September 21, 2012: The Tennessee Department of Health notified the CDC that a patient developed meningitis about 19 days after being injected with an epidural steroid at a Tennessee ambulatory surgical center.
September 25, 2012: New England Compounding Center (NECC) in Framingham, Massachusetts, recalled three lots of preservative-free methylprednisolone acetate used in epidural steroid injections.
September 28, 2012: Investigators identified a case of meningitis outside of Tennessee, which alerted them of possible contamination of a widely-distributed medication.
October 1, 2012: The FDA began its inspection of NECC’s facility. Via microscope, investigators observed foreign particulate matter in an unopened vial of preservative-free methylprednisolone acetate.
October 3, 2012: NECC voluntarily shut down operations and expanded its recall to include all methylprednisolone acetate and other drugs pertaining to the spinal canal. NECC also surrendered its pharmacy registration to the Massachusetts Board of Registration and Pharmacy.
October 4, 2012: The FDA began further testing to identify the fungus causing the contamination.
As of this date, a total of 35 cases and five deaths were reported, and fungus was identified in specimens obtained from five patients.
– 25 cases and three deaths occurred in Tennessee
– one case occurred in Indiana
– one case occurred in North Carolina
– two cases occurred in Florida
– two cases and one death occurred in Maryland
– four cases and one death occurred in Virginia
The 23 states that received preservative free methylprednisolone acetate among the three recalled lots include: 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, Virginia, Texas, and West Virginia.
October 6, 2012: As a precautionary measure, NECC recalled all products made at and distributed from the compounding pharmacy.
October 7, 2012: The number of meningitis cases rose to 91, an increase of 27 people in one day, according to a Missouri news station.
October 8, 2012: Senator Richard Blumenthal of Connecticut wrote a letter to the FDA concerning the NECC fungal meningitis outbreak.
October 9, 2012: The Ohio State Board of Pharmacy suspended NECC’s distribution license in Ohio, saying the “company’s professional practice presented a danger of immediate and serious harm to others,” according to Boston.com.
Rep. John D. Dingell wrote a letter to the FDA concerning the NECC fungal meningitis outbreak.
Rep. Fred Upton and the Committee on Energy and Commerce wrote a letter to the CDC concerning the NECC fungal meningitis outbreak.
October 10, 2012: Boston.com reported 137 cases and 12 deaths among 10 states. Fox News reported one death in Florida, one in Maryland, three in Michigan, six in Tennessee, and one in Virginia.
NBC reported that two types of fungus have been identified per the CDC: one of 11 meningitis patients tested positive for the mold Aspergillus, and 10 tested positive for a black mold called Exserohilum rostratum.
Rep. Fred Upton and the Committee on Energy and Commerce wrote a letter to the FDA concerning the NECC fungal meningitis outbreak.
Congressman Edward J. Markey also wrote to the FDA concerning the outbreak.
October 11, 2012: NBC News reported 170 cases and 14 deaths, among 11 states.
Online sources also reported a confidential settlement between NECC and a widow whose 83-year-old husband died from bacterial meningitis in 2004 from a contaminated injection.
Late in the afternoon, Fox News updated the number of people at risk for developing fungal meningitis to 14,000, which is 1,000 more than previously thought. The number rose after speaking with health authorities, the CDC reportedly said.
According to the same article, the FDA has said that 50 vials of epidural steroid taken from NECC and other healthcare facilities has tested positive for meningitis-causing fungus.
The Chicago-Tribune reported that a Minnesota woman filed the first personal injury lawsuit against NECC. Barbe Puro claims to have suffered headaches and nausea after a September 17 epidural steroid shot. The chronic back pain sufferer is awaiting blood test and spinal tap results to see if she has fungal meningitis. Three people in her state have been confirmed to have it.
The paper also reported that the U.S. House of Representatives has asked NECC to outline its business practices and how this contamination occurred. The panel will be held no later than October 18.
October 12, 2012: U.S. Senators Bob Corker and Lamar Alexander wrote a letter to the FDA asking about its jurisdiction over compounding pharmacies and what it knows about NECC specifically, chattanoogan.com reported.
NECC cut 50 percent of its workforce, amounting to 40 employees.
October 14, 2012: CDC said the number of fungal meningitis cases rose to 205 among 14 states, according to Reuters. The death toll remained at 15.
Reuters also reported that a dozen emails showed that NECC violated Massachusetts law by selling drugs to clinics without asking for a list of patients’ names and prescriptions.
October 15, 2012: Per WLPN.org, NECC voluntarily surrendered its license in Tennessee, which has been the hardest hit state in the fungal meningitis outbreak with 53 cases and six deaths. The state department of health’s attorney reportedly said this is a permanent solution whereas board of pharmacy suspensions are temporary.
The CDC updated its tally of infections to 214 cases in 15 states. “Most have meningitis, but two have infections apparently caused by steroid injections in the joints, including the ankle,” NBC News reported.
According to an FDA advisory, the NECC contamination may now include the triamcinolone acetonide steroid injection, which is similar to the afore-linked methylprednisolone acetate injection, cardioplegic solution, which is used during open heart surgery, and, potentially, opthalmic products.
A lawsuit was filed in Tennessee on behalf of Robert and Janet Russell.
October 16, 2012: The FDA revised its October 15, 2012, announcement to state that only one heart transplant patient has developed fungal meningitis, not two.
Colette Rybinski, widow of first fungal meningitis outbreak victim Thomas Rybinski, filed a lawsuit in Tennessee against NECC. Rybinski died on September 29 after receiving an epidural steroid injection on July 30, according to The Tennessean.
Two New Jersey residents, Jennifer Marko and Brian Pennington, filed lawsuits against NECC, according to NBC News. Pennington was injected with the epidural steroid on September 10, and Marko was injected on September 19, but neither has contracted meningitis yet.
Michigan resident Brenda Bansale also filed a fungal meningitis lawsuit against NECC today.
Search warrants in hand, the FDA raided NECC’s facility, an FDA spokesman told evening news reporters.
The Ohio Department of Health has instructed 64 medical offices in the state to contact any patient who may have been injected with an NECC drug between May and October 3, when the compounding pharmacy shut down production. For a list of those clinics, please click here.
October 17, 2012: The Centers for Disease Control reported that 247 people are infected with meningitis and 19 people have died, according to NBC News.
An 80-year-old Virginia man, Basil Proffitt, has filed a $5 million lawsuit against NECC after becoming “deathly ill” with fungal meningitis. He was injected on September 12.
October 18, 2012: The CDC and FDA confirmed the presence of fungus Exserohilum rostratum in unopened vials of preservative-free methylprednisolone acetate (80mg/ml) taken from Lot #[email protected], BUD 2/6/2013.
New York reported its first confirmed case of meningitis, increasing the national total of cases to 254. The NECC fungal meningitis outbreak now spans 16 states and 20 people have died, according to the Chicago Tribune.
October 19, 2012: With North Carolina reporting its first death in the fungal meningitis outbreak, the CDC has raised the death toll to 23 and the number infected to 281.
The CDC also reported that voriconazole may be the most effective treatment for those who’ve been infected with Exserohilum or Aspergillus during the NECC fungal meningitis outbreak. According to the U.S. National Library of Medicine, voriconazole is an antifungal medication that comes in both tablet and liquid form and “slow[s] the growth of the fungi that cause infection.”
Unfortunately, the cure shares some of the same side effects as the fungal infection, including:
- vision problems such as blurriness or photosensitivity;
- chills; and
Anti-fungal medications may also cause kidney damage, according to fungal disease expert Peter Pappas, MD, who is reportedly advising the CDC during the NECC fungal meningitis outbreak.
For other adverse side effects, possible drug interactions, or what to do in case of an overdose, please click here.
Doctors do not recommend taking anti-fungal treatments as a preventative measure.
October 22, 2012: The CDC updated its tally to 294 cases of fungal meningitis. The number of deaths remained at 23 and the number of joint infections held steady at three.
The FDA issued a MedWatch safety alert in which it listed customer names and addresses that received NECC products on or after May 21, 2012. It quickly removed the lists from its website when it learned those lists contained incorrect information, the Detroit News reported.
Massachusetts Department of Public Health released over 1,000 pages of documents re: NECC and Ameridose infractions dating back a decade.
“Investigators recommended a formal reprimand,” NewsChannel5.com in Nashville, TN, reported. “But NECC’s lawyer argued that it would be bad for business.”
The compounding pharmacy had contamination problems in 2002 and 2003, including the epidural steroid injection that caused the 2012 fungal meningitis outbreak.
A 2006 independent review of NECC’s facility revealed “floors that had not been cleaned in three months,” according to NewsChannel5.
Tennessee Department of Health spokesman Woody McMillan told NBC News that Lot 6 of NECC’s epidural steroid infection “was the source of infection in the majority of our patients.” (See Oct. 23 note)
October 23, 2012: The CDC updated the fungal meningitis case count to 304 cases of fungal meningitis and four (knee, hip, shoulder, or elbow) joint infections. The number of deaths remained at 23.
Georgia reported its first case: a 66-year-old Macon woman with “very few symptoms, if any, of meningitis,” the Telegraph reported.
The Massachusetts Department of Health released “Preliminary Investigation Findings.” Since beginning its investigation September 26, 2012, it has found that:
- NECC did not wait for safety results from an outside lab before shipping Lots [email protected] (Lot 6 — see Oct. 22 note) and [email protected];
- NECC failed to sterilize products for the minimum 20 minutes required;
- NECC failed to test equipment;
- NECC failed to clean the compounding area and “this contamination may subsequently lead to contamination of compounded medications”;
- Floor mats were soiled;
- A leaking boiler caused a pool of water in the clean room where drugs were packaged.
This defective boiler “created an environment in which contaminations could have occurred,” Massachusetts health department official Madeleine Biondolillo told reporters.
For the Massachusetts Department of Public Health’s Preliminary Findings, click here (pdf).
October 24, 2012: After posting and quickly revoking a list of customer names and addresses that received NECC products on or after May 21, 2012, the FDA has released another list, per Dayton Daily News. That 345-page list of NECC customers and the products they received may be found here.
Late in the day, the CDC revised its fungal meningitis case count to 312. Five people now have joint infections, raising the total to 317. Another person has died, raising that total to 24.
A 16-year-old Indiana girl has also contracted fungal meningitis. CBS News said she began getting epidural steroid injections after a trampoline injury resulted in a herniated disk. After suffering a severe headache, nausea, and a stiff neck, her doctors confirmed that she has the illness.
Her mother told news station WSBT that she plans to file a fungal meningitis lawsuit against NECC for hospital bills, doctor bills, antifungal treatment prescriptions, and the time that she had to take off from work to care for her daughter.
October 25, 2012: Fungal meningitis infections climbed to 323 cases in 18 states, per NBC News. The number of joint infections and deaths did not change.
October 26, 2012: The FDA’s Department of Health and Human Services released FDA Form 483, its investigation of NECC, which it issued to NECC owner Barry J. Cadden.
According to an FDA press release, “The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations.”
Those conditions included:
- 83 vials of preservative-free methylprednisolone acetate (the epidural steroid injection responsible for the 2012 fungal meningitis outbreak) containing “greenish black foreign matter”
- 17 vials of epidural steroid contaminated with “white filamentrous material”
- “[G]reenish yellow discoloration,” “tarnished discoloration,” “dark particulate,” and “white, filamentrous substances” where sterilization was to take place
- Mold and bacteria in countless locations
- A leaking boiler and a wet floor “soiled with thick white debris and thick black, granular material” where equipment was prepared
For the FDA Investigation of NECC, click here (pdf).
October 27, 2012: The CDC reported 337 fungal meningitis cases, seven joint infections; and 25 deaths.
October 29, 2012: The CDC reported 347 fungal meningitis cases; seven shoulder, elbow, hip, or knee infections; and 25 deaths.
October 30, 2012: The CDC reported 356 fungal meningitis cases; seven shoulder, elbow, hip, or knee infections; and 28 deaths.
October 31, 2012: Countless news sources reported that, according to the CDC, the number of NECC-related deaths rose to 29 on Halloween. At 4 p.m., however, the CDC’s case count map noted that Virginia downsized its number of deaths from three to two.
Cases of fungal meningitis rose from 356 on Tuesday to 368 on Halloween. The number of shoulder, elbow, hip, or knee infections also rose from seven to nine. Nineteen of 23 states have been affected.
In yet another “precautionary measure” during the 2012 fungal meningitis outbreak, NECC’s sister company, Ameridose LLC, recalled all of its products. The Associated Press quoted Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, as saying, “We found there was not adequate assurance of sterility in their sterile products.”
For a complete list of products recalled by Ameridose, click here (pdf).
November 1, 2012: The CDC reported 377 cases of fungal meningitis; the number of joint infections remained at nine; and the number of deaths remained at 28.
The FDA reported lab results from three lots of NECC’s preservative-free injectable betamethasone and one lot of its cardioplegia solution.
Batches of betamethasone containing bacteria:
Batch of cardioplegia solution containing bacteria:
November 2, 2012: The CDC reported 395 cases of fungal meningitis. The number of joing infections and deaths remained the same.
The New York Times reported that fungal meningitis patients — particularly those in Michigan — and patients who did not contract the illness are developing internal abscesses where they were injected with NECC’s contaminated steroid. The main symptom is severe pain, according to writer Denise Grady. The abscesses may only be detected by an MRI.
Some patients are also developing arachnoiditis, “a nerve inflammation near the spine that can cause intense pain, bladder problems and numbness,” per the New York Times.
A Pennsylvania woman filed a fungal meningitis lawsuit against NECC; owner Gregory Conigliaro, pharmacist Lisa Conigliaro Cadden, and Douglas Conigliaro; sister compounding pharmacy Ameridose; and sales division Medical Sales Management.
Michele Erkan claims she contracted fungal meningitis 10 months before the NECC recall after receiving three epidural steroid injections, according to heraldonline.com.
November 5, 2012: The CDC updated its fungal meningitis case count map to 409 fungal meningitis cases, 10 joint infections, and 30 deaths. It also advised that it would not be updating the map until November 7, 2012.
The FDA sent a letter to Tennessee light therapy company the Avalon Effect for violating the Federal Food, Drug, and Cosmetic Act. The company reportedly stated on its website that its light therapy products may benefit fungal meningitis patients.
November 6, 2012: NECC’s license was suspended in Indiana. The state’s pharmacy board delivered a unanimous vote.
The House Energy and Commerce Committee has subpoenaed NECC co-founder Barry Cadden, since he told his lawyer that he would not appear voluntarily at a November 14 congressional hearing, according to the Associated Press. FDA Commissioner Margaret Hamburg, however, is planning to testify.
NECC pharmacists and pharmacy technicians have been banned from working in the compounding industry, according to the Boston Globe. The Massachusetts Board of Pharmacy released a letter stating that these NECC employees “may present an immediate or serious threat to the public health, safety, and welfare.”
Massachusetts Board of Pharmacy Director James D. Coffey has been fired, according to the Associated Press. Colorado’s pharmacy board reportedly complained to Coffey in July that NECC was shipping drugs in bulk, when compounding pharmacies are merely supposed to tailor individual prescriptions. The complaint occurred before NECC shipped its third lot of contaminated epidural steroid.
Coffey allegedly forwarded Colorado’s complaint to attorney Susan Manning, who also did nothing. She has been placed on administrative leave, per the AP.
Tennessee researchers have found that fungal meningitis outbreak patients tend to be women over age 60, epidural steroid patients who received more than one injection, and those who were injected with a vial of NECC’s contaminated steroid that was over 50 days old.
November 7, 2012: The CDC reported 414 fungal meningitis cases, 10 joint infections, and 31 deaths.
The lot numbers involved in the meningitis outbreak:
- Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #[email protected], BUD 11/17/2012
- Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #[email protected], BUD 12/26/2012
- Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #[email protected], BUD 2/6/2013
Patients could have been injected with these as far back as May 2012, according to online sources.
Meningitis-infected patients developed symptoms approximately one to four weeks after their epidural steroid injection. Symptoms include fever, new or worsening headache, nausea, and symptoms consistent with a basilar, or brainstem, stroke.
Some patients suffered only mild symptoms such as a new or worsening headache without fever or neck stiffness.
Sources: CDC, HAN, Google