As of today, Monday, there have been 271 confirmed meningitis cases, and 21 deaths, spanning 16 states, as reported by the U.S. Center for Disease Control and Prevention (CDC). This outbreak has been linked to contaminated vials of methylprednisone acetate, an injectable steroid used to treat back and joint pain. As we reported earlier this month, the steroids were made by New England Compounding Center in Framingham, Massachusetts and distributed to hospitals and medical clinics nationwide.
Sealed vials of the steroid contained Exserohilum rostratum, a fungus found in soil and plants. It is unclear how the fungus got into the sealed vials.
The CDC has confirmed 26 cases of Exserohilum meningitis, as well as one case each of Aspergillus and Cladosporium meningitis.
The New England Compounding Pharmaceuticals, Inc., which used the name ‘New England Compounding Center,’ has recalled all of its’ products and shut down operations this month.
Approximately 14,000 patients are believed to have received injections of the suspected contaminated steroids.
The Massachusetts Health Department reported that the company shipped 17,676 vials of the steroid methylprednisone acetate to 76 clinics in 23 states from July through September. The “potentially contaminated injections were given as early as May 21, 2012,” according to the CDC.
A compounding pharmacy, such as the New England Compounding Center who produced the tainted steroid medications, takes medications from pharmaceutical manufacturers and makes them into specific dosages and strengths to be used by doctors. Compounding pharmacies do not need Food and Drug Administration’s approval before their medications are sold and the agency has no jurisdiction over how products are manufactured or labeled for use.
Meningitis is an inflammation of the membranes covering the brain and spinal cord. Affected patients start showing a variety of symptoms as early as one week; the longest duration from the time of injection to the time of onset of symptoms in the current outbreak is 42 days, according to the CDC’s Dr. Benjamin Park. “But we want to emphasize that we don’t know what the longest will be,” he said. He stressed that patients who received injections of the recalled medication should stay attuned to the subtle symptoms “for months.”
Meningitis is diagnosed with a spinal tap (lumbar puncture), which draws cerebrospinal fluid from the spine to be inspected for signs of the disease. If detected, it is treated with high doses of intravenous antifungal medications.
The CDC reported that fungal meningitis is not contagious. Symptoms include fever, headache, nausea and neurological problems, consistent with deep brain stroke.
The steroid was sent to California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and West Virginia, the CDC said.
The FDA has informed the states which hospitals and clinics received products from the New England Compounding Center connected to the outbreak. The agency will list on its website the health-care providers that purchased any drugs from this company. Dr. Clark-Lynn, a spokeswoman for the FDA, said, “we have reason to believe they were working in all 50 states.”
It is believed that this nationwide meningitis outbreak is likely to cause a flood of lawsuits that could include physicians, health clinics, hospitals and others connected in any way with the contaminated medications, according to legal specialists.
At least a dozen lawsuits have been filed across the country by patients claiming to be infected with the tainted steroids from New England Compounding Center, accusing them of pharmacy malpractice, general negligence, breach of warranties and other wrongdoing.
There have been a couple of lawsuits filed, targeting physicians who injected patients with steroids from New England Compounding Center, alleging negligence and violation of product liability laws in that state.
The potential lawsuits involving affected patients nationwide can involve hundreds of millions of dollars in claims. So far, suits have been filed in both federal and state courts in Florida, Massachusetts, Michigan, Minnesota, New Jersey, Tennessee and Virginia.
The first nationwide class action was filed on Friday in U.S. District Court in Dallas by a patient who suffered headaches, nausea, dizziness and stiffness in her neck after she was treated in Michigan. The complaint contends that Texas is the most appropriate location to pursue all the claims stemming from the outbreak, because more than 100 Texas residents were injected with the steroid at the same Texas facility.
Some experts say that New England Compounding Center (or their insurer) may not be able to afford lawyers to handle the multiple cases and that they do not have the assets to pay all of the awards.
There is concern now that New England Compounding Center will file bankruptcy in the near future since they will never have enough money to compensate everyone affected.
It is anticipated that there will be many more cases reported, as symptoms present.
For a list of the facilities that received vials of the steroid from the infected lots can be found at the website cdc.gov.
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