A deadly fungal meningitis outbreak continues to sweep across the country. A CDC and FDA investigation has confirmed that the outbreak of a rare form of fungal meningitis is directly linked to contaminated epidural steroid injections produced by the New England Compounding Center (NECC), in Framingham, Mass. The outbreak stems from three lots of contaminated methylprednisolone acetate steroid injections, which were recalled in September. Now, the company has completely shut down all operations and has recalled all products that were compounded and distributed from its facility in Framingham, Mass. The FDA recommends that health care professionals and consumers not use any product that was produced by NECC at this time. Over 270 people across 16 states have been diagnosed with fungal meningitis linked to the contaminated injections. At press time there had been 23 deaths reported.
Fungal meningitis is an infection of the protective membranes of the brain and spinal cord. Symptoms of fungal meningitis include fever, new or worsening headache, sensitivity to light, stiff neck, new weakness or numbness in any part of the body, slurred speech, and increased pain, redness, or swelling at the injection site. In some patients affected by the current outbreak, fungal meningitis has invaded blood vessels and caused strokes. According to the CDC, the onset of symptoms in most patients has occurred from one to four weeks after receiving the infected epidural steroid injection. However, longer and shorter periods between the injection and the onset of symptoms have been reported, in some instances up to 42 days later. A CDC spokesman emphasized that patients who received injections of the recalled drug should be cautious of subtle symptoms for months, as the potential length of the dormancy period is still unknown. Patients who are experiencing any of these symptoms and are concerned about whether they received a contaminated injection should contact their doctor immediately. The CDC is encouraging physicians to contact patients who have received an injection using any of three contaminated lots that were distributed to clinics in 23 states beginning May 21, 2012. The CDC has emphasized that fungal meningitis cannot be transmitted from human to human.
Fungal meningitis can be diagnosed through a lumbar puncture, which draws cerebrospinal fluid from the spine that can be tested for signs of the disease. If fungal meningitis is detected, it can be treated with strong antifungal medications. Officials are warning that early treatment is vital. While the length of treatment is currently unknown, the CDC and FDA are advising physicians that patients may need months of treatment. The majority of reported cases have occurred in patients who received spinal epidural injections of the recalled steroid injections. However, joint infections have also occurred in patients receiving the contaminated injections in peripheral joints to treat ankle, knee, and shoulder pain.
NECC, the company that produced the contaminated injections, continues to be at the center of this ongoing controversy. NECC is a compounding pharmacy, which dilutes, mixes, and prepares drugs into formulations not typically available from actual pharmaceutical manufacturers. Compounding pharmacies, such as NECC, are only permitted to make medications based on specific prescriptions for individual patients. They are not allowed to manufacture and distribute drugs on a large scale. Compounding pharmacies like NECC are not subject to full FDA regulations like traditional drug manufacturers. Instead, they are licensed and regulated by state law.
It seems very obvious that NECC misled regulators and performed work beyond the scope of its state license. NECC violated Massachusetts state law by producing and distributing large quantities of the contaminated steroid injections linked to the current fungal meningitis outbreak. The Massachusetts Department of Public Health, the CDC, and the FDA are currently investigating NECC, while dealing with the ongoing outbreak. Several states have revoked NECC’s state pharmacy license, while NECC voluntarily surrendered its Massachusetts license. Another drug company with the same owners, Ameridose LLC, has temporarily stopped its compounding and manufacturing operations while its facilities are being inspected by regulators.
NECC is now facing lawsuits related to the fungal meningitis outbreak in Minnesota, Michigan, Tennessee, Virginia, and Indiana. Additionally, the officers behind NECC are being targeted in a lawsuit that seeks to freeze their personal assets during pending litigation. The lawsuit filed in a state court in Boston attempts to pierce the corporate veil and go after the individuals behind NECC. This is not the first time NECC has been sued over its steroid injections. In 2004, a widow sued NECC claiming that her husband was infected with bacterial meningitis by a tainted steroid injection from the company in 2002 and died as a result. NECC settled the lawsuit through a confidential agreement. As the number of people infected with fungal meningitis during the current outbreak continues to rise, NECC is expected to face more legal action.
The full extent of this deadly outbreak is currently unknown, as new cases are being reported daily. Potentially contaminated steroid vials were sent to 76 facilities in 23 states, with an estimated 14,000 people receiving the injections before the recall. The states with clinics that received these contaminated injections are California, Nevada, Idaho, Texas, Minnesota, Illinois, Indiana, Michigan, Ohio, Tennessee, Florida, Georgia, South Carolina, North Carolina, Virginia, West Virginia, Maryland, Pennsylvania, New Jersey, New York, Connecticut, Rhode Island, and New Hampshire. According to Alabama health officials, 44 facilities in Alabama received medications from NECC, but none of these medications are believed to be contaminated with the infection.
Although no contaminated injections were sent to Alabama, 19 Alabamians were exposed to potentially contaminated injections by way of medical procedures performed in Tennessee and Florida. One Alabama man who received the injections in Florida has died within the last month. Officials are awaiting autopsy results to establish the cause of death. Five of the other 18 Alabamians are showing possible symptoms, while 12 have shown no symptoms and one person has not been contacted. If you need more information relating to this matter, contact Melissa Prickett or Chad Cook, both lawyers in our firm’s Mass Torts Section, at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com or Chad.Cook@beasleyallen.com.
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