Last week, this blog posted about the nationwide meningitis outbreak (see here), but the situation has grown worse since that post. More patients have died or become ill, and the defective products potentially causing meningitis infections have multiplied, according to news reports and a statement earlier this week by the Food and Drug Administration (FDA).
The initial outbreak seemed to be caused by a steroid injected for ailments like back pain. However, now the company with the tainted steroid, the New England Compounding Center in Framingham, Massachusetts, may have also distributed other tainted drugs for eye surgery and open-heart surgery. Officials are not certain of the link between the drugs and two new cases of infections, but they warn that other people might be at risk. The initial meningitis outbreak from the tainted steroid has now killed 15 people and infected around 200 people in 15 different states.
The FDA is recommending that doctors of all patients who may have been exposed to any of the potentially contaminated drugs – the steroid, heart surgery medicine, or medicine used during eye surgery – from the New England Compounding Center be notified of the risks and alerted to possible symptoms of infection. At the moment, this is a precaution, as it is not clear that the two other types of drugs caused the recent infections.
The New England Compounding Center has been shut down and six states have pulled its license- Massachusetts, Michigan, New Hampshire, Ohio, Maryland, and Virginia.
This scare also highlights a serious nationwide problem in the area of compounding drugs. Even if Georgia was not one of the worst hit states this time, and we hope that remains the case, this kind of problem could occur again with any number of drugs. Compounding is when pharmacies mix medicine for an individual patient, at least that is how the trade started. The practice has been regulated by states, rather than the federal authorities. Because of this loophole, some pharmacies doing compounding have become mini-drug companies existing outside the scope of regulators like the FDA. This is even more problematic because, as this outbreak has shown, the drugs do not stay in one state but are shipped around the country affecting people nationwide. The FDA says they don’t even know how much of a share of compounding these large scale pharmacies have.
“There’s no bright line in statute distinguishing what the FDA can regulate,” according to Daniel Carpenter, a political scientist at Harvard University who specializes in regulatory law. There was an attempt in 1997 to define “compounding” and establish clearer standards, but in 2002 the US Supreme Court overturned that definition. Politics and lobbying have also become important, as the pharmaceutical industry has enormous resources.
Atlanta Product Liability Attorney
If you or someone in your family has been injured by a defective product, whether medical related or not, the product liability lawyers at Sammons & Carpenter can assist you. These cases are often complicated and require experts, and an experienced attorney can help you understand and get through your case. Please call us at 404-814-8948, or fill out our confidential online case evaluation form for a free consultation.