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Thousands Exposed to Meningitis-Linked Steroid Injection. Feds Call for Increased Regulation of Drug Compounding Industry

The fungal meningitis outbreak resulting from steroid injections has been all over the news for the past week or so. The steroids were apparently contaminated at the New England Compounding Center.

Here are links to many stories on this growing tragedy, compiled by the American Association for Justice:

The AP (10/12) reports, “A Minnesota woman who may have received tainted steroid injections blamed for the nationwide outbreak of fungal meningitis sued the drug seller on Thursday, though she hasn’t been diagnosed with the rare illness.” According to the AP, the suit “alleges that Barbe Puro suffered headaches and nausea after receiving injections in her neck to ease chronic back pain in September, but she believed the symptoms weren’t abnormal. She said she was later contacted by the Minnesota Department of Health, informing her that she may have received contaminated shots sold by the New England Compounding Center.” The story also notes that this Federal lawsuit against the New England Compounding Center seems to be the first lawsuit arising from the current meningitis outbreak, although more such suits are expected in the future.

Meningitis outbreak rises to 170 cases, 14 deaths. The latest meningitis outbreak update from the US Centers for Disease Control and Prevention resulted in widespread media coverage, with most news outlets noting that Idaho became the first Western state to report the disease.

ABC World News (10/11, story 6, 0:50, Sawyer, 7.43M) (10/11, story 6, 0:50, Sawyer) reported, “In the ongoing story of that meningitis outbreak, the cases are not just growing, but leaping.”

The CBS Evening News (10/11, story 5, 2:40, Pelley, 5.58M) (10/11, story 5, 2:40, Pelley) reported, “We got word today from the Centers for Disease Control that 14,000 people may have received the tainted steroid shots that have sometimes led to meningitis. Idaho has become the 11th state to report an infection. There are now 170 cases and 14 people have died.”

The Los Angeles Times (10/12, Muskal, 629K) (10/12, Muskal) “Nation Now” blog reports that the CDC “said 11 states now have cases and that Idaho, the first Western state, has been added to the list. Other states that have reported cases are Florida, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Tennessee and Virginia.”

USA Today (10/12, Alcindor, 1.78M) (10/12, Alcindor) adds that the latest deaths occurred in “Florida and Indiana, states which had already been listed as affected by the controversy.” In addition, meningitis “victims have died in six states: six in Tennessee, three in Michigan, two in Florida and one each in Maryland and Virginia.”

Also covering the CDC update are the Minneapolis Star Tribune (10/12, Stoxen, 328K) (10/12, Stoxen), the Baltimore Sun (10/12, Cohn, 202K) (10/12, Cohn) “Picture of Health” blog, the Indianapolis Star (10/12, Rudavsky, 190K) (10/12, Rudavsky), the York County (ME) Coast Star (10/12, McCord) (10/12, McCord), the Boston Globe (10/12, Wallack, Kowalczyk, Lazar, 228K) (10/12, Wallack, Kowalczyk, Lazar), the Boston Globe (10/12, Finucane, 228K) (10/12, Finucane) “MetroDesk” blog, the Fox News (10/12, Serrie) (10/12, Serrie) website, HealthDay (10/12, Reinberg, Steele) (10/12, Reinberg, Steele), MedPage Today (10/12, Neale) (10/12, Neale) and Medscape (10/12, Brooks) (10/12, Brooks).

Contaminated steroid not limited to back pain shots. The AP (10/12, Neergaard) (10/12, Neergaard) reports that of all but one of the 170 people “have a rare fungal form of meningitis after receiving suspect” steroid (methylprednisolone acetate) injections “for back pain.” The CDC said an “ankle infection” from the tainted injection was confirmed in Michigan.

On its website, CBS News (10/12) (10/12) reports that officials on Thursday said patients who “received a steroid shot in their joints may present signs of infection at the injection site if they were given the same contaminated injections” tied to the meningitis outbreak.

Dow Jones Newswire (10/12, Dooren, Subscription Publication, 2.08M) (10/12, Dooren) adds that FDA officials on Thursday announced that agency investigators have found fungus growing in at about 50 vials of the steroid compound. They said pending tests results would give them a better idea on where the contamination originated.

The AP (10/10, Stobbe) reports that the “number of people sickened by a deadly meningitis outbreak has now reached 119 cases, including 11 deaths,” according to updates the Centers for Disease Control and Prevention posted online Tuesday. New Jersey was the “10th state to report at least one illness”; and the other states with meningitis cases tied to the tainted steroid shots include “Tennessee, Michigan, Virginia, Indiana, Florida, Maryland, Minnesota, North Carolina and Ohio.”

USA Today (10/10, Alcindor, Szabo) says the CDC update indicates meningitis “victims have died in four states: six in Tennessee, three in Michigan, and one each in Maryland and Virginia.”

Bloomberg News (10/10, Edney) adds that of the 119 reported cases, “39 were in Tennessee, 25 in Michigan and 24 in Virginia.” CDC spokesperson Curtis Allen said Tuesday that the majority of the estimated “13,000 people” who were administered the potentially contaminated steroid injection “will not get sick.” But Allen noted that the agency still “expects more infections” tied to the tainted shot.

The Los Angeles Times (10/10, Muskal) says Federal health officials “have tied the meningitis outbreak to vials of steroids” produced by the New England Compounding Center (NECC) in Framingham, Massachusetts. CDC and Food and Drug Administration “officials said the steroid injections were used to combat back pain”; and an FDA inspection “discovered that at least one vial of the steroid had been contaminated by a fungus.”

ABC News (10/10, Moisse) on its website notes that the outbreak of “aspergillus meningitis has been linked to an injectable steroid, called methylprednisolone acetate,” produced by the NECC. The DC’s Foodborne, Waterborne, and Environmental Diseases Division’s Medical Officer, Dr. Benjamin Park, said that “If patients are concerned, they should contact their physician to find out if they received a medicine” from one of the recalled lots. Dr. Park said that most of the meningitis cases are occurring in “older adults,” who, aside from back pain, are otherwise healthy. According to the CDC, 76 healthcare facilities and pain clinics “in 23 states” received the methylprednisolone acetate lots that are now under recall.

The Boston Globe (10/10, Kowalczyk) in its “White Coat Notes” blog reports that the CDC “said hospitals and doctors should contact patients who received injections for low back pain from three lots of preservative-free methylprednisolone acetate (80mg/ml),” which the NECC recalled on Sept. 26. The CDC also “moved back the time frame that caregivers began giving the potentially contaminated injections to May 21″; previously, the agency “said the injections began in July.”

NBC News (10/10, Aleccia) in its “Vitals” blog notes that the NECC “has closed voluntarily, relinquished its state license and recalled its products, which include steroids, painkillers and dozens of other drugs,” according to the FDA. The agency determined fungus was growing in “at least one sealed vial” of the drug. NBC noted that although the FDA “does not regulate” compounding pharmacies, it its often “called in when contamination is suspected.”

ABC World News (10/8, story 4, 0:30, Sawyer) reported, “Now we move to the outbreak of meningitis: 105 confirmed cases now in 9 states; and at least eight people have died.”

The CBS Evening News (10/8, lead story, 3:00, Pelley) reported, “Today Federal officials estimated 13,000 Americans received steroid injections that may have been contaminated with a potentially lethal fungus.” CBS (LaPook) added, “The Centers for Disease Control believes the majority will not get sick; and Dr. William Schaffner agrees.” LaPook explained that Dr. Schaffner “has been tracking the outbreak at the Vanderbilt University Hospital in Nashville.” Dr. Schaffner was shown saying: “If there’s a bit of a silver lining in this dark cloud it’s that apparently the attack rate, the proportion of people actually developing an infection, is very small. It’s really about 1% or less.”

Bloomberg News (10/9, Edney, Hart) reports that the Food and Drug Administration linked the meningitis outbreak to contaminated methylprednisolone acetate injection produced by the New England Compounding Center (NECC) in Framingham, Massachusetts. The NECC issued a statement Monday, saying it is “cooperating with probes” underway by the both the FDA and the CDC.

ABC News (10/9, Lupkin, Moisse) on its online Health page notes that the FDA linked the meningitis outbreak to aspergillus fungi in a “sealed vial of the steroid” at the NECC. However, the FDA’s Center for Drug Evaluation and Research Office of Compliance Acting Director Dr. Ilisa Bernstein said the agency is still “in the process of further identifying the fungal contaminate. Our investigation into the source of this outbreak is still ongoing,” Dr. Bernstein emphasized.

CNN (10/9, Cohen, Falco) on its website adds that the NECC “said that the new recall was being announced out of an abundance of caution and that there is no indication any of its other products are contaminated.” Previously, the FDA “asked doctors, clinics and consumers to stop using any of the pharmacy’s products”; and on Oct. 3, the NECC “voluntarily surrendered its license to operate until the FDA investigation into the contamination is complete.” In the meantime, the agency is “urging anyone who has experienced problems following an injection with the NECC product to report it to MedWatch.”

According to Reuters (10/9, Ghianni), Federal health authorities and the Massachusetts Department of Health said that from May to September, the NECC shipped three lots of potentially contaminated methylprednisolone acetate injections to 76 pain clinics and other healthcare facilities in 23 states. The CDC estimates about 13,000 patients could have received the tainted injections of methylprednisolone acetate for back or neck pain.

The New York Times (10/9, A14, Grady, Subscription Publication) says Federal health officials estimate of “how many people were injected with any of the 17,676 doses shipped around the country, is based on reports from state health departments and clinics” that used methylprednisolone acetate. Meanwhile, the NECC has “shut down, surrendered its license and recalled all its products, not just the steroid.” At present, it is “not known if all the vials of medicine in the implicated lots were contaminated with the disease-causing fungus, or if everyone exposed to it will become ill,” but CDC spokesperson Curtis Allen “predicted that most exposed people would not become sick.”

On its front page, the Boston Globe (10/9, A1, McCabe) adds that the NECC shipped the potentially tainted injections to “facilities in 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,” according to the CDC.

The Washington Post (10/9, Sun, Somashekhar) reports that the CDC’s update indicates “105 cases of meningitis linked to the injections have been reported”; and 23 of the 105 cases are in Virginia; and “one person has died” in Virginia.

In continuing coverage, several news entities noted that the meningitis outbreak has prompted state and Federal lawmakers to call for calling for stronger government oversight of compounding pharmacies.

On NBC Nightly News (10/8, story 4, 2:20, Williams), NBC (Costello) reported, “As demand for the less expensive drugs has grown, so has the amount of companies who mix medications from 5,000 in 2009 to 7,500 in 2012. The compounders are regulated by states, not the FDA.” Former FDA Chief Counsel Sheldon Bradshaw was shown saying, “It is hard to know whether…there are no risks with these compounded drugs, because they’re under no obligation to report them to the FDA.”

In a front-page story, the Wall Street Journal (10/9, A1, Martin, Burton, Dooren, Subscription Publication) reports that at present, Federal, state and state pharmacy boards have a part in regulating specialty pharmacies, but their drug products are not subject to the strict FDA approval process. But as the outbreak widened Monday, Rep. Ed Markey (D-MA) sent a letter to FDA Commissioner Margaret Hamburg, MD, calling for the agency to have a greater role in overseeing compounding facilities. The Journal quotes Rep. Markey as saying in the letter, “Compounding pharmacies currently fall into a regulatory black hole.”

The Financial Times (10/9, Rappeport, Subscription Publication) quotes the FDA’s Office Of Unapproved Drugs And Labeling Compliance Director Kathy Anderson as saying, that at present, “Compounding drugs are not approved by FDA and they don’t undergo that same premarket approval” process that “FDA-approved drugs do.”

Reuters (10/9, Morgan, Begley), noting that specialty pharmacies do not have to prove the safety and efficacy of the drug formulations they compound, says US Sen. Richard Blumenthal (D-CT) called for the FDA to the obtain full oversight of the industry. Reuters quotes Sen. Blumenthal saying that the compounding industry’s present “relative immunity from standards of safety and effectiveness seems anomalous and unacceptable.” Notably, Reuters points out that Blumenthal is a member of the Senate Committee on Health, Education, Labor, and Pensions, which supervises the FDA’s jurisdiction.

CBS News (10/9) on its website posts a video of Vanderbilt University Medical Center Chair Dr. William Schaffner calling for “more government regulation” of compounding pharmacies on “CBS This Morning.” According to the International Academy of Compounding Pharmacists, there are “7,500 compounding pharmacies” in the US, “representing 3 percent of prescriptions filled,” and gaining “$3 billion” in revenue, annually. “They seem to have fallen into a regulatory gap. That’s something that really needs to be addressed by the Congress,” Dr. Schaffner stressed. “I really think that going forward we need to have a regulatory structure that doesn’t permit this [meningitis outbreak] to happen,” he added.

Meanwhile, the AP (10/9) reports that the Massachusetts Legislature’s Public Health Committee Chair Rep. Jeffrey Sanchez “says legislative leaders are monitoring the latest developments from the federal Food and Drug Administration and Massachusetts Department of Public Health. The Boston Democrat said Monday he’s hasn’t ruled out the possibility of public hearings, but said right now he has more questions than answers.” Sanchez explained that if “there is some action Massachusetts lawmakers can do to tighten state regulations, he wants to make sure he has all the information he needs before making any recommendations.”

The Boston Herald (10/9, Cassidy, Remal) adds that on Monday, Massachusetts Secretary of Health and Human Services JudyAnn Bigby issued a statement saying, “Our joint response and investigation with the FDA will continue until we have all the answers and information we need to determine what if any regulatory changes need to be made at the state and federal level.”

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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