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$100 Million Settlement Reached in Deadly NECC Meningitis Outbreak

Dec 27, 2013

A settlement has finally been reached in the deadly meningitis outbreak tied to the now-bankrupt New England Compounding Pharmacy Inc. (NECC).

The owners and insurers of Framingham, Massachusetts’ NECC have agreed to pay more than $100 million, according to Reuters, to compensate the victims of the outbreak and their families, and creditors. The accord is preliminary and requires court approval and final documentation and the settlement does not cover claims against various clinics that sold the tainted injection or the vendors used by NECC.

Meant to resolve many claims brought over tainted steroid injections that were associated with NECC, the settlement involves injections of methylprednisolone acetate associated with the deaths of 64 people and the illnesses of 751 across 30 states, Reuters reported, citing U.S. Centers for Disease Control and Prevention (CDC) data. The compounded injections were prescribed for back pain.

The outbreak followed the shipment of tainted NECC vials of the steroid to an array of medical facilities nationwide, Reuters wrote. The pharmacy filed for bankruptcy protection December 21, 2012; the firm shut down two months prior.

Pharmacy owners denied any wrongdoing or liability; settlement funds are expected to come from the owners and insurers, as well as tax refunds and proceeds from the sale of a related business, according to Reuters.

The original outbreak likely began with a Tennessee man being treated with an unusual form of meningitis that did not appear to have a bacterial or viral cause. Evidence of fungal infection was detected and involved the mold, Aspergillus fumigatus. Doctors advised the state’s public health authorities and, soon, injections of the methylprednisolone acetate steroid were linked to this and other cases.

NECC mixed at least 14,000 vials of methylprednisolone acetate, shipping the drugs to more than 70 pain management and other health care clinics in 23 states. Testing revealed that many were contaminated with a fungus responsible for the outbreak of the deadly form of meningitis. NECC was later discovered to also be tainted with a fungus that was not Aspergillus; a black mold, Exserohilum rostratum, is believed to have been the culprit in the outbreak. That mold is one of several organisms that normally only rarely cause human disease, but was discovered in some vials containing the steroid and in several of those sickened.

The tainted steroid was injected into patients’ spines or joints for chronic back pain. A second wave of fungal infections was diagnosed in dozens of patients and included symptoms such as excruciating abscesses or inflamed back nerves. The infections were difficult to cure, noted The Boston Globe previously. Because the infections mimicked patients’ original back pain, patients were often unaware that they are suffering from a spinal infection, according to a health alert issued by the CDC.

Of those who received steroids laced with black mold from NECC and who were sickened and survived, many experienced relapse, undergoing several hospitalizations and most suffering devastating treatment side effects, including hallucinations, serious kidney damage, trouble concentrating, upset stomach, swollen feet and ankles, and hand tremors, according to The Boston Globe.

Released patients required regular blood testing; electrocardiograms; MRIs; and spinal taps, which are known to be painful. Treated patients likely required medication anywhere from three to 12 months; however, physicians were unclear as to treatment times and if the fungus would ever be fully eradicated from patients’ bodies, according to patients, lawyers, and infectious disease specialists interviewed by The Boston Globe.

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