What Caused the Recent Fungal Meningitis Outbreak?
By Jim Lewis, Medical Malpractice Lawyer
The recent outbreak of fungal meningitis has many in the medical community desperate to get to the bottom of the cause. Possibilities abound and everyone appears to have a theory. Could it have been some moldy ceiling tiles? What about the dirty shoes of a careless employee? How about a contaminated ingredient?
There are many ways the fungus could have gotten inside the New England Compounding Center, a pharmacy in Massachusetts that has been blamed for the outbreak. The steroid injections made by the compounding pharmacy have already been recalled after leading to the death of 25 people and sickness in nearly 350 more.
So far regulators from both state and federal agencies have been quiet about what problem may have led to the contamination. It has been revealed that inspectors found fungus growing in more than 50 vials from the pharmacy. FDA investigators remain on the scene in Farmingham, Massachusetts in an attempt to better understand what went wrong.
Despite the lack of information, outside experts tend to agree that dirty conditions in the plant are likely to blame. This could include a number of possible sources of contamination, including faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees.
One problem for the pharmacy is that the drug used in the steroid injection is made without preservatives meaning there is no additive that is able to kill germs lurking in the medicine. Given this lack of preservative, it’s critical that the drug be manufactured under incredibly sterile conditions.
Though compounding pharmacies aren’t as tightly regulated as major manufacturers, they are supposed to follow certain basic rules including cleaning the floors and all other surfaces daily, monitoring the air supply in “clean rooms” where the drugs are actually made, ensuring that employees wear gloves and gowns and testing samples from each lot. These rules of standard practice exist in the U.S. Pharmacopeia, a national standards book for compounding medicines that is written by a nonprofit scientific organization.
To make the steroid used in this case, a chemical powder from a supplier was mixed with a liquid, sterilized through heating, then pumped into vials. It’s possible that the powder was contaminated, either at the New England Compounding Center or another location. Given the vast amount of the medicine produced, the time it would take to make the batches might allow the medicine time to be contaminated. It’s also possible that if a worker took a break for coffee or to go to the bathroom that they could have hurried back into the lab without properly washing up, thus introducing contamination.
Though this event has received a significant amount of media attention, it’s important to note that it’s not as uncommon as many people would think. In fact, just last year there were three similar incidents. At least 33 patients came down with fungal eye infections linked to a compounding pharmacy in Florida; a dozen patients were blinded after an outbreak caused by another compounder in Florida; and nine people in Alabama died from taking IV nutritional supplements made by a compounder in that state.
The North Carolina Injury Lawyer’s Perspective:
As experienced North Carolina dangerous drug attorneys, my colleagues and I have helped clients through many cases like this one. Sadly, thousands of people experience the pain of taking a medication prescribed by their doctor only to have it cause serious health problems later on. This happens far too often and the side effects can last a lifetime.
If you have been injured by a dangerous or defective drug, you may be able to hold the company that manufactured and marketed the drug accountable by filing claims for compensation. Read this article to begin learning about your legal rights and options when a faulty product leads to injuries.
About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.