April 29, 2013

Patients Warned to Stay Vigilant for Symptoms while Federal and State Regulators Investigate Operation of New England Compounding Center.

As of last evening, the death toll in the meningitis outbreak of 2012 had risen to 14. The number of people dead and sick has risen for 5 consecutive days, and there are now 170 reported cases of infection in 10 different states. Deaths from meningitis tainted steroid injections, prepared at the New England Compounding Center, have occurred in Virginia, Maryland, Tennessee, Michigan, and Florida. Cases of fungal meningitis from the tainted steroid injections have been confirmed in Idaho, Minnesota, North Carolina, Ohio, and New Jersey.  And this could just be the beginning.

The New England Compounding Center, the company responsible for putting the tainted steroid injections into the market place, produced and shipped 14,000 doses of the drug before the outbreak was discovered. Determining which patients received it, and whether their doses were contaminated, will be impossible. Therefore, the CDC has asked that all patients who received steroid injections remain vigilant in noticing signs and symptoms of meningitis for the next several months. The CDC has reported that this prolonged period of vigilance is necessary because the disease can have a protracted incubation period.

General information about the disease as reported by the CDC’s Dr. Todd Weber:

  • Fungal infection of the central nervous system has been confirmed in at least 25 patients, with the most common pathogen being exserohilum.
  • Historically, fungal meningitis is very rare, and exserohilum has not been seen previously as a cause of fungal meningitis.
  • That means this is new territory for public health and the clinical community.
  • In cases of confirmed fungal meningitis, the CDC is recommending routine empiric treatment protocols to cover the possibility of bacterial infection, with the addition of broad-spectrum antifungal agents for the fungus.
  • The CDC is recommending patients be treated with intravenous voriconazole (VFEND), preferably at a dose of 6.0 mg/kg every 12 hours, combined with daily intravenous liposomal amphotericin B, preferably at a dose of 7.5 mg/kg.
  • In cases where people have been exposed but remain without symptoms, the CDC is not recommending antifungal drug treatment, but patients should be monitored closely for the onset of symptoms, and a low level of suspicion should be employed for use of lumbar puncture to detect changes in the cerebrospinal fluid (CSF).

The New England Compounding Center

The facts coming to light in the wake of the meningitis outbreak paint the picture of a company more focused on profits than patient safety.  Since the outbreak, it has been discovered that the New England Compounding Center had been acting more like a drug manufacturer and less like a compounding pharmacy for years.

Dr. Madeleine Bionddillo, the Director of Massachusetts Bureau of Health, the State Agency with oversight responsibilities for the New England Compounding Center, told reporters that NECC’s shipment of mass produced steroid injections was in violation of the company’s license.  Massachusetts Governor Duval Patrick has stated that the New England Compounding Center was “acting more like a drug manufacturer” which was in clear violation of its license with the State.

The FDA’s Deputy Commissioner for Global Regulatory Policy has gone on record and stated that the New England Compounding Center was warned about this same behavior in 2006 in a letter for the FDA, and that the FDA has had its eye on the company for years.

The logical question then is: how was the New England Compounding Center allowed to keep sending drugs all over the country in violation of its license if State and Federal Regulators knew about it?

The Cochan Firm will represent the people and families so tragically affected by this senseless act of corporate malfeasance.  If you, or someone you know, needs our help, please contact us immediately. The first lawsuits have already been filed.