Our Chicago medical malpractice lawyers urge consumers to be wary about drugs that come from compounding pharmacies, in light of the growing meningitis outbreak. A recent The New York Times article elaborates on the neglect shown by New England Compounding Center that led to the deadly outbreak.
Legal experts say that the lax rules regulating compounding pharmacies
contributed to the sale of about 18,000 vials of a dangerous drug to pain
clinics in more than 20 states.
Health officials say the vials may have been contaminated with a fungus.
It appears that a Kentucky judge fell victim to the fatal fungus. He suffered serious neck pain following a car accident and turned to to spinal injections with a steroid medicine for relief. Unfortunately, the judge died just a few weeks ago and is believed to be one of the earliest victims of the widening meningitis outbreak.
One legal question surrounding this topic is how such a dangerous oversight could happen when reputable doctors and hospitals were involved. It could be that certain doctors and clinics are avoiding expensive drug manufacturers and turning to compounding pharmacies that can offer the drugs at lower prices. These compounding pharmacies mix their own combinations of drugs with much less federal supervision than big drug manufacturers have to undergo.
The Massachusetts compounding company that is believed to be responsible for the meningitis outbreak has a history of safety violations. Six years ago, health inspectors found that the company illicitly manufactured a standardized anesthetic topical cream and improperly repackaged a drug. It even told physicians that the name of an office staff member was enough to place an order, in spite of rules calling for a prescription for a specific patient.
Federal officials recently said that all patients who were given the steroid drug injection manufactured by New England Compounding need to be traced immediately and made aware of the risk.
A New Hampshire medical practice purchased the suspicious injectable steroid from the drug maker when its regular supplier had no stock. The CEO of the company said that he preferred compounding pharmacies because they are able to manufacture drugs without the kind of alcohol that larger drug makers frequently use as a preservative.
Approximately 186 of this medical practice’s patients were treated with the suspicious injection that may have been contaminated with fungus. Of those, approximately two dozen experienced symptoms that be tied to a meningitis diagnosis.
Even before the connection to meningitis, spinal injections were associated with other rare but severe side effects, such as nerve damage, strokes and paralysis. Though the steroids have been FDA approved for treating joint inflammation, they did not get the green light from the FDA for epidural injections close to the spinal cord.
A study published in the journal Spine points out that less than half of
the steroid injections were administered for the conditions for which
they were supposed to be most beneficial. These conditions include pain
radiating into the arms or legs and herniated discs.
Since compounding manufacturers do not have to abide by the same FDA rules as their large scale counterparts, this opens the door for serious health violations. The type of meningitis tied to this outbreak is difficult to treat and can cause strokes or death.
It is a crime to place an unapproved drug in the stream of commerce. Many innocent patients treated with contaminated drugs suffered serious physical injuries and even death. Even more meningitis cases are expected, and will require the assistance of a rare meningitis lawyer.