Four days ago, I reported on what was news to very few people at that point in time: That a Massachusetts pharmaceutical compounding facility, the New England Compounding Center, had unknowingly distributed thousands of vials of a fungally-infected steroid commonly used to treat back and spine injuries.
Since then, the outbreak has continued to spread. The Centers for Disease Control (CDC) now reports that75 medical facilities in 23 states received the contaminated steroid injections from NECC. The NECC manufactures a variety of specialty pharmaceutical products that it distributes to medical facilities around the country. Tennessee has seen the most deaths related to this defective product (six so far,) as well as the most infections (39.) In addition to the most recent death in Florida (in Marion County, where six non-fatal infections have also been reported,) deaths have been reported in Maryland, Michigan and Virginia. Confirmed cases of the disease in have occurred in Indiana, Minnesota, North Carolina, and Ohio. Other states that received the contaminated drug are California, Connecticut, Georgia, Idaho, Illinois, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, South Carolina, Texas and West Virginia.
Meningitis is a horrific, often fatal disease that causes swelling of the protective membranes of the spinal cord and the brain. It is typically caused by an infection, frequently by bacteria or a virus, but it can also be caused by less common pathogens such as fungi. Fungal meningitis is very rare and, unlike viral and bacterial meningitis, it is not contagious. Click here to learn more about it.
Victims – those who have not died as well as the 12 fatalities so far – contracted the meningitis after being injected in the spine with a preservative-free steroid known as methylprednisolone acetate. The steroid is commonly used to treat back pain and inflammation, and was contaminated by a fungus. The steroid is used to treat pain and inflammation. According to the CDC, upwards of 13,000 people may have been injected with the drug between May 21 and September 24, when this problem was first reported. As I reported previously, NECC has voluntarily recalled not only all lots of this affected steroid, but all of their products, until they can more accurately determine the safety of their operations. The pharmacy has also voluntarily surrendered its license to operate until FDA investigators can complete their analysis and risk assessment.
Most prescription drugs in the U.S. don’t come from compounding pharmacies like NECC. Manufacturers like NECC create customized medications for patients that don’t benefit from “traditionally manufactured” pharmaceuticals. In fact, only about ten [percent do, according to a 2003 report by the federal government. What’s the difference between the 90% of drugs that come from traditional pharmacies and the 10% of drugs and products that come from “compounding pharmacies”? Drugs that are manufactured by compound pharmacies aren’t required to pass FDA premarket inspection and approval. Instead, state pharmacy boards are supposed to be responsible for the oversight and licensing of these pharmacies. As you can see, such oversight appears to have been lacking here in Massachusetts, where this product was manufactured. (No surprise there, let me assure you.)
Treatment of the infection required hospitalization and intravenous administration of anti-fungal medications. The sooner a patient receives treatment, the more likely it is that he or she will survive the infection.
The FDA is urging anyone who has experienced problems following an injection with the NECC product to report it to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.
Once medical treatment is begun, anyone sickened by this defective product should contact an experienced Massachusetts defective products law firm that specializes in product liability. Massachusetts law provides that people who have been injured due to a defective product, such as this contaminated steroid, can receive damages for their injuries. A warning: If you or someone you care about has been impacted by this defective medical product, do not consult a law firm that does not specialized expertise and years of proven results to back it up.
This area of litigation is very complicated. If you end up being represented by a law firm with inadequate expertise in this subject matter, you could end up losing your case, and potentially a lot in financial damages.