The Massachusetts Department of Public Health says the compounding pharmacy, New England Compounding Center, tied to a widespread fungal meningitis outbreak had dirty floors and a leaky boiler. Inspectors also reported finding lapses in the use and maintenance of autoclaves, machines designed to kill any potential contaminant, at NECC. The safety issues may have compromised the safety and sterility of NECC’s products, including the tainted steroid (methylprednisolone acetate) injections given to patients suffering from severe back and joint pain.
Compounding pharmacies create custom-order drugs and dispense drugs to fill the gaps left by the nation’s drug shortage problem, according to industry experts. The companies usually mix drugs requested by physicians for patients with special needs, such as an allergy to an inactive ingredient in the manufactured version or an inability to swallow pills.
While states maintain oversight over all pharmacies, the U.S. FDA has the authority to step in once a compounder crosses the line into drug manufacturing, which is illegal without FDA approval. The agency has guidelines, but experts say the rules are unclear and the FDA does not consistently enforce its policies. As a result of the meningitis outbreak, some members of Congress and various U.S. Department of Health and Human Services officials are asking for additional FDA authority to oversee compounders.
Although compounding pharmacies are only supposed to make drug mixtures based on a prescription from a doctor, NECC was making medicine in large batches. More than 17,000 vials of the tainted steroids were shipped to physician offices and clinics across the country, including facilities in Pennsylvania, New Jersey and Delaware.
According to the complete list of facilities released by the FDA, area facilities that received shipments from NECC include everything from individual doctors to large hospitals. Some of the hospitals included on the list are Thomas Jefferson University Hospital, Pennsylvania Hospital, Methodist Hospital, Hahnemann University Hospital, Cooper University Hospital and Our Lady of Lourdes Medical Center.
So far, more than 300 cases have been reported to the Centers for Disease Control and Prevention. Of those cases, 23 people in 17 states have died. If you suspect that you may have received a tainted steroid injection or if you are experiencing symptoms that you believe may be the result of meningitis or a fungal infection, you should seek medical treatment immediately.
The Philadelphia personal injury attorneys at Messa & Associates are experienced at handling cases involving injuries as a result of defective drug and pharmaceutical products. Our extremely skilled team of personal injury attorneys and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a tainted steroid shot, a defective drug or medical device, a negligent medical provider, or have endured any other type of personal injury, contact the personal injury attorneys of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More