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Tainted Steroid Victims Closer to Seeing Justice

May 8, 2014

A just-filed federal settlement with a bankruptcy judge will create a multi-million dollar fund meant for compensation to victims of the meningitis outbreak that was tied to a Massachusetts compounding pharmacy and tainted spinal steroid injections.

The 2012 nationwide outbreak sickened over 750 people across a score of states and killed 64 others. To blame was a tainted steroid manufactured by the New England Compounding Center (NECC), according to the Centers for Disease Control and Prevention, wrote The Associated Press (AP).

The settlement was filed with a federal bankruptcy judge and would create a trust fund of more than $100 million, when finalized the AP wrote. Ultimately, the NECC surrendered its license and filed for bankruptcy.

The settlement requires approval by Judge Henry Boroff, and was reached between NECC’s owners and the court-appointed bankruptcy trustee. NECC’s owners must pay $50 million; $25 million will be covered by NECC’s insurers, reported the AP. Under the agreement, NECC’s owners may obtain another $20 million in tax refunds, which will be put into the fund, as well as proceeds from a proposed sale of an NECC-affiliated company, Ameridose, which is expected to bring help reach the $100 million needed for the fund. Distributions are expected to begin early next year and will be distributed to the families of people who died as a result of the tainted injections, to those who suffered serious injuries, and to creditors.

Patients who were treated with injections of methylprednisolone acetate, which was produced by NECC, were initially sickened with fungal meningitis. Illnesses, later, included other dangerous infections.

NECC mixed at least 14,000 vials of methylprednisolone acetate and shipped the drug vials to more than 70 pain management and other health care clinics in 23 states. Testing conducted on a sampling of vials revealed that many were contaminated with a fungus that was responsible for the outbreak of the deadly form of meningitis.

The fungal infection involved the mold, Aspergillus fumigatus, which was linked to the steroid, methylprednisolone acetate, that originated at NECC. The tainted steroid was injected into patients’ spines or joints for chronic back pain. NECC was later discovered to be tainted with a fungus that was not Aspergillus, but with a black mold, Exserohilum rostratum, believed to have been the culprit in the outbreak. That mold is one of several organisms that only rarely cause human disease and has been discovered in some vials containing the steroid and in several of those sickened.

A second wave of fungal infections was diagnosed in dozens of patients and included symptoms such as excruciating abscesses or inflamed back nerves. Those infections were particularly difficult to cure, and, because the infections mimic patients’ original back pain, many might not have been aware that they were suffering from a spinal infection, according to a health alert issued at the time by the CDC.

Many people who received steroids laced with black mold from NECC survived but were sickened and then relapsed, undergoing multiple hospitalizations, with most suffering devastating treatment side effects, including hallucinations, serious kidney damage, trouble concentrating, upset stomach, swollen feet and ankles, and hand tremors. Once released, patients required regular blood testing; electrocardiograms; MRIs; and spinal taps, which are known to be painful. Medication was needed from three to 12 months, but physicians had been 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.

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