Meningitis Outbreak Patients Face Large Medical Bills

For the victims of the fungal meningitis outbreak of last year, the suffering has yet to end. 

In addition to suffering from a painful and life-threatening illness, the victims of the meningitis outbreak have one more hurdle to jump: massive medical bills.

It was reported that many sufferers of the fungal meningitis outbreak that was the result of contaminated vials of injectable steroid have to sort through medical bills for medications and treatments that their insurers do not cover, such as MRIs that will detect if there are any spinal complications. Some of the powerful antifungal drugs were charged at $8000 per injection. Some patients needed up to three such shots per day.

The bills range from a few thousand dollars to more than $200,000. There are many lawsuits against the compounding pharmacy (New England Compounding Center) that manufactured and distributed the medication, but since the pharmacy declared bankruptcy, those lawsuits have been delayed for an indeterminate period of time. In the meantime, patients must struggle to cope with bills that they are far from able to afford.

Many of the patients aren’t out of the woods yet. Many still suffer from debilitating pain and lingering infections.

At St. Thomas Health, a Tennessee hospital and neurosurgical center that is treating many of the fungal meningitis victims, representatives say that they are working with patients and their insurers to offset some of the financial burden of the extensive treatments. However, since the medical center also administered the tainted epidural shots, it is the belief of many of the attorneys that the hospital should bear all of the responsibility. According to attorney Mark Chalos, “For the people who got sick from tainted injections at St. Thomas, St. Thomas is now charging tens of thousands of dollars to treat them.” Mr. Chalos contends that the medical center purchased inferior compounded medications at $6.60 per dose, and charged $1000; sometimes more.

The home care bills for many of the victims can exceed $7000 monthly. The antifungal treatments cause significant fatigue and hallucinations, even after treatments have stopped, since the medications take awhile to exit the system. Many patients continually suffer from severe back pain that renders them unable to drive or even care for themselves.

One patient, Amarjit Deol, who was admitted to the hospital after suffering partial blindness, loss of motor function and severe pain, was told she wasn’t allowed to leave until she paid the $950 for medications she would need for aftercare. Only after she negotiated a payment of approximately one third of the bill was she released.

To add insult to injury, Mrs. Deol received a letter from Medicare stating that it would recover the costs of the payments if she won any award from a claim against the compounding pharmacy or the medical center from which she received her epidural injections. To date, she has not even filed any lawsuits.[1]

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[1] Roche, Walter: Many Meningitis Victims Owe Tens of Thousands in Bills USA Today 4/3/2013 http://www.usatoday.com/story/news/nation/2013/04/03/fungal-meningitis-costs/2048843/

Epidural Steroid Injections Could Cause More Harm Than Good

For many with chronic back pain, epidural injections are the only reliable source of relief.  However, a recently published study suggests that consistent administrations of steroid could result in more harm than good.  In the following article, Dr. Michael Omidi discusses the study, as well as the possible complications that could arise from the steroid treatments.

The recent fungal meningitis outbreak was caused by a tainted batch of injectable steroids (methylprednisolone acetate) meant for the treatment of chronic back pain. Now, according to a new study, it seems that the back problems that the steroid was meant to relieve might actually be made worse by the epidural injections [1].

In a study that was recently published in the journal Spine, a group of physicians followed 276 patients from the ages of 53-75 with more or less similar degrees of chronic back pain for four years. Of the 276 subjects, 69 received epidural steroid injections as a part of pain management therapy, while the remaining 207 did not. The authors of the study expected to see a wider variation of painful symptoms in the subjects who had not had epidural injections versus those who did. Instead, it seems that the subjects that underwent epidural injections displayed considerably less improvement after corrective surgical procedures than those who did not. 

The study was too small to draw any concrete conclusions, but it does seem that the steroid injections might hamper the healing process post surgery.

The subjects were all suffering from spinal stenosis, a condition wherein the open spaces within the spine gradually narrow, putting pressure on the spinal cord and causing sometimes extreme pain. The steroid injections ease the pain temporarily by surrounding the conflicted nerves.

Because spinal stenosis is a degenerative condition, the addition of the steroids may facilitate that degeneration, making the prognosis after surgery more grave than if the treatment was never administered.

Epidural injections are only recommended for patients who suffer from crippling back pain that may also spread to the arms, legs and head. These injections are not meant to cure the condition; only to make the symptoms more bearable. However, it is estimated that only approximately half of all the patients who receive epidural injections for treatment of back pain derive significant pain relief.

It should be noted that steroid injections should be viewed as a last resort in the event that other physical therapies and medications prove ineffective.

The injectable steroid used in such epidural injections that caused the fungal meningitis outbreak was methylprednisolone acetate, a steroid that was obtained through compounding pharmacies because FDA-regulated drug manufacturers do not make a version of the drug without preservatives.  The compounding pharmacy that was responsible for the contamination of the drug that was distributed to thousands of clinics throughout the nation has since declared bankruptcy.

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[1] Bakalar, Nicholas: Back Pain Unrelieved By Steroid Shots New York Times 3/5/2013 http://well.blogs.nytimes.com/2013/03/05/back-pain-unrelieved-by-steroid-shots/?ref=health

Facilitating Full Recovery after Fungal Meningitis

Unfortunately, people who have recovered from fungal meningitis are not out of the woods just yet; full recovery can take anywhere from six months to a full year – and that is without additional infections. In the following article, Dr. Michael Omidi discusses how to care for oneself, how to facilitate full recovery, and what symptoms to watch out for.

When the fungal meningitis outbreak first hit, it was estimated that patients exposed to the tainted steroid who hadn’t developed symptoms of fungal meningitis would be in the clear, so to speak, if they continued to by symptom-free by mid January. However, different medical experts have produced different timelines, and some believe that it is very possible to still come down with the potentially deadly illness even today.

Fungal meningitis is an especially virulent strain of meningitis that is difficult to treat. The medications that have proved effective unfortunately also trigger severe side effects, so they are not ideal for older people or people with compromised immune systems. Long term exposure to the anti-fungal drugs can actually cause kidney damage. The people who were exposed to this illness were people who were receiving treatments for chronic back pain, many of whom were older persons that are less capable of tolerating or warding off potential complications.[1]

If you have been exposed to fungal meningitis through exposure to the tainted batch of steroids, make sure you visit your doctor if you experience persistent headaches, back pain, leg pain, confusion, neck stiffness, pain, or nausea.

Treatments for fungal meningitis are long and arduous; they require more or less constant monitoring and administration of anti-fungal medications. Additionally, there are other medical complications that can arise, namely epidural abscesses and arachnoiditis.

Epidural abscesses are inflammations near the site of the epidural injection and are often undetectable since they are far below the surface of the skin. Patients often can’t distinguish pain caused by the abscess from the pain caused by meningitis. These abscesses can cause severe pain and limited mobility and they must be drained. Dead tissue must be removed surgically and months of anti-fungal medications must be administered in order to clear the infection.

Arachnoiditis is a serious, chronic neurological condition caused by trauma or infection of the arachnoid, a membrane surrounding the spinal column. Patients with arachnoiditis are often in constant pain and unable to stand or sit for long periods of time, in some cases even experiencing incontinence. There is no cure for arachnoiditis; patients must undergo consistent pain management therapy and treatment.

If you are recovering from fungal meningitis, make sure you continue taking your medications exactly as your physician instructed. Try your best to avoid further infections from other sources; wash your hands regularly and keep your countertops and surfaces clean and sterilized. If you can’t detect any improvement or your medications don’t seem to be having any effect, see your doctor immediately.  If you become confused, develop seizures or a fever, or it becomes difficult for you to be roused from sleep, call 911.

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[1] Goodman, Brenda: Fungal Meningitis Patients: A Long Road to Recovery WebMD 12/26/2012 http://www.webmd.com/news/20121226/fungal-meningitis-victims-recovery

Michael Omidi on Alternatives to Epidural Injections

Amount of Fungal Meningitis Victims Still on Rise

Unfortunately, the number of new victims in the recent fungal meningitis outbreak has not stopped growing. It was reported recently that North Jersey has had its first recorded case of meningitis that has resulted from the contaminated batch of steroids compounded from the New England Compounding Center. One fungal meningitis death was reported in Indiana (bringing the total deaths in Indiana from fungal meningitis to 7), and two in Maryland. Many of the patients that received the contaminated injections had them administered at pain clinics—facilities that specialize in providing relief for chronic back pain. One has to wonder if this outbreak has caused any practitioners of pain management to rethink epidural injections as an elective procedure.

Two Confirmed Cases of Fungal Meningitis in New Jersey

Thus far, New Jersey has two confirmed cases of fungal meningitis from the tainted batch of compounded drugs, but no deaths. Tennessee has the highest number of deaths of any state affected by the contaminated steroids.

New Jersey Reported Cases Could Increase

Both of the New Jersey patients received epidural injections in late September. It can take several months for the symptoms of fungal meningitis to become apparent, so there still might be cases yet to develop, although as time progresses, the risk that new infections will emerge will get lower. Mold infections tend to grow slowly, and incubation periods vary, with infected patients typically showing signs a few weeks post exposure.

Fungal Meningitis is a SEVERE Condition

Fungal meningitis is a potentially life threatening condition that requires immediate medical intervention. Patients who do not seek treatment at the first signs of infection risk permanent neurological damage and even death.

This medical catastrophe was caused by mold growth in a batch of poorly maintained steroid medications, but patients seeking relief from back pain should be aware that epidural injections—even pure injections—pose a risk for severe complications. Any injection near the spine can lead to serious infections such as arachnoiditis, which is a chronic condition that can cause persistent back pain, trouble standing and sitting, incontinence and even paralysis. While physicians are always careful about injecting medications close to the spine, mistakes can be made; the needle can slip and puncture the spine, and the injection site can be vulnerable to epidural abscesses, which are difficult to diagnose or detect since they are relatively deep below the skin.

While chronic back pain can be debilitating, with the pain even migrating to the head, arms and legs, it is critically important to explore multiple options for therapy before agreeing to submit to epidural steroid injections. There are numerous forms of physical therapy that produce wonderful results. Degenerated or herniated discs do cause a small percentage of chronic back pain or sciatica. However, in many cases, lower back pain is the result of slack core muscles. When certain muscle groups lack the strength to support the back, the muscles that are burdened with the bulk of the work become strained, causing acute pain. If at all possible, if you suffer from lower back pain, try to get more than one opinion on the best course of treatment before making a final decision.

Dr. Michael Omidi on Meningitis Filed Lawsuits

50 Federal Lawsuits Have Been Filed Against NECC

It was recently announced that approximately 50 federal lawsuits have been filed against the New England Compounding Center, the compounding pharmacy that fabricated and distributed the tainted steroids. The lawsuits have been filed in nine states.

The fungal meningitis outbreak was a medical catastrophe. The sickness and death that resulted from the New England compounding pharmacy has caused the FDA to look at compounding pharmacy practices very closely, and discover that other facilities, including Ameridose, distributed tainted medications to hospitals and clinics, although no resulting sicknesses have been reported.

NECC responsible for 590 Patients

The lawsuits charge that the New England Compounding Center (NECC), through its negligence, caused the death and/or illness of 590 patients. The suits seek millions of dollars in damages for wrongful death, pain and suffering, emotional distress and lost wages.

NECC Surrenders Pharmacy License

Since the outbreak, NECC has surrendered its pharmacy licenses, recalled all products, laid off all employees. Although NECC had liability insurance, it is uncertain if the policies would cover damages of this magnitude. Because it is very likely that NECC will not have adequate funding to support the potential compensation, several of the lawsuits have included additional defendants, including the marketing firm Medical Sales Management, the sister company Ameridose, and NECC co-founders Barry Cadden and Greg Conigliaro.

It is speculated that there might be numerous lawsuits to follow, and physicians, nurses, hospitals, medical clinics and those who physically handled the drug vials might be sued. Since the contamination was so severe that it could be seen with the naked eye, anyone who was associated with the medical centers that administered the drugs could be liable for not reporting that the contents of the vials were clearly tainted.

Full Scope of Damage Could Take Years

The discovery phase—the gathering and review of evidence and depositions—could take years. Moreover, the full scope of the medical emergency might not be fully appreciated; more potential victims could yet be discovered. It was reported recently that several patients in states that have not yet recorded incidences of fungal meningitis have developed severe meningitis-like symptoms. However, these cases have not been diagnosed because doctors had not been able to find traces of fungus in the patients’ spinal fluid, although at least one of the patient’s symptoms caused sufficient alarm to necessitate antifungal medications to be prescribed.

The debilitating physical symptoms of fungal meningitis would legitimately render the patient unable to work. A patient infected with fungal meningitis would suffer from persistent headaches, nausea, backaches, blurred vision, dizziness and speech troubles. One diagnosed, a patient would have to be under constant medical supervision while the appropriate medications were administered, and recovery time can take weeks.

Dr. Michael Omidi on New Meningitis Related Illnesses

Cases of Infection on Rise in Tennessee and Michigan

Cases of infections resulting from the tainted steroids from the New England Compounding Center appear to be on the rise, according to health officials in Tennessee and Michigan.

The new infections aren’t fungal meningitis, but epidural abscesses—collections of pus on the bones of the scull or the spine that can lead to fungal meningitis if left untreated. There have been 37 new cases of abscesses in Michigan and 23 in Tennessee.

Although health officials stress that these abscesses aren’t life threatening, they can potentially cause serious problems, like chronic back pain, incontinence, an abscess on the spinal cord itself and bone infections.

Fortunately, because the Tennessee and Michigan patients who have received the epidural injections of contaminated steroid were under more or less constant medical supervision, these abscesses were detected early, so the prognosis is generally positive. However, epidural abscesses are difficult to detect with the naked eye at the early stages. Symptoms of spinal epidural abscesses are bladder and bowel incontinence, back pain, fever, weakness and difficulty moving a particular part of the body (depending upon where the abscess is located.)

Majority of Cases Detected Early

The cases of potential complications and infections are more difficult to predict in other regions of the United States, however, because it is widely believed that the number of patients who have been exposed to the potentially deadly fungal infection is greater that what is being counted. Certain patients in California who had received epidural steroid injections from NECC were notified that they could potentially be infected with fungal meningitis, but there hasn’t been any follow up. People who have not experienced symptoms of fungal meningitis were not as closely monitored as those who have, and might therefore be at risk of developing complications from epidural abscesses.

Medical Community and CDC not Counting Many Cases

Patients from several states, including California, which did not report any fungal meningitis infections, are claiming that the medical community and the Center for Disease Control are not counting them as official cases. The National Research Center for Women and Families believes that there are many more cases of infection stemming from the tainted drugs, but they are, for whatever reason, going undocumented.

New Infections not Classified as Medical Emergency

The new infections appear to be outside of the central nervous system, and aren’t classified as a medical emergency the way fungal meningitis is. What is worrying to most health officials is the fact that fungal meningitis could develop from the abscesses. According to the Tennessee health department commissioner John Dreyzehner, “We indeed could have a second wave of meningitis for some people. The medical community can't tell you with precision when the risk ends.”

Meningitis Symptoms and Treatments

500 Confirmed Cases and 40 Deaths Now Reported

Health officials are only just beginning to get an idea of the scope of meningitis outbreak. There have been more than 500 confirmed cases and close to 40 deaths, and that isn’t even counting the patients with meningitis symptoms who, while having been injected with medications from New England Compounding Pharmacy, haven’t been injected with the methylprednisolone acetate, which was the drug that was verified to have been contaminated.

Symptoms for fungal meningitis are the same as the symptoms for bacterial or viral meningitis, the more common forms of infection. Fungal meningitis occurs when one of several types of fungus gets into the bloodstream and attacks the spinal cord (the recipients of the tainted steroid were especially vulnerable, since the fungus was being injected next to their spinal cords). It cannot be transmitted from person to person, but ingesting fungus spores in the atmosphere, or working with infected soil can lead to fungal meningitis. People with compromised immune systems are susceptible to fungal meningitis.

What is Fungal Meningitis

Fungal meningitis is the inflammation of the spinal cord lining and the brain; the fungus travels up the spinal cord via the spinal fluid and settles in the brain, which has almost no defense mechanisms. Symptoms of fungal meningitis include headaches, stiff necks, fever, light sensitivity, weakness and nausea. Fungal meningitis can also cause blood clots and lead to stroke. Many of the patients who contracted fungal meningitis from the tainted drug supply died from stroke, making the diagnosis difficult, since doctors don’t often test for additional medical disorders when a patient succumbs to stroke.

Confirming Fungal Meningitis and Treatments

The only way of confirming that the infection is fungal meningitis with any degree of certainty is by spinal tap or lumbar puncture, where a sample of spinal fluid is extracted and tested for the presence of fungus. Because fungal meningitis is so rare, there aren’t as many efficient treatments for the disease as there are for bacterial and viral meningitis (viral meningitis often doesn’t even require medications). Treatments are administered intravenously, and can often take a month or longer to effectively kill the fungal infection. These treatments must also be given in a hospital setting so that a physician can monitor the patient. The drugs, voriconazole and amphotericin B, can cause damage to the liver and kidneys.

Unfortunately, the fungal meningitis symptoms start off so slowly that infected patients might not feel the need to seek medical attention until the infection has taken aggressive hold (some of the symptoms are similar to migraine headaches). It is important that anyone who has had injections of any kind from the New England Compounding Pharmacy (especially those who have even mild symptoms) get tested for the onset of fungal meningitis.

Meningitis Epidural Shot Risks

Epidural Steroid Injections

Unfortunately, fungal meningitis hasn’t been the only condition that has resulted from the tainted batch of compounded medications from the New England Compounding Center, and it isn’t the first that has arisen from the practice of injecting steroids near the spinal column. Physicians are of differing opinions about whether the use of epidural steroid injections is ethical or even safe, and the recent health crisis is causing many regulatory bodies to look more closely at the practice.

Risks of Epidural Steroid Injections

Although steroid injections are approved for pain relief in joints, epidural injections of steroids aren’t endorsed by the FDA. However, it is common practice for physicians to recommend or use drug treatments that are not specifically intended for a particular purpose, and many patients report significant or total relief from crippling back pain, which sometimes spreads into the arms and legs. It is generally believed that epidural injections are safer than surgery or even drug treatments, which can lead to prescription pain medication addiction. Nevertheless, performing injections near the spinal column is a very tricky business; the physician risks causing permanent nerve damage, depriving the site of oxygen and even injecting the drug directly into the spinal fluid. There have been cases of chronic complications, including arachnoiditis (an inflammation of the membrane of the spinal column that leads to numbness, incontinence, sexual dysfunction and even paralysis) and even death.

Sufferers of chronic and debilitating back pain due to herniated discs are considered the appropriate recipients of epidural steroid injections, but a study in 2007 revealed that they make up less than half of the patients who receive this treatment. According to Dr. Laxmaiah Manchikanti, chairman of the International Society of Interventional Pain Physicians, only 20 percent of doctors performing this procedure have received the appropriate training.

Financial Incentive for Performing Epidural Steroid Injections

There might also be a financial incentive to perform these treatments as well. Medical insurers and Medicaid pay sometimes hundreds of dollars per injection, and there are clinics around the nation that are devoted to exclusively providing epidural steroid injections for back pain management.

It is believed by many physicians that steroids that are free of preservatives are less risky to patients than their counterparts. However, because preservative-free epidural steroid injections are not manufactured by drug companies, clinics and physicians must use compounded drugs, which are not heavily regulated and, as we have seen with the recent meningitis and tainted drug crisis, are vulnerable to contamination.

Sufferers of chronic back pain should seek multiple opinions on the best treatment course, and only submit to epidural injections after different therapies have been exhausted. The potential complications from epidural injections are scary, to say the least, it should be noted that they occur in only one in 10,000 cases, according to Dr. James P. Rathmell, who is involved in an FDA review of catastrophic neurological damage from injections.

Physician reported to state health department about tainted batches of steroids months ago

Several months ago, a physician made her state health department aware of a tainted batch of methylprednisolone acetate, a steroid that is injected near the spinal column in order to treat some forms of chronic back pain, which seemed to be causing a violent form of fungal meningitis. This fungus was highly resistant to conventional forms of treatment, and finds the brain tissue the most hospitable environment, since the brain has low resistance to infection. Samples of the fungus have been difficult to detect in the infected patients; the most common and accurate method of detection has been extracting and testing spinal fluid. So what is this fungus, and how did it get into these medications?

Exserohilum rostratum: Cause of Infections

The fungus that caused these infections is called Exserohilum rostratum. It is highly resistant to the drug treatments, and because it is a pathogen that normally feeds on plant matter, it hasn’t received much research. It exists primarily in tropical and sub-tropical regions, but even though the laboratory was in New England, the messy environment would still be inviting to the fungus, which is airborne, and can travel in the winds from southern regions during the warmer months.

E. rostratum primarily attacks grasses. Plants have natural defensive mechanisms in place to keep the fungus from totally destroying them, but they cannot kill it outright. The fungus is like a vulture; it exists on plants and waits until the plant dies before it feeds on the remains. It can multiply very quickly; a colony can develop from a single spore in as little as two days.

What caused the meningitis outbreak?

While E. rostratum is almost never the cause of eye or sinus infections, there are increasing examples of this spore, and others related to it, causing more soft tissue infections than had ever been previously seen. Nevertheless, when the fungus was injected directly into the spinal column, it was easily carried by the spinal fluid—a nutritious and comfortable environment for the spores—into the brain, where it may have caused the strokes that killed some of the infected patients.

The sloppy conditions in which the medications were compounded would have been a welcoming environment for the spores, which can accumulate on lawn clippings and launch themselves into the air via a natural static electricity-based ejection mechanism. The fact that they got into the vials of medication isn’t surprising, under the circumstances, but why did they only contaminate some of the batches and not all of them? It is speculated that the spores were blown into the air from a nearby source on only one windy day, but no one yet knows the exact cause.

Fungal Meningitis: Dr. Pettit discuses her patients story

In September of this year, a patient with an unusually virulent case of meningitis came to the attention of Dr. April Pettit. After having been administered antibiotics, the usual treatment for bacterial meningitis, this patient did not seem to be getting better; in fact, he was steadily deteriorating. Unsure of the kind of strain she was dealing with, Dr. Pettit sent a sample of the patient’s spinal fluid for testing. The results were surprising, to say the least.

Test Results: Fungal Meningitis

The lab reported that the meningitis was of the fungal variety. Fungal meningitis is not transmissible from person to person, and is extremely difficult to diagnose; fungal meningitis can trigger strokes, and physicians do not necessarily examine stroke patients for infections. Dr. Pettit asked the patient’s family (the patient was, by now, too weak to speak)if he had received an injection for chronic back pain into his spine. Dr. Pettit immediately called the state health department with this information.

Spinal Steroid Injections Contaminated

Spinal steroid injections for treatment of back pain are a common practice; millions of people undergo this procedure every year. The steroid medication in question, methylprednisolone acetate, was contaminated in the compounding pharmacy from which it originated. Compounding pharmacies are laboratories that prepare drug solutions for clinics and hospitals. These facilities commonly mix different drugs in accordance with a particular physician’s prescriptions. These solutions are not necessarily meant for large scale consumption, but nevertheless, many compounding pharmacies mix large batches of drugs that are, in turn, purchased by hospitals and clinics. These solutions are not regulated by the Food and Drug Administration, and compounding pharmacies do not have to adhere to the same rigorous safety regulations as do regular drug manufacturing companies. These compounding pharmacies open sterile vials of drugs from the manufacturer and mix them with other solutions or repackage them in smaller doses, leaving them vulnerable to contamination. Injectable medications must be mixed in sterile conditions—the surrounding air must be sterilized as well as the surfaces—since the body cannot fight off infections introduced directly into the circulatory system as efficiently as it can through the gastrointestinal tract.

Why Hospitals Purchase from Compounding Facilities

Why would hospitals purchase large batches of unregulated, dubious drugs? Perhaps because these compounded drugs are often cheaper than the pharmaceuticals from large drug companies, or because these specialty drugs are otherwise difficult to obtain. Whatever the reasons may be, compounding is meant to be for a specific patient’s needs, not a one-size-fits-all practice.

So contaminated "it could be seen with the naked eye"

When the vials of methylprednisolone acetate were examined, the fungal contamination was so virulent it could be seen with the naked eye. Before the outbreak was discovered, more than 17,000 vials of contaminated methylprednisolone acetate were shipped to clinics and hospitals in 23 states. To date, 32 people have died as a result of exposure to the contaminated drug, including Dr. April Pettit’s patient.