Articles Posted in Meningitis Outbreak

According to a recent story from NBC News, many U.S. Senators continue to ask tough questions of state and federal regulators responsible for the safety of pharmaceutical products across the country. The questioning was spurred by the widespread and high-profile fungal meningitis outbreak tied to contaminated epidural shots. Over 17,000 vials of a spinal steroid injection from a single pharmaceutical compounding center were sent to clinics in 23 differen states–those steroids were contaminated with a fungus. All told about 14,000 doses were given to patients before the problem was identified and all of the steroid were recalled.

Current Infected Counts

According to the U.S. Centers for Disease Control and Prevention website on the situation, 480 people have been identified as having contracted fungal meningitis in the latest outbreak. In addition, 33 people have died. Those deaths were essentially caused by strokes that were connected to the meningitis. Seniors and other vulnerable patients were most at risk of suffering more serious complications from the meningitis.

The fungal meningitis outbreak that has ravaged over 400 patients in 23 states has affected another resident in Illinois. According to the latest reports on the incident from the Centers for Disease Control and Prevention (CDC) a second Illinois resident has come down with meningitis as a result of contaminated spinal steroid injections produced by the New England Compounding Center (NECC). Thus far 29 people have died as a result of the outbreak, many of them due to strokes that were spurred by the meningitis. The seriousness of the problem, and the potentially life-threatening nature of the incident makes it absolutely incumbent for all those who may be affected to act prudently to protect their health and well-being.

Medical officials explain fungal meningitis is quite rare, and it often has a long incubation period. That means that the signs of symptoms of meningitis might not show up for some time after the contaminated steroid is injected into the body. In other words, affected community members are not entirely out of the woods yet–it is important to keep a close eye on possible signs of meningitis if you were one of the estimated 350 patients who received the injection in our area.

The Illinois Department of Health and Human Services previously explained that the injection given for back pain were used at three local APAC Centers for Pain Management. One is located in the Thorek Hospital professional buiding in Chicago; the second is the APAC Lincoln Park; and the third is in Westchester, Illinois. Those patients should have already received certain testing to determine if they developed the meningitis. However, because of the latency period, the earlier test might not automatically pick up the inflammation.

Considering that the spinal steroid associated with the fungal meningitis was only recalled last month and investigations continue into the details of the incident, it is too early to know with certainty how various legal development will play out in these cases. That is made even more true by the fact that not all of those affected by the incident have actually come forward yet to explain their situation to legal professionals. In addition, as we have previously explained, the long incubation period for the fungus at issue might mean that those who develop the meningitis may actually still not know for sure. Long story short, we’ve got a long way to go before different details of the case are finalized and specific pronouncements can be made about how legal details will likely play out.

However, one beginning question that many local community members might be asking relates to who might be held responsible for this obviously preventable tragedy. Right now there are various possibile responsible parties: the compounding company where the fungus was tracked to (New England Compounding Center), the individual medical professionals who gave out the drug, the clinics where they worked, the suppliers of the contaminated drugs, and potentially others. When first looking into the matter, legal professionals must start with a wide scope and alter the details as more information comes in regarding exactly what happened at every step of the chain which allowed certain patients to receive the dangerous drug.

Product or Service?

The Wall Street Journal published a story this weekend that provides even more insight on the dangers present at the “compounding” pharmacy behind the highly publicized and incredibly destructive meningitis outbreak. Known as a “drug mixing” pharmacy, the New England Compounding Center (NECC) has come under intense scrutiny since the outbreak was traced to contamination of spinal steroid medication from the plant.

Recently the U.S. Food and Drug Administration (FDA) released more information about the state of affairs at the pharmacy which paints a bleak picture of the safety standards at the location. It is a reminder of the hidden dangers faced by all consumers when using products–including medications–where they are forced to rely on the safety steps place by the manufacturers themselves.

According to the story, the FDA conducted a detailed inspection of the plant this month to determine how far reaching the contamination actually was. The results are staggering. About 1/4 of the material examined by investigators had “greenish black foreign matter” visible in the vial to the naked eye. In total, 50 vials were sent for closer testing. Of that group, all fifty came back as contaminated with fungus. Of course, most of us are shocked by the fact that these sorts of sterilization problems could be found anywhere, let alone a pharmaceutical plant where the safety of the products obviously hinge on an ability to ensure no pathogens are present.

As readers know, a mass fungal meningitis outbreak has been sweeping across half of the country. Facilities in twenty three states received contaminated vials of a spinal steroid injection, with hundreds already having been infected, 24 killed, and thousands more waiting for confirmation that they have or have not developed meningitis as a result of their injection. It is a terribly tragic situation, and it is critical that all of us pay attention to the individual stories at the heart of the ordeal.

For example, reported on one story involving a family that has been decimated as a result of this incident. According to the report, a husband a wife both recieved the contaminated injections–usually given for back pain. They did not have the shot at the same time, however. The wife had hers in August and the husband about a month later in mid-September. They obviously had no idea at the time, but those shots would change their lives and that of their family forever.

Only a few days after the husband had his shot, the wife began to feel sick and showing signs of the meningitis. Only September 22nd she suffered one the most serious consequences associated with the condition–a stroke in her brainstem. The stroke proved damaging, and the woman passed away about a week later. Experts explain that the vast majority of the deaths connected to the outbreak thus far occur in that matter, from stroke complications.

More information is trickling out on the pharmaceutical plant in New England linked to the disasterous meningitis outbrea that has affected hundreds across the country, including in Illinois. As reported in a recent Journal Gazette story, the plant in question had obvious cleanliness problems which made it only a matter of time before serious contamination problems occured. On top of that, the current problems were not unprecedented as issues were identified long ago at the facility. Unfortunatey, changes were not made and oversight was lacking, which allowed the issue to fester–ultimately leading to this outbreak which has already affected nearly 300, killed at least 23, and left thousands open to serious health risks.

Past Problems At the Compounding Facility

The story shared information on the latest inspection of the plant, conducted after it was identified as the source of the meningitis contamination. The inspectors found obvious problems. For one thing, visible black specks of fungus in certain steroid at the facility. In addition, a leaking boiler was found near a “cleaning room” at the pharmacy–an obvious safety risk and indication of the lack of commitment to keeping the products free of possible contamination.

Over 14,000 individuals across the country are at risk of developing fungal meningitis as a result of several batches of contaminated spinal steroid injections. As we have previously explained, medical patients in at least 23 states received the injections for back pain which, unbeknownst to them, put them at risk of fungal meningitis. Meningitis is an inflammation of special membranes around the brain and spinal cord. It most often develops as a result of pathogens like viruses or bacteria. However, in rare situations it can also be caused by a fungus.

One unique aspect of the fungus is its long latency period. It can incubate for weeks or even months. That means that those who received the spinal steroid injections contaminated with fungus might not learn for quite some time whether or not they contracted the illness as a result of the now-recalled product. Over 17,000 vials were made but experts eplain that about 14,000 were given out before the problem was discovered and the recall. Thus far at least 282 patients have been positiviely identified as having contracted the illness with 23 deaths. The deaths are primarily caused by strokes which themselves were caused by the fungal meningitis.

The Waiting Game

Sad news continues to emerge regarding the fungal meningitis infection traced to contaminated spinal injections. According to a recent NBC News report, the total count of infected patients and fatalities continue to rise. As of Wednesday, the U.S. Centers for Disease Control and Prevention noted that 247 patients have been identified as having fungal meningitis. In addition, the death count has risen to nineteen. The story notes that the sickest patients have taken the meningitis harder than others. Most deaths have been caused by strokes connected to the meningitis. This is a common trend with various acts of medical malpractice or pharmaceutical negligence–the patients with the most intial vulnerabilities face the most serious consequences from the problems.

The U.S. Food and Drug Administation (FDA) has identified the source of the problem, the NECC–a “compounding” pharmacy in New England. The FDA conducted a sweep of the NECC facility and voiced serious concern about the state of the drugs there. Following the raid there were serious concerns about the sterility of many of the products created and send out by the business.

Congressional Action

Unfortunately, more news is coming out regarding the meningitis outbreak that has plagued dozens of state, including Illinois, and that news is discouraging. According to recent report over the weekend from NBC News, the total infected count has risen to 197. In addition, yet another patient who developed the fungal meningitis has died, raising the death count to 15. Also, for the first time there has been a reported meningitis case in Illinois. This is yet another reminder of the need for all local residents and their families to be incredibly vigilant about this situation to ensure full and proper treatment is received if necessary.

Slow Growth

According to reports from the Centers for Disease Control and Prevention (CDC), the problem has been traced to at lease three batches of spinal steroids at a compounding plant in New England. The vials were delivered to at least 23 states (including Illinois), though cases of meningitis have thus far only been reported in 13 of those states. The contaminated steroid were apparently used between mid-summer and September of this year.

In many injury cases, past conduct of the parties factor into the legal issues at play. That is because these cases are rooted in negligence–did the defendant act unreasonably? The determination of what is or is not reasonable is based, in part, of past conduct and experience. It is reasonable to take actions to correct risks that your know exist. You know they exist if there have been problems in the past.

However, it is important to note that product liability rules are somewhat different than traditional negligence cases. While past conduct may impact a determination of reasonableness, in some cases reasonableness is not even a factor. That includes some product liability cases where “strict liability” is applied. This refers to legal rules which requires companies to pay for the harm caused by their products regardless of whether specific act of negligence can be identified.

These issues are important to consider in the ongoing spinal steroid recall case. It is instructive to understand exactly what this company knew or should have known about the safety of its products and protocols.

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