Thousands of people have been harmed by drugs made by New England Compounding Center (NECC). The serious injuries include fungal meningitis, stroke and paraspinal/spinal infections. To date, most of the illnesses are from NECC methylprednisolone acetate (MPA): 510 infections and cases of stroke, 360 of them meningitis, 8 stroke, 128 spinal/paraspinal infections, 14 peripheral joint infections. The CDC and FDA found fungus, Exserohilum rostratum, in implicated lots of NECC MPA.
Meningitis was the initial spinal infection (of the meninges membrane) diagnosed in this outbreak. For several weeks patients have also been diagnosed with spinal and paraspinal infections, all of them at or near the NECC injection site. Some of these patients also had meningitis. We are also getting contacted by patients who were given shots of other NECC drugs, including triamcinolone, which the CDC has linked to illness. Both bacteria and fungus have been found in NECC triamcinolone.
The 128 CDC-confirmed paraspinal/spinal infections include the following:
- Epidural abscess
- Vertebral osteomyelitis
The states with confirmed NECC paraspinal/spinal infection patients includes the following: Florida (2), Indiana (7), Maryland (1), Michigan (102), Minnesota (2), New Jersey (1), New York (1), Ohio (1), Rhode Island (1), Tennessee (8) and Virginia (2). Most of these cases are epidural abscess.
Diagnosis of Spinal and Paraspinal Fungal Infection
In most of these fungal infection cases, it is important to diagnose and treat the infection quickly. If left untreated, there may be permanent damage to tissue or bone or the patient may die. The problem is that they may be difficult to diagnose.
Although patients with these localized paraspinal/spinal infections frequently have new or worsening back pain, symptoms may be mild or clinically difficult to distinguish. Based on current information, CDC recommends the following diagnostic protocol:
- In patients with new or worsening symptoms at or near the injection site, physicians should obtain an MRI with contrast of the symptomatic area(s), if not contraindicated. This recommendation also applies to patients being treated for meningitis. In some cases, radiologic evidence of abscess or phlegmon has become apparent on repeat MRI studies performed subsequent to an initially normal imaging procedure. Clinicians should therefore have a low threshold for repeat MRI studies in patients who continue to have symptoms localizing to the site of injection, even after a normal study. However, the optimal duration between MRI studies is unknown.
- CDC has received reports of patients being treated for fungal meningitis who had no previous evidence of localized infection at the site of injection, but who were subsequently found to have evidence of localized infection (e.g., epidural abscess, phlegmon, discitis, vertebral osteomyelitis, or arachnoiditis) on imaging studies. Therefore, in patients being treated for meningitis, even in the absence of new or worsening symptoms at or near the injection site, clinicians should strongly consider obtaining an MRI of the injection site approximately 2-3 weeks after diagnosis of meningitis. Early identification of new disease may facilitate additional specific interventions (e.g., drainage) and provide information for measuring effectiveness of therapy thereafter.
- For patients demonstrated to have epidural abscess, phlegmon, discitis, vertebral osteomyelitis, or arachnoiditis, early consultation with a neurosurgeon to discuss whether surgical management, including debridement, is warranted in addition to antifungal therapy. Debridement is surgery to remove any dead tissue.
Attorneys Fred Pritzker and Ryan Osterholm are leading our NECC litigation team as we file lawsuits against NECC and others.