Articles Posted in Wrongful Death Lawyers

A recent article in USA Today discussed a terrifying new superbug with origins here in North Carolina that has caused serious worries across the healthcare industry, leading to deaths in medical facilities large and small across the country. The bug, known as Carbapenem-Resistant Enterobacteriaceae, or CRE, is known for fighting off doctors’ last line of defense, carbapenem antibiotics. The bacteria are causing serious concern among those in the medical industry, especially nursing homes and small hospitals, as it tends to prey on the most vulnerable patients.

The bacteria made news this summer after a CRE strain attacked the National Institutes of Health outside Washington, D.C.; seven people ultimately died as a result. Research shows that since the first case of a CRE infection was reported in a North Carolina hospital back in 2001, there have been thousands of CRE cases throughout the country, showing up as everything from pneumonia to intestinal and urinary tract infections.

The bacteria’s resistance to even the strongest antibiotics has some worried about doctors’ ability to control the illness. Death rates among patients with CRE infections are around 40 percent, much worse than other common healthcare infections such as MRSA or C-Diff, which have been problems for places catering to the sick and elderly for decades.

Since starting in North Carolina, CREs have spread to at least 41 other states, according to the CDC. Many more cases have gone unreported given that it can be difficult to obtain a proper lab test confirming the presence of the bacteria in smaller hospitals and nursing homes. Many small medical facilities lack the capacity to identify CRE or the resources needed to isolate patients carrying the bacteria.
Surprisingly, given how serious the illness can be, there is no billing code for CRE infections under Medicare or Medicaid and there is no federal reporting requirement for the infections. This makes it hard to get a good national picture of the disease and only spotty records from around the country exist. One example is in Los Angeles County where one year of surveillance through mid-2011 turned up 675 cases at hospitals, nursing homes and clinics. In Maryland, a 2011 survey by the state health department identified 269 patients carrying CRE and estimated that up to 80 percent of the state’s hospitals had seen at least one case during the year.

Sadly, for at-risk patients in medical facilities throughout North Carolina there is little chance that a new drug will be developed to kill the CRE bacteria. Manufacturers have said they have no new antibiotics in development that are able to kill the bacteria. Moreover, there’s little financial incentive for drug companies to act given the bacteria’s ability to adapt to new drugs and become resistant to them as well.

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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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