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/

No Link Between Meningitis Outbreak in New York and Los Angeles Say Health Officials

Concern has been raised over possible meningitis outbreaks in Los Angeles and New York City, but health officials are stating that there is no connection between them. 

There have been concerns raised between a meningitis outbreak that has occurred in New York, infecting as many as two dozen people and resulting in the deaths of seven, and a death caused by meningitis in LA County. A recent press release from Los Angeles County Department of Public Health has announced the findings of its investigation into the death of Brett Shaad who passed away as a result of meningococcal meningitis. The findings stated that Public Health "has not identified any other cases of meningococcal disease associated with this patient nor identified any linkage between this patient and cases being reported in other areas of the country."

The primary concern was the possible link between an outbreak in Los Angeles and the meningitis outbreak in New York City that has claimed the lives of seven men over the last two years.

The possibility of an outbreak in Los Angeles led to groups, and eventually local health officials, providing residents with meningitis vaccines. City Councilman John Duran and the AIDS Healthcare Foundation strongly urged for vaccination, which was provided to over 3,000 people during the initiative.

For those concerned about contracting meningitis in Los Angeles or New York City you can learn more about the issue in this NBC News article.

New Jersey Pharmacy Recalls Drugs Due to Mold

Similar to the events of the fungal meningitis outbreak of September 2012, a compounding pharmacy has recalled a number of drugs due to mold contamination. Michael Omidi examines the recall and the reasons behind it.

A compounding pharmacy in New Jersey, Med Prep Consulting Inc., recently announced a recall of their products including drugs utilized in surgeries and labor as well as pain relievers and antibiotics, leading the United States Food and Drug Administration (FDA) to issue warnings to medical and healthcare professionals.

The recall is not a result of illnesses being reported as in the case of the fungal meningitis outbreak caused by products from the New England Compounding Center, but there is concern from the FDA that the mold contamination found in the products could result in illness for patients. The FDA is currently working with health officials in the states of New Jersey and Connecticut to isolate any potential contamination.

The products that are being recalled are used for those that are hospitalized inpatient or outpatient and are only provided by trained healthcare professionals at facilities, practices, or clinics. None of the products are directly released to patients for at-home use or self-administration.


All of the facilities that have received the products believed to be contaminated have been notified and a full list of the products that have been recalled can be found in a press release from Med Prep on the FDA website. 

Controversy in Culpability Surrounding Meningitis Outbreak

Because the fungal meningitis outbreak was so catastrophic in terms of lives lost and pain needlessly suffered, it was only a matter of time before survivors began to seek remuneration from the parties responsible. Not only are the owners of the compounding pharmacy being sued, many of the physicians who administered the tainted shots are also facing litigation.

While it cannot be denied that the blame for the fungal meningitis disaster lays at the feet of a compounding pharmacy that flouted not only governmental regulations, but also basic pharmaceutical practices of health, safety and due diligence, many patients are nonetheless beginning to wonder if the clinics that administered the tainted shots shouldn’t bear some responsibility as well.

The entire matter is extremely delicate. While it is true that the New England Compounding Center was woefully inept at maintaining an environment suitable for the production of an extremely delicate and difficult to manufacture drug, the Massachusetts regulatory boards did little, if anything to oversee or police their practices. The NECC was inspected several times by the FDA as well as state board officials, who issued warnings and concerns that were completely ignored, and yet the regulatory bodies did nothing to follow up on those warnings, leaving thousands of patients in jeopardy.

One of the main reasons compounding pharmacies distribute so many vials of epidural steroid is because many physicians believe in the studies that report of the dangers of using injectable drugs that contain preservatives. While there are many conflicting studies regarding the potential hazards of preservatives in injectable applications, the crux of the objection to the commonly used pharmaceutical preservatives is that they may trigger outbreaks of arachnoiditis, an incurable inflammation of the arachnoid membrane which surrounds the spinal column. This condition is painful, chronic, has debilitating side effects, and requires more or less constant pain management therapy and treatment. Injectable steroids that do not contain preservatives can only be obtained through compounding pharmacies, not FDA regulated drug companies.

The lack of chemical preservatives, however, leaves these drugs extremely vulnerable to bacterial and fungal contamination. If improperly stored, these vials of medicines can turn into a breeding ground for all types of microbes. As we have seen, this can have disastrous consequences.

It has been reported that the injectable steroids that were distributed from the NECC were so contaminated that matter could be seen in the vials with the naked eye. If this was the case, is it then possible that the physicians who continued to use these obviously problematic drugs could then be partially culpable for the fungal meningitis outbreak?

Perhaps there is enough blame to go around. Unfortunately for the victims, the NECC, having declared bankruptcy, simply does not have the money to compensate the victims adequately, and legal experts have clearly advised their clients to seek compensation where they can: from the physicians and medical centers.

It is impossible to know the extent of the culpability of the individual doctors and treatment centers. If it can be proven that these drugs were administered even after it was suspected that there could be something wrong with them, then perhaps the victims have a point. However, for doctors acting in good faith with the sincere desire to alleviate the pain and suffering of their patients, it would be unfortunate to be painted with the same brush as a negligent compounding pharmacy.

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.

Spinal Epidural Abscesses - Meningitis Outbreak

Outbreak of a Virulent Strain of Meningitis

The outbreak of a virulent strain of meningitis due to a tainted supply of steroids was only one of the illnesses in what has become a national health crisis.

Many patients have complained of swelling and pain at the epidural injection site, even after the meningitis symptoms have cleared up. It appears that epidural abscesses have formed on some patients, even after having taken powerful antifungal medications. Epidural abscesses form under the skin; they can only diagnosed with certainty using an MRI. Some cases can be cleared with drug treatments, others require surgical intervention.

Spinal Epidural abscess

An epidural abscess is the collection of pus that can be found either in the skull or alongside the spinal column. Spinal epidural abscesses are typically caused by bacteria, but can also be due to fungal infections, or result from a spinal trauma or surgery. Patients with epidural abscesses typically experience neck or back pain, fever, difficulty with urination or bowel and bladder incontinence.

While it is possible to recover completely from an epidural abscess, it can return even after aggressive treatment. If left untreated, permanent nervous system damage could occur, and even paralysis or death.

The black fungus that infected more than 500 patients nationwide and killed nearly 40 was so prevalent in the vials of medication that it could be seen with the naked eye. The epidural injections left patients vulnerable to conditions such as meningitis, arachnoiditis and epidural abscesses because the slightest slip of the needle could have sent the fungus into the spinal column, which is a welcoming environment for fungus due to the temperature and the nutrient content. The fungus would then be carried in the spinal fluid up to the brain, which has very limited defense mechanisms against infection.

While meningitis was the most common infection resulting from the contaminated drug, there have been a few cases of epidural abscesses without accompanying meningitis. Unfortunately, fungal epidural abscesses are fairly rare, and many hospitals have very little or no experience treating them. While some abscesses can be surgically removed, others are wrapped around delicate nerves and cannot be extracted. Some patients have multiple epidural abscesses.

Patients who have received or are receiving treatment for fungal meningitis must continue to receive evaluations by their physicians for additional infections and complications, even well after the infection appears to have cleared up. It is critically important to address epidural abscesses immediately, before nerve damage sets in that could be irreversible.

Unregulated Compounding Pharmacies

Sometimes, tragedy has to strike before action is taken

For the past two decades, the United States congress has been pressured to enact regulations on compounding pharmacies that act as manufacturers of specialty medications. Rather than submitting to the same regulations as standard drug manufacturers, compounding pharmacies were not seen as “manufacturers,” even though they were creating pharmaceuticals for distribution to medical facilities.

How is it different? Both manufacturers and compounding pharmacies are supplying medications to the public for consumption. However, compounding pharmacies are not supposed to be making large batches of medications and distributing them as substitutions for FDA approved pharmaceuticals—and yet, that is exactly what these pharmacies were doing.

Unregulated Compounding Pharmacies

Before the deadly meningitis outbreak, before it became clear that numerous unregulated compounding pharmacies were operating under questionable and, sometimes, downright unsanitary conditions, compounded medications were seen as a perfectly legitimate and less expensive alternative to standard brand-name drugs. Many members of congress and several advocacy groups touted compounding pharmacies as a trustworthy alternative to big drug companies. During drug shortages, compounding pharmacies were often called upon to mix alternative versions of needed medications. As the practice became more commonplace, and the option of cheaper and easily accessible compounded drugs became more enticing, compounding pharmacies became small-scale manufacturers. Eventually, they were accused of copying legitimately manufactured drugs and distributing them cheaply. The reason for the disparity in price was due to the fact that compounding pharmacies use ingredients from unapproved sources.

There have been previous examples of contaminated or dubious medications from compounding pharmacies; a compounding pharmacy in South Carolina was responsible for several illnesses and one death from a batch of contaminated medication; in 2001, the FDA examined samples from 12 different pharmacies and discovered that 30% did not pass quality tests.

Because compounding pharmacies are not under the jurisdiction of the FDA, the FDA has no power to regulate them. State boards of health are responsible for policing them, but often choose not to; only two states—Texas and Missouri—issue random tests of compounded drugs. The only way a compounding pharmacy is made to follow FDA regulations is if that pharmacy is found to be manufacturing drugs. The only way the FDA can determine whether or not a pharmacy is manufacturing drugs is to look at records of the volume of compounded drugs shipped, which the pharmacies insist that the federal government has no right to do. In fact, often the only way the FDA even becomes aware of tainted products from compounding pharmacies is to read about pharmaceutical related illnesses in the news, or if the victims report to them directly. Unlike drug manufacturers, compounding pharmacies are not obligated to report instances of product causing patients harm.

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.

Dr Michael Omidi on Meningitis Outbreak

Dr Michael Omidi Discusses the Recent Meningitis Outbreak, as well as other illnesses that are now being linked to contaminated infections

The recent meningitis outbreak was the one of the biggest health disasters ever caused by a tainted drug. To date, more than 400 people have been infected, and 32 have died. Unfortunately, it seems that meningitis is not the only dangerous illness caused by the contaminated steroid injections; many patients are now suffering from epidural abscesses and arachnoiditis, even though the fungal meningitis seemed to be under control.

Epidural Abscesses and Arachnoiditis Linked to Contaminated Steroid Injections

Epidural abscesses are pus-filled inflammations of the spine or bones of the skull. These abscesses can be caused by bacterial or fungal infections and, in the cases of the contamination victims, can cause meningitis. Epidural abscesses are often found in patients who have had invasive back surgery, bone infections of the spine or are intravenous narcotics users.

Epidural Abscess Symptoms

The symptoms of epidural abscess are back pain, fever, weakness and incontinence. This condition can lead to very serious complications, including brain damage, bone infection and even paralysis. It is very important to seek medical treatment at the first signs of epidural abscess, although because the abscess might not be evident at the surface of the skin detection might be difficult. However, anyone suffering persistent back pain, nausea and fever should visit their doctor.

Arachnoiditis Symptoms

Arachnoiditis is a swelling of the membranes surrounding the spinal cord. This painful condition occurs when certain bacteria, chemicals or viruses are introduced to the spine, and can also be triggered by trauma or spinal surgery. This condition causes burning pain in the legs and back, spinal numbness, muscle cramping, loss of bladder and bowel function and even, in severe cases, paralysis. Treatments can be long and difficult, and typically consist of pain management exercises and, sometimes, psychotherapy. Arachnoiditis is a chronic condition with symptoms that can be made less severe with treatments, but never totally eliminated. Surgery is not widely used due to the fact that relief is only temporary and the procedures are very dangerous.

Fungal Meningitis Symptoms

Fungal meningitis is an aggressive form of meningitis that attacks the membranes covering the spinal cord and brain. Symptoms include nausea, light sensitivity, stiff neck, severe headaches and fever. Although the symptoms for fungal, bacterial and viral meningitis are the same, fungal and bacterial meningitis are medical emergencies, whereas viral meningitis often doesn’t require medical treatment. It is critically important to seek medical attention at the onset of these symptoms so immediate treatment can be administered. Meningitis, when left untreated, might lead to seizures, stroke, brain damage and hearing loss.

Moving Forward

It isn’t easy, perhaps even impossible, to predict what further medical complications may arise from this catastrophe. Unfortunately, even after the disgraceful sloppiness of compounding pharmacies became known, it is still common for citizens to order pharmaceuticals online from dubious sources. Hopefully, this disaster will open up public awareness about medical treatment practice, and cause both doctors and patients to scrutinize the origins of their drugs.


Dr. Michael Omidi is a philanthropist, whose charitable organizations include Animal Support and No More Poverty, both of which he founded with his brother Julian Omidi.