Evidence is mounting against New England Compounding Center that steroid products made and distributed by the company caused patients to suffer fungal meningitis and stroke. To date the Centers for Disease Control and Prevention (CDC) has confirmed 105 cases of fungal meningitis in patients who had lumbar epidural steroid injections containing preservative-free methylprednisolone acetate (80mg/ml), a steroid product compounded by New England Compounding Center (NECC), located in Framingham, Massachusetts. Many of these patients also had strokes. At least 8 of the outbreak victims have died.
Attorney Fred Pritzker has been contacted by several patients who had these injections. According to Pritzker, a national meningitis lawsuit lawyer who recently won over $40 million for clients injured by another medical product, “This is one of the largest outbreaks ever associated with a compounding pharmacy.” Pritzker is calling on New England Compounding Center to make an immediate disclosure about key safety practices, including the following: the results of any testing done on the implicated preservative-free methylpredinsolone acetate; whether the company had a quality assurance program in place to prevent and detect contamination of its methylpredinsolone acetate; the results of any safety audits, if there were any; procedures followed to clean and disinfect the equipment and surfaces used to produce, package and store its methylpredinsolone acetate; and any information the company has found so far in its own investigation into the source of the fungal contamination.
New England Compounding Center has recalled all of its products and is now closed, according to the FDA. The NECC steroid products associated with the meningitis outbreak to clinics in 23 states: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia.
CDC’s interim data show that all infected patients received injection with preservative-free methylpredinsolone acetate compounded by New England Compounding Center. FDA has reported observing fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from NECC. FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus. To date, two fungi, Aspergillus and Exserohilum have been found in cultures of the cerebrospinal fluid of outbreak victims. Exserohilum and Aspergillus can cause meningitis and stroke.
