How the Outbreak Happened: Compounding Firm’s Poor Track Record

So how exactly did this fungal meningitis outbreak happen? Was it an innocent mistake that could not have been prevented? Are the risk factors that caused this accident the same that affect other pharmaceutical compounding plants across the country? Is there anything that can be done to ensure no more families are forced to endure what thousands are enduring now in the wake of this deadly spinal steroid contamination?

These and similar questions are being asked by invovled parties across the country. We need to get to the bottom of this fiasco while ensuring all those affected are supported and those accountable are held to task.

It is far too early to make any definitive statements about this exact case. However, investigators, including many from the U.S. Food and Drug Administration as well as intrepid individual researchers, have uncovered details about the history and goings-on at the compounding plant. The information presented thus far is not pretty.

Past Pharmacy Safety Problems
For example, a recent Journal Gazette story discussed how state investigators released information about terrible conditions aneara “cleaning room” in the now-temporarily closed facility. They noted that there was a leaking boiler near the room, an obvious safety risk. On top of that, visible black specks of fungus were found inside steroids in the plant. In addition, thousands of the contaminated products were apparently sent out by the company before test results came back on the safety of the steroids. This is what allowed the problem to occur.

The state has already moved to take some preliminary action in the case. Steps have been initiated to revoke the license of the facility as well as the licenses of three individual pharmacists who were allegedly linked to the disaster. Yet, the governor of the state where the plant is located made clear that these preliminary steps were still insufficient. He has already made calls for changes which allow more oversight of these facilites, including the ability to make more surprise inspections. As in the case of nursing home quality standards, the ability to take important steps like surprise inspections is a crucial way to ensure the full weight of state power is put to bear to mandate reasonable safety standards.

Legal Accountability
Obviously the patients who received the shots hundreds of miles away from this plant would never suspect that the drug that their clinic gave them would have been created in such deplorable conditions. However, because of the decentrilized nature of our consumer system today, these sorts of situations are liable to happen when certain actors (like pharmaceutical companies) do not prioritize safety. It is simply impossible for patients (or sometimes even the doctors who receive the drug shipments) to be able to individually identify the risk of contamination. There is no way to operate without some trust in the manufacturing process.

This is one of many reasons why it is absolutely essential for misconduct in these situations to be handled strongly. When makers of these products violate the trust they are given–usually in an effort to cut corners and maximize profits–they are responible for the harm that results. To ensure that there is accountability in your individual case, please take a moment to reach out to the meningitis outbreak lawyers and product liability attorneys at our firm who can help ensure your rights are respected every step of the way.

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Medical Device Recall Reminder: Stryker Hip Implants

Products that are mass produced can harm tens, hundreds, or even thousands of community members if mistakes are made during the manufacturing or designing process. For that reason it is entirely reasonable for those who make these products to be held to high standards to ensure community members are kept safe. One key reason for this is that most consumers have no reasonable way to determine the safety of the products.

That is particularly true when it comes to things like medical devices. Many seniors and nursing home residents seek out medical care for varous injuires and ailments. When visiting those professionals it is not common to second-guess everything said or done by the doctor. Of course, reasonable inquiry is helpful, but at the end of the day most patients rely on the expertise of their doctors. That includes relying on the quality of the products used by the doctors when performing their work. But if those materials are not up to quality standards, then medical patients might be seriously harmed in preventable ways as a result. This is never acceptable, and it is crucial for those hurt in these sorts of medical device incidents to demand accountability.

Stryker Hip Corrosion Problems
This issue was prominently on display recently in one instance which might have affected local seniors. Many people have problems with their hips as they age, and they are often advised on the potential benefits of a hip replacement. This involves surgery where an articial hip replacement device is installed inside the body. When everything goes according to plan, the replacement surgery can have very clear benefits for the patient. However, if problem develop, the replacement can turn into a nightmare.

Unfortunately, that is exactly what happened to some seniors who received the now-recalled Stryker Rejuvenate and ABG II modular-neck hip stems. These products, it is now known, posed high risks of metal corrosion. The metal on the devices, once corroded, cause a range of problems. That includes anything from ion metal poisoning to the ultimate failure of the device. These problems cause serious pain, mobility problems, and often require risky revision surgery. Sadly, a growing number of people have reported these issues. The rising tally of problems led the prodcut to be recalled this summer.

In the aftermath of the Stryker hip recall, those affected slowly began seeking out legal help to ensure there was accountability and compensation following the problems with defective hip replacement systems. Some of those lawsuits are just now being filed, though many community members are just now learning about the situation and seeking out attorneys. Part of those initial suits involve suggestions that the company might have known about the corrosion risks early on. The products were not recalled until July, but a May study showed clearly that the metal used in the products had a very high risk of problems.

The lawyer at our firm are working closely with those affected by hip recalls, including those stemming from these Stryker Rejuvenate and ABG III products. If you or a loved one may have been affected, please reach out to our office at any time to see how we can help.

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Worries Rise As Meningitis Outbreak Spreads Across the Country

Seemingly every day brings news of more community members who have been infected with fungal meningitis, a rising number of whom are suffering serious injury (and even death) as a result. The meningitis outbreak is linked to a now-recalled spinal pain injection. A New England pharmaceutical compounding company is allegedly resonpsible for the situation.

According to estimates released by the U.S. Centers for Disease Control and Prevention (CDC), over 14,000 patients received the injections in pain centers across the country. The epidural shots were given mostly to help relieve back pain. However, unbeknownst to those receiveing the injections, the pain medication were tainted with a fungus. The fungus sometimes entered the body during the injection and may cause meningitis. Meningitis is an inflammation of protective membranes around the brain and spinal cord.

The Stress & Worry of Waiting
What is often forgotten in the focus on rising numbers of affected community members, however, is the toll that all those who receive the injection have to face–regardless of whether or not they end up with meningitis. That is true in all cases of infection where those exposed are forced to wait in extreme worry until they find out about their own potential illness. The harm may even be greater than normal in this particuarl case as a result of the uniqueness of fungal meningitis. That is because there is a long latency period for the fungus. Just because one is not automatically affected following the spinal injection does not mean they are in the clear. In fact, it can take weeks or even months before the patient knows for sure if they are infected, that is because there may be a long incubation period for this type of meningitis.

A New York Times story on the steroid recall recently delved into this unique and often-overlook situation. One mother and daughter’s story was shared. Both received the spinal steroid injections recenly and are still waiting on pins and needles to figure out if either are affected. The fifty-seven year old daughter shared of her mother, “She’s worried sick about me, and I’m worried sick about her. She’s 80 years old, and if she were to come down with it, she would have very little chance of survival.”

Thousands and thousands of others across the country, including some in Chicago and Ilinois sitting, waiting, and facing the same concerns. It is a heartbreaking situation that no one should ever have to go through.

Part of the challenge that medical officials are focused on now is identiying who is most at risk of developing the meningitis. Of course no one wants to just wait around without any guidance on their risk of contracting the meningitis. That is why, hopefully, experts will soon have guidance on who is most at risk. That way proper follow-up treatment can be had as soon as possible.

Legal Help in Illinois for Meningitis Outbreak
The attorneys at our firm are working with all those in Chicago and Illinois who have been affected by this outbreak. If you or a family member has been affected by this situation it is critical to seek out legal help to preserve your rights. It is entirely unacceptable for any patient to be forced to endure the immense stress of waiting for answers on this outbreak and to have to deal with the aftermath. Please take a moment to call our office to learn how we can help.

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Local Seniors Should Be on Notice for Stryker Hip Recall

One issue that affects many seniors is mobility. As the body ages, different bones, joints and muscle begin to break down–often making it difficult for seniors to get around on their own two feet. Fortunately, medical advances in recent decades have opened up more and more options to help community members retain their mobility for as long as possible. One of the most common tools is a replacement of the hip. Hips take a toll over the course of a lifetime, and when they break down it is usually impossible to walk without severe pain. A replacement involves implanted devices put into the body to return strength to the joint. When working properly, these implants are incredibly helpful, often making the difference between a senior who is able to live on their own or forced to have close day-to-day assistance.

Yet, as with all medical solutions, the hip replacement is only as good as it is safe. Unfortunately, some hip replacement systems have actually not worked as planned–causing serious problems for the patients who received them. For example, this July a hip replacement system was pulled from the market over safety concerns. The Stryker Orthopaedic Rejuvenate Modular Hip Implant or “ABG II modular-neck hip system,” was found to pose unacceptably high risks of problems. Thousands of patients may have been affected by those problems. It is crucial for local residents to understand the situation to determine if they or a loved one might have been harmed.

Stryker Hip Recall
According to recent reports, this latest hip recall mostly centers of corrossion problems. Like the other high-profile recent hip replacement recall from DePuy Orthopaedics, the Stryker hips were a “metal-on-metal” product. The key issue is that the metal can corrode. This corrosion might result in metallic particles being released into the body. Those can causee a range of problems, including: (1) Metallosis (inflammation of the joints as a result of the particles); (2) Necrosis (the death of tissue around the implant); (3) Osteolysis (bone loss as a result of the particles). Taken together, these problems often cause severe pain, swelling, discomfort, and mobility concerns. Far from helping to solve a medical problem, if defective the device causes much more harm than good. In some cases a risky revision surgery is required to correct the problem.

It goes without saying that no senior should ever have to deal with the complications of a defective medical device. Unfortunately, the reality is that thousands of seniors may actually fall victim to this sort of problem. These Stryker devices were quite popular before the recall. Estimates suggest that as many as 20,000 patients may actually have received these devices. It is unclear exactly how many of that group have been harmed as a result of probems with the product.

Stryker Hip Recall Lawyers in Illinois
The attorneys at our firm are working with all those harmed by this hip recall. Those hurt may be able to use the civil justice system to receive compensation for all of their losses as a result of the defective hip.

If you suspect that you (or a loved one) might be harmed by problems with their hip implant, the first step is to seek out medical help. In addition, it is important to protect your legal rights by contacting an attorney soon afterwards to ensure the appropriate steps are following to protect your claim. The hip recall lawyers at our firm can help with these issue. Take a moment to reach out to our office today.

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Latest Updates on Fungal Meningitis Outbreak

Earlier this week federal official released updated information on fungal meningitis infections which have affected hundreds across the country. Over the last two weeks we have discussed how this outbreak has spread across the country, with more and more involved patients identified. An NBC News report on Wednesday provided even more sad news. According to the story another four medical patients have died as a result of the fungal meningitis they contracted via the infected spinal steroid injections. That brings the total of deaths to nineteen. RIght now the total infected count is at 247–a significant growth from when we first started discussing this story at the beginning of the month. The sickest patients to start–which likely included some seniors–seemed to face the most trouble as a result of the meningitis.

Amazingly, we still may not be near the end of the outbreak. Officials from the Center for Disease Control and Prevention report that the total number of infection is actually expected to rise even higher. That is because almost 17,000 vials of the steroid may have been sent out, with a majority of them actually used before they were recalled in late September.

National Call for Accountability
Considering the size and scope of the inident, it is not surprising that there have been calls from federal officials for clear answers on how something like this could have occurred. According to the latest story, several members of Congress have indicated that federal investigations will be invovled, but thus far no hearings have been called. Also, two U.S. Senators have written to the U.S. Food and Drug Administration asking for more information on what happened. In particular, the officials were concerend that the NECC plant in New England where the infection originated violated clear state and federal rules. In fact, the investigators who raided the compounding plant were taken about by the status of the facility and worried that other products at the plan might be problematic.

Reminders About the Meningitis Outbreak in Illinois
For those who are just learning about this outbreak, it is important to note that Illinois is one of the twenty three states in which the infected spinal injections were delivered–only nineteen have thus far reported infected patients. According to the Illinois Department of Public Health at least three clinics in the state actually dispersed the injections to the patients. That includes the APAC Lincoln Park, APAC facility in Westchester, and at the Thorek Memorial Hosptial in Chicago.

The IDPH noted that those who received the pain injection–given in the back–were identified and tested. Still, all those who may have been harmed in this outbreak should be aware of potential signs or symptoms of meningitis. This includes headache, fever, neck stiffness, slurred speech, weakness in one side of the body, and sensitivity to light. Those affected may not all be present in any different situation. Additionally, federal disease control officials have indicated that fungal meningitis does not immediately lead to clear symptoms in patients. Instead, it may develop slowly, with serious signs only much later.

If you or someone you know may have been harmed by this outbreak, please take a moment to contact our office. We are investigating the incident and working with those affected by this unprecedented outbreak. Obviously it is unacceptable for a medical patient to be harmed by pharmaceutical products made unsafely.

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Settlement in Wrongful Death Lawsuit Following Nursing Home Rape

Perhaps the most heart-wrenching form of abuse and neglect at assisted living facilities and nursing homes invovles sexual assault. Many seniors living in these communities have very unique vulnerabilities. That makes them prey to those willing to commit the most harmful and invasive acts on those unable to properly defend themselves. Nothing is more personal and protected than our own bodies, and to have that body forcefully attacked and invaded in always unacceptable. For this reason, nursing homes must, in all circumstances, do everything in their power to prevent exploitation of elderly community members in their care.

Often the biggest threats comes from inside the nursing home itself. Resident on resident attacks–physical and sexual–are far more common than most appreciate. Nursing home owners, administrators, and caregivers know this, however. That means that it is never acceptable for these responsible parties to argue that the attacks were unforseen or that nothing could have been done to prevent it. In almost all cases, when resident on resident incidents are fully investigated, it becomes clear that certain warning signs were missed and basic safety protocols were ignored which allowed the attack to occur. At those times, full legal accountability must be had. It is only then that the home is pressured to make change to improve safety. Also, holding nursing homes accountable for these incidents may even influence the conduct of facilities not named in the suit. Other nursing home owners and operators may pay attention to the consequences of misconduct at other homes and change their own protocols in order to prevent similar attacks.

Recent Case
One recent legal case involving these issues illustrates how facilities are able to be held accountable following a serious incident. A JS Online story this week explained how a settlement was reached between two parties following the sexual assault and ultimate death of a 90-year old nursing home resident. According to the story the nursing home resident was attacked in January of 2009 while living in the home. She died two and a half weeks later. Negligence and wrongful death claims were eventually filed by the resident’s family.

Those claims alleged various problems at the home. Most notably, the article argues that the sexually agressive resident who perpetrated the attack was left unattended by nurses who knew of his proclivities. The resident had sexually assault another female resident earlier. By not properly protecting other residents, their negligence allowed the attacks to occur. In addition, the claims suggest that the staff at the facility were not properly trained on the risks and prevalence of resident on resident attacks. Their lack of proper understanding of the issues was a factor in their poor preparations which allowed the assault to occur.

Eventually this case went to trial. However, after four days of trial, the parties were able to reach a settlement without the need for a jury to decide the matter. Many community members are surprised to learn that many cases settle in the middle of trial. Settlements are usually preferred because they are more efficient, less costly, and allow both sides to agree on fair compensation following an incident. In that way, if forcing a judge or jury to decide can be avoided, then that is almost always the best option.

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U.C. Irvine Receives a Little Help in their Battle against Elder Abuse

The University of California Irvine reports that it received a three-year $1 million grant from the United States Administration on Aging in order to help them combat elder abuse involving individuals with dementia. The Program in Geriatrics will use the funds to implement its “Take AIM Against Elder Abuse” program.homecare.jpeg

U.C. Irvine is one of five institutions receiving grants under the new federal initiative aimed at testing promising community-based elder abuse prevention practices. The $1 million grant will be dispersed over a three year period. Kathleen Sebelius, the U.S. Secretary of Health and Human Services announced the grant at a meeting of the Elder Justice Coordinating Council in Washington, D.C. on October 10. Dr. Laura Mosqueda, the chair of U.C. Irvine’s Department of Family Medicine and the director of the geriatrics program, also spoke at the council meeting. Dr. Mosqueda was quoted as saying, “The sad fact is that about one of every two people with dementia is abused or neglected. This grant allows us to develop and evaluate a new model to reduce the risk of elder abuse.” Dr. Mosqueda went on to describe the fact that if you look at the abuse statistics and then also look at the fact that one out of every two people over 85 is diagnosed with dementia, then you will see how large the impact of this program can be. The Administration on Aging estimates that by 2030 one in five Americans will be over the age of 65; therefore, the impact of this grant will be even more important down the road.

As of September 2011, U.C. Irvine’s Program in Geriatrics was ranked among the top 50 in the country by U.S. News and World Report. As a result, the U.S. Administration on Aging designated it as the National Center on Elder Abuse. This means that U.C. Irvine’s program is a “clearinghouse” for practical information supporting federal, state, and local efforts to prevent, identify, and respond to instances of elder abuse.

The Center of Excellence on Elder Abuse and Neglect, U.C. Irvine’s geriatrics program, is seen as a pioneer in its efforts to raise awareness and reduce the incidence of elder abuse. It serves as both a national and international model for other programs. The center also operates as a “living laboratory” where new approaches to help eliminate various forms of elder abuse are implemented and measured for effectiveness.

The Takeaway

It is important to note the importance of developing new ways to identify and stop all forms of elder abuse. Individuals suffering from dementia represent an especially vulnerable segment of society. The numbers reported show a growing problem that will be exacerbated as the population ages. In 2030, when it is estimated that one in five Americans will be over the age of 65, it will be too late and the numbers will be too vast to try and apply band-aid solutions to the problem of elder abuse.

Individuals suffering from dementia are not only more susceptible to physical abuse and neglect, but they are also more susceptible to instances of financial fraud. That is another aspect of the problem not addressed by today’s announcement, but it is an important consideration. Individuals who currently look after elderly loved ones, friends or family, need to be aware of programs like the one at U.C. Irvine. People must be proactive with the care of elderly loved ones to protect them against all forms of abuse.

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Illinois Nursing Home Quarterly Violator’s Report: All Faith Pavilion

Yesterday we shared a story pulled from the latest list of “quarterly violators” as published by the Illinois Department of Public Health (IDPH). The list is a helpful way for interested local community members to jump into some of the reports by state officials into problematic incidents at assisted living facilities in our state. The sad reality is that incidents like these occur all the time throughout Illinois, and, much of the time, no one ever finds out about it. While state officials working with limited time and resources usually do the best job they can to address violations of quality of care standards, there is simply not enough oversight to ensure most troubling incidents result in significant action. Even then, the power to penalize those who provide substandard care is often limited. That is particuarly true when considering the resources of some of the largest long-term care facilities. A small fine that is fought against for months and often-reduced may have little deterrent effect forcing facilites to enact actual sustained changes that will limit misconduct on the future.

However, that is not to say that these instances of fines and violations aren’t important. At the very least they are a reminder to local community memebrs of the need to be vigiliant about misconduct against the elderly.

All Faith Pavilion Incident
According to the latest IDPH report, the All Faith Pavilion, based in Chicago, received notice of a Type “A” Violation late last spring. That also came with a conditional fine of $25,000. The violations stemmed from the facility’s failure to prevent a mentally and physically impaired resident from being sexually assaulted on at least two occassions over the course of a few months. This sort of violation is particuarly heartbreaking, because it symbolizes the extent to which so many residents are dependent upon caregivers for support and how their vulnerabilities can be taken advantage of in the worst way.

The IDPH report lists a string of problems connected to these instances of nursing home sexual assault. Not only did the facility fail to prevent the multiple attacks, but their response to the incident was haphazard and woefully lacking. In particuar, the nursing home officials did not notify the resident’s phyisican immediately after the incident so that she could receive appropriate care. As a result the resident was denied appropriate medical care for several days. Similarly, they did not properly notify law enforcement officials or state officials. Not unexpectedly considering this track record, the home also did not properly conduct its own investigation into the incident to determine what happened in a timely fashion.

Unfortuantely, this minimal response to serious incidents is indicative of the lack of priority some homes place on rooting out these problems. All too often when something like this happens the first repsonse of the caregivers is not to help those hurt and get to the bottom of the incident but to cover their own backs. Hiding instances of mistreatment and assuming that all mistakes are one-time events is a common theme in nursing home neglect cases. For this reason, it is critical to put constant pressure on these homes until they get the message that none of these incidents are acceptable. If it is beneficial to the facility’s bottom line for them to cover up mistakes, they are more likely to do so. Families must be vigilant about the care their loved ones receive so that faciliites are called out when they fail to act reasonably.

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Illinois Nursing Homes Quarterly Violators Report: Alden Wentworth Rehab

Recently, the Illinois Department of Public Health issued it’s “Quarterly Violator’s Report.” This report–viewed here–includes a list of various facilities across the state which have been cited for different violations over the past few months. Helpfully, the website includes access to the full reports from each of these incidents. In that way, intersted readers are able to delve more deeply into the details of the situation to understand what happened and learn about what incidents actually occur in facilities across the state each day. Of course, the citations issued here represent only a fraction of the actual problematic incidents that occur in Chicago assisted living facilities and similar homes throughout Illinois.

Latest Incident
This particular incident occured last spring at the Alden Wentworth Rehabilitation and Healthcare Center based in Chicago. It involved several “Type A” Violations and a conditional $20,000 fine. One of the underlying problems, according to the report, was a lack of communication by the facility between doctors at the nursing home and hosptial where a resident was discharged from. Attorneys working on neglect cases often see this type of negligence–those providing care do not share all pertinent information, and resident suffers as a result of bungled treatment.

In this situation, instructions from the hosptial to the nursing home were explicit. They noted that the resident was not to receive narcotics upon moving to the long-term care facility. However, those instructions were not passed on to or heeded by the attending physician at the long-term care facility. As a result, contrary to explicit medical orders, the resident received narcotics. This lasted for three weeks before the resident died. The resident’s death certificate listed narcotic intoxication as a cause.

The doctor and the hosptial explained that he recalled the exact order, noting that the patient could receive pain medication, just not narcotics–he had a history of drug abuse. Common narcotic pain medications include fentanyl (often in patch form) and Vicodin. However, a nurse at the nursing home admitted that she did not explain those instructions to the nursing home doctor. As a result of the communication error, the resident was given a Fentanly patch which also contributed to his death.

This incident, and the many like it, is a reminder of the fact that serious injury and even death often result from simple oversights and mistakes by caregivers. When discussing the poor conditions in so many homes there may be a tendency to assume that critiques are all related to gross recklessness or intentional abuse. But those incidents are more the exception. On the other hand, basic neglect, like communicaton errors that lead to medication mistakes, are quite common. Considering the fragility of many seniors at these facilities, even simple mistakes threaten lives. It is for that reason that we must keep pressure on facilities to improve. Allowing basic neglect without real pressure to change means that lives will be lost unnecessarily in the future.

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First Illinois Diagnosis In Fungal Meningitis Outbreak

The fungal meningitis outbreak got a little closer to home this weekend, as the first case of an Illinois resident developing the infection was reported. This is a sad reminder of the need for all residents who may have been infected by this situation, including many seniors, to act quickly to ensure their health and protect their legal rights.

According to the latest reports from NBC News, the total number of patients who have developed fungal meningitis in the latest outbreak is 197. At least 15 patients have died as a result of the serious ailment. All of the cases have thus far been traced back to a pharmaceutical compounding plant in New England. The plant made various medications which were sent to many state across the country, including Illinois. So far at least 13 states have reported cases of patients developing fungal meningitis as a result of the outbreak. In Illinois, those who visited one of three APAC clinics over the past few months are most at risk of developing the problem. According to the Illinois Department of Public Health, those three clinics which received the contaminated spinal steroid injections include the APAC facility in Westchester, APAC in Lincoln Park, and at the Thorek Memorial Hospital.

Seniors are often more vulnerable to all sorts of medical outbreaks, because, at times, their bodies are less efficient at fighting back bodily invaders–like a fungal infection. Of course it is critical for all those at risk in this situation to get appropriate medical treatment, but seniors are always at significant risk because ailments that might be beaten by a younger individual could prove more serious to the elderly.

In this case, the CDC explains that the most common symptoms of the condition include: stiffness in the neck, headache, fever, skin irritation at the injection site, slurred speech, dizziness, and weakness. Any residents experiencing some of these symptoms are urged to act prudently to get appropriate medical help. It is critical for residents to appreciate that even if they received the injection a few months ago, the symptoms might not develop until later. Experts explain that the fungal meningitis often does not show up until later, and even then, the initial symptoms are often very subtle. It is usually only until some times has passed that real problems develop. For this reason the CDC expects more cases of the meningitis to show up in the coming days and weeks.

As investigators continue to look into the cause of the outbreak they have identified various problems at the facility. For one thing, this is not the first time that allegations have come in involving meningitis infection from the products made by the company. In addition, the plant may have been working beyond the scope of its license–a clear violation of state (and potentially federal) rules.

Meningitis Help in Illinois
Our lawyers are investigating this particular outbreak and are working with all those affected. We have significant experience working on cases of professional negligence, including many in the medical field. Please take a moment to call our office if you or a loved one many have been affected by this case. There is no obligation and no cost to the call. Considering the nature of this outbreak, it is likely that some negligence and problematic conduct was involved which might result in compensation for those affected.

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