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.

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.

Meningitis Regulatory Failures

FOIA Reveals Compounding Pharmacies Supplied Thousands of Tainted Vials

Documents that were recently released in response to the Freedom of Information Act revealed that the compounding pharmacy that supplied thousands of tainted vials of methylprednisolone acetate had thwarted or side-stepped Food and Drug Administration attempts to regulate its practices for more than ten years. It was also revealed that the efforts that were made by the agency were ineffective, since regulatory jurisdiction of compounding pharmacies lies with the states, not the federal government.

The documents show that the compounding pharmacy, New England Compounding Center in Massachusetts, would frequently refuse to release documents to the FDA, continue to distribute drugs that were under investigation and often refute the legal authority of the FDA to regulate it. There are examples of the compounding center pharmacists willfully giving inspectors false information and concealing the fact that unapproved drugs were being supplied. After becoming aware that the New England Compounding Center was distributing an unapproved eye surgery dye called trypan blue, the FDA inspectors were told that there was none in stock. However, a supply was later found in the clean room of the facility. The chief pharmacist told the agency that NECC would continue to distribute trypan blue, and the FDA had no legal authority to stop it.

There were warnings of potential health risks from the practices of the New England Compounding Center as far back as 2002, and according to a memo summarizing a meeting held with Massachusetts regulators, there was a “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”

The FDA, however, often failed to act upon its findings in a timely manner. One inspection didn’t result in a report until nearly two years later, when many of the practices that were cited were no longer in operation.

Because compounding pharmacies were never meant to act as national drug manufacturers, there are no actions or regulations in place to govern them. Compounding pharmacies exist in order to provide physicians with specially mixed medications by request; they are not supposed to manufacture drugs for mass distribution, but that is exactly what many of these companies are doing. In order for a compounding pharmacy to come under the jurisdiction of the federal government, it must be proven that the pharmacy is actually manufacturing drugs, but since these pharmacies are legally able to withhold their own records, proof is very difficult to obtain. Drug manufacturers are heavily regulated by the Food and Drug Administration—they must periodically submit to inspections, provide detailed documentation and only distribute drugs that have been approved. Compounding pharmacies are not bound by any of these regulations.