Charlotte Injury Lawyers Blog

A company with the same founders as the specialty pharmacy linked to a deadly fungal meningitis outbreak is recalling all of its products after federal inspectors said it must improve its sterility testing process.

Officials with the FDA have said that a routine inspection turned up inadequate quality assurance related to Ameridose’s sterile products. The FDA was quick to say that it has not discovered any infections linked to the recalled products from Ameridose. In a statement, Ameridose declared it issued the recall “out of an abundance of caution.”

Ameridose makes several injectable drugs which can be used in anesthesia or to correct acid imbalances in the body during critical care. Ameridose agreed to shut down for inspection in October after contaminated steroids from the New England Compounding Center (NECC) were linked to a growing fungal meningitis outbreak.

The FDA warned that six drugs produced by Ameridose were already on the FDA’s list of drugs in short supply. According to the FDA, the Ameridose recall could exacerbate one or more of the shortages of these drugs. Given the shortages, the FDA is working with manufacturers of the six drugs, asking that they ramp up production if they are willing and able to do so.

According to the Centers for Disease Control and Prevention, there have been reports of 386 fungal meningitis cases throughout the country related to the NECC recall. The CDC also announced that there have been 28 deaths in the following states, including one here in North Carolina: Florida (3), Indiana (3), Maryland (1), Michigan (7), Tennessee (11) and Virginia (2).

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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 28 people and sickness in nearly 363 more (http://health.usnews.com/health-news/news/articles/2012/10/30/fungal-meningitis-outbreak-toll-now-28-dead-363-sickened).

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.

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The Food and Drug Administration recently announced that the agency launched an investigation concerning five deaths and one non-fatal heart attack linked to consumption of the Monster Energy Drink. The Monster Energy Drink is a heavily caffeinated soda that has grown in popularity in recent years among those eager for a boost, especially young people.

Reports indicate that several people suffered adverse reactions after consuming the drink which contains a whopping 240 milligrams of caffeine. To put that number into some perspective, one Monster Energy Drink contains about seven times the caffeine in a typical 12-ounce can of soda.

The FDA issued a statement saying that it was taking the reports of death seriously and will begin a thorough investigation to determine if any action should be taken. Although the FDA caps the amount of caffeine in soda at 0.02 percent, there is no such limit for energy drinks, something that may need to change in the future. Though a response from the regulatory agency is a good thing, the timing leaves something to be desired as reports first surfaced back in 2004. The agency says so far there’s no proof that the drinks directly caused the deaths or injuries.

The FDA’s announcement follows quickly on the heels of a report that a wrongful death suit was filed in California by parents of a 14-year-old girl who died after consuming two cans of the Monster Energy Drink in less than 24 hours. The child’s parents argue that the soft drink company failed to properly warn consumers about the dangers associated with consuming its products.

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