimulator. Thus, for the remainder of her life, Traci will be forced to rely on conventional pain medications and steroid injections – methods that fall far short in their ability to control her severe pain.

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