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.
